Cisplatin-vindesine-mitomycin (MVP) vs cisplatin-ifosfamide-vinorelbine (PIN) vs carboplatin-vinorelbine (CaN) in patients with advanced non-small-cell lung cancer (NSCLC): a FONICAP randomized phase II study
Cisplatin-vindesine-mitomycin (MVP) vs cisplatin-ifosfamide-vinorelbine (PIN) vs carboplatin-vinorelbine (CaN) in patients with advanced non-small-cell lung cancer (NSCLC): a FONICAP randomized phase II study
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DOI：
10.1038/bjc.1998.393
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发表时间：
1998-06-01
影响因子：
8.8
通讯作者：
Rosso, R
中科院分区：
文献类型：
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作者：
Baldini, E;Tibaldi, C;Rosso, R
本研究是一项多中心随机II期临床试验，旨在评价三种含铂联合方案治疗晚期非小细胞肺癌（NSCLC）的活性和毒性。三种方案为：MVP（丝裂霉素-C 6 mg m（-2）第1天，长春地辛3 mg m（-2）第1和15天，顺铂80 mg m（-2）第1天，每28天），PIN（顺铂80 mg m（-2）第1天，异环磷酰胺3 g m（-2），第1天;长春瑞滨25 mg m（-2），第1天和第8天，每81天一次）和CaN（卡铂350 mg m（-2）第1天，长春瑞滨25 mg m（-2）第1天和第8天，每28天一次）。共有140名未经化疗的患者进入研究; 49名患者接受MVP治疗，48名接受PIN治疗，43名接受CaN治疗。67%的病人患有第四期疾病。基于“意向治疗”计算的缓解率如下：MVP，14.3%（95% CI 5.94-27.2%）; PIN，16.7%（95% CI 7.4-30.2%）;和CaN，14%（95% CI 5.3-27.9%）。MVP、PIN和CaN治疗的患者的总体中位生存期分别为256、269和243天。骨髓抑制是最常见的毒性：MVP、PIN和CaN治疗的患者中分别有14.3%、25%和18.6%观察到3-4级白细胞减少。该多中心II期随机试验显示MVP、PIN和CaN可在门诊基础上给药，毒性可接受。不幸的是，这三种方案的活性显著低于先前单机构II期试验中报告的活性。
In the present multicentre randomized phase II trial, the activity and toxicity of three platinum-based combination regimens for the treatment of advanced non-small-cell lung cancer (NSCLC) were evaluated. The three regimens were: MVP (mitomycin-C 6 mg m(-2) on day 1, vindesine 3 mg m(-2) on days 1 and 15, and cisplatin 80 mg m(-2) on day 1 every 28 days), PIN (cisplatin 80 mg m(-2) day 1, ifosfamide 3 g m(-2) day 1 and vinorelbine 25 mg m(-2) day 1 and 8 every 81 days) and CaN (carboplatin 350 mg m(-2) day 1 and vinorelbine 25 mg m(-2) days 1 and 8 every 28 days). A total of 140 chemotherapy-naive patients entered the study; 49 patients were treated with MVP, 48 with PIN and 43 with CaN. Sixty-seven per cent of the patients had stage IV disease. Response rates, calculated on an 'intention to treat' basis, were as follows: MVP, 14.3% (95% CI 5.94-27.2%); PIN, 16.7% (95% CI 7.4-30.2%); and CaN, 14% (95% CI 5.3-27.9%). The overall median survivals were 256, 269 and 243 days for patients treated with MVP, PIN and CaN respectively. Myelosuppression was the most frequent toxicity: grade 3-4 leucopenia was observed in 14.3%, 25% and 18.6% of patients treated with MVP, PIN and CaN respectively This multicentre phase II randomized trial shows that MVP, PIN and CaN can be administered on an outpatient basis with acceptable toxicities. Unfortunately, the three regimens showed an activity significantly lower than that reported in previous single-institution phase II trials.