Miranda J. Payne, Katerina Argyropoulou, Cheng Han, Sandie Wellman, and Mark R. Middleton, National Institute for Health Research Biomedical Research Centre, Oxford University Hospitals National Health Service Trust, Oxford; Paul Lorigan, Christie Hospital, Manchester; James J. McAleer, Cancer Centre, Belfast City Hospital, Belfast, Northern Ireland; David Farrugia, Cheltenham Hospital, Cheltenham; Neville Davidson, Chelmsford Hospital, Chelmsford; Charles Kelly, Newcastle General Hospital, Newcastle upon Tyne; David Chao, Royal Free Hospital, Hampstead; and Ernest Marshall, Clatterbridge Centre for Oncology, Bebington, Wirral, United Kingdom.
J Clin Oncol. 2014 Jan 20;32(3):185-90. doi: 10.1200/JCO.2013.49.8717. Epub 2013 Dec 16.
High-dose interferon alfa-2b (HDI) has emerged as a potentially effective adjuvant therapy in patients with resected melanoma at high risk of recurrence. Evidence suggests it may be the early, very-high-dose part of the regimen that is critical. This pilot study sought to provide an early indication of whether the same effects can be achieved with the intravenous component of HDI alone and inform the feasibility and design of a phase III trial.
Patients with stage 2B, 2C, 3B, and 3C melanoma were randomly assigned to receive interferon alfa-2b (IFN-α-2b) 20 MIU/m(2) intravenously (IV) daily 5 days per week for 4 weeks (arm A) versus the same regimen followed by IFN-α-2b 10 MIU/m(2) administered subcutaneously three times per week for 48 weeks (arm B) and observed for relapse-free survival (RFS) and overall survival.
Between 2003 and 2009, 194 patients were enrolled (arm A, 96; arm B, 98). After median follow-up of 39.5 months, RFS was 22.7 months (95% CI, 14.1 to 38.1 months) in arm A versus 33.3 months (95% CI, 18.2 to not reached) in arm B (P = .28). The proportions of patients free of relapse at 2 years were 50% and 54.1% (P = .569; hazard ratio, 0.89), respectively. Overall survival favored arm B (median, 41.5 months v not reached; P = .05).
Clinical outcomes were better in patients who had the longer regimen. Our results do not support either the use of a month of IV HDI alone in place of the year-long regimen or the initiation of a larger trial on this question.
高剂量干扰素 alfa-2b（HDI）已成为高复发风险的黑色素瘤患者潜在有效的辅助治疗方法。有证据表明，可能是方案的早期、超高剂量部分是关键。这项初步研究旨在提供一个早期的迹象表明，是否可以单独使用 HDI 的静脉成分实现相同的效果，并为 III 期试验提供可行性和设计的信息。
2B、2C、3B 和 3C 期黑色素瘤患者被随机分配接受干扰素 alfa-2b（IFN-α-2b）20 MIU/m（2）静脉内（IV）每天 5 天，每周 4 周（A 组）与相同的方案，然后每周皮下注射 IFN-α-2b 10 MIU/m（2），共 48 周（B 组），并观察无复发生存（RFS）和总生存。
在 2003 年至 2009 年间，共纳入 194 例患者（A 组 96 例，B 组 98 例）。在中位随访 39.5 个月后，A 组的 RFS 为 22.7 个月（95%CI，14.1 至 38.1 个月），B 组为 33.3 个月（95%CI，18.2 至未达到）（P =.28）。在 2 年内无复发的患者比例分别为 50%和 54.1%（P =.569；危险比，0.89）。总生存时间 B 组占优势（中位，41.5 个月 v 未达到；P =.05）。
临床结果在接受较长方案的患者中更好。我们的结果既不支持使用一个月的 IV HDI 替代一年的方案，也不支持在此问题上进行更大规模的试验。
