Stadler Rudolf, Luger Thomas, Bieber Thomas, Köhler Ulrike, Linse Ruthild, Technau Kristin, Schubert Roland, Schroth Katja, Vakilzadeh Feredoun, Volkenandt Matthias, Gollnick Harald, Von Eick Harald, Thoren Fredrik, Strannegård Orjan
Department of Dermatology, Academic Medical Centre, Minden, Germany.
Acta Oncol. 2006;45(4):389-99. doi: 10.1080/02841860600630954.
In a prospective, controlled, randomised, multicentre study 252 patients with totally resected cutaneous melanoma (248 in stage II-III and 4 in stage IV) were either treated with two doses of dacarbazine (DTIC) followed by a 6-month treatment with 3 MU thrice weekly of highly purified natural interferon-alpha (n = 128; arm A) or received no adjuvant treatment (n = 124; arm B). Treatment was well tolerated. After a median follow-up of 8.5 years ITT analysis showed that the difference in survival was statistically significant with respect to melanoma-related deaths (HR = 0.65, CI = 0.46-0.97, p = 0.022) and close to significance with respect to overall survival (HR 0.71, CI 0.49-1.00, p = 0.052). The risk reduction of melanoma-associated death, calculated by Cox proportional hazards modelling, after adjusting for identified predictive variables, was almost 50% (p = 0.002). The overall efficacy of the treatment appeared to be mainly attributable to effects observed in patients with deep and/or metastasizing tumours (HR 0.60, CI 0.40-0.90, p = 0.013).
在一项前瞻性、对照、随机、多中心研究中，252例皮肤黑色素瘤完全切除患者（II - III期248例，IV期4例），一组先接受两剂达卡巴嗪（DTIC）治疗，随后接受为期6个月的高纯度天然α干扰素治疗，每周三次，每次3 MU（n = 128；A组），另一组不接受辅助治疗（n = 124；B组）。治疗耐受性良好。中位随访8.5年后，意向性分析显示，黑色素瘤相关死亡的生存率差异具有统计学意义（HR = 0.65，CI = 0.46 - 0.97，p = 0.022），总生存率差异接近显著（HR 0.71，CI 0.49 - 1.00，p = 0.052）。通过Cox比例风险模型计算，在调整已识别的预测变量后，黑色素瘤相关死亡的风险降低近50%（p = 0.002）。治疗的总体疗效似乎主要归因于在深部和/或转移性肿瘤患者中观察到的效果（HR 0.60，CI 0.40 - 0.90，p = 0.013）。
