Rixe O, Borel C, Paraiso D, Benhammouda A, Petit T, Antoine E, Bizzari J P, Auclerc G, Soubrane C, Weil M
SOMPS, Hopital de la Salpétriere, Paris, France.
Melanoma Res. 1995 Dec;5(6):419-24. doi: 10.1097/00008390-199512000-00005.
Fotemustine and dacarbazine constitute the most active single chemotherapeutic agents in the treatment of melanoma. In this phase II study we evaluated the activity and toxicity of a combination of fotemustine, dacarbazine and vindesine as a means of increasing response rate and survival time. Between September 1989 and November 1993, 43 patients with advanced melanoma were treated with a combination of 100 mg/m2 fotemustine on days 1 and 8, 250 mg/m2 dacarbazine on days 15 and 16 and 2 mg/m2 vindesine on days 15 and 16 as induction treatment. After a 5-week rest period, the patients exhibiting a response or stable disease received the same drugs administered once every 28 days as maintenance therapy until either progression or toxicity was observed. Among 41 evaluable patients, there were six complete responses and eight partial responses. The overall response rate was 32% (95% confidence interval: 18-46%), with 8 months median duration of response. Median survival time was 10 months. This regimen was well tolerated. From this large phase II study, we conclude that such a combination is active against advanced malignant melanoma and seems to be more effective than fotemustine or dacarbazine used alone, especially on visceral metastatic sites.
福莫司汀和达卡巴嗪是治疗黑色素瘤最有效的单一化疗药物。在这项II期研究中，我们评估了福莫司汀、达卡巴嗪和长春地辛联合用药的活性和毒性，以提高缓解率和延长生存时间。1989年9月至1993年11月期间，43例晚期黑色素瘤患者接受了诱导治疗，具体方案为第1天和第8天给予100mg/m²福莫司汀，第15天和第16天给予250mg/m²达卡巴嗪，第15天和第16天给予2mg/m²长春地辛。经过5周的休息期后，病情缓解或稳定的患者每28天接受一次相同药物的维持治疗，直至病情进展或出现毒性反应。在41例可评估的患者中，有6例完全缓解，8例部分缓解。总缓解率为32%（95%置信区间：18 - 46%），中位缓解持续时间为8个月。中位生存时间为10个月。该方案耐受性良好。从这项大型II期研究中，我们得出结论，这种联合用药对晚期恶性黑色素瘤有活性，似乎比单独使用福莫司汀或达卡巴嗪更有效，尤其是对内脏转移部位。
