[ News ] Analysis ] Commentary ] Controversy ] June 25, 2013 ] Vol. 35 ] No.

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The Independent Hem/Onc News Source
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Oncology Drug Shortage Update

BY HEATHER LINDSEY

A new survey documents that cancer drug shortages have occurred

frequently, led to treatment delays, increased the risks of errors and
adverse outcomes, complicated research, and increased the costs of medications.
The survey, by the Hematology-Oncology Pharmacy Association, is the first to
focus specifically on oncology. Page 14

•  Advanced NSCLC: 60 Gy Standard

•  Seminoma: Opting Out of Adjuvant Therapy Safe
Lung Cancer: •  Immunotherapy ‘Poised to Change Treatment Paradigm’ Leukemia Researcher Lukas
Meeting Spotlights •  DLBCL: CT Surveillance Adds Little Value Wartman Describes 10-Year
Progress in Molecularly •  CLL: Enthusiasm for Idelalisb Personal Battle Against
Guided Therapy p.10 •  Fitness & Cancer Prognosis  pp.18, 25, 28, 33, 36, 37 Adult ALL p.20

[ A L S O ] SHOP TALK������������������������������������������������������������������������������������������3
EDITH PEREZ: How I Treat Patients with Advanced HER2-Positive Breast Cancer ��������������������5
Exercise, Estrogen, & Breast Cancer Risk: New Data��������������������������������������������������������������������11
JOE SIMONE: Changing Views of Leaders and Leadership ��������������������������������������������������������16
Science Symposium for ACS’s 100th Anniversary��������������������������������������������������������������������������24
GEORGE SLEDGE: On Buildings����������������������������������������������������������������������������������������������32
Stronger ‘Alliance’ Leads to Better Compliance, Enhanced Well-Being������������������������������������������34
POETRY by Cancer Caregivers����������������������������������������������������������������������������������������������������40

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 18
For Advanced Patients with Advanced NSCLC,
oncology times • june 25, 2013 • oncology-times.com
60 Gy Dose for Radiation Therapy Still the Standard
BY ROBERT H. CARLSON
R
adiation oncologists have de-
bated for years whether a dose
higher than the standard 60 Gy
would lead to better outcomes in
non-small cell lung cancer (NSCLC).
The answer is in—it does not.
In a Phase III study comparing 60 vs.
74 Gy in patients with advanced NSCLC
undergoing concurrent chemotherapy,
­patients receiving the higher dose had a
56 percent greater risk of death than did
those receiving 60 Gy, and a 37 percent
greater risk of local failure.
The standard-dose was also associated
with significantly fewer treatment-related
deaths.
“I’m sure many The RTOG 0617 study was highlighted
doctors were in a news conference by the American Society
of Clinical Oncology, held in advance of the
expecting that Annual Meeting (Abstract 7501).
“After a decade of research, we can
using the higher ­finally close the chapter on the high-dose
dose would have vs. s­tandard-dose therapy debate in lung
cancer therapy,” said ASCO President
a better outcome, Sandra M. Swain, MD. And while 60 Gy
is the standard dose for this patient
so these were very ­population, “I’m sure many doctors were
surprising results, expecting that using the higher dose would
have a better outcome, so these were very
especially using surprising results, especially using the bet-
ter radiation techniques that were designed
the better radiation to be more precise.”
techniques that One of those sur-
prised was the study’s
were designed to lead author, Jeffrey
D. Bradley, MD,
be more precise.” Professor of Radiation
Oncology at Washington University
School of Medicine in St. Louis, who
noted that earlier Phase I and Phase II
clinical trials with high-dose radiotherapy
in NSCLC did show promising increases
in median survival.
“But a lot of Phase III trials turn out
negative when the Phase II trials were
looking good—that’s why we do Phase
III trials,” said Bradley, representing the
Radiation Therapy Oncology Group.
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He said the researchers expected at the
outset of RTOG 0617 that high-dose radia-
tion therapy would lead to better outcomes.
“We were surprised, though also pleased,
to discover that less-intense treatment led
to better control of cancer progression and
spread, and even improved overall survival.”
“After a decade of
research, we can finally
close the chapter on the
high-dose vs. standard-
dose therapy debate in
lung cancer therapy.”
From 464 patients with Stage III NSCLC,
the researchers randomly selected patients to
receive radiation at 60 Gy or 74 Gy. All pa-
tients received concurrent weekly paclitaxel
(45 mg/m2) and carboplatin (AUC=2). The
study had a double randomization, and ap-
proximately half of the patients were ran-
domly selected to r­eceive cetuximab, in a
400 mg/m2 loading dose on day 1 followed
by weekly doses of 250 mg/m2.
For 419 patients eligible for analysis,
at a median follow up of 17.2 months,
­median survival was 28.7 months for the
60 Gy arm (213 patients) vs. 19.5 months
for the 74 Gy arm (206).
The 18-month overall survival rates
were approximately 67 percent vs. 54 per-
cent, respectively.
“The survival data for both study arms
were higher than what has been seen in
previous RTOG studies,” Bradley said.
The rates of Grade 3/4 adverse events
were about 74 and 78 percent, respectively,
and the only large statistically significant
JEFFREY D. BRADLEY, MD: “A lot of
Phase III trials turn out negative when
the Phase II trials were looking good—
that’s why we do Phase III trials. … We
were surprised, though also pleased, to
discover that less-intense treatment led
to better control of cancer progression
and spread, and even improved overall
survival.”
difference was in esophagitis, with a 37 per-
cent increased risk in the high-dose arm.
The primary cause of death was lung
cancer, similar in both groups at 72.2 vs.
73.5 percent, respectively. But
there were more treatment-related
deaths on the 74 Gy arm—10, vs.
two on the 60 Gy arm.
Local failure rates were quite
­different—about 25 percent at 18 months
for 60 Gy vs. 39 percent for 74 Gy. The
­distant failure rates were approximately
42 vs. 48 percent, respectively.
Bradley said higher radiation dose,
higher esophagitis/dysphagia grade, greater
gross tumor volume, and heart volume
above 5 Gy were predictive of less favorable
overall survival on multivariate analysis.
The high-dose arm was closed after an
interim analysis showed that it was not su-
perior to the standard-dose arm, as Bradley
reported at the plenary session of the
American Society for Radiation Oncology
Annual Meeting. He noted that the new
data, on the overall survival ­benefit of 60 Gy,
is independent of the effect of ­cetuximab,
and that patients receiving 60 Gy with or
without cetuximab are still being followed.
“At this point there is no clear reason
for the lack of benefit in the high-dose
arm,” he said, noting that one possible
explanation is increased dose to the heart,
although left ventricular ejection fractions
were not evaluated by the researchers.
Other possible explanations are
­extended therapy duration, unreported
toxicities, or possible too-tight margins in
the high-dose arm.
The study was supported by grants
from the National Cancer Institute and Eli
Lilly and Company. OT