Petrioli R, Frediani B, Manganelli A, Barbanti G, De Capua B, De Lauretis A, Salvestrini F, Mondillo S, Francini G
Medical Oncology Division, University of Siena, Italy.
Cancer. 1996 Jan 15;77(2):344-51. doi: 10.1002/(SICI)1097-0142(19960115)77:2<344::AID-CNCR18>3.0.CO;2-1.
The aim of this randomized Phase II study was to compare the efficacy and toxicity of a cisplatin-containing regimen with a carboplatin-containing regimen for patients with recurrent or metastatic bladder cancer.
Fifty-seven patients with recurrent or metastatic bladder cancer were randomized to receive M-VEC treatment (methotrexate, vinblastine, epirubicin, and cisplatin) (n = 29) or M-VECa treatment (methotrexate, vinblastine, epirubicin, and carboplatin) (n = 28). The chemotherapy was scheduled at 28-day intervals. Recombinant granulocyte-colony stimulating factors were administered daily when the absolute neutrophil count fell below 1000/mm3. The development of ototoxicity was evaluated by measuring auditory brain stem response.
Of the 57 entered patients, 55 were evaluable for response and toxicity. The overall clinical response rate was 71% (with 25% complete responses) in the M-VEC group and 41% (with 11% complete responses) in the M-VECa group (P = 0.04). M-VEC chemotherapy was associated with more pronounced side effects. There was a statistically significant difference between M-VEC and M-VECa in terms of gastrointestinal toxicity (P = 0.04), nephrotoxicity (P = 0.03), and neurotoxicity (P = 0.02) during Cycle 3 of chemotherapy. Leukopenia and neutropenia were worse in the M-VECa arm, but not significantly so (P = 0.4). Ototoxicity was only detected in one of seven examined M-VEC patients after two cycles of chemotherapy.
M-VECa has a low level of gastrointestinal, renal, neurologic, and otologic toxicity, but is apparently less effective than M-VEC in the treatment of recurrent or metastatic bladder cancer. However, a larger, randomized Phase III trial is needed to confirm these results.
这项随机II期研究的目的是比较含顺铂方案与含卡铂方案对复发性或转移性膀胱癌患者的疗效和毒性。
57例复发性或转移性膀胱癌患者被随机分为接受M-VEC治疗（甲氨蝶呤、长春花碱、表柔比星和顺铂）（n = 29）或M-VECa治疗（甲氨蝶呤、长春花碱、表柔比星和卡铂）（n = 28）。化疗按28天周期安排。当绝对中性粒细胞计数低于1000/mm³时，每天给予重组粒细胞集落刺激因子。通过测量听觉脑干反应评估耳毒性的发生情况。
57例入组患者中，55例可评估疗效和毒性。M-VEC组的总体临床缓解率为71%（完全缓解率为25%），M-VECa组为41%（完全缓解率为11%）（P = 0.04）。M-VEC化疗的副作用更明显。在化疗第3周期，M-VEC和M-VECa在胃肠道毒性（P = 0.04）、肾毒性（P = 0.03）和神经毒性（P = 0.02）方面存在统计学显著差异。M-VECa组的白细胞减少和中性粒细胞减少更严重，但差异无统计学意义（P = 0.4）。在接受两个周期化疗的7例M-VEC患者中，仅1例检测到耳毒性。
M-VECa的胃肠道、肾脏、神经和耳毒性较低，但在治疗复发性或转移性膀胱癌方面明显不如M-VEC有效。然而，需要进行更大规模的随机III期试验来证实这些结果。
