Bouché O, Ychou M, Burtin P, Bedenne L, Ducreux M, Lebreton G, Baulieux J, Nordlinger B, Martin C, Seitz J F, Tigaud J M, Echinard E, Stremsdoerfer N, Milan C, Rougier P
University Hospital, Reims, France.
Ann Oncol. 2005 Sep;16(9):1488-97. doi: 10.1093/annonc/mdi270. Epub 2005 Jun 6.
The aim of this study was to evaluate the efficacy of adjuvant chemotherapy after resection for gastric cancer in a randomized controlled trial.
After curative resection, stage II-III-IVM0 gastric cancer patients were randomly assigned to postoperative chemotherapy or surgery alone. 5-Fluorouracil (5-FU) 800 mg/m(2) daily (5-day continuous infusion) was initiated before day 14 after resection. One month later, four 5-day cycles of 5-FU (1 g/m(2) per day) plus cisplatin (100 mg/m(2) on day 2) were administered every 4 weeks.
The study was closed prematurely after enrollment of 260 patients (79.7% N+), owing to poor accrual. At 97.8 months median follow-up, 5- and 7-year overall survival were 41.9% and 34.9% in the control group versus 46.6% and 44.6% in the chemotherapy group (P=0.22). Cox model hazard ratios were 0.74 [95% confidence interval (CI) 0.54-1.02; P=0.063] for death and 0.70 (95% CI 0.51-0.97; P=0.032) for recurrence. An invaded/removed lymph nodes ratio >0.3 was the main independent poor prognostic factor identified by multivariate analysis (P=0.0001). Because of toxicity, only 48.8% of patients received more than 80% of the planned dose.
There was no statistically significant survival benefit with this toxic cisplatin-based adjuvant chemotherapy, but a risk reduction in recurrence was observed.
本研究的目的是在一项随机对照试验中评估胃癌切除术后辅助化疗的疗效。
根治性切除术后，II - III - IVM0期胃癌患者被随机分配至术后化疗组或单纯手术组。在切除术后第14天之前开始每日静脉输注5-氟尿嘧啶（5-FU）800mg/m²（连续输注5天）。1个月后，每4周进行4个为期5天的周期化疗，方案为5-FU（每日1g/m²）联合顺铂（第2天100mg/m²）。
由于入组不佳，在纳入260例患者（79.7%为N+）后，该研究提前终止。在97.8个月的中位随访期，对照组的5年和7年总生存率分别为41.9%和34.9%，化疗组分别为46.6%和44.6%（P = 0.22）。Cox模型死亡风险比为0.74[95%置信区间（CI）0.54 - 1.02；P = 0.063]，复发风险比为0.70（95%CI 0.51 - 0.97；P = 0.032）。多因素分析确定侵袭/切除淋巴结比值>0.3是主要的独立不良预后因素（P = 0.0001）。由于毒性，只有48.8%的患者接受了超过计划剂量80%的化疗。
这种基于顺铂的毒性辅助化疗在生存方面没有统计学上的显著获益，但观察到复发风险有所降低。
