Avril M F, Bonneterre J, Delaunay M, Grosshans E, Fumoleua P, Israel L, Bugat R, Namer M, Cupissol D, Kerbrat P
Institut Gustave Roussy, Villejuif, France.
Cancer Chemother Pharmacol. 1990;27(2):81-4. doi: 10.1007/BF00689087.
A total of 70 patients presenting with a disseminated malignant melanoma were entered into a multicentric study of combination chemotherapy using dacarbazine and fotemustine. In all, 63 patients were evaluable, 31.8% of whom had previously received cytotoxic chemotherapy. The protocol consisted of induction treatment with a weekly infusion of 100 mg/m2 fotemustine on days 1 and 8 and a daily infusion of 250 mg/m2 dacarbazine on days 15/18 followed by a 4- to 5-week rest period. Responding and stabilized patients were given maintenance treatment comprising fotemustine (100 mg/m2, day 1) and dacarbazine (250 mg/m2, days 2/5) every 3 weeks. The response rate was 33.3% (9 complete responses (CRs) and 12 partial responses (PRs)) and was outstanding among pretreated patients (34.9%). Responses were also documented in cerebral (28.6%), visceral (23.1%) and nonvisceral (43.3%) metastatic sites. Toxicity was mainly hematologic (22.2%, grade III/IV leukopenia; 20.3%, grade III/IV thrombocytopenia) and was acceptable. These results are encouraging in terms of the antitumor activity against nonvisceral metastases (43.3%) and the percentage of CRs obtained (23.3%), and they confirm the activity of fotemustine in cerebral metastatic sites.
共有70例播散性恶性黑色素瘤患者进入了一项使用达卡巴嗪和福莫司汀的联合化疗多中心研究。总共63例患者可进行评估，其中31.8%之前接受过细胞毒性化疗。方案包括诱导治疗，第1天和第8天每周输注100mg/m²福莫司汀，第15/18天每天输注250mg/m²达卡巴嗪，随后休息4至5周。反应和病情稳定的患者每3周接受一次维持治疗，包括福莫司汀（100mg/m²，第1天）和达卡巴嗪（250mg/m²，第2/5天）。缓解率为33.3%（9例完全缓解（CR）和12例部分缓解（PR）），在预处理患者中表现突出（34.9%）。在脑转移（28.6%）、内脏转移（23.1%）和非内脏转移（43.3%）部位也记录到缓解。毒性主要是血液学毒性（22.2%，III/IV级白细胞减少；20.3%，III/IV级血小板减少），且可接受。这些结果在针对非内脏转移的抗肿瘤活性（43.3%）和获得的CR百分比（23.3%）方面令人鼓舞，并且证实了福莫司汀在脑转移部位的活性。
