Comella P, Daponte A, Casaretti R, Ionna F, Fiore F, Presutti F, Frasci G, Caponigro F, Gravina A, Parziale A P, Mozzillo N, Comella G
Division of Medical Oncology A, National Tumor Institute, Naples, Italy.
Eur J Cancer. 1997 Jul;33(8):1326-9. doi: 10.1016/s0959-8049(97)00120-2.
Forty-three consecutive patients with advanced melanoma not previously treated with cytotoxic drugs (22 of them had already received adjuvant recombinant interferon alpha 2a (rIFN alpha 2a)) were given a combination of intravenous (i.v.) fotemustine (FM), 100 mg/m2 on day 1, and dacarbazine (DTIC), 250 mg/m2 i.v. on days 2-5, every 3 weeks. rIFN alpha 2a was administered at the dosage of 3 MIU subcutaneously 3 times a week until progression. Four complete and 13 partial responses were registered, for an overall response rate of 40% (95% CI, 25-56%). Activity of this regimen was similar in patients with mainly visceral (10/22, 45%) or soft tissue (6/13, 46%) involvement. The median duration of responses was 24 weeks. Median survival time was 40 weeks, with a 13% 2 year survival rate. Neutropenia and thrombocytopenia affected 67% and 51% of patients, but were of WHO grade 4 in only 2% and 5% of them, respectively. Side-effects attributable to rIFN alpha 2a were mild and manageable. In conclusion, the combination of FM + DTIC and rIFN alpha 2a seemed well tolerated and relatively active in patients with advanced melanoma. However, the role of rIFN alpha 2a in affecting the long-term outcome of patients is still questionable.
43例先前未接受过细胞毒性药物治疗的晚期黑色素瘤患者（其中22例已接受过辅助重组干扰素α2a（rIFNα2a）治疗），每3周接受一次静脉注射福莫司汀（FM）（第1天，100mg/m²）和达卡巴嗪（DTIC）（第2 - 5天，250mg/m²静脉注射）联合治疗。rIFNα2a以3MIU皮下注射，每周3次，直至病情进展。记录到4例完全缓解和13例部分缓解，总缓解率为40%（95%CI，25 - 56%）。该方案对主要累及内脏（10/22，45%）或软组织（6/13，46%）的患者活性相似。缓解的中位持续时间为24周。中位生存时间为40周，2年生存率为13%。中性粒细胞减少和血小板减少分别影响67%和51%的患者，但WHO 4级的分别仅占2%和5%。rIFNα2a引起的副作用较轻且可控。总之，FM + DTIC与rIFNα2a联合方案在晚期黑色素瘤患者中似乎耐受性良好且活性相对较高。然而，rIFNα2a对患者长期预后的影响作用仍存在疑问。
