A comparative clinical assessment of combination chemotherapy in the management of advanced gastric carcinoma
A comparative clinical assessment of combination chemotherapy in the management of advanced gastric carcinoma
复制标题
联合化疗治疗晚期胃癌的临床比较评估
作者：
M. O’connell
本报告总结了一项比较4种联合化疗方案（5-FU，阿霉素+丝裂霉素C（FAMi）; 5-FU，阿霉素+甲基-CCNU（FAMe）; 5-FU，ICRF-159 +甲基-CCNU（FIMe）和5-FU +甲基-CCNU（FMe））的晚期胃癌随机多机构临床试验的结果。181例可评价患者接受化疗。在59例具有可测量的指示病灶的患者中观察到这些客观肿瘤缓解率：FAMi，3/12（25%）; FAMe，3/10（30%）; FIMe，4/19（21%）; FMe，1/18（6%）。四个治疗组的生存分布显著不同（P < 0.05），观察到这些中位生存期（从化疗开始的周数）：FAMi，29.6; FAMe，34.4; FMe，22.9; FIMe，17.4。当使用考克斯协变量模型分析时，发现两个非治疗变量与生存率显著相关：治疗前的体力状态（P < 0.0001）和有无可测量的转移性疾病（P < 0.001）。在对这些和其他临床变量的影响进行调整后，发现两种治疗方案与改善生存率相关：FAMi治疗（P < 0.01）和FAMe治疗（P = 0.07）。毒性一般为中度，主要包括胃肠道副作用和骨髓抑制。结论：FAMi和FAMe方案治疗晚期胃癌上级FIMe和FMe方案。
This report summarizes the results of a randomized multi‐institutional clinical trial in advanced gastric carcinoma comparing four combination chemotherapy regimens: 5‐FU, Adriamycin + mitomycin C (FAMi); 5‐FU, Adriamycin + methyl‐CCNU (FAMe); 5‐FU, ICRF‐159 + methyl‐CCNU (FIMe); and 5‐FU + methyl‐CCNU (FMe). One‐hundred‐eighty‐one evaluable patients received chemotherapy. These objective tumor response rates were observed among the 59 patients with measurable indicator lesions: FAMi, 3/12 (25%); FAMe, 3/10 (30%); FIMe, 4/19 (21%); FMe, 1/18 (6%). The survival distributions for the four treatment groups were significantly different (P < 0.05), with these median survivals observed (in weeks from the onset of chemotherapy): FAMi, 29.6; FAMe, 34.4; FMe, 22.9; FIMe, 17.4. Two nontreatment variables were found to be significantly associated with survival when analyzed using the Cox covariate model: pretreatment performance status (P < 0.0001), and presence or absence of measurable metastatic disease (P < 0.001). After adjustments for the effects of these and other clinical variables, two treatment regimens were found to be associated with improved survival: FAMi therapy (P < 0.01), and FAMe therapy (P = 0.07). Toxicity was, in general, moderate and consisted primarily of gastrointestinal side effects and myelosuppression. We conclude that the FAMi and FAMe regimens are superior to the FIMe and FMe regimens in the management of advanced gastric cancer.