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Adjuvant capecitabine and oxaliplatin for gastric cancer after D2 gastrectomy (CLASSIC): A phase 3 open-label, randomized controlled trial
The Lancet - Early Online Publication, 01/09/2012
Clinical Article
Bang YJ et al. – Adjuvant capecitabine plus oxaliplatin treatment after curative D2 gastrectomy should be considered as a treatment option for patients with operable gastric cancer.
Methods- Capecitabine and oxaliplatin adjuvant study in stomach cancer (CLASSIC) study was an open-label, parallel-group, phase 3, randomized 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/m2 twice daily on days 1 to 14 of each cycle) plus intravenous oxaliplatin (130 mg/m2 on day 1 of each cycle) for 6 months or surgery only
- Block randomiZation 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
- Primary endpoint was 3 year disease-free survival, analysed by intention to treat
- Study reports a prespecified interim efficacy analysis, after which the trial was stopped after a recommendation by the data monitoring committee
- 1035 patients were randomized (520 to receive chemotherapy and surgery, 515 surgery only)
- Median follow-up was 34·2 months (25·4—41·7) in 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 (HR 0·56, 95% CI 0·44—0·72; p<0·0001)
- Grade 3 or 4 AEs 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
- Most common AEs in intervention group were nausea (n=326), neutropenia (n=300), and decreased appetite (n=294)