Department of Melanoma, Istituto Nazionale Tumori Fondazione Pascale, Via Mariano Semmola, 80131, Naples, Italy.
J Transl Med. 2013 Feb 13;11:38. doi: 10.1186/1479-5876-11-38.
The effect of the addition of fotemustine and/or interferon (IFN) to standard therapy with dacarbazine alone in patients with advanced malignant melanoma was investigated in a multicenter, randomized 2x2 factorial design trial.
A total of 260 patients were randomly assigned to one of four treatment groups: (A) fotemustine and dacarbazine repeated on 3-week cycle; (B) same treatment as (A) plus IFN-α2b three times per week; (C) dacarbazine alone repeated on 3-week cycle; (D) same treatment as (C) plus IFN-α2b three times per week. Two comparisons were planned to assess the efficacy of fotemustine (groups A+B vs. C+D) and IFN-α2b (groups A+C vs. B+D).
Addition of fotemustine did not significantly improve overall survival (OS) (p=0.28) or progression-free survival (PFS) (p=0.55); Hazard ratio (HR) for OS was 0.93 (95% CI 0.71-1.21). Similarly, addition of IFN-α2b did not improve OS (p=0.68) or PFS (p=0.65); HR for OS was 0.92 (95% CI 0.70-1.20). Overall response rate was not improved by the addition of either fotemustine (p=0.87) or IFN-α2b (p=0.57). The combination of all three drugs resulted in the highest occurrence of adverse events.
No significant improvement in outcomes were observed with the addition of either fotemustine or IFN-α2b to dacarbazine.
ClinicalTrials.gov: NCT01359956.
在一项多中心、随机 2x2 析因设计试验中，研究了在晚期恶性黑色素瘤患者中，将福莫司汀和/或干扰素（IFN）加入单独使用达卡巴嗪的标准治疗中的效果。
共有 260 名患者被随机分配到以下四个治疗组之一：（A）福莫司汀和达卡巴嗪每 3 周重复一次；（B）与（A）相同的治疗加上每周三次的 IFN-α2b；（C）达卡巴嗪每 3 周重复一次；（D）与（C）相同的治疗加上每周三次的 IFN-α2b。计划进行两次比较，以评估福莫司汀（A+B 组与 C+D 组）和 IFN-α2b（A+C 组与 B+D 组）的疗效。
添加福莫司汀并未显著改善总生存期（OS）（p=0.28）或无进展生存期（PFS）（p=0.55）；OS 的风险比（HR）为 0.93（95%CI 0.71-1.21）。同样，添加 IFN-α2b 也未改善 OS（p=0.68）或 PFS（p=0.65）；OS 的 HR 为 0.92（95%CI 0.70-1.20）。添加福莫司汀（p=0.87）或 IFN-α2b（p=0.57）均未提高总缓解率。三种药物联合使用导致不良反应发生率最高。
在达卡巴嗪中加入福莫司汀或 IFN-α2b 并未观察到结局的显著改善。
ClinicalTrials.gov：NCT01359956。
