Schippinger W, Samonigg H, Schaberl-Moser R, Greil R, Thödtmann R, Tschmelitsch J, Jagoditsch M, Steger G G, Jakesz R, Herbst F, Hofbauer F, Rabl H, Wohlmuth P, Gnant M, Thaler J
Department of Internal Medicine, Medical University of Graz, A-8036 Graz, Austria.
Br J Cancer. 2007 Oct 22;97(8):1021-7. doi: 10.1038/sj.bjc.6604011. Epub 2007 Sep 25.
The purpose of this trial was to investigate the efficacy of adjuvant chemotherapy with 5-fluorouracil (5-FU) and leucovorin (LV) in stage II colon cancer. Patients with stage II colon cancer were randomised to either adjuvant chemotherapy with 5-FU/LV (100 mg m(-2) LV+450 mg m(-2) 5-FU weekly, weeks 1-6, in 8 weeks cycles x 7) or surveillance only. Five hundred patients were evaluable for analyses. After a median follow-up of 95.6 months, 55 of 252 patients (21.8%) have died in the 5-FU/LV arm and 58 of 248 patients (23.4%) in the surveillance arm. There was no statistically significant difference in overall survival (OS) between the two treatment arms (hazard ratios, HR 0.88, 95% CI 0.61-1.27, P=0.49). The relative risk for tumour relapse was higher for patients on the surveillance arm than for those on the 5-FU/LV arm; however, this difference was not statistically significant (HR 0.69, 95% CI 0.45-1.06, P=0.09). Consequently, disease-free survival (DFS) was not significantly different between the two trial arms. In conclusion, results of this trial demonstrate a trend to a lower risk for relapse in patients treated with adjuvant 5-FU/LV for stage II colon cancer. However, in this study with limited power to detect small differences between the study arms, adjuvant chemotherapy failed to significantly improve DFS and OS.
本试验的目的是研究5-氟尿嘧啶（5-FU）和亚叶酸钙（LV）辅助化疗在II期结肠癌中的疗效。II期结肠癌患者被随机分为接受5-FU/LV辅助化疗组（第1 - 6周，每周100mg/m² LV + 450mg/m² 5-FU，8周为1个周期，共7个周期）或仅接受监测组。500例患者可纳入分析。中位随访95.6个月后，5-FU/LV组252例患者中有55例（21.8%）死亡，监测组248例患者中有58例（23.4%）死亡。两组治疗方案的总生存期（OS）无统计学显著差异（风险比，HR 0.88，95%可信区间0.61 - 1.27，P = 0.49）。监测组患者肿瘤复发的相对风险高于5-FU/LV组患者；然而，这种差异无统计学显著性（HR 0.69，95%可信区间0.45 - 1.06，P = 0.09）。因此，两组的无病生存期（DFS）无显著差异。总之，本试验结果表明，II期结肠癌患者接受5-FU/LV辅助化疗后复发风险有降低趋势。然而，在本研究中，检测两组间微小差异的效能有限，辅助化疗未能显著改善DFS和OS。
