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Gastrectomy Plus Chemotherapy Versus Chemo-Therapy Alone For Advanced Gastric Cancer With A Single Non-Curable Factor (Regatta)
Gastrectomy Plus Chemotherapy Versus Chemo-Therapy Alone For Advanced Gastric Cancer With A Single Non-Curable Factor (Regatta)
Gastrectomy Plus Chemotherapy Versus Chemo-Therapy Alone For Advanced Gastric Cancer With A Single Non-Curable Factor (Regatta)
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
Results
Discussion
Conclusion
Introduction
Advance gastric cancer
With non-curable factors
Poor
prognosis
most
patients die
within 1
year
Chemotherapy
Standard of
care
Introduction
Palliative resection
When
Introduction
1980-early 2000s
Improve OS
Median OS
Introduction
Retrospective
Single institutional case series
Selection bias : Gastrectomy
good ECOG, few comobidities,
small tumor burden
Limitation
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
Results
Results
Results : OS
13.7-19.8
11.8-16.3
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
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
Affect outcome
Limitation
3. Quality of life
not done
4. Nutritional parameters
not done
Conclusion
LOGO
Thank You !