High-dose recombinant interleukin 2 therapy for patients with metastatic melanoma: Analysis of 270 patients treated between 1985 and 1993
High-dose recombinant interleukin 2 therapy for patients with metastatic melanoma: Analysis of 270 patients treated between 1985 and 1993
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DOI：
10.1200/jco.1999.17.7.2105
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发表时间：
1999-07-01
影响因子：
45.3
通讯作者：
Rosenberg, SA
中科院分区：
文献类型：
--
作者：
Atkins, MB;Lotze, MT;Rosenberg, SA
用途：为了确定高剂量静脉推注白细胞介素2（IL-2）方案治疗转移性黑色素瘤患者的短期和长期疗效和毒性，患者和方法：1985年至1993年期间，270例可评估患者参加了8项临床试验。IL-2（Proleukin [阿地白介素]; Chiron Corp，Emeryville，CA）600，000或720，000 IU/kg通过每8小时15分钟静脉内输注给药，在5天内连续给药多达14次，如临床耐受的，具有最大支持，包括升压药。在休息6至9天后安排第二个相同的治疗周期，结果：总的客观有效率为16%，总的客观有效率为16（95%置信区间，12%至21%）;有17例完全缓解（CR）（6%）和26例部分缓解（PR）（10%）。缓解发生在所有疾病部位和肿瘤负荷较大的患者中。达到CR的患者的中位缓解持续时间尚未达到，达到PR的患者的中位缓解持续时间为5.9个月，12例（28%）缓解患者（包括10例（59%）达到CR的患者）保持无进展。在任何患者中，疾病没有进展超过30个月。基线体力状态和患者是否接受过既往全身治疗是对IL-2治疗反应的唯一预测预后因素。毒性虽然严重，但通常在治疗完成后迅速逆转。6例患者（2%）死于不良事件，均与脓毒症有关。结论：高剂量IL-2治疗似乎通过产生持久的CR或PR而使某些转移性黑色素瘤患者受益，应考虑用于适当选择的黑色素瘤患者。(C)1999年，美国临床肿瘤学会。
Purpose: To determine the short- and long-term efficacy and toxicity of the high-dose intravenous bolus interleukin 2 (IL-2) regimen in patients with metastatic melanoma,Patients and Methods: Two hundred seventy assessable patients were entered onto eight clinical trials conducted between 1985 and 1993. IL-2 (Proleukin [aldesleukin]; Chiron Corp, Emeryville, CA) 600,000 or 720,000 IU/kg was administered by 15-minute intravenous infusion every 8 hours for up to 14 consecutive doses over 5 days as clinically tolerated with maximum support, including pressors, A second identical treatment cycle was scheduled after 6 to 9 days of rest, and courses could be repeated every 6 to 12 weeks in stable or responding patients, Data were analyzed through fall 1996.Results: The overall objective response rate was 16% (95% confidence interval, 12% to 21%); there were 17 complete responses (CRs) (6%) and 26 partial responses (PRs) (10%), Responses occurred with ail sites of disease and in patients with large tumor burdens. The median response duration for patients who achieved a CR has not been reached and was 5.9 months for those who achieved a PR, Twelve (28%) of the responding patients, including 10 (59%) of the patients who achieved a CR, remain progression-free. Disease did not progress in any patient responding for more than 30 months. Baseline performance status and whether patients had received prior systemic therapy were the only predictive prognostic factors for response to IL-2 therapy. Toxicities, although severe, generally reversed rapidly after therapy was completed. Six patients (2%) died from adverse events, all related to sepsis,Conclusion: High-dose IL-2 treatment seems to benefit some patients with metastatic melanoma by producing durable CRs or PRs and should be considered for appropriately selected melanoma patients. (C) 1999 by American Society of Clinical Oncology.