Interferon alfa-2a and interleukin-2 with or without cisplatin in metastatic melanoma: A randomized trial of the European Organization for Research and Treatment of Cancer Melanoma Cooperative Group
Interferon alfa-2a and interleukin-2 with or without cisplatin in metastatic melanoma: A randomized trial of the European Organization for Research and Treatment of Cancer Melanoma Cooperative Group
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DOI：
10.1200/jco.1997.15.7.2579
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发表时间：
1997-07-01
影响因子：
45.3
通讯作者：
Eggermont, AMM
中科院分区：
文献类型：
--
作者：
Keilholz, U;Goey, SH;Eggermont, AMM
目的：干扰素α-2a（IFN α）和大剂量白细胞介素-2（IL-2）联合治疗转移性黑色素瘤有效。顺铂（CDDP）的加入导致了大于50%的响应率，进行该研究以确定在具有IFN α和高剂量IL-2的细胞因子治疗方案中加入CDDP是否影响转移性黑色素瘤患者的存活。晚期转移性黑色素瘤患者被随机分为两组，一组在第1天至第5天接受IFN α 10 × 106 U/m2皮下注射治疗，另一组在第5天接受IFN α 10 × 106 U/m2皮下注射治疗。第3天至第8天IL-2剂量静脉递减方案（18 mIU/m（2）/6小时、18 mIU/m（2）/12小时、18 mIU/m（2）/24小时和4.5 mIU/m（2）/24小时x 3），第1天不使用（A组）或使用（B组）CDDP 100 mg/m（2）。治疗周期每28天重复一次，最多4个cycles.Results：138例晚期转移性黑色素瘤患者，其中87%有内脏转移，累积的试验，两种方案是可行的，在一个多中心的设置，客观反应率为18%，没有CDDP和33%（P = 0.04）。无进展生存期为53天（未使用CDDP）和92天（使用CDDP）（P = .02，Wilcoxon; P = .09，对数秩）。治疗组之间的生存率无统计学显著差异，所有患者的中位总生存期为9 months.Conclusion：除了CDDP与IFN α和IL-2的细胞因子治疗不影响晚期转移性黑色素瘤患者的生存，尽管显着增加的反应率和无进展生存。(C)1997年，美国临床肿瘤学会。
Purpose: The combination of interferon alfa-2a (IFN alpha) and high-dose interleukin-2 (IL-2) is active in metastatic melanoma. The addition of cisplatin (CDDP) has resulted in response rates greater than 50%, This study was performed to determine whether the addition of CDDP to a cytokine treatment regimen with IFN alpha and high-dose IL-2 influences survival of patients with metastatic melanoma.Patients and Methods: Patients with advanced metastatic melanoma were randomly assigned to receive treatment with IFN alpha 10 x 10(6) U/m(2) subcutaneously on days 1 through 5 and a high-dose intravenous decrescendo regimen of IL-2 on days 3 through 8 (18 mIU/m(2)/6 hours, 18 mIU/m(2)/12 hours, 18 mIU/m(2)/24 hours, and 4.5 mIU/m(2)/24 hours x 3) without (arm A) or with (arm B) CDDP 100 mg/m(2) on day 1. Treatment cycles were repeated every 28 days to a maximum of four cycles.Results: One hundred thirty-eight patients with advanced metastatic melanoma, of whom 87% had visceral metastases, were accrued for the trial, Both regimens were feasible in a multicenter setting, The objective response rate was 18% without and 33% with CDDP (P = .04). The progression-free survival was 53 days without and 92 days with CDDP (P = .02, Wilcoxon; P = .09, log-rank). There was no statistically significant difference in survival between treatment arms, with a median overall survival duration for all patients of 9 months.Conclusion: The addition of CDDP to cytokine treatment with IFN alpha and IL-2 does not influence survival of patients with advanced metastatic melanoma, despite a significant increase in response rate and progression-free survival. (C) 1997 by American Society of Clinical Oncology.