O'Bryan R M, Crowley J J, Kim P N, Epstein R B, Neilan B, Coltman C A, Stuckey W J, Pazdur R
Henry Ford Hospital, Detroit, Michigan.
Cancer. 1990 Feb 15;65(4):856-60. doi: 10.1002/1097-0142(19900215)65:4<856::aid-cncr2820650404>3.0.co;2-6.
Small cell lung cancer patients who failed primary systemic therapy or who failed after response were randomly assigned to salvage treatment with etoposide (VP-16) and cisplatin (CDDP) or bis-chloro-ethylnitrosourea, thiotepa, vincristine, and cyclophosphamide (BTOC). Good risk patients were those who had tolerated prior chemotherapy well, those who had not had prior radiation therapy, and those who were 65 years of age or younger. Patients with a history of poor tolerance, prior radiation therapy, or those who were older than 65 years of age were classified as poor risk. Forty-five patients were randomized to the BTOC regimen and 58 to the VP-16/CDDP regimen. The overall remission rate was 13% (13 of 103 patients). Good risk patients treated with the BTOC regimen had a remission rate of 27% (three of 11 patients), which was the same rate as patients treated with the VP-16/CDDP regimen (three of 11 patients). Poor risk patients had remission rates of 9% (three of 34 patients) with the BTOC regimen and 9% (four of 47 patients) with the VP-16/CDDP regimen. The median survival time from the start of therapy was 16 weeks for all patients. BTOC good risk patients had a median survival time of 10 weeks, as compared with 14 weeks for poor risk patients. VP-16/CDDP good risk patients had a median survival time of 35 weeks, as compared with 12 weeks for poor risk patients. Although based on small numbers, the advantage in survival time for good risk patients treated with VP-16/CDDP over those treated with BTOC is statistically significant. Prior exposure to VP-16 did not influence the outcome of patients treated with VP-16/CDDP. Both regimens produced moderate toxicity, but were generally well tolerated. It was concluded that VP-16/CDDP may be a useful salvage treatment for good risk patients, despite its limited remission rate. Also, it was found that BTOC has no value for patients in this setting and that neither regimen helps patients who are poor risk.
一线全身治疗失败或缓解后复发的小细胞肺癌患者被随机分配接受依托泊苷（VP - 16）和顺铂（CDDP）或双氯乙基亚硝脲、噻替派、长春新碱和环磷酰胺（BTOC）进行挽救治疗。预后良好的患者是那些对先前化疗耐受性良好、未曾接受过放疗且年龄在65岁及以下的患者。有耐受性差病史、曾接受过放疗或年龄超过65岁的患者被归类为预后不良。45例患者被随机分配至BTOC方案组，58例患者被分配至VP - 16/CDDP方案组。总缓解率为13%（103例患者中的13例）。接受BTOC方案治疗的预后良好患者缓解率为27%（11例患者中的3例），与接受VP - 16/CDDP方案治疗的患者缓解率相同（11例患者中的3例）。预后不良患者接受BTOC方案的缓解率为9%（34例患者中的3例），接受VP - 16/CDDP方案的缓解率为9%（47例患者中的4例）。所有患者从治疗开始的中位生存时间为16周。BTOC预后良好的患者中位生存时间为10周，而预后不良的患者为14周。VP - 16/CDDP预后良好的患者中位生存时间为35周，而预后不良的患者为12周。尽管样本量较小，但接受VP - 16/CDDP治疗的预后良好患者在生存时间上优于接受BTOC治疗的患者，差异具有统计学意义。先前使用过VP - 16并不影响接受VP - 16/CDDP治疗患者的预后。两种方案均产生中度毒性，但总体耐受性良好。得出的结论是，尽管VP - 16/CDDP缓解率有限，但可能是预后良好患者有用的挽救治疗方法。此外，发现BTOC在此情况下对患者无价值，且两种方案对预后不良的患者均无帮助。
