Cellerino R, Tummarello D, Porfiri E, Guidi F, Isidori P, Raspugli M, Biscottini B, Fatati G
Clinica Oncologica, Università di Ancona, Italy.
Eur J Cancer Clin Oncol. 1988 Dec;24(12):1839-43. doi: 10.1016/0277-5379(88)90095-8.
From April 1985 to September 1987, 92 patients with advanced NSCLC were randomized to receive cytotoxic chemotherapy, Arm A (treated), or supportive care, Arm B (control). Chemotherapy consisted of the CEP combination (cyclophosphamide 500 mg/m2 i.v. day 1; epirubicin 50 mg/m2 i.v. day 1; cisplatin 80 mg/m2 i.v. day 1) alternated every 4 weeks with the MEC' combination (methotrexate 30 mg/m2 i.v. day 1; etoposide 200 mg/m2 i.v. day 1; CCNU 70 mg/m2 per os, day 1) until progression. Eight-nine patients (44 treated and 45 controls) were eligible for survival and 77 evaluable for response (38 treated and 39 controls). Response rate was: in Arm A, 8/38 (21%) partial response, 20/38 (53%) stable disease and 10/38 (26%) progressive disease; in Arm B, 18/39 (46%) stable disease and 21/39 (54%) progressive disease. Median time to progression was 4 months (range = 1-14) for treated and 2 months (range = 1-9) for controls (P = 0.001). Median survival was 8.5 months (range = 1+ to 25) for Arm A versus 5 months (range = 1+ to 28+) for Arm B; this difference was not statistically significant (Breslow test: chi-square = 2.75, P = 0.097; Mantel-Cox: chi-square = 0.32, P = 0.56). Treatment related toxicity was gastrointestinal WHO grade 3 in 22/102 (22%) CEP courses and in 10/91 (11%) MEC' courses respectively. Other observed side-effects were not clinically important. From these data our treatment was not clearly superior to supportive care in prolonging survival. This suggests the need for the inclusion of a control group in future chemotherapeutic trials of NSCLC.
1985年4月至1987年9月，92例晚期非小细胞肺癌患者被随机分为两组，A组（治疗组）接受细胞毒性化疗，B组（对照组）接受支持性治疗。化疗方案为CEP方案（环磷酰胺500mg/m²静脉注射第1天；表柔比星50mg/m²静脉注射第1天；顺铂80mg/m²静脉注射第1天）与MEC'方案（甲氨蝶呤30mg/m²静脉注射第1天；依托泊苷200mg/m²静脉注射第1天；洛莫司汀70mg/m²口服第1天）每4周交替使用，直至病情进展。89例患者（44例治疗组和45例对照组）符合生存评估标准，77例患者（38例治疗组和39例对照组）可进行疗效评估。疗效如下：A组，8/38（21%）部分缓解，20/38（53%）病情稳定，10/38（26%）病情进展；B组，18/39（46%）病情稳定，21/39（54%）病情进展。治疗组的疾病进展中位时间为4个月（范围1 - 14个月），对照组为2个月（范围1 - 9个月）（P = 0.001）。A组的中位生存期为8.5个月（范围1 +至25个月），B组为5个月（范围1 +至28 +个月）；差异无统计学意义（Breslow检验：卡方 = 2.75，P = 0.097；Mantel - Cox检验：卡方 = 0.32，P = 0.56）。治疗相关毒性方面，在CEP疗程中22/102（22%）出现WHO 3级胃肠道毒性，在MEC'疗程中10/91（11%）出现。其他观察到的副作用在临床上并不重要。从这些数据来看，我们的治疗方案在延长生存期方面并不明显优于支持性治疗。这表明在未来非小细胞肺癌化疗试验中需要纳入对照组。
