| D2胃切除後の胃癌に対するカペシタビンとオキサリプラチンの補助療法を評価した第Ⅲ相無作為化オープン比較試験 |
| D2胃切除：胃に血液を送り込んでいる血管に沿うリンパ節も一緒に切除する手術 | ||
| カペシタビン：フルオロウラシル（5-FU）のプロドラッグで，結腸・直腸癌や胃癌の組織内で高濃度の5-FUに変換 | ||
| オキサリプラチン：白金含有抗癌剤で5-FU製剤との併用によりすぐれた抗腫瘍効果を発揮 | ||
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| D2胃切除を受けたステージⅡ～ⅢBの胃癌患者にカペシタビンとオキサリプラチンを併用投与した群（投与群）と何も投与しなかった群（非投与群）における3年間無症候生存率を比較したところ，投与群では74％，非投与群では59％であった。グレード3ないし4の有害事象発現率は投与群で56％，非投与群で6％であったが，投与群でもっともよくみられたものは吐き気，好中球減少症，および食欲減退であった。D2胃切除後の補助療法剤の選択肢に，カペシタビンとオキサリプラチンの併用を入れてもよいことを示唆している。 | ||
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| Abstract | ||
| Adjuvant capecitabine and oxaliplatin for gastric cancer after D2 gastrectomy (CLASSIC): a phase 3 open-label, randomised controlled trial | ||
| Bang, Y-J et al. for the CLASSIC trial investigators | ||
| 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/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 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. (The Lancet, Volume 379, Issue 9813, Pages 315 - 321, 28 January 2012) |
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