Abrahamson G M, Bird J M, Newland A C, Gaminara E, Giles C, Joyner M, Kelsey S M, Lewis D, McCarthy D M, Roques A W, Tew C J, Treacy M, van de Pette J, Samson D
Riverside Haematology Group, London.
Br J Haematol. 1996 Sep;94(4):659-64. doi: 10.1046/j.1365-2141.1996.d01-1852.x.
This randomized study was designed to determine whether response to VAD chemotherapy could be prolonged by using rh alpha-2b-interferon (IFN) at a dose of 3 mU three times per week, either concurrently with VAD (VIC) or as maintenance after completion of VAD (VIF). Maintenance IFN was given for 9 months in order for the duration of IFN therapy to be similar in both groups. 72 patients were randomized between December 1988 and August 1993. The majority of patients had poor prognostic features. The objective response rate was similar in each arm, 78% in VIF and 77% in VIC. Of the 56 responders, 33 have relapsed, three died in remission, and 18 proceeded to high-dose therapy, withdrew for other reasons or were lost to follow-up and were censored from analysis at the relevant time point. Only two patients remain in remission (both in partial remission). Median PFS was 15 months for both VIF and VIC, compared with 16.5 months for a historic control group treated with VAD alone (n.s.). The estimated median survival in VIF was 43 months and in VIC 22 months, compared with 45 months in the historic controls (n.s.). These findings indicate that neither maintenance nor concurrent IFN prolongs response to VAD.
这项随机研究旨在确定使用剂量为3百万单位、每周三次的重组α-2b干扰素(IFN),无论是与VAD化疗同时使用(VIC方案)还是在VAD化疗完成后作为维持治疗(VIF方案),是否能够延长对VAD化疗的反应。给予维持治疗的IFN为期9个月,以便两组的IFN治疗持续时间相似。1988年12月至1993年8月期间,72例患者被随机分组。大多数患者具有不良预后特征。各治疗组的客观缓解率相似,VIF方案为78%,VIC方案为77%。在56例缓解患者中,33例复发,3例在缓解期死亡,18例接受了大剂量治疗、因其他原因退出或失访,并在相关时间点从分析中删失。仅2例患者仍处于缓解状态(均为部分缓解)。VIF方案和VIC方案的中位无进展生存期均为15个月,而单独接受VAD化疗的历史对照组为16.5个月(无显著性差异)。VIF方案的估计中位生存期为43个月,VIC方案为22个月,而历史对照组为45个月(无显著性差异)。这些结果表明,无论是维持治疗还是同时使用IFN,均不能延长对VAD化疗的反应。