Veronesi A, Magri M D, Tirelli U, Carbone A, Mazza F, Franceschi S, Talamini R, Ardizzoni A, Canobbio L, Rosso R
Division of Medical Oncology, Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy.
Am J Clin Oncol. 1988 Oct;11(5):566-71. doi: 10.1097/00000421-198810000-00012.
All consecutive eligible patients with non-small-lung carcinoma seen at Centro di Riferimento Oncologico and Istituto Nazionale per la Ricerca sul Cancro were entered into a randomized chemotherapy study. Conditions of eligibility included advanced stage (stage III not amenable to radiation therapy or i.v.), measurable or evaluable lesions, age less than 70 years, performance status (PS) greater than 40, and no previous chemotherapy. Patients were randomized to either CAMP (cyclophosphamide 300 mg/m2 i.v., adriamycin 20 mg/m2 i.v., methotrexate 15 mg/m2 i.v. days 1 and 8, procarbazine 100 mg/m2 orally from day 1 to day 10, every 4 weeks) or DE (cisplatin 20 mg/m2 i.v. for five consecutive days and etoposide 75 mg/m2 i.v. on the same days, every 3 weeks). Treatment was continued until progression. Out of the 136 patients randomized, 133 were eligible (CAMP 62, DE 71) and 108 evaluable. Patient characteristics included male/female ratio 57/5 (CAMP) and 61/10 (DE), median age of 60 years (CAMP) and 59 years (DE), PS greater than or equal to 70 for 39 (CAMP) and 50 (DE), PS less than 70 for 23 (CAMP) and 21 (DE), stage III for 18 (CAMP) and 15 (DE), and stage IV for 44 (CAMP) and 56 (DE). DE was superior to CAMP in terms of response rate, defined as responding/evaluable patient ratio (38.2% versus 20.8%); however, the responding/eligible patient ratio was not significantly different in the two groups. The superiority of DE tended to be more marked in stage III patients, in patients with PS greater than or equal to 70, and in the squamous histological type. Toxicity was acceptable (one toxic death) and evenly distributed in the two treatment groups; only renal toxicity was prevalent in the DE group. Survival (all eligible patients) was significantly better in the DE than in the CAMP group. Whether DE chemotherapy is superior to a no-chemotherapy approach has not been evaluated in this study and remains to be determined.
所有在肿瘤参考中心（Centro di Riferimento Oncologico）和国家癌症研究所（Istituto Nazionale per la Ricerca sul Cancro）就诊的连续性符合条件的非小细胞肺癌患者均纳入一项随机化疗研究。符合条件的情况包括晚期（III期，不适合放疗或静脉注射治疗）、可测量或可评估的病灶、年龄小于70岁、体能状态（PS）大于40且既往未接受过化疗。患者被随机分为CAMP方案组（环磷酰胺300mg/m²静脉注射、阿霉素20mg/m²静脉注射、甲氨蝶呤15mg/m²在第1天和第8天静脉注射、丙卡巴肼100mg/m²从第1天至第10天口服，每4周重复）或DE方案组（顺铂20mg/m²静脉注射，连续5天，依托泊苷75mg/m²静脉注射，在相同日期，每3周重复）。治疗持续至病情进展。在随机分组的136例患者中，133例符合条件（CAMP组62例，DE组71例），108例可评估。患者特征包括男女比例（CAMP组57/5，DE组61/10）、中位年龄（CAMP组60岁，DE组59岁）、PS大于或等于70者（CAMP组39例，DE组50例）、PS小于70者（CAMP组23例，DE组21例）、III期（CAMP组18例，DE组15例）和IV期（CAMP组44例，DE组56例）。DE方案组的缓解率（定义为缓解/可评估患者比例）高于CAMP方案组（38.2%对20.8%）；然而，两组的缓解/符合条件患者比例无显著差异。DE方案组的优势在III期患者、PS大于或等于70的患者以及鳞状组织学类型患者中更为明显。毒性可接受（1例毒性死亡）且在两个治疗组中分布均匀；仅DE组肾毒性较为常见。DE组（所有符合条件患者）的生存率显著高于CAMP组。本研究未评估DE化疗是否优于非化疗方法，仍有待确定。
