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Gastrectomy
plus
chemotherapy
versus chemotherapy alone
for
advanced gastric cancer with
a single non-curable factor
(REGATTA):
Kazumasa Fujitani, Han-Kwang Yang,
Junki Mizusawa, et.al. The Lancet
Oncology Volume 17, Issue 3, Pages 309318

Narueta Srisuk
Vachiraphuket Hospital

Contents
1

Introduction

Patients and Methods

Results

Discussion

Conclusion

Introduction
Advance gastric cancer
With non-curable factors

Hepatic, peritoneal, or distant lymph node metastases

Poor
prognosis
most
patients die
within 1
year

Chemotherapy
Standard of
care

Introduction
Palliative resection
When

The presence of major symptoms such as

bleeding or obstruction
Why

To reduce tumor volume

Introduction
1980-early 2000s

Advance gastric cancer with

a single non-curable factor
Gastrectomy + Chemotherapy
Absence of any serious symptoms
(bleeding and obstruction)

Improve OS
Median OS

8.0-12.2 mo with gastrectomy

2.4-6.7 mo without gastrectomy

Introduction

Retrospective
Single institutional case series
Selection bias : Gastrectomy
good ECOG, few comobidities,
small tumor burden

Limitation

None was randomised

www.themegallery.com

Objective
To investigate the additional of
gastrectomy to standard chemotherapy
Improves overall survival among patients
with a single non-curable advanced gastric
cancer
Superiority trial in phase III open label,
first randomised controlled trial

Objective
Primary endpoints
- Overall survival (OS)
[Superiority]
- Sample size : 330 pt (165 pt/gr)
- One-sided alpha 5% & 80% power
- To detect a 2-year survival difference
of 10% (20% with chemotherapy alone vs 30% with
gastrectomy plus chemotherapy)

Objective
Secondary endpoints
- Progression Free Survival (PFS)
- Safety
Adverse events associated with either
gastrectomy or chemotherapy
CTCAE version 3.0 ; monthly
CT abdominal, CEA and CA19-9
; every 3 months

Objective
Statistical Analysis
- 1st Interim analysis
date at which half of sample size
- 2nd Interim analysis
the entired planned sample size
- Kaplan-Meier Methods
- Log-rank tests : DFS, OS
- Cox models : HR
- Preplanned & Post-hoc subgroup
analysis :Interaction between treatment & subgroup

Methods
Inclusion Criteria
- Gastric cancer T1-3
- No metastasis other than
: Hepatic metastasis (H1)
: Peritoneal metastasis (P1)
: Para-aortic LN (16a1/b2)
- No apparent pleural effusion or thoracotomy
- ECOG PS 0-1
- Sufficient oral intake without active bleeding from tumor
- No previous treatment for gastric cancer except endoscopic
submucosal dissection
- Adequate organ and bone marrow function
- Written informed consent

Methods
Exclusion Criteria
- Active coexisting cancer
effect OS
- Pregnant or breastfeeding
- Severe mental disorder
- Active infection
- Systemic administration of corticosteroids; flucytosine,
phenytion, or warfarin treatment
- Comobidities
; CVD, unstable hypertension, DM and severe
respiratory disease requiring continuous oxygen treatment
- HER2 positive
; Trastuzumab
standard treatment

Methods
Gastrectomy plus Chemotherapy
total, distal, or proximal gastrectomy with D1 LN dissection
8 weeks after surgery followed by Chemotherapy regimen

Advanced
gastric cancer
Single noncurable factor
: H1,P1 or
LN 16a1/b2

R
1:1
1:1

Chemotherapy alone
Oral S-1 : days 1-21
BSA <1.25 m22, 80 mg;
1.251.5 m22, 100 mg and
Cisplatin 60 mg/m22 : day 8
Cycle repeated q 5 weeks

>1.5 m22, 120 mg)

Results

Results

Results : OS

Median (mo) 95%CI

16.6
14.3

13.7-19.8
11.8-16.3

Results : 2 years PFS

2 yrs PFS
8.4%
13.0%

95%CI
3.7-15.5
6.9-21.2

Results

Results
Number of Chemotherapy Cycles delevered by tumor location

Results: Safety

Discussion
2 years Overall Survival
Gastrectomy plus chemotherapy did not
superior to chemotherapy alone in a survival advantage
of advanced gastric cancer with a single non-curable factor

Limited power to detect a difference between

groups
Study was terminated before the planned
sample size was accrued

Discussion
Post-hoc subgroup analysis
Location with upper-third tumor
Gastrectomy + CMT significantly worse OS
Median number of CMT cycles reduce after
gastrectomy to half of that for CMT alone
Compliance with chemotherapy after gastrectomy
Total gastrectomy < other types of gastrectomy

Discussion
Post-hoc subgroup analysis
Clinical N Stage (N0-1)
Gastrectomy + CMT significantly worse OS
Median number of CMT cycles was higher in
CMT alone

Discussion
Primary tumor location
Not balanced between groups
If Inclusion Criteria
restricted to the patient with lower-third tumor

Positive Outcome

Discussion
GYMSSA trial
ongoing another randomised trial
Gastrectomy + Metastasectomy followed by
systemic treatment VS Systemic therapy alone
Differ from this study
Focused on pure reduction surgery without
matastasectomy

Limitation
1. Planned sample size
early termination
restricting the statistical power to support conclusion

2. Quality of the study : Partly impaired

5% pt >> ineligible
14% pt >> didnt receive CMT

Affect outcome

Limitation
3. Quality of life
not done

4. Nutritional parameters
not done

Conclusion

Gastrectomy plus chemotherapy cannot be

justified to treat patients with advanced gastric
cancer, even with a single non-curable factor.
Chemotherapy alone remains the
Standard of care for these patients.

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