Complexities and Variations in

Pharmaceutical Therapy for Cancer:

Next steps toward achieving quality care
Editorial Advisory Board
Richard J. Boxer, MD, FACS
Clinical Professor, Health Policy and
Family and Community Medicine
Medical College of Wisconsin
Milwaukee, WI
and
Clinical Professor, Urological Surgery
University of Wisconsin Medical School
Madison, WI
Albert M. Brady, MD, FACP
Medical Director, Oncology Services
St. Joseph Mercy Oakland
Pontiac, MI
Robert W. Dubois, MD, PhD
Chief Executive Officer
Protocare Sciences
Santa Monica, CA
Paul A. Godley, MD, PhD, MPP
Associate Professor of Medicine
Division of Hematology and Oncology
University of North Carolina
Chapel Hill, NC
Bruce E. Hillner, MD
Professor of Medicine
Department of Medicine
Medical College of Virginia
Virginia Commonwealth University
Richmond, VA
Deborah Y. Kamin, PhD Pearl B. Moore, RN, MN, FAAN
Director, Public Policy Chief Executive Officer
American Society of Clinical Oncology Oncology Nursing Society
Alexandria, VA Pittsburgh, PA
Kathleen N. Lohr, PhD
Chief Scientist, Health Services Janice H. Platner, JD
and Policy Research Director of Administration and Programs
Research Triangle Institute National Breast Cancer Coalition
Research Triangle Park, NC Washington, DC
and
Adjunct Professor, Health Policy
and Administration
School of Public Health
University of North Carolina Martin Raber, MD
Chapel Hill, NC Senior Vice President, Strategic and
Business Planning
M.D. Anderson Cancer Center
The University of Texas
Houston, TX
Jennifer Malin, MD
Clinical Instructor
UCLA Division of Hematology
and Oncology
Los Angeles, CA Ellen L. Stovall
and Executive Director
Consultant National Coalition for Cancer Survivorship
RAND Silver Spring, MD
Santa Monica, CA
Rodger J. Winn, MD
LaMar McGinnis, MD, FACS Consultant
Senior Medical Consultant Oncology Program Management
American Cancer Society Houston, TX
Atlanta, GA
William T. McGivney, PhD
Chief Executive Officer
National Comprehensive Cancer Network
Rockledge, PA
Executive Summary
R
ecent reports have addressed problems with the qual-
ity of cancer care. Although insufficient information
has hindered assessment of pharmaceutical aspects of
such care, limited available data suggest that under-
use, overuse, and variations in use of curative and palliative
agentsa exist. For example, pain medication is underutilized in
palliative care for cancer patients,1,2 and the National Cancer
Policy Board recently concluded that many postmenopausal
women do not appear to be receiving indicated adjuvantb
chemotherapy and hormone therapy for breast cancer.3 Thus,
recent evidence of inappropriate usec of pharmaceuticals in can-
cer care represents one compelling reason to explore the quali-
ty of such care and factors that limit its provision.
Tremendous advances in science have yielded improved can-
cer treatments. New pharmaceutical products offer the poten-
tial for improved survival and quality of life. Yet concern
exists that these treatments are not being optimally applied.
Health insurance–related issues (e.g., lack of insurance, cov-
erage restrictions), poor patient-provider communication,
and insufficient provider knowledge can restrict patient
access to these products.3 Conversely, the desire for a cure,
reimbursement issues, and confusion about standards of care
raise the potential for unnecessary or excessive care.5–8 The
slow translation of new knowledge into clinical practice is
reflected by surveys evaluating provider knowledge and prac-
tice patterns (e.g., Hatzell et al9 and McFall et al10), including
those demonstrating low or variable compliance with oncolo-
gy clinical practice guidelines (e.g., Bennett et al8). These find-
ings, coupled with the high morbidity and mortality associa-
ted with cancer, constitute another compelling reason to
explore and optimize pharmaceutical treatment for cancer.
Advance the Measurement of Quality and
Reporting Relevant to Pharmaceutical Care
An important means of optimizing pharmaceutical care for
cancer is enhancing the assessment of such care. Factors that
have limited quality assessment of pharmaceutical care for
cancer include a lack of consensus in defining quality phar-
maceutical care, insufficient valid measures of quality,d and
the absence of information about current prescribing and
drug use patterns.12–13 Although limited data indicate that
some pharmaceuticals are underused or overused in cancer
care, the most common finding is variations in use according
a
These agents include cytotoxic antineoplastics, hormones, biological therapies (e.g., biological response modifiers, colony-stimulating factors), miscellaneous antineoplastics, and supportive
agents (e.g., analgesics, antiemetics).
b
Adjuvant therapy refers to additional drug or other treatment (e.g., radiation therapy) designed to enhance the effectiveness of the primary therapy. In this example, adjuvant therapy refers to
chemotherapy and/or hormone therapy following breast-conserving surgery for breast cancer.
c
Chassin4 has defined poor-quality care using an overuse/underuse/misuse construct in which overuse refers to provision of a service when the risk exceeds the potential benefit and underuse
refers to failure to provide an effective services when it would have produced a favorable outcome.
d
Quality measures are standardized measures of quality used in quality assessment. They may assess provider and health care characteristics (structural quality), providers’ actions on behalf
of their patients (process quality), or the outcomes of these services in terms of the patients’ health and well-being (outcomes).3,11
e
Variations in patterns of care (e.g., rates of drug utilization) may or may not be indicative of poor-quality care.12 More rigorous assessment refers to evaluating quality by systematic reference
to objective standards (explicit review).
Complexities and Variations in Pharmaceutical Therapy for Cancer
to factors such as patient characteristics (e.g., age, ethnici-
ty),2,14–16 provider characteristics (e.g., specialty, professional
affiliations),17 and insurance type (e.g., Mortenson et al18). As
factors such as patient preferences, comorbidities, and treat-
ment side effects influence treatment decisions, more rigorous
assessmente is needed to determine the significance of such
variations. Other factors that complicate assessing the quality
of pharmaceutical care for cancer include gaps in knowledge
about certain aspects of care (e.g., transition from curative to
end-of-life care), as well as the tendency to avoid publishing
examples of negative outcomes or unnecessary care.19
Recommendations:
■ Seek research funding from public and private sources (e.g.,
government, pharmaceutical industry) to:
• Clarify standards and components of quality pharma-
ceutical care for cancer;
• Construct, test, and implement quality measures speci-
fically relevant to pharmaceutical care (e.g., appropriate-
ness of regimen, dose, and use of adjunctive therapies;
cost-effectiveness; associated patient functional capacity
and quality of life);
• Develop comparative databases that contain current
information about drug prescribing and use patterns;
• Carry out Phase IV-V studies to see how drugs are being
used in clinical practice, if they are used in accordance
with FDA-approved indications, and whether evidence
of underutilization or overutilization exists; and
• Carry out studies that assess the influence of system and
provider factors on the quality of pharmaceutical care for
cancer and fill in gaps in knowledge.
■ Encourage publication of reports that describe care associat-
ed with negative outcomes or potentially unnecessary care.
■ Address limitations of existing cancer registries and other
databases and encourage the development of new databases.
These databases should provide comprehensive information
about all aspects of care and offer means for monitoring (to
ensure accuracy of data) and linkage to other databases.3
Promote the Practice of
Evidence-Based Medicine
Most reports about the quality of health care, including can-
cer care, have addressed the need to promote the practice of
evidence-based medicine. Research, clinical trials, clinical
practice guidelines (CPGs), and information systems are
means of collecting and disseminating new medical evidence
1
to facilitate this process. Clinical trials are the means by which
new technologies and pharmaceuticals are evaluated against
current standards of care and may offer cancer patients access
to the best and most promising treatment.3 However, few
adults with cancer participate in clinical trials due to factors
including physician under-referral and lack of insurance cov-
erage.3,20,21 CPGs are systematically developed recommenda-
tions about some or all aspects of decision making for a par-
ticular condition or clinical situation.22 Despite significant
efforts in the development, dissemination, and implementa-
tion of oncology CPGs, their success in changing physicians’
perspectives and practice patterns has been mixed.3 The like-
liest reason for a number of oncology CPG failures appears to
be failure to implement systems that have a means of holding
the provider accountable for his or her performance.23
Outcome databases and information systems offer a means to
encourage guideline adherence by permitting evaluation and
comparison of providers’ performance (i.e., a means of ensur-
ing accountability).24,25 Yet an obstacle to implementing infor-
mation systems is the large capital investment required. Other
ways in which information systems can improve quality of
pharmaceutical care for cancer include supporting continued
research and innovation, reducing medical (e.g., medication
dosage) errors, and providing a means of disseminating new
medical information (e.g., CPGs, evidence reports, technolo-
gy assessments).4,24
Recommendations:
■ Continue educating consumers, providers, and third-party
payers about the importance of clinical trials in developing new
treatments, and support other efforts to improve third-party
coverage of patient costs associated with trial participation.
■ Seek funding for research to determine:
• The true costs of cancer-related clinical trials,
• Who should bear the added costs (if any), and
• Factors other than coverage issues contributing to under-
enrollment of eligible patients.
■ Seek funding for further research to study optimal means of
developing, disseminating, and implementing oncology
CPGs, including mechanisms to ensure adherence and
accountability (e.g., associated outcome databases that pro-
vide data for evaluating provider performance).
■ Encourage greater public- and private-sector financial
investment in the development and implementation of
advanced information systems.
Expand and Strengthen the Role of Cancer
Patients in Promoting Quality Care
Cancer patients are not always listened to and included in
treatment decisions,26–28 and the content of physician commu-
nication varies with patient characteristics such as age, ethnici-
f
The Charter of Paris Against Cancer was recently signed by international government officials, leading researchers, and patient advocates at the World Summit Against Cancer held in Paris,
France, in February 2000.
2 Complexities and Variations in Pharmaceutical Therapy for Cancer
ty, income, and education level.29 For example, despite evidence
that elderly patients are as likely as young patients to prefer
aggressive, lifesaving treatment,30,31 some cancer treatments
appear to be underutilized in elderly patients because of mis-
taken assumptions about patient preferences or life expectancy.3
In addition, many cancer patients are not being provided
appropriate psychological support,32 including diagnosis and
treatment of clinical depression.33 Recently proposed bills of
rights (e.g., the Consumer Bill of Rights and Responsibilities,
the Oncology Nursing Society’s Patients’ Bill of Rights for
Quality Cancer Care) represent efforts to ensure consumer and
patient rights to these and other elements of quality care.24,34
Cancer patients also are seeking an increased role in policy
development and decision making related to cancer care. The
recently signed Charter of Paris Against Cancerf calls for the
protection and expansion of patients’ rights, among other
directives aimed at improving quality of care (e.g., increased
commitment to research, improved patient access to clinical
trials).35 This charter identifies informed patient advocates as
“key strategic partners” in the advancement of standards of
care and survival and notes that patients are uniquely posi-
tioned to focus the overall anticancer effort and the optimal
use of resources.35 Thus, patient input should be obtained in
the development of CPGs and clinical trials as well as other
mechanisms to advance evidence-based medicine.
Recommendations:
■ Educate consumers about patient rights, components of
quality care, and what consumers can do to improve the
quality of pharmaceutical care for cancer (advocacy).
■ Design educational interventions to improve providers’
communication skills, awareness of patient rights, and
knowledge of appropriate psychosocial support for cancer
patients.
■ Support patient rights initiatives and recruit members from
the professional community to serve as patient advocates.
■ Include patients in the development of mechanisms to advance
evidence-based practice and the quality of cancer care.
Conclusion
Reasons to explore the quality of pharmaceutical care for can-
cer include recent reports of inappropriate care and the
potential for optimal pharmaceutical care to improve survival
and quality of life. As little is known about many aspects of
such care, this paper outlines steps to enhance quality assess-
ment and fill in gaps and knowledge as well as optimize appli-
cation of pharmaceuticals to cancer care. Critical to the suc-
cess of these measures is collaboration among the public and
private sectors in areas including research, education, advo-
cacy, and database and information system development.
I. Introduction Section II summarizes methods of assessing health care quali-
ty and concerns about the quality of heath care in general.

G
ood quality health care has been described as “pro- Section III addresses compelling reasons to explore the quali-
viding patients with appropriate services in a tech- ty of pharmaceutical care for cancer, and Section IV follows
nically competent manner, with good communica- with specific examples of practice variations and inappropri-
tion, shared decision making, and cultural sensitiv- ate care. While a detailed discussion of underlying reasons for
ity.”1 Major shifts in the organization and financing of the disparities in quality is beyond the scope of this paper, Section
health care system, rapid advances in technology, and con- V outlines next steps to improving the quality of pharmaceu-
cerns about access to health care have generated recent con- tical care for cancer (e.g., research, database improvements).
cern about the quality of health care. This concern has been
heightened by recent reports by public- and private-sector
groups describing wide “practice gaps”g in the quality of care.
Several reports have specifically addressed problems with the
quality of cancer care. For example, the National Cancer Policy
Board (NCPB) recently concluded, “some individuals with
cancer do not receive care known to be effective for their con-
dition.”3 While the magnitude of the problem is not known,
II. Health Care Quality
the NCPB believes it is substantial. The President’s Cancer
Panel also recently challenged the availability of appropriate
cancer care due to the “lack of a professional consensus and Definitions and measurement of quality
considerable public confusion about what constitutes quality
of care for the more than 100 types of cancer”4. This panel fur- What is quality of care?
ther observed that “efforts to define, implement, measure, and In defining quality of health care, several sources have relied
assess quality in cancer care have been stymied by insufficient on the Institute of Medicine’s definition: “Quality of care is the
data, scientific evidence of widely ranging rigor, and compet- degree to which health services for individuals and popula-
ing professional, payer, and patient interests.”4 tions increase the likelihood of desired health outcomes and
are consistent with current professional knowledge.”5
Insufficient data and a lack of consensus in defining appro- Identified components of quality care include the presence of
priate care also appear to have thwarted efforts to assess the technical quality,i emphasis on health promotion and disease
quality of pharmaceutical aspects of cancer care. Given the prevention, informed participation of patients, a scientific
evidence that optimal pharmaceutical care for cancer can foundation or evidence base supporting a specific practice,
improve patient survival and quality of life, this issue war- and efficient use of financial resources.6 In contrast, poor-
rants more detailed examination. The primary objectives of quality care has been described as the overuse, underuse, or
this paper are to delineate and explore what we know to date misuse of health-related services. In this construction, over-
about the quality of pharmaceutical treatment for cancerh and use refers to the provision of a service when its risk of harm
to identify potential limitations in the provision of appropri- exceeds the potential benefit; underuse, to failure to provide
ate pharmaceutical care. As insufficient peer-reviewed data an effective service when it would have produced a favorable
have limited prior efforts at assessment, anecdotal data (e.g., outcome; and misuse, to avoidable complications of appro-
survey reports) also are considered in this paper. Additional priate care.7 Poor-quality care also has been described as “too
objectives include (1) sending a call for additional research much care (e.g., unnecessary tests, medications, or proce-
funding to the cancer community, government, accrediting dures, with associated risks and side effects), too little care
bodies, and pharmaceutical industry; (2) promoting (e.g., not receiving a lifesaving surgical procedure), or the
improved availability of data about cancer drug utilization wrong care (e.g., medicines that should not be given together,
patterns; and (3) stimulating discussion to facilitate reaching poor surgical techniques).”1
a consensus in defining quality cancer and pharmaceutical
care. Only with clear definitions and access to important
information about pharmaceutical agents (e.g., patterns of
use, outcomes, cost-effectiveness) can the quality of pharma-
ceutical treatment for cancer be meaningfully assessed and
improved. Additional clinical and health services research can This project was funded by the National Pharmaceutical Council Inc.
facilitate this process by filling in gaps in medical knowledge, Address correspondence and reprint requests to the National
Pharmaceutical Council Inc., 1894 Preston White Drive, Reston, VA
improving the means of quality assessment, and delineating 20191 or make requests by email at www.npcnow.org.
mechanisms to ensure quality.
g
A practice gap is a discrepancy between what would be considered “the best practice” and the “actual practice,” or the care that should be provided and the care received by the patient.2
h
Pharmaceutical care refers to treatment with curative and palliative products, including cytotoxic antineoplastics, hormone therapies, biological therapies (e.g., biological response modifiers,
colony stimulating factors), other adjunct and miscellaneous antineoplastics, and ancillary agents (e.g., analgesics, antiemetics).
i
Technical quality refers to whether the right diagnostic and treatment decisions are made and whether care is effectively and skillfully provided.

Complexities and Variations in Pharmaceutical Therapy for Cancer 3

How is quality of care measured?
Quality may be measured at any level of the health care sys-
tem by expert judgment (implicit review) or systematic refer-
ence to objective standards (explicit review). An example of
the former is having a clinician review a medical chart and
express judgment as to whether the care provided was good
or bad. A disadvantage of this method is the lack of prior stan-
dards or agreement about the existence of good or better care.
In contrast, explicit review uses specific quality measures and
a priori criteria to provide a more systematic approach to
quality assessment. These quality measures often are based on
one or more of the three classic components of quality of care
introduced by Donabedian.8,9 These consist of “structural
quality,” which refers to provider and health care system char-
acteristics; “process quality,” which refers to what providers
do to, for, or on behalf of patients and how well they do it;
and “outcomes” or the end results of services in terms of
patients’ health and well-being.
Steps involved in explicit review can be summarized as follows:
• Identify which structural components or processes of
care are linked to desired patient outcomes by reviewing
the literature and soliciting the opinions of experts.
• Develop measures to evaluate the structure, process, and
outcomes of care.
• Establish a priori criteria for levels of care (e.g., poor through
excellent) to permit qualitative classification of care.
• Apply measures to samples of data (e.g., administrative
records, medical records, patient surveys, cancer registry
databases) to determine the degree to which effective
care is being provided.
Many existing quality assessment systems depend primarily on
process measures. However, there is increasing interest in
moving toward outcomes measures, which some experts con-
sider to be the most direct measure of the health of a popula-
tion.1 Clinical status, functional status, and consumer satisfac-
tion are three important types of outcomes. Clinical status
refers to the functioning of a patient’s organ systems (i.e., the
biological outcome), whereas functional status refers to the
patient’s ability to participate in physical, mental, and social
activities. A related concept, health-related quality of life,
extends the definition of functional status to include a person’s
sense of well-being and external factors (e.g., social support).
Who measures the quality of health care?
Interest in assessing the quality of health care is growing.
Major reasons for this include the recent health care system
restructuring, increasing reports of quality problems, and
mounting pressure from both the public and private sectors
for increased accountability and information to facilitate
health-related decisions (e.g., plan selection, value-based pur-
chasing). Numerous public- and private-sector groups and
4 Complexities and Variations in Pharmaceutical Therapy for Cancer
agencies are involved in the quality assessment and improve-
ment of health care in general (Table 1) and specifically can-
cer care (Table 2). Tables 1 and 2 list examples of these groups
and agencies as well as sources of information about their
activities.
Health care system in flux
What factors contribute to concern about the quality of
health care in general?
To provide context for this paper’s major objectives, it is use-
ful to examine eight factors that have contributed to concern
about the quality of health care in general. These issues and
events may be summarized as follows:
Health care system changes. Recent changes in the health care
system include a proliferation of new organizational types, the
growing dominance of managed care, and the increasingly frag-
mented delivery of health care services.10 Contributing to the
latter is the growing number of treatment settings and provider
types as care shifts from inpatient to outpatient settings.10
Concern about health care quality is related to the potential for
“disconnects” in the delivery of care as care shifts between
providers and settings.3,10 Frequent changes in the membership
of practitioner panels in health plans also may contribute to
treatment discontinuities when patients are required to switch
providers midtherapy. There is also concern about limited or
delayed access to specialists with the shift of responsibility for
patient management to primary care providers.3
Reimbursement strategies. Recently created financial incentives
associated with new organizational structures and reimburse-
ment strategies have generated some concern about health
care quality.2 These incentives are intended to promote opti-
mal utilization of health care services, but they have been
shown to decrease both unnecessary and necessary care.11
Lack of equal opportunity and access. Access refers to the “time-
ly use of affordable personal health services to achieve the
best possible health outcomes.”12 These well-established
links12,13 have generated concern about disparities in access to
health care services.14 A major cause of diminished access to
health care services is lack of health insurance.3,10 It is esti-
mated that one in seven Americans currently lacks health
insurance coverage, and this percentage is rising.15 Uninsured
individuals face obstacles such as delays in obtaining care,
limited choice about providers and facilities, and treatment
discontinuities,16,17 as well as higher morbidity and mortality
rates.18,19
Increased health care spending. Despite a decline in the rate of
increase in health care costs during the early to mid-1990s,10
 Table 1.

Organizations Involved in Quality Assessment

and Improvement of General Health Carea
Government Agencies and Related Organizationsb Private-Sector Organizationse
Agency for Healthcare Research and Qualityc Foundation for Accountability
• http://www.ahcpr.gov/ (home page) • http://www.facct.org/ (home page)
• http://www.ahcpr.gov/qual/ (quality assessment page) • http://www.facct.org/measures.html (measuring quality)
• http://www.guideline.gov (guideline clearinghouse) • NCPBd 1999 report3
• NCPBd 1999 report3
Joint Commission on Accreditation of Healthcare Organizations
Centers for Disease Control and Prevention • http://www.jcaho.org/ (home page)
• http://www.cdc.gov/ (CDC home page) • http://www.jcaho.org/qualitycheck/ (allows quality check of specific
• http://www.cdc.gov/cancer/ (National Center for Chronic Disease health organizations)
Prevention and Health Promotion) • NCPBd 1999 report3
• http://www.cdc.gov/cancer/npcr/index.htm (National Program of
Cancer Registries) National Committee for Quality Assurance
• http://www.ncqa.org/Pages/Main/index.htm (home page)
Health Care Financing Administration • http://www.ncqa.org/pages/communications/publications/
• http://www.hcfa.gov/ (home page) pubdesc.htm (publications and resources)
• http://www.hcfa.gov/quality/qlty-1.htm (quality of care • NCPBd 1999 report3
information)
• NCPBd 1999 report3

President’s Advisory Commission on Consumer Protection and

Quality in the Health Care Industry
• http://www.hcqualitycommission.gov/ (home page)
• http://www.hcqualitycommission.gov/final/ (final report to
President: Quality First: Better Health Care for All Americans)
• http://www.hcqualitycommission.gov/cborr/ (Consumer Bill of
Rights and Responsibilities)

a
This is not a comprehensive listing of all agencies involved in quality assessment and improvement of health care.
b
These government groups and agencies provide oversight, initiate regulatory actions, and/or make purchasing decisions regarding general health care.
c
This agency was formerly known as the Agency for Health Care Policy and Research (AHCPR).
d
NCPB is the National Cancer Policy Board.
e
These trade associations, nonprofit research groups and health plans, hospitals, and individual providers provide information for monitoring of the
professional community.

national health care spending is projected to double between
1996 and 2007.20 Increased costs get passed on to group pur-
chasers and consumers as higher premiums and levels of
employee cost sharing.10 High deductibles, copayments or
coinsurance, and coverage caps contribute to higher con-
sumer out-of-pocket expenditures, which in turn may influ-
ence access to services.3
Changing U.S. demographics. Older individuals are constituting
an increasingly greater percentage of the U.S. population as
life expectancy continues to rise.10 The number of Medicare
beneficiaries is expected to almost double over the next 30
years.21 In addition, members of racial or ethnic “minority”
groups are expected to comprise nearly half of the U.S. pop-
ulation by 2050.22 These demographic changes are significant
given the susceptibility of these and other vulnerable popula-
tions (e.g., terminally ill or disabled persons) to problems in
using the health care system (e.g., treatment discontinuities,
lack of coordination among multiple providers, difficulty
receiving approval for uncommon or costly treatments).10
Communication barriers, reflecting language and cultural dif-
ferences or a poor state of health, also may adversely influence
the quality of care by reducing a patient’s ability to compre-
hend information, express treatment preferences, provide
informed consent, or obtain services consistent with cultural
norms.10
Rapid advances in knowledge and technology. The recent explo-
sion of new health knowledge and technology has produced
many new pharmaceutical agents and interventions.10 In
1999, the Food and Drug Administration (FDA) approved 35
new drugs and 5 biologics, pushing the total number of med-
icines introduced in the 1990s up to 370.23 This pace of prod-
uct approval is expected to increase with the accelerating rate
of scientific discovery and treatment advances as well as
recent FDA initiatives.4,24 The latter have eased and broadened
access to investigational drugs and created fast-track path-
ways to FDA marketing approval.24 While offering the poten-
tial for improved survival and quality of life, these changes
place added demands on practitioners who need to be knowl-
edgeable about evolving technologies and able to translate
disparate findings into clinical practice.10

Complexities and Variations in Pharmaceutical Therapy for Cancer 5

 Table 2.

Examples of Cancer-Specific Organizations Involved in Quality

Assessment and Improvement of Cancer Carea
National Cancer Institute National Comprehensive Cancer Network
• http://www.nci.nih.gov/ (NCI home page) • http://www.nccn.org/ (home page)
• http://cancernet.nci.nih.gov/index.html (NCI CancerNet) • http://www.nccn.org/guidelines.htm (guidelines)
• http://www.nci.nih.gov/intra/intra.htm (research) • http://www.nccn.org/outcomes.htm (NCCN Oncology
• NCPBb 1999 report3 Outcomes Database)
• NCPBb 1999 report3
American Cancer Society
• http://www.cancer.org/ (ACS home page) National Breast Cancer Coalition
• http://www.cancer.org/research/index.html (research) • http://www.natlbcc.org/homeindx.asp (home page)
• NCPBb 1999 report3 • http://www.natlbcc.org/trainingindx.asp (advocacy training)
• http://www.natlbcc.org/eduindx.asp (education)
American College of Surgeons Commission on Cancer
• http://www.facs.org/ (ACS home page) Oncology Nursing Society
• http://www.facs.org/about_college/acsdept/cancer_ • http://www.ons.org/ (ONS Web site)
dept/programs/ncdb/whatsncdb.html (National Cancer Data Base)
• NCPBb 1999 report3 National Coalition for Cancer Survivorship
• http://www.cansearch.org (home page)
Association of Community Cancer Centers • http://www.cansearch.org/policy/statements/imperatives/
• http://www.accc-cancer.org/ (home page) imperatives.htm (publication)
• http://www.accc-cancer.org/guides.html (guidelines)
• NCPBb 1999 report3

American Society of Clinical Oncology

• http://www.asco.org/ (home page)
• http://www.asco.org/prof/pp/html/f_gs.htm (guidelines)
• NCPBb 1999 report3

This is not a comprehensive listing of all agencies involved in quality assessment and improvement of cancer care.
a

NCPB is the National Cancer Policy Board.

b

Physician dissatisfaction and concerns about insurance coverage.
Higher rates of physician dissatisfaction correlate with the
growth of managed care and have been attributed, in part, to
pressure to reduce clinical autonomy.10 In one survey, 38% of
physicians reported a decline in their ability to make deci-
sions and 41% reported a decrease in time spent with
patients.25 Physicians also have expressed concern about lack
of insurance coverage for patient services perceived as neces-
sary. In a recent physician survey conducted by the American
Medical Association’s Institute of Ethics, 37% of physicians
reported that patients had requested that they deceive third-
party payers (e.g., exaggerate the severity of the patient’s con-
dition) to obtain coverage for services sometimes or often
within the past year.26 In addition, 48% of physicians report-
ed suggesting that patients pay out-of-pocket for needed but
excluded services, and 31% reported not offering useful serv-
ices to patients because of health plan utilization rules.
of experts including the National Roundtable on Health Care
Quality, the Quality of Health Care in America Committee,
and the President’s Advisory Commission on Consumer
Protection and Quality in the Health Care Industry (see
Appendix). These reports summarize evidence of overuse,
underuse, misuse, and variations in use of health-related serv-
ices associated with a number of prominent disease states
including heart disease, diabetes, and cancer (Table 3).7,10,27
Schuster et al recently reported that large gaps in care exist for
all types of care (preventive, acute, and chronic), health facil-
ities, health insurance types, age groups, and geographic
regions. 2 In addition, the Quality of Health Care in America
Committee recently concluded that, although there is still
much to learn about the types of medical errors that occur in
health care, a serious concern for patients exists.27

Recent reports describing disparities in health care quality. More

substantial and direct evidence of problems with health care
quality comes from recent reports by researchers and panels

6 Complexities and Variations in Pharmaceutical Therapy for Cancer

III. Rationale for Exploring
the Quality of Pharmaceutical
Care for Cancer
The reports that describe the widespread gaps in health care
quality also recommend a number of national objectives for
improving health care quality. These include ensuring appro-
priate access to and use of health services, expanding research
on new treatments, and increasing patient participation in
care. The President’s Advisory Commission specifies that such
aims should be “based on criteria that include focusing on
common and/or costly conditions, areas where wide variabil-
ity in practice exists, and improvements that have the greatest
impact on reducing morbidity and mortality and improving
functional capacity.”10 Cancer, its care, and the pharmaceuti-
cal products used in its care fulfill these respective criteria.
Thus, the quality of cancer care, including associated phar-
maceutical treatment, represents an appropriate focus of
attention.
Cancer is costly
Cancer is a costly disease. The National Institutes of Health
estimates that the overall annual costs for cancer at $107 bil-
lion.28 Of this amount, direct medical costs account for $37
billion, indirect morbidity costs (lost productivity due to ill-
ness) account for $11 billion, and indirect mortality costs
(lost productivity due to premature death) account for $59
billion.29 More than half of the $37 billion in direct medical
costs is spent on treatment for breast, lung, and prostate can-
cers.29 Breast cancer and prostate cancer are the most com-
monly diagnosed nonskin cancers in American women and
men, respectively, and lung cancer accounts for the most can-
cer-related deaths.3,29
Cancer is also costly in terms of lives. One in every four
deaths in the United States is caused by cancer, making can-
cer the second leading cause of death among Americans.29 In
2000, about 1.2 million new cases of cancer (excluding skin
cancers) are expected to be diagnosed, and approximately
552,000 Americans are expected to die from cancer.29
Ultimately, cancer will affect one third of individuals in the
United States and two thirds of all families.30
Wide variability in cancer care exists
Recent reports by expert panels have described wide varia-
tions and gaps in cancer care. For example, the 1999 report
by the NCPB, Ensuring Quality Cancer Care, describes a “wide
gulf between what could be construed as the ideal and the
reality of [Americans’] experience with cancer care.”3 In their
1998 report, Cancer Care Issues in the United States: Quality of
Care, Quality of Life, the President’s Cancer Panel describes
“marked disparities in treatments provided, in access to can-

Table 3.

Examples of Disparities in General Health Carea

Variations Medical
Source Underuse Overuse in Services Errors
President’s Preventative Some surgeries Regional variations Missed diagnosis;
Advisory care: (hysterectomy, in some surgeries misinterpretations
Commission immunizations, carotid endarterectomy, (e.g., hysterectomy), of laboratory
report routine cancer coronary artery medical treatments and imaging
(1998)10 screening, bypass grafting); (e.g., hormone studies; surgical
counseling about hospitalizations; replacement errors; medication,
risky behavior and prescription therapy), and prescribing, and
Acute care: medications (e.g., hospitalization administration
beta-blockers antibiotics for viral rates for some errors
after myocardial illnesses, nonsteroidal conditions (e.g.,
infarction anti-inflammatory asthma, diabetes,
Chronic care: drugs) pneumonia,
rehabilitation after mental illness)
stroke or hip fracture,
screening for diabetic
retinopathy,
antidepressant
therapy for depression

a
This is not a comprehensive listing of areas of inappropriate care. Rather, the table presents examples of disparities in health care documented by
multiple investigators and listed in the President’s Advisory Commission report.10

Complexities and Variations in Pharmaceutical Therapy for Cancer 7

cer prevention and treatment services, and most essentially, in
patient outcomes.”4 This group of experts further concluded:
“Most people in America are not receiving what might be con-
sidered the highest quality [cancer] care.”4
These reports include data from the published literature that
support these sweeping conclusions. For example, estimates
suggest that only 30% and 56% of individuals older than 50
years underwent recommended screening examinations for
colorectal cancer and breast cancer in 1992 and 1994, respec-
tively.31 More recent data from sources including the Behavior
Risk Factor Surveillance System (BRFSS) and a 1999 National
Cancer Institute (NCI)/Health Care Financing Administration
(HCFA) national telephone survey suggest that rates of mam-
mography have since improved.32,33 However, BRFSS data and
results from the National Health Interview Survey and the
Medicare Current Beneficiary Study show that the percentage
of women undergoing breast (and cervical) cancer screening
decreases with increasing age.34 These sources of data also
show that only 25% of individuals 55 years or older under-
went fecal occult blood testing (FOBT) and 45% underwent
endoscopy for colorectal cancer screening between 1995 and
1997. 34
Conversely, overutilization of services also has been observed.
Despite evidence that the use of bone scans and other imag-
ing studies does not improve breast cancer outcomes by iden-
tifying metastases, 34% of patients received a bone scan and
21% underwent computed tomography, in one study.35
Similarly, an audit of the medical records of 107 patients with
non–small cell lung cancer revealed that 50% of patients had
undergone an excessive number of preoperative scans com-
pared with the number recommended by National
Comprehensive Cancer Network guidelines.36
There also is evidence of practice variations and inappropriate
care in cancer treatment. For example, rates of breast-con-
serving surgery for breast cancer vary according to geograph-
ic region, hospital characteristics (e.g., size, case volume), and
patient demographics (e.g., age, race, socioeconomic sta-
tus).35,37–39 It also appears that many women with breast cancer
are not receiving appropriate adjuvantj (postoperative)
chemotherapy and/or hormone therapy.3,40,41 Although the
NCPB acknowledged certain limitations of available data
(e.g., low volume, outdated information, lack of adjustments
for case mix), the panel recently concluded that “serious
problems” may exist with the quality of care provided to
women with breast cancer in the United States.3
Adjuvant therapy refers to additional drug or other treatment (e.g., radiation therapy) designed to enhance the effectiveness of the primary therapy. For example, adjuvant chemotherapy or hor-
j
mone therapy may be administered postoperatively to patients with breast cancer following breast-conserving surgery.
8 Complexities and Variations in Pharmaceutical Therapy for Cancer
Improved cancer care, including
pharmaceutical treatment, can reduce
morbidity and mortality and improve
functional capacity
During the past three decades, significant improvements in
cure rates have been accomplished with the incorporation of
chemotherapy and radiotherapy into management plans.
Tremendous advances in our understanding of the biology of
cancer have facilitated the development of new treatments and
agents that offer improved efficacy, fewer side effects, novel
applications (e.g., prevention), and new means of treating side
effects (e.g., colony-stimulating factors [CSFs] for neutropenia).
The rapid pace at which pharmaceutical treatment for cancer is
evolving is illustrated by the 354 anticancer drugs in develop-
ment in 1999.42 This pace is expected to continue with recent
FDA initiatives directed toward early access to and accelerated
approvals for investigational anticancer drugs.24 All of these
changes suggest the potential for cancer-related mortality, mor-
bidity, and quality of life to be greatly improved.
Yet despite these and other reasons for optimism, there is con-
cern that pharmaceutical care for cancer is not being optimal-
ly applied. For example, limited published data suggest that
some pharmaceuticals may be underused (e.g., adjuvant
chemotherapies for some cancers, analgesics).35,40,41,43
Conversely, anecdotal data suggest that some patients are
receiving second- or third-line chemotherapies in clinical sit-
uations for which there is little evidence that such treatments
are effective.44 However, the presence and magnitude of these
problems are difficult to establish without a universally
accepted definition for quality pharmaceutical care, adequate
quality measures, and data about drug utilization patterns.
Optimizing care requires the ability to adequately assess the
quality of care. Thus, given the potential for optimal pharma-
ceutical care to greatly reduce mortality and morbidity and
improve quality of life, these methodological issues warrant
closer attention.
IV. Pharmaceutical Treatment
for Cancer: Practice Patterns,
Variations, and Quality
Practice variations or quality problems?
An ideal discussion of the quality of pharmaceutical care for
cancer would be based entirely on data from studies in the
peer-reviewed literature that used appropriate quality measures
and criteria to assess quality of care (i.e., explicit review).
However, few such studies exist. Some studies merely report
patterns of use of pharmaceuticals. Numerous other studies
have compared patterns of pharmaceutical care across various
parameters (e.g., patient age, race/ethnicity, geographic region),
but without using quality measures or criteria. Other studies
consist of surveys that evaluated rates of service utilization
among populations but could not reliably assess the appropri-
ateness of care. Exploration of all of these types of studies is
useful as they may demonstrate variations in practice patterns
suggestive of quality problems. However, further study, using
appropriate quality measures and criteria, is needed to permit
inferences to be made about the quality of care.1 Process and
outcome measures used in explicit reviews take into account
how factors such as patient preference and characteristics may
influence outcomes. For example, appropriate process meas-
ures allow one to determine whether low rates of a service
reflect service underutilization (i.e., poor-quality care) or
patient preference (i.e., appropriate service was offered but the
patient declined). In addition, good outcome measures are case
mix–adjusted, thereby allowing one to determine whether low
survival rates reflect poor-quality care or factors outside the
health care system’s control (e.g., patient age, comorbidities).
Data sources and availability
This section of the paper explores what is known about phar-
maceutical care for cancer by considering data from multiple
sources (e.g., original investigations, physician surveys,
expert reports, cancer registries). These data describe practice
patterns and variations in pharmaceutical care for cancer as
well as the quality of such care. Although limited conclusions
about quality can be made from data describing variations in
practice, these data are important for demonstrating areas and
directions for future quality assessment.
Individual studies that provide data about multiple cancers or
multiple treatments are reviewed, as well as groups of studies
on the following topics:
• Underuse of adjuvant therapy10 for breast and colon cancer,
• Underuse of analgesics for pain control, and
• Unnecessary or excessive use of some pharmaceutical
agents.
Complexities and Variations in Pharmaceutical Therapy for Cancer
Many other types of pharmaceutical care for cancer are equal-
ly worthy of attention (e.g., chemotherapy for metastatic breast
cancer). However, the absence of available data and/or a clear
definition of appropriate care precluded such exploration.
Individual studies: Multiple
cancers and treatments
U.S. General Accounting Office
A 1988 U.S. General Accounting Office study provided some
early data regarding patterns of pharmaceutical use for a vari-
ety of cancers.45 The objective of this study was to estimate the
number of Americans who were clinically eligible for, but did
not receive, state-of-the-art cancer treatment over a 10-year
span. The investigators used data from the Surveillance,
Epidemiology, and End Results (SEER) cancer registery data-
base to examine usage patterns of multiple “breakthrough”
cancer treatments between 1975 and 1985. These consisted
of (1) adjuvant (postoperative) chemotherapy for node-posi-
tive colon cancer and node-positive breast cancer (pre-
menopausal); (2) chemotherapy for limited small cell lung
cancer, non-seminoma testicular cancer, Stage IIIB or IV
Hodgkin’s disease, and diffuse intermediate or high-grade
non-Hodgkin’s lymphoma; and (3) adjuvant radiation treat-
ment for rectal cancer.
All of these treatments had already been proven in controlled
experiments to extend survival; in some cases, this knowledge
had been available for 10 or more years. Nevertheless, the
investigators still found considerable variation in the use of
these proven therapies. For example, 90% of eligible patients
had received chemotherapy for Hodgkin’s disease in 1985. In
contrast, only 6% of eligible patients had received adjuvant
chemotherapy for node-positive colon cancer, and 63% of eli-
gible patients had received adjuvant therapy for node-positive
breast cancer. Trends consisted of a rising use of radiation ther-
apy for rectal cancer and a declining use of chemotherapy for
colon cancer. The NCPB concluded that these results illustrate
the “slow rate of diffusion of innovation” in cancer care.3
Kaluzny et al
In 1995, Kaluzny and colleagues demonstrated variations in
the use of adjuvant chemotherapy for several cancers accord-
ing to oncologist affiliation or nonaffiliation with Community
Clinical Oncology Program (CCOP).46 Initiated by NCI in
1983, the CCOP links community cancer specialists and pri-
mary care physicians with cancer centers and clinical cooper-
ative groups to increase community involvement in NCI-
sponsored clinical trials.3 Several studies have compared prac-
tice patterns between CCOP affiliated- and non–CCOP-affili-
ated physicians.46–48 Kaluzny and colleagues compared rates of
use of adjuvant therapy for colon, rectal, and breast cancer
9
between CCOP-affiliated oncologists and non–CCOP-affiliat-
ed oncologists from 1987 to 1990.46 They found that patients
treated by CCOP-affiliated oncologists were more likely to
have received adjuvant therapy during this interval.
Mortenson et al
A 1997 report by Mortenson and colleagues provides insight
into how health care system factors may influence oncologists’
prescribing patterns.49 Based on increasing anecdotal reports
of “hassles” (e.g., payment denials, delayed approvals for rec-
ommended services, and administrative bottlenecks) associat-
ed with managed care settings, Mortenson et al designed a
survey to investigate how these factors influence oncologists’
ability to deliver care. Surveys were mailed to approximately
2000 oncologists representing a randomly selected, regional-
ly proportional, national sample. Of 322 respondents, 72%
indicated that they had active managed care contracts, most-
ly consisting of discounted fee-for-service contracts with sep-
arate drug reimbursement. Approximately 37% of all respon-
dents reported frequent problems with coverage for clinical
trials, and 22%, for terminal or follow-up care. Clinicians
with managed care contracts also reported frequent delays in
approval of studies and referrals (40%) and reduced reim-
bursement for chemotherapy (55%). Some oncologists
reported feeling hesitant to prescribe treatment for their
patients due to these factors. Rates of “hesitation to prescribe”
among all respondents were estimated as 26.6% for hospital-
izations, 27.5% for expensive chemotherapy (i.e., new thera-
pies), 24.9% for clinical trials, and 13.3% for supportive care.
However, these rates were two to five times higher among
oncologists providing care for patients under managed care
contracts versus fee-for-service plans.
Based on these and other data, the authors concluded that
“managed care plans are affecting the practice patterns of
oncologists and the care offered to patients.”49 However,
restraint on practice is not necessarily a quality problem, and
the appropriateness of care is not measurable in a survey. In
fact, hesitation to prescribe could lead to better care if the
oncologists were overprescribing. Furthermore, the response
rate to this survey was only 16%. Thus, rather than defini-
tively reflecting underutilization of services, these results indi-
cate the need for studies that specifically evaluate the quality
of care across diverse practice settings and under different
reimbursement policies.
Compilations of data
Adjuvant therapy for breast cancer
There are several reasons why systemic adjuvant therapy
(chemotherapy, hormone therapy) for breast cancer is a good
area to explore. First, the high prevalence of breast cancer has
generated active efforts at quality assessment, and thus, some
10
data (i.e., practice patterns and variations) about adjuvant
care. In contrast, little is known about the quality of
chemotherapy for metastatic breast cancer.6 Second, random-
ized clinical trial (RCT) data have shown that adjuvant
chemotherapy and hormone treatment significantly reduce
the risk of recurrence and mortality from breast cancer.50–52
Clinical trials also have provided extensive support for links
between process and outcomes for breast cancer, some of
which relate to pharmaceutical treatment for breast cancer.
This means that it has been possible to establish treatment
standards and develop process measures that compare actual
care against these standards.1 In this case, the relevant process
measure used by researchers is whether patients with locally
advanced breast cancer appropriately received systemic adju-
vant therapy.
Practice patterns, trends, and variations in use. Limited evidence
suggests that low and varying percentages of patients with
breast cancer received adjuvant therapy during the mid- to
late 1980s. For example, data from studies by Hillner et al,40
Osteen,53 and Hand et al54 suggest that rates of adjuvant ther-
apy for patients with Stage II breast cancer ranged from 44%
to 56% during this period. The U.S. General Accounting
Office study revealed that 63% of premenopausal patients
with node-positive breast cancer who were eligible for adju-
vant chemotherapy received this treatment in 1985.45
However, data from both the SEER cancer registry and the
National Cancer Data Base (NCDB) illustrate temporal trends
toward increasing use of adjuvant therapies,5,55 as demonstrat-
ed by a study by Johnson et al.56
Johnson et al evaluated temporal trends in use of adjuvant
therapy between 1983 and 1989 to evaluate the effect of a
1988 NCI clinic alert advising physicians of the potential ben-
efits of using adjuvant therapy in patients with node-negative
breast cancer. 56 Data were abstracted from samples of patient
records at both CCOP and non-CCOP sites. Immediately fol-
lowing the clinic alert, the percentage of women with node-
negative disease who received adjuvant therapy increased
from 26% to 54%. The percentage of women with node-pos-
itive disease who received adjuvant therapy also increased
from 81% to 90%. One year later, percentages of patients with
node-negative and node-positive disease receiving adjuvant
therapy were 46% and 79%, respectively. It is not clear
whether the clinic alert influenced treatment for node-posi-
tive disease.3 The NCPB concluded that the “proportion of
women receiving adjuvant therapy in this study approaches a
level one might expect if all women who could benefit from
adjuvant therapy were being offered treatment.”3 However,
inferences and comparisons regarding the quality of treatment
are limited by the authors’ failure to distinguish between cases
that were from CCOP hospitals, control hospitals, or the
SEER registry.1 The facilities that chose to participate in NCI’s
CCOP are more likely to have an interest in cancer treatment
and adhere to NCI treatment guidelines.3
Complexities and Variations in Pharmaceutical Therapy for Cancer
More recent data from the late 1980s through the early- to
mid-1990s also suggest improving or high levels of adherence
to treatment standards for adjuvant therapy for breast cancer
in select patient populations.3 A notable exception is the
underuse of adjuvant therapy in postmenopausal women.3
Examples of studies that support these conclusions include
those by Hillner et al35,40 and Guadagnoli et al.41
Hillner et al used 1989–1991 data from the Virginia Cancer
Registry to evaluate the quality of care for 918 patients with
Stage I–III breast cancer. 35 These patients were 64 years of age
or younger and were covered by Blue Cross/Blue Shield insur-
ance. Although the authors were unable to assess the use of
adjuvant hormone therapy through claims data, they deter-
mined that 83% of the women 50 years of age or younger
(and assumed to be premenopausal) had received adjuvant
chemotherapy for node-positive disease. These results differ
from those reported in their 1996 study (using 1985–1989
data), in which only 44% of patients with positive lymph
nodes received any adjuvant therapy and 33%, hormone ther-
apy.40 However, noteworthy differences between these popu-
lations included different age groups (patients were 65 years
of age or older in the 1996 study) and insurance plans
(Medicare vs. private insurance). Thus, it is unclear the extent
to which the difference in adjuvant chemotherapy rates
reflects improved care versus differences in patient popula-
tions and/or insurance type.
Guadagnoli and colleagues provided additional information
about the use of adjuvant therapy in premenopausal and post-
menopausal women.41 They compared care received by
women with Stage I or II breast cancer at 18 Massachusetts
hospitals and 30 Minnesota hospitals between 1993 and
1995. Rates of adjuvant chemotherapy in premenopausal
women with node-positive disease were 97% and 94%,
respectively. However, only 63% of postmenopausal women
in Massachusetts and 59% of postmenopausal women in
Minnesota with positive lymph nodes and positive estrogen
receptor status received adjuvant hormone therapy.
Conclusions and notable gaps in information. Limited available
data suggest that rates of use of adjuvant chemotherapy for
breast cancer are approaching recommended levels in select
populations. These observations are consistent with NCDB
data illustrating improvements in diagnosis and treatment for
breast cancer between 1985 and 1995.55 However, available
data do not tell us (1) whether patients received care consis-
tent with a published regimen, (2) whether patients received
the appropriate dose, or (3) whether patients received appro-
priate pharmacologic support (e.g., antiemetics, CSFs). Apart
from RCT data, consultants for the NCPB report could only
find one study in the peer-reviewed literature that addressed
adherence to combination chemotherapy.6 Schleifer et al audit-
ed the care of 107 women with breast cancer treated by 29
oncologists in three university-affiliated practices from 1988 to
1989. 57 Fifty-two percent of patients experienced at least one
Complexities and Variations in Pharmaceutical Therapy for Cancer
unjustified dose reduction for factors unrelated to toxicity,
with higher rates of regimen nonadherence among the elderly
and clinic patients. However, information about total dose
intensity was not provided, limiting conclusions about the
technical quality of care.
Limited available data also suggest that use of adjuvant thera-
py inappropriately declines with increasing patient age and
may be too low in postmenopausal women. The NCPB recent-
ly concluded that many women, perhaps as many as 60%, do
not appear to be receiving adjuvant chemotherapy and/or hor-
mone therapy for breast cancer.3 However, they also acknowl-
edged that data need to be interpreted cautiously due to their
age (much from the 1980s), unknown accuracy (i.e., cancer
registry data), and lack of adjustments for differences in the
case mix (e.g., patient comorbidities, age). Also, little is known
about how outcomes (especially functional status and patient
satisfaction), patient factors (e.g., preferences, tolerance of side
effects), and health care system factors (i.e., other than lack of
insurance) influence service utilization rates.1,6 Future studies
should explore these and related quality issues (e.g., appropri-
ateness of chemotherapy for metastatic breast cancer) by
applying explicit quality measures and criteria to samples of
recent (i.e., late 1990s) data.
Adjuvant therapy for colorectal cancer
Like adjuvant therapy for breast cancer, adjuvant chemother-
apy for colorectal cancer has been shown to have a major
impact on survival.30 Improvements in overall and stage-spe-
cific survival over the past 20 to 30 years have been attributed
to improved surgical techniques as well as the addition of
adjuvant chemotherapy.6 Thus, adjuvant therapy for colorec-
tal cancer is now widely accepted as the standard of care for
patients with Stage III disease.29 Despite this circumstance, lit-
tle is known about the current quality of such care.
Practice patterns, trends, and variations in use. An early glimpse
of practice patterns came from the previously described U.S.
General Accounting Office study. These investigators estimat-
ed that only 6% of Americans who were clinically eligible for
adjuvant chemotherapy for node-positive colon cancer in
1985 received this “innovative” therapy.45 More recent data
from the NCDB suggest that rates of adjuvant therapy
improved in the late 1980s and early- to mid-1990s. In 1996,
the Commission on Cancer reported that 46% of patients
with Stage III colorectal disease nationally received adjuvant
chemotherapy between 1985 and 1993.58 In a 1998 report
about rectal and rectosigmoid adenocarcinoma, they reported
that trends toward earlier diagnosis and improved multi-
modal therapy for the treatment of Stage II and III disease
were continuing.59
However, another 1998 report suggests that underutilization
of adjuvant chemotherapy may be a problem in some patient
populations. An HCFA-affiliated Colorado peer review organ-
11
ization matched cancer registry data with Medicare A and B
claims data to assess factors associated with the use of adju-
vant therapy for Stage III colon cancer and Stage I and II
breast cancer.60 According to the NCPB, underutilization of
adjuvant therapy was found among patients 65 and older,
particularly for Stage III colon cancer.3,60 Advancing age
appeared to be the principal factor associated with failure to
use adjuvant therapies and did not appear to be explained by
patient comorbidities.
Conclusions and notable gaps in information. Collectively, these
data suggest that rates of use of adjuvant therapy for colorec-
tal cancer are improving, but that underuse of adjuvant
chemotherapy may exist in some populations (e.g., the elder-
ly). However, further study is needed to determine whether
these practice patterns and variations reflect poor-quality
care. Rates of utilization tell whether the service was provid-
ed. However, they do not address whether the dosing regimen
was appropriate, the care was consistent with patient prefer-
ences, or the care was withheld for legitimate reasons (e.g.,
patient preferences, comorbidities). Future studies should
explore these issues as well as the potential influence of
provider and health care system factors on practice patterns.
Use of pharmaceuticals for pain management
Palliative treatment for cancer is important for relieving symp-
toms (e.g., pain, nausea), easing distress (e.g., anxiety, depres-
sion), providing comfort, and improving quality of life. Yet
there is evidence of practice variation and inadequate use of
supportive pharmaceuticals (e.g., analgesics, antiemetics) in
palliative care. The use of analgesics represents a good area to
explore for several reasons: (1) most cancer patients experi-
ence pain, (2) published pain management guidelines outline
appropriate care, and (3) several studies have evaluated treat-
ment for pain using quality measures and criteria for adequa-
cy of pain control.
Practice variations, underuse, and guideline adherence. Cleeland
et al explored the adequacy of pain control in 1308 outpa-
tients with metastatic cancer being treated from 1990 to 1991
at 54 sites affiliated with the Eastern Cooperative Oncology
Group.43 Patients rated the severity of their pain during the
preceding week, their degree of pain-related functional
impairment, and the degree of relief provided by analgesics.
Their treating physicians described factors contributing to the
pain and its treatment and also estimated the pain’s impact on
the patient’s ability to function. The adequacy of prescribed
analgesic drugs was evaluated by using guidelines developed
by the World Health Organization.
Sixty-seven percent of the patients (871 of 1308) reported hav-
ing pain or the need for daily analgesics, and 36% (475 of
k
The Agency for Health Care Policy and Research is now known as the Agency for Healthcare Research and Quality (AHRQ).
12
1308) reported pain that limited their ability to function.43 Of
those with pain who provided sufficient information (n = 597),
42% were found to have received insufficient analgesics. These
patients reported less pain relief and greater pain-related func-
tional impairment compared with patients receiving sufficient
pain control. Cleeland et al also found that patients treated at
centers that mostly treat racial minorities were three times as
likely to have inadequate pain management. Other factors asso-
ciated with inadequate pain control included advanced age
(>70 years), female gender, better performance status, and a
discrepancy between patient and physician in judging the
severity of pain. Based on these results, the authors concluded
that “many patients with cancer have considerable pain and
receive inadequate analgesia.”43 Subsequent studies (e.g.,
Cleeland et al,61 Levin et al,62 Levy63) have provided data leading
to similar conclusions. The 1997 study by Cleeland et al
showed that 65% of minority cancer patients did not receive
guideline-recommended analgesic prescriptions in a clinic set-
ting compared with 50% of nonminority patients (P < .001).61
In addition to the above factors, patient beliefs and fears61,64 as
well as insufficient or no health insurance coverage65 can
influence the adequacy of pain control. However, provider
awareness, beliefs, attitudes, and behaviors are considered the
greatest barrier to effective analgesia in cancer patients.3
Therefore, several studies have assessed rates of practice
guideline adherence. For example, Rischer and Childress
evaluated hospital adherence to guidelines after widespread
dissemination of the 1994 Agency for Health Care Policy and
Researchk (AHCPR) pain management guidelines.66 They used
process measures to evaluate treatment for pain at seven acute
care Utah hospitals before and after a guideline dissemination
intervention. Most process measures of care improved postin-
tervention. However, the absence of a control group preclud-
ed determining whether this improvement was attributable to
the intervention.3 In 1997, an HCFA-affiliated Minnesota peer
review organization evaluated hospital adherence to AHCPRk
and American Pain Society cancer pain management guide-
lines by reviewing the medical records of 271 cancer
patients.67 Ninety-three percent of the hospitals had docu-
mented some form of a patient’s initial self-assessment of pain.
However, only 26% had used effective means of communi-
cating pain intensity and pain reassessment was inconsistent.
Conclusions. Available data suggest that many cancer
patients—especially the elderly, women, and members of eth-
nic and racial minority groups—are not receiving adequate
pharmaceutical therapy for pain. Data also suggest that a dis-
crepancy between patient and physician judgments about the
severity of the pain contributes to inadequate pain manage-
ment and, potentially, so does inconsistent use of pain man-
agement guidelines. Future studies need to examine these
issues using more recent data and also explore other factors
Complexities and Variations in Pharmaceutical Therapy for Cancer
thought to influence physician prescribing rates for narcotics
(e.g., concerns about side effects, patient tolerance/depend-
ence, and regulatory scrutiny).68
Unnecessary or excessive utilization of
pharmaceuticals in cancer care
Many of the data described thus far have addressed practice
variations and potential underuse or misuse of chemotherapy.
However, there is also concern about unnecessary or exces-
sive use of pharmaceutical products, especially for cancers in
which chemotherapy is thought to have a limited effect on
survival. Interestingly, consultants for the NCPB report could
find no studies in the peer-reviewed literature that addressed
such quality problems with objective data (i.e., survey stud-
ies).6 The President’s Cancer Panel recently noted that explo-
ration of unnecessary care (e.g., third-line chemotherapies,
unneeded or marginally efficacious surgeries) is difficult
because such care is “seldom studied, published, or publi-
cized, and negative outcomes are rarely reported.”4 Therefore,
this subsection differs from the above subsections in several
respects. First, it is largely guided by expert opinion, derived
from surveys, commentaries, and personal communications.
Second, this subsection considers potential reasons for exces-
sive or unnecessary pharmaceutical care to clarify the scope of
this potential problem.
Guideline development. Some information about potential
overuse of pharmaceuticals in cancer care comes from exam-
ining areas of care associated with recent clinical practice
guideline development. For example, the American Society of
Clinical Oncology (ASCO) issued guidelines for the use of
hematopoietic growth factors in 1994 due to concerns that
growth factors were being used inappropriately and exces-
sively (e.g., administered to patients with afebrile neutropenia
in whom growth factors do not improve outcomes).3,69 In
1997, ASCO issued guidelines for the treatment of unre-
sectable non–small cell lung cancer due to marked variations
in practice according to geography and physician specialty
and training.3,70
Expert opinion. Several commentaries published in the peer-
reviewed literature provide expert opinions about the issue of
overuse. For example, Weissman et al recently expressed
some concerns about “how the use of chemotherapy has
evolved and seems to define our specialty.”44 These oncolo-
gists acknowledged that the use of chemotherapy has pro-
duced some “dramatic gains in cancer medicine.” However,
Braverman expressed concern about unnecessary chemother-
apy in a series of observations about oncology care upon
entering the 1990s.71 Braverman also acknowledged a series of
breakthroughs with pharmaceutical treatments, but observed
that “many medical oncologists recommend chemotherapy
for virtually any tumour.”
Complexities and Variations in Pharmaceutical Therapy for Cancer
Potential reasons for excessive or unnecessary use of pharmaceuti-
cals. Potential reasons for inappropriate care include the
desire to do well for the patient, reimbursement policies, lack
of knowledge, and patient-driven forces. For example,
Weissman et al noted that “oncologists desperately want to do
‘well’ for their patients, to help them live and ‘beat’ their can-
cers or the symptoms of these cancers.”44 Consistent with this
perspective, Benner et al recently concluded that the frequent
use of second-line regimens for metastatic breast cancer by
Maryland oncologists likely reflects efforts to accommodate
patients who desired further, albeit less optimal, chemothera-
py.72 However, Eisenberg has reported that physician practice
patterns are guided by both concern for patient-related fac-
tors (i.e., financial situation, clinical status, expectations, pref-
erences) and “various costs and benefits to themselves” (e.g.,
economic benefits, need for peer approval, convenience).73
Chassin74 and others also have noted that compensation on a
per-procedure basis creates a financial incentive to provide
more care. The potential for overuse of chemotherapy cer-
tainly exists given that a significant portion of a typical med-
ical oncologist’s income stems from the administration of
chemotherapy in the office setting.75
There is also the potential for provider confusion about
appropriate standards to lead to inappropriate care. For
example, McFall et al classified judgments about adjuvant
chemotherapy for Dukes’ B2 (Stage II) and Dukes’ C (Stage
III) colon cancer among 1138 general surgeons, internists,
and family practitioners.48 Data were collected shortly before
the 1990 NIH Consensus Development Conference, during a
period of “considerable uncertainty” about the relative role of
surgical and adjuvant therapeutic approaches to colon cancer.
McFall et al found that only 24% of surgeons and 16% of
nonsurgeons endorsed the NIH consensus position: adjuvant
therapy recommended for Dukes’ C (Stage III) colon cancer,
but not Dukes’ B2 (Stage II) outside of clinical trials (experi-
mental therapy).48 This response was more common among
surgeons, CCOP-affiliated physicians, and older physicians.
Thirty-eight percent of surgeons and 50% of nonsurgeons
considered adjuvant chemotherapy experimental for both
cancer stages, whereas 29% of surgeons and 22% of nonsur-
geons rated adjuvant therapy as common/accepted practice
for both stages of colorectal cancer. Thus, lack of clarity about
standards of care has the potential to adversely influence care.
Conclusions and notable gaps. Anecdotal evidence suggests that
unnecessary and excessive use of pharmaceuticals in cancer
care does exist and that the genesis of the problem may be
multifactorial. However, there are limited data about such
quality problems obtained through carefully controlled stud-
ies. What is needed are studies that apply quality measures
and criteria to national samples of data to determine the
extent of this problem and underlying factors.
13
Implications of findings
The above-described studies permit some conclusions about
the quality of pharmaceutical care for cancer in certain clini-
cal situations. Yet conclusions are limited by the caveats and
methodological weaknesses associated with many of these
studies. A number of these limitations reflect factors outside
of an individual researcher’s control, including (1) the absence
of a comprehensive source of current information about drug
prescribing and use patterns, (2) the absence of a universally
accepted definition for quality pharmaceutical care for cancer,
and (3) the associated insufficiency of valid quality measures.
The presentation of these results, however, does serve several
purposes. First, these data indicate areas that need more rig-
orous assessment. Second, they illustrate what needs to be
done to permit such assessment. Section V of this paper pro-
poses next steps to improving the quality of pharmaceutical
care for cancer patients, including means of facilitating quali-
ty assessment.
V. Next Steps Toward Achieving
Quality Pharmaceutical Care
for Cancer
Given the paucity of information about the quality of phar-
maceutical care for cancer, a detailed discussion of barriers to
quality care would be based mostly on conjecture. Therefore,
this section explores factors that have raised concern about
the potential for inappropriate care and identifies areas that
need further assessment, development, and/or corrective
action. Seven areas that require further attention have been
identified.
Advance the measurement of quality and
reporting relevant to pharmaceutical care
The quality of pharmaceutical care for cancer cannot be ade-
quately assessed, nor optimized, without clear standards for
quality pharmaceutical care, valid quality measures, and data
about pharmaceutical prescribing and usage patterns. Thus,
consumers, providers, and payers must reach a consensus
about what constitutes appropriate pharmaceutical care for
individual cancer types. This consensus will lay the ground-
work for the development, testing, and implementation of
quality measures specifically relevant to the pharmaceutical
care (e.g., appropriateness of regimen, dose, and use of
adjunctive therapies; associated patient functional capacity
14
and quality of life; cost-effectiveness). Applied to appropriate
samples of data, these measures will yield information about
quality that then can be broadly disseminated. Additional
clinical and health service research can facilitate these
processes by clarifying research findings, improving measure-
ment systems, and identifying mechanisms to disseminate
quality-related data.
The cancer community could:
• Promote greater financial investment in quality-of-care
research by the public and private sectors, including the
government and pharmaceutical industry.
• Encourage and consider input from all health care par-
ticipants in defining appropriate pharmaceutical care,
constructing and implementing relevant quality meas-
ures, and selecting means to disseminate quality-related
data.
Improve availability of data about drug
prescribing and usage patterns
Data from the literature and cancer registries have allowed
investigators to determine the extent to which some pharma-
ceutical treatments for cancer are being used and factors that
may influence these rates. However, the absence of specific
data about drug prescribing and usage patterns often has pre-
vented investigators from determining whether such care was
appropriate. That is, were the regimen, dose (± reduction for
toxicity), and use of supportive therapies consistent with cur-
rent standards of care? Was the planned treatment completed
or appropriately altered for disease progression? Furthermore,
reports of negative outcomes or unnecessary care are seldom
published, and existing cancer databases (as well as medical
records) are associated with limitations (e.g., incomplete or
inaccurate data).3,4 Therefore, it is difficult to assess the valid-
ity of concerns about inappropriate use of pharmaceuticals in
cancer care.
In addition to the literature and cancer registries, another
major potential source of data about drug prescribing and
usage patterns is the pharmaceutical industry. In 1997, Amgen
initiated a retrospective chart review program, Project
ChemoInsight®, to collect information about adjuvant therapy
for breast cancer.76,77 This program has recently been expanded
to review chart information for patients with non-Hodgkin’s
lymphoma. Their comparative database tracks adjuvant thera-
py for breast cancer across more than 800 sites and provides
information about dose intensity, dose delay, dose reduction,
drug combination, and febrile neutropenia (some sites) in
more than 18,000 patients76,77 This database is considered an
important tool for evaluating physician practice patterns, as it
permits anonymous comparisons of care at both the individ-
ual and group practice level.
Complexities and Variations in Pharmaceutical Therapy for Cancer
The cancer community could:
• Encourage the government and pharmaceutical industry
to develop comparative databases for pharmaceutical
care.
• Ask the government and pharmaceutical industry to
support Phase IV–V studies to see how drugs are being
used, whether they are being used in accordance with
FDA-approved indications, and whether evidence of
underutilization or overutilization exists.
• Promote publication of studies (apart from RCTs) with
sufficient information about pharmaceutical treatment to
permit assessment of technical quality of care.
• Encourage publication of reports that describe care asso-
ciated with negative outcomes or potential unnecessary
care.
• Continue upholding the standard that research by all
groups be carried out in an autonomous manner.
• Address limitations of cancer registries and other data-
bases and encourage the development of new databases.
Ideally, databases should be automated and provide
(1) comprehensive information about all aspects of care
(e.g., patient’s demographics, case mix factors, condi-
tion, treatments, and outcomes; treatment settings;
provider’s specialty; type of delivery system); (2) a means
for monitoring to ensure accuracy of data; and (3) a
means for being linked to other databases.3
Further explore practice variations,
potential quality problems, and gaps
in knowledge related to pharmaceutical
care for cancer
Limited available data suggest that utilization rates of phar-
maceuticals vary with various patient, provider, and health
care system factors. However, methodological limitations of
many of these studies make the significance of these observa-
tions unclear. There is also concern about how recent health
care changes (e.g., new reimbursement policies, increased
market penetration of managed care organizations [MCOs])
may influence the quality of cancer care.2,3 Available data fail
to either address or support such concerns. For example,
despite concern about MCO restrictions on referrals to spe-
cialists and use of some pharmaceuticals, comparison studies
suggest that cancer care in managed care and fee-for-service
settings is comparable.3 However, these studies have been
criticized for multiple methodological limitations (e.g., out-
dated data, small sample sizes, nonrandom case selection)
and do not specifically focus on pharmaceutical care.3 Thus,
there is a need for controlled studies that assess the effect of
system and provider factors on the quality of pharmaceutical
care or identify potential factors associated with better out-
comes, or both. There is also a need for additional studies to
fill in gaps in knowledge. For example, little is known about
patient fears related to therapies (e.g., nausea, hair loss), the
Complexities and Variations in Pharmaceutical Therapy for Cancer
quality of life associated with many treatments, and whether
transitions from curative treatments to end-of-life care (i.e.,
use of supportive agents only) are occurring appropriately.
Studies of cost-effectiveness of agents also are needed to facil-
itate decision making conducive to quality care.
The cancer community could:
• Send a call to public and private sectors for greater finan-
cial investment in health services research.
• Encourage funding agencies to issue requests for pro-
posals for studies that (1) assess the influence of system
and provider factors on the quality of pharmaceutical
care for cancer, (2) identify potential factors associated
with better outcomes, (3) assess the quality of palliative
and end-of-life care, and (4) assess cost-effectiveness.
Improve enrollment rates for adults in
cancer clinical trials
For a number of kinds and stages of cancer, RCTs can provide
access to the best available and most promising new treat-
ments.3 Thus, despite the status of RCTs as “experimental” ther-
apy, many individuals in the cancer community consider access
to them to be an important component of quality cancer care
(e.g., the Oncology Nursing Society [ONS],78 the National
Coalition for Cancer Survivorship [NCCS],79 the American
Federation of Clinical Oncologic Societies80). However, it is esti-
mated that fewer than 2% of cancer patients 50 years of age and
older participate in cooperative clinical trials sponsored by the
NCI.81 This is in stark contrast to the more than 70% of chil-
dren with cancer who participate in RCTs.3 As studies have
linked poor access to care to poor health outcomes, many are
concerned about poor access to RCTs.12,13
A variety of reasons have been proposed for the underenroll-
ment of patients in cancer RCTs. Physicians are thought to
under-refer patients to clinical trials because of concerns
about the patient’s age, health status, ability to travel, and
potential time demands.82,83 Studies also have shown that
patient demographics influence enrollment rates. For exam-
ple, under-representation of African American patients and
women in clinical trials led to federal mandates about the
recruitment of these populations.84 Hutchins et al recently
reported significant under-representation of patients 65 years
and older in Southwest Oncology Group treatment trials con-
ducted from 1993 to 1996.84
Most insurers (e.g., Medicare, most state Medicaid, most
MCOs) limit or deny coverage of the costs of participation in
RCTs for policy reasons.3 This is a major reason for under-refer-
ral of patients to RCTs by physicians.82 For example, 37% of the
oncologists surveyed by Mortenson et al reported “frequent
problems” with coverage of RCTs.49 Approximately 25% of
respondents reported that they “hesitate to prescribe” RCTs
15
based on administrative hassles, and rates of hesitation to pre-
scribe were severalfold higher among oncologists with man-
aged care contracts.49 Klabunde et al similarly concluded that
insurance type influences clinical trial enrollment after review-
ing data from more than 2300 adults evaluated for enrollment
in NCI-sponsored clinical trials.85 They reported that patients
with fee-for-service coverage were more than twice as likely to
be enrolled in a trial than patients with other coverage types,
including managed care. They also reported that patient refusal
accounted for the nonenrollment of almost 40% of those who
were clinically eligible to participate. Thus, Klabunde et al con-
cluded there is a need for continued efforts in educating physi-
cians and the public about the value of RCTs.85
The cancer community could:
• Continue education of consumers, providers, and third-
party payers about the important role of RCTs in devel-
oping new treatments as well as offering promising state-
of-the-art treatments for many patients.
• Encourage research to determine the true cost of clinical
trials and address who should bear the added costs, if any.
• Develop a comprehensive, readily accessible (e.g.,
online) source of information about all cancer clinical
trials for both public and professional use. This could
include integration of existing online sources of infor-
mation.
• Support other efforts to improve third party coverage of
patient costs associated with clinical trials.86
• Explore underlying reasons for potentially high nonen-
rollment rates by eligible patients apart from coverage
issues (e.g., fears or concerns about the experimental
nature of RCTs, fear of placebos).
• Explore concerns that eligibility criteria for clinical trials
are too rigid.
Increase investment in
information systems
Advanced information systems offer a number of means by
which pharmaceutical care can be monitored and improved.
For example, information systems offer the potential to
advance evidence-based health care; improve coordination of
care (e.g., scheduling of chemotherapy); reduce medical (e.g.,
dosing) errors; facilitate comparison of performance of practi-
tioners, plans, and facilities; and support continued research
and innovation.10,74 Information systems also offer a potential
means of simplifying coding and providing reminders for
clinical documentation. Collectively, these features can
encourage quality care by decreasing the likelihood of treat-
ment discontinuities and medical errors, improving efficiency,
reducing administrative demands on clinicians (i.e., more
time to devote to patient care), and facilitating performance
comparisons as a basis for continuous quality improvement.
The major obstacle to implementing advanced information
systems is the significant financial investment required.87
16
The cancer community could:
• Encourage, via education, greater financial investment in
development and implementation of information sys-
tems by both the public and the private sectors.
• Fund research to identify feasible methods and strategies
for development of quality monitoring systems and eval-
uate the cost-effectiveness of such systems.
• Promote development of a national cancer quality mon-
itoring system to ensure collection of timely and mean-
ingful information about cancer care.
Improve development, dissemination, and
implementation of clinical practice
guidelines
Some people have suggested that lack of information is the
main reason for serious quality problems in health care.88,89
Most reports about the quality of health care have concluded
that a stronger commitment to evidence-based medicine is
needed. One means of translating new evidence into clinical
practice is through CPGs. However, the success of CPGs in
changing physicians’ perspectives and practice patterns has
been mixed.3 For example, Hatzell et al recently found little
evidence that an NCI guideline–based educational initiative
did much to heighten rural primary care physicians’ aware-
ness of state-of-the-art colorectal and breast cancer thera-
pies.90 On a postintervention survey, 70% of the physicians
failed to acknowledge chemotherapy as experimental for
Dukes’ B colon cancer; 25% failed to recognize a combination
of surgery, chemotherapy, and radiation as a standard treat-
ment for rectal cancer; and 67% failed to indicate that adju-
vant therapy was an accepted practice for treating Stage I
breast cancer. The low levels of awareness of NCI guidelines
were further reflected by low breast-sparing surgery rates for
women living in the intervention region.90 In addition,
Bennett et al found that the response of oncologists to the
1994 ASCO hematopoietic colony-stimulating factor guide-
lines was mixed.69 Although decreased and more appropriate
use of CSFs was documented in 1997, CSFs were still being
used in some clinical situations (e.g., afebrile and uncompli-
cated febrile neutropenia) despite guideline recommendations
against such therapy.
Failure of CPGs to change oncology practice has been attrib-
uted to a variety of factors, including problems with develop-
ment, dissemination, and implementation.3 Guidelines con-
sidered the most likely to succeed are those with features such
as (1) internal development (input from local providers) or
development by a respected group, (2) dissemination accom-
panied by specific educational interventions, and (3) imple-
mentation plans including patient-specific reminders at the
time of consultation.91,92 However, as illustrated by Hatzell and
colleagues, even dissemination of CPGs via educational initia-
tives does not ensure success.90 In fact, failure to implement
Complexities and Variations in Pharmaceutical Therapy for Cancer
systems with a means of holding providers accountable for
their performance is the likeliest reason for a number of
oncology guideline failures.93 Thus, experts also consider an
essential element of successful CPG implementation to be a
system or mechanism to ensure adherence.91,92 Systems for
ensuring CPG adherence represent the most logical target for
further investigation to improve the success of CPGs in
changing oncologists’ practice patterns.
One mechanism of promoting CPG adherence that appears
promising is the National Comprehensive Cancer Network
(NCCN) Oncology Outcomes Database.94 This outcomes
database measures adherence of NCCN clinicians to NCCN
guidelines and provides clinical and other outcomes data to
evaluate provider performance (i.e., quality of care). Such
systems and databases represent a promising continuous
quality improvement (CQI) method that could be comple-
mented by communication of the guidelines to patients in a
format that is helpful to them. The American Cancer Society
(ACS) and NCCN are currently collaborating on a project in
which NCCN guidelines intended for oncologists are being
translated into an understandable format for patients.95
Patient guidelines for breast cancer and prostate cancer were
introduced by the ACS and NCI in 1999. 95 ASCO also has
introduced patient guidelines for follow-up care for breast
cancer and advanced lung cancer treatment.96
Although guidelines from multiple sources (e.g., NCCN,
ASCO) cover many cancer types, there is still a need to
expand the number of oncology CPGs to include areas of care
not currently covered.3 For example, CPGs could be devel-
oped to guide the appropriate use of chemotherapy in the pal-
liative setting, especially second- and third-line chemothera-
pies. Other potential areas of guideline expansion include
cancer detection, ancillary problems, supportive modalities,
and long-term psychosocial and economic concerns.97
The cancer community could:
• Seek funding for further research to study optimal means
of developing, disseminating, and especially, implement-
ing oncology CPGs. This research should include explo-
ration of mechanisms to ensure adherence and account-
ability, including the use of outcomes databases. There is
also a need for more information about why providers
do not comply with CPGs.
• Expand the number of CPGs to include guidelines for can-
cer types and areas of care not currently covered by CPGs.
Strengthen the hand of the
consumer in health care
Consumers are seeking greater rights and a stronger role in
their health care, as exemplified by the recently proposed
Consumer Bill of Rights and Responsibilities.10 The ONS has
developed a similar bill specifically for cancer patients,98 and
Complexities and Variations in Pharmaceutical Therapy for Cancer
the NCCS has outlined 12 principles to promote quality care
for cancer.79 In February 2000, the Charter of Paris Against
Cancer was signed at the World Summit Against Cancer in the
New Millennium.99 Its 10 major directives include those
directed at protecting and expanding patients’ rights; increas-
ing the commitment to research; improving access to cancer
clinical trials, prevention, and screening programs; and
addressing patients’ quality-of-life issues. Thus, patients’
rights have emerged as a pressing issue in cancer care.
One aspect of patients’ rights relates to the interpersonal qual-
ity of care. Evidence suggests that patients are not being
included in medical decision making, listened to, and provid-
ed appropriate psychosocial support—all of which constitute
basic patient rights. For example, 27% of the women who
underwent mastectomy in one study reported that their sur-
geons had not discussed the option of breast-conserving sur-
gery with them.39 In a survey of terminally ill patients, 41%
reported that they had not discussed their prognosis or wish-
es regarding resuscitation with their providers.100,101 The
Charter of Paris Against Cancer emphasizes the right all patients
have to equal access to information concerning the disease and
treatment options, as well as open and collaborative commu-
nication with health care professionals and scientists.99
Patients with cancer face major psychosocial challenges.
These include adapting to personal consequences of cancer
(e.g., facing loss of a body part or function, relationships, or
financial security), adjusting to social consequences of cancer
(e.g., facing the stigma of cancer, overcoming obstacles to job
security and insurability), and navigating the health care sys-
tem.102 Yet surveys conducted at Memorial Sloan-Kettering
Cancer Center suggest that far less than 10% of the 20%–35%
of cancer patients with significant levels of psychosocial dis-
tress are referred to appropriate resources for help.103 Passik et
al reported that, in their study, physicians only identified 13%
of their cancer patients who manifested symptoms of moder-
ate to severe depression.104 Thus, headway needs to be made
in improving psychosocial support for cancer patients.
In addition to these basic rights, cancer patients and con-
sumers are seeking a more active role in global decision mak-
ing and policy development related to cancer care. The
Charter of Paris Against Cancer acknowledges that individual
and constituency-based patient advocacy has “directly and
favorably impacted the war against cancer” when “rooted in
an understanding of and commitment to quality science and
evidence-based medical practice.”99 It notes that the patient is
“uniquely positioned to focus the overall anti-cancer effort on
eradication of disease and the optimal use of resources.”
Article VII of the charter calls for the medical research, indus-
try, and policy communities to “regard informed patient advo-
cates as key strategic partners in all aspects of the fight against
cancer care, including the advancement of standards of care
and survival.” It also calls for the professional medical com-
munity to recognize the benefit of an informed and active
17
public and to facilitate popular commitment to the scientific
process and evidence-based practice. Thus, consumers
should be included in the development of clinical trials and
CPGs and join the cancer community in promoting the prac-
tice of evidence-based medicine.
Important means of ensuring patients’ rights are via education,
advocacy, and research. Future educational initiatives directed
at providers should address communication and interpersonal
skills and outline specific patient rights. Education directed at
consumers should clarify consumer rights and responsibilities
as well as how consumers may obtain, interpret, and use qual-
ity-related data in medical decision making. Consumers also
should be educated about how they can play a role in improv-
ing health care quality (advocacy). Additional health service
research can facilitate these processes by identifying means of
presenting information to consumers in an easily understood
format and exploring consumer-friendly and cost-effective
means of disseminating this information.10 There is also a need
for research related to psychosocial issues and outcomes.
Other means by which care could be improved for patients
include (1) obtaining input from patients in developing quali-
ty measures; (2) developing databases of patient-based, condi-
tion-specific information about quality of life and other out-
comes to facilitate medical decision making; (3) expanding
interactive systems that allow patients to communicate with
other patients105; and (4) recruiting members from the profes-
sional community (e.g., oncology nurses, ACS volunteers) to
serve as patient advocates.
The cancer community could:
• Educate consumers about patient rights, components of
quality care, and what consumers can do to improve
quality of care.
• Develop educational initiatives targeting provider com-
munication and interpersonal skills and knowledge of
supportive care and patient rights.
18
• Support health service research to (1) develop patient-
focused quality measures (e.g., measures of interperson-
al quality, patient satisfaction, quality of life); (2) devel-
op quality and outcomes databases; and (3) determine
optimal means of disseminating quality-related informa-
tion to consumers.
• Support research to assess psychosocial issues, including
outcomes research (e.g., health-related quality of life,
effectiveness of psychotherapeutic interventions),
exploratory studies (e.g., long-term psychological seque-
lae of cancer, impact of burden on family caregivers),
and comparative/intervention studies (e.g., evaluation of
psychosocial and educational interventions, clinical tri-
als for reducing symptom distress).102
• Recruit members of the professional community (e.g.,
oncology nurses, ACS volunteers) to serve as patient
advocates.
• Support other efforts directed at increasing patients’
rights (e.g., ONS Patient Bill of Rights for Quality Cancer
Care, Treaty of Paris Against Cancer).
Conclusion
Little is known about many aspects of pharmaceutical care for
cancer. The above-described steps outline concrete actions
intended to fill in gaps in knowledge, enhance quality assess-
ment, and optimize application of pharmaceuticals to cancer
care. Critical to the success of these measures is collaboration
between the public and the private sectors. Such collabora-
tion should include, but not be limited to, areas such as
research, education, advocacy, and database and information
system development.
Complexities and Variations in Pharmaceutical Therapy for Cancer
Appendix
National Roundtable on Health Care Quality
As part of a 1994 initiative, the Institute of Medicine (IOM)
assembled the National Roundtable on Health Care Quality to
measure, monitor, and improve health care in the U.S.7 After
reviewing the available data, this group of consumers, health
care experts, clinicians, and representatives from business,
government, and managed care organizations concluded that
“serious and widespread quality problems exist throughout
American medicine.” Their consensus statement, describing
“large gaps between care people should receive and care they
do receive,” was published in the Journal of the American
Medical Association in 1998.
President’s Advisory Commission on Consumer
Protection and Quality in the Health Care Industry
The President’s Advisory Commission (PAC) also reviewed the
literature as part of their mission to promote and ensure con-
sumer protection and health care quality.10 Similar to the
National Roundtable panel, this commission concluded:
“While most Americans receive high-quality care, too many
patients receive substandard care.”10 Their final (1998) report,
Quality First: Better Health Care for All Americans, describes
four types of quality problems: underuse, overuse, and varia-
tions in use of services, and medical errors.
Committee on Quality of Health Care in America
In 1998, the IOM assembled the Committee on Quality of
Health Care in America to develop a strategy that would result
in a threshold improvement in health care quality over the
Complexities and Variations in Pharmaceutical Therapy for Cancer
next 10 years. 27 Their 1999 report, To Err Is Human: Building
a Safer Health System, addresses issues related to patient safe-
ty, a subset of overall quality-related concerns, and lays out an
agenda for reducing errors in health care and improving
patient safety. While the committee believes there is still much
to learn about the types of errors committed in health care
and why they occur, they believe enough is known to recog-
nize that a serious concern exists for patients. Two large stud-
ies, one conducted in Colorado and Utah and another in New
York, found that adverse events occurred during 2.9% and
3.7% of hospitalizations, respectively.106–108 In both studies,
more than half of the adverse events occurred because of pre-
ventable medical errors. Total national costs of preventable
adverse events (medical errors resulting in injury) are esti-
mated to be between $17 billion and $29 billion109,110 and
medication errors alone are thought to account for more than
7000 deaths annually.111
RAND
A 1998 RAND study, “How Good is the Quality of Health
Care in the United States?,” synthesized results from 48 arti-
cles describing services delivered to half a million people for
a broad range of conditions and across many settings.2 These
researchers concluded that large gaps in care exist (1) for all
types of care (preventive, acute, and chronic); (2) in different
types of health facilities; (3) for different types of health insur-
ance; (4) for all age groups; and (5) across the whole country
as well as in individual locations.
19
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