Hermans J, Bonenkamp J J, Boon M C, Bunt A M, Ohyama S, Sasako M, Van de Velde C J
Department of Medical Statistics, University of Leiden, The Netherlands.
J Clin Oncol. 1993 Aug;11(8):1441-7. doi: 10.1200/JCO.1993.11.8.1441.
An overview is presented of reports published since 1980, in which postoperative adjuvant chemotherapy is compared with surgery alone for patients with gastric cancer. A MEDLINE literature review yielded 123 reports, 14 of which were relevant randomized trials; data from 11 of these trials were (or became) available for analysis of crude mortality odds. These 11 trials included 2,096 patients.
Odds ratios were calculated by comparing the adjuvant treatment arm with the observation-only arm. Those odds ratios that could be considered homogeneous yielded an estimated common odds ratio of 0.88 (95% confidence interval [CI], 0.78 to 1.08), which was slightly, but far from significantly, in support of adjuvant treatment.
The results confirm the common opinion that the adjuvant chemotherapy regimens prescribed in these trials, although effective in phase II studies, do not improve survival. Furthermore they indicate that postoperative chemotherapy in general offers no additional survival benefit for patients with curatively resected gastric cancer.
In conclusion, at present, postoperative chemotherapy cannot be considered as standard adjuvant treatment. New trials of adjuvant therapy for gastric cancer must include a no-treatment control arm.
对1980年以来发表的报告进行综述，其中比较了胃癌患者术后辅助化疗与单纯手术的疗效。通过医学文献数据库（MEDLINE）检索文献，共获得123篇报告，其中14篇为相关随机试验；这14项试验中的11项试验数据（或后来获得的数据）可用于分析粗死亡率比值。这11项试验共纳入2096例患者。
通过比较辅助治疗组与单纯观察组计算比值比。对那些可认为具有同质性的比值比进行合并，得出估计的共同比值比为0.88（95%置信区间[CI]，0.78至1.08），这略微支持辅助治疗，但远未达到显著水平。
结果证实了普遍观点，即这些试验中规定的辅助化疗方案虽然在II期研究中有效，但并不能提高生存率。此外，结果还表明，总体而言，术后化疗对接受根治性切除的胃癌患者并无额外的生存益处。
总之，目前术后化疗不能被视为标准的辅助治疗方法。新的胃癌辅助治疗试验必须包括一个不进行治疗的对照组。
