Mitchell Malcolm S, Abrams Judith, Thompson John A, Kashani-Sabet Mohammed, DeConti Ronald C, Hwu Wen-Jen, Atkins Michael B, Whitman Eric, Ernstoff Marc S, Haluska Frank G, Jakowatz James G, Das Gupta Tapas K, Richards Jon M, Samlowski Wolfram E, Costanzi John J, Aronson Frederick R, Deisseroth Albert B, Dudek Arkadiusz Z, Jones Vicky E
University of California, San Diego, School of Medicine and Cancer Center, San Diego, CA, USA.
J Clin Oncol. 2007 May 20;25(15):2078-85. doi: 10.1200/JCO.2006.10.1709.
To compare the overall survival (OS) of patients with resected stage III melanoma administered active specific immunotherapy and low-dose interferon alfa-2b (IFN-alpha-2b) with the OS achieved using high-dose IFN-alpha-2b.
An Ad Hoc Melanoma Working Group of 25 investigators treated 604 patients from April 1997 to January 2003. Patients were stratified by sex and number of nodes and were randomly assigned to receive either 2 years of treatment with active specific immunotherapy with allogeneic melanoma lysates and low-dose IFN-alpha-2b (arm 1) or high-dose IFN-alpha-2b alone for 1 year (arm 2). Active specific immunotherapy was injected subcutaneously (SC) weekly for 4 weeks, at week 8, and bimonthly thereafter. IFN-alpha-2b SC was begun on week 4 and continued thrice weekly at 5 MU/m2 for 2 years. IFN-alpha-2b in arm 2 was administered according to the Eastern Cooperative Oncology Group 1684 study regimen.
Median follow-up time was 32 months for all patients and 42 months for surviving patients. Median OS time exceeds 84 months in arm 1 and is 83 months in arm 2 (P = .56). Five-year OS rate is 61% in arm 1 and 57% in arm 2. Estimated 5-year relapse-free survival (RFS) rate is 50% in arm 1 and 48% in arm 2, with median RFS times of 58 and 50 months, respectively. The incidence of serious adverse events as a result of treatment was the same in both arms, but more severe neuropsychiatric toxicity was seen in arm 2.
OS and RFS achieved by active specific immunotherapy and low-dose IFN-alpha-2b were indistinguishable from those achieved by high-dose IFN-alpha-2b. Long RFS and OS times were observed in both treatment arms.
比较接受主动特异性免疫疗法和低剂量干扰素α-2b（IFN-α-2b）治疗的III期黑色素瘤切除患者的总生存期（OS）与使用高剂量IFN-α-2b所达到的总生存期。
一个由25名研究人员组成的特设黑色素瘤工作组在1997年4月至2003年1月期间治疗了604例患者。患者按性别和淋巴结数量分层，并随机分配接受为期2年的用同种异体黑色素瘤裂解物进行的主动特异性免疫疗法和低剂量IFN-α-2b治疗（第1组），或单独接受高剂量IFN-α-2b治疗1年（第2组）。主动特异性免疫疗法每周皮下注射（SC）1次，共4周，在第8周时注射1次，此后每两个月注射1次。IFN-α-2b皮下注射从第4周开始，以5MU/m²的剂量每周注射3次，持续2年。第2组中的IFN-α-2b按照东部肿瘤协作组1684研究方案给药。
所有患者的中位随访时间为32个月，存活患者为42个月。第1组的中位总生存期超过84个月，第2组为83个月（P = 0.56）。第1组的5年总生存率为61%，第2组为57%。第1组的估计5年无复发生存率（RFS）为50%，第2组为48%，中位无复发生存时间分别为58个月和50个月。治疗导致的严重不良事件发生率在两组中相同，但第2组出现了更严重的神经精神毒性。
主动特异性免疫疗法和低剂量IFN-α-2b所达到的总生存期和无复发生存期与高剂量IFN-α-2b所达到的总生存期和无复发生存期无差异。在两个治疗组中均观察到较长的无复发生存期和总生存期。
