Assistance Publique, Hôpitaux de Marseille, Hôpital Timone, Université de la Méditerranée, CHU Timone, Marseille Cedex 5, France.
Endocr Relat Cancer. 2009 Dec;16(4):1351-61. doi: 10.1677/ERC-09-0104. Epub 2009 Sep 2.
The aim of this randomized multicenter phase III trial was to compare chemotherapy and interferon (IFN) in patients with metastatic carcinoid tumors. Patients with documented progressive, unresectable, metastatic carcinoid tumors were randomized between 5-fluorouracil plus streptozotocin (day 1-5) and recombinant IFN-alpha-2a (3 MU x 3 per week). Primary endpoint was progression-free survival (PFS). From February 1998 to June 2004, 64 patients were included. The two arms were well matched for median age, sex ratio, PS 0-1, previous chemotherapy, surgery, or radiotherapy. The median PFS for chemotherapy was 5.5 months versus 14.1 for IFN (hazard ratio=0.75 (0.41-1.36)). Overall survival (OS), tolerance, and effects on carcinoid symptoms were not significantly different. Despite a trend in favor of IFN, there was no difference in PFS and OS in advanced metastatic carcinoid tumors and therapeutic effect of both treatments was mild.
本随机多中心 III 期临床试验旨在比较转移性类癌肿瘤患者的化疗和干扰素（IFN）治疗。对有明确记录的进行性、不可切除、转移性类癌肿瘤患者进行 5-氟尿嘧啶加链脲佐菌素（第 1-5 天）和重组 IFN-α-2a（每周 3 MU x 3）之间的随机分组。主要终点是无进展生存期（PFS）。1998 年 2 月至 2004 年 6 月，共纳入 64 例患者。两组在中位年龄、性别比、PS 0-1、既往化疗、手术或放疗方面匹配良好。化疗的中位 PFS 为 5.5 个月，IFN 为 14.1 个月（风险比=0.75（0.41-1.36））。总生存期（OS）、耐受性和类癌症状的影响无显著差异。尽管 IFN 有获益趋势，但在晚期转移性类癌肿瘤中，PFS 和 OS 无差异，两种治疗的疗效均较轻。
