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Adjuvant capecitabine and oxaliplatin for gastric cancer after D2 gastrectomy (CLASSIC): a phase 3 open-label, randomised controlled trial.

Authors
 Yung-Jue Bang  ;  Young-Woo Kim  ;  Han-Kwang Yang  ;  Hyun Cheol Chung  ;  Young-Kyu Park  ;  Kyung Hee Lee  ;  Keun-Wook Lee  ;  Yong Ho Kim  ;  Sang-Ik Noh  ;  Jae Yong Cho  ;  Young Jae Mok  ;  Yeul Hong Kim  ;  Jiafu Ji  ;  Ta-Sen Yeh  ;  Peter Button  ;  Florin Sirzén  ;  Sung Hoon Noh 
Citation
 LANCET, Vol.379(9813) : 315-321, 2012 
Journal Title
 LANCET 
ISSN
 0140-6736 
Issue Date
2012
MeSH
Adenocarcinoma/drug therapy* ; Adenocarcinoma/mortality ; Adenocarcinoma/surgery ; Aged ; Antineoplastic Combined Chemotherapy Protocols/adverse effects ; Antineoplastic Combined Chemotherapy Protocols/therapeutic use* ; Capecitabine ; Chemotherapy, Adjuvant* ; Deoxycytidine/administration & dosage ; Deoxycytidine/adverse effects ; Deoxycytidine/analogs & derivatives ; Disease-Free Survival ; Female ; Fluorouracil/administration & dosage ; Fluorouracil/adverse effects ; Fluorouracil/analogs & derivatives ; Gastrectomy* ; Humans ; Male ; Middle Aged ; Organoplatinum Compounds/administration & dosage ; Organoplatinum Compounds/adverse effects ; Stomach Neoplasms/drug therapy* ; Stomach Neoplasms/mortality ; Stomach Neoplasms/surgery ; Survival Rate
Keywords
Adenocarcinoma/drug therapy* ; Adenocarcinoma/mortality ; Adenocarcinoma/surgery ; Aged ; Antineoplastic Combined Chemotherapy Protocols/adverse effects ; Antineoplastic Combined Chemotherapy Protocols/therapeutic use* ; Capecitabine ; Chemotherapy, Adjuvant* ; Deoxycytidine/administration & dosage ; Deoxycytidine/adverse effects ; Deoxycytidine/analogs & derivatives ; Disease-Free Survival ; Female ; Fluorouracil/administration & dosage ; Fluorouracil/adverse effects ; Fluorouracil/analogs & derivatives ; Gastrectomy* ; Humans ; Male ; Middle Aged ; Organoplatinum Compounds/administration & dosage ; Organoplatinum Compounds/adverse effects ; Stomach Neoplasms/drug therapy* ; Stomach Neoplasms/mortality ; Stomach Neoplasms/surgery ; Survival Rate
Abstract
BACKGROUND: D2 gastrectomy is recommended in US and European guidelines, and is preferred in east Asia, for patients with resectable gastric cancer. Adjuvant chemotherapy improves patient outcomes after surgery, but the benefits after a D2 resection have not been extensively investigated in large-scale trials. We investigated the effect on disease-free survival of adjuvant chemotherapy with capecitabine plus oxaliplatin after D2 gastrectomy compared with D2 gastrectomy only in patients with stage II-IIIB gastric cancer. METHODS: The capecitabine and oxaliplatin adjuvant study in stomach cancer (CLASSIC) study was an open-label, parallel-group, phase 3, randomised controlled trial undertaken in 37 centres in South Korea, China, and Taiwan. Patients with stage II-IIIB gastric cancer who had had curative D2 gastrectomy were randomly assigned to receive adjuvant chemotherapy of eight 3-week cycles of oral capecitabine (1000 mg/m(2) twice daily on days 1 to 14 of each cycle) plus intravenous oxaliplatin (130 mg/m(2) on day 1 of each cycle) for 6 months or surgery only. Block randomisation was done by a central interactive computerised system, stratified by country and disease stage. Patients, and investigators giving interventions, assessing outcomes, and analysing data were not masked. The primary endpoint was 3 year disease-free survival, analysed by intention to treat. This study reports a prespecified interim efficacy analysis, after which the trial was stopped after a recommendation by the data monitoring committee. The trial is registered at ClinicalTrials.gov (NCT00411229). FINDINGS: 1035 patients were randomised (520 to receive chemotherapy and surgery, 515 surgery only). Median follow-up was 34·2 months (25·4-41·7) in the chemotherapy and surgery group and 34·3 months (25·6-41·9) in the surgery only group. 3 year disease-free survival was 74% (95% CI 69-79) in the chemotherapy and surgery group and 59% (53-64) in the surgery only group (hazard ratio 0·56, 95% CI 0·44-0·72; p<0·0001). Grade 3 or 4 adverse events were reported in 279 of 496 patients (56%) in the chemotherapy and surgery group and in 30 of 478 patients (6%) in the surgery only group. The most common adverse events in the intervention group were nausea (n=326), neutropenia (n=300), and decreased appetite (n=294). INTERPRETATION: Adjuvant capecitabine plus oxaliplatin treatment after curative D2 gastrectomy should be considered as a treatment option for patients with operable gastric cancer. FUNDING: F Hoffmann-La Roche and Sanofi-Aventis.
Full Text
http://www.sciencedirect.com/science/article/pii/S0140673611618734
DOI
22226517
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Surgery (외과학교실) > 1. Journal Papers
1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers
Yonsei Authors
Noh, Sung Hoon(노성훈) ORCID logo https://orcid.org/0000-0003-4386-6886
Chung, Hyun Cheol(정현철) ORCID logo https://orcid.org/0000-0002-0920-9471
Cho, Jae Yong(조재용) ORCID logo https://orcid.org/0000-0002-0926-1819
URI
https://ir.ymlib.yonsei.ac.kr/handle/22282913/91380
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