Crinò L, Clerici M, Figoli F, Carlini P, Ceci G, Cortesi E, Carpi A, Santini A, Di Costanzo F, Boni C
Medical Oncology Division, Policlinico Hospital, Perugia, Italy.
Ann Oncol. 1995 Apr;6(4):347-53. doi: 10.1093/oxfordjournals.annonc.a059183.
Cisplatin-based chemotherapy is generally considered the most active treatment for advanced non-small-cell lung cancer. The combination of cisplatin and etoposide had for some time been the standard treatment at our center. Of the other active regimens, cisplatin in combination with mitomycin-C, vindesine or ifosfamide (MVP or MIC) showed the highest response rates. We decided to perform a comparative trial of the three 'best' regimens in order to define a possible standard regimen in advanced NSCLC.
From May 1989 to April 1992, 393 consecutive, previously untreated NSCLC patients, stages IIIB and IV, were randomized to receive either cisplatin (120 mg/sqm day 1) + etoposide (100 mg/sqm days 1-3) every 3 weeks (PE) or cisplatin (120 mg/sqm every 4 weeks) + mitomycin-C (8 mg/sqm days 1-29-71) + vindesine (3 mg/sqm days 1-8-15-22) (MVP) or cisplatin (120 mg/sqm day 1) + mitomycin-C (6 mg/sqm day 1) + ifosfamide (3 mg/sqm day 2) every 3 weeks (MIC). Of these, 382 were evaluable for survival and 360 for response.
Response rates were statistically higher for both MIC (40%) and MVP (36%) than for the PE arm (23%). Survival estimates analyzed by the log-rank test showed a significant benefit (p < 0.04) for patients treated with three-drug regimens (MVP; MIC) as compared to those in the PE arm. The main toxicity was myelosuppression; thrombocytopenia WHO grade 3-4 was worse in the MIC arm; nephrotoxicity grade 3-4 was also more frequent in the MIC arm.
A three-drug cisplatin-based regimen (MVP; MIC) should be considered as reference treatment in NSCLC.
以顺铂为基础的化疗通常被认为是晚期非小细胞肺癌最有效的治疗方法。顺铂与依托泊苷的联合方案曾一度是我们中心的标准治疗方案。在其他有效的治疗方案中，顺铂与丝裂霉素-C、长春地辛或异环磷酰胺联合使用（MVP或MIC）显示出最高的缓解率。我们决定对这三种“最佳”方案进行比较试验，以确定晚期非小细胞肺癌可能的标准治疗方案。
从1989年5月至1992年4月，393例连续的、未经治疗的ⅢB期和Ⅳ期非小细胞肺癌患者被随机分组，每3周接受一次顺铂（第1天120mg/m²）+依托泊苷（第1 - 3天100mg/m²）（PE），或顺铂（每4周120mg/m²）+丝裂霉素-C（第1、29、71天8mg/m²）+长春地辛（第1、8、15、22天3mg/m²）（MVP），或顺铂（第1天120mg/m²）+丝裂霉素-C（第1天6mg/m²）+异环磷酰胺（第2天3mg/m²）每3周一次（MIC）。其中，382例可评估生存情况，360例可评估缓解情况。
MIC组（40%）和MVP组（36%）的缓解率在统计学上均高于PE组（23%）。通过对数秩检验分析的生存估计显示，与PE组相比，接受三药联合方案（MVP；MIC）治疗的患者有显著获益（p < 0.04）。主要毒性为骨髓抑制；MIC组3 - 4级血小板减少更严重；MIC组3 - 4级肾毒性也更常见。
基于顺铂的三药联合方案（MVP；MIC）应被视为非小细胞肺癌的参考治疗方案。
