RESULTS OF TREATMENT OF 255 PATIENTS WITH METASTATIC RENAL-CELL CARCINOMA WHO RECEIVED HIGH-DOSE RECOMBINANT INTERLEUKIN-2 THERAPY
RESULTS OF TREATMENT OF 255 PATIENTS WITH METASTATIC RENAL-CELL CARCINOMA WHO RECEIVED HIGH-DOSE RECOMBINANT INTERLEUKIN-2 THERAPY
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DOI：
10.1200/jco.1995.13.3.688
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发表时间：
1995-03-01
影响因子：
45.3
通讯作者：
LOUIE, AC
中科院分区：
文献类型：
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作者：
FYFE, G;FISHER, RI;LOUIE, AC
目的：为了确定高剂量的白细胞介素-2（IL-2）治疗转移性肾细胞癌患者的疗效和毒性，患者和方法：255评估患者进入7个II期临床试验。阿地白介素（aldesleukin; Chiron Corp，Emeryville，CA）600，000或720，000 IU/kg，每8小时通过15分钟静脉内（IV）输注给药，在5天内连续给药14次，如临床耐受，并提供最大支持，包括升压药。第二个相同的治疗周期安排后5至9天的休息，和课程可以重复每6至12周在稳定或响应patient.Results：总体客观反应率为14%（90%置信区间[CI]，10%至19%），12（5%）完全反应（CR）和24（9%）部分反应（PR）。缓解发生在所有疾病部位，包括骨、完整的原发性肿瘤和内脏转移瘤，以及肿瘤负荷较大或个体病灶较大的患者。达到CR的患者的中位反应持续时间尚未达到，但达到PR的患者为19.0个月。基线东部肿瘤协作组（ECOG）体力状态（PS）是IL-2反应的唯一预测预后因素。虽然治疗与重度急性毒性相关，但这些毒性通常在治疗完成后迅速逆转。然而，4%的患者死于不良事件判断可能或可能treatment-related.Conclusion：高剂量IL-2似乎有利于一些患者的转移性肾细胞癌产生持久的CR或PR。尽管存在严重的急性治疗相关毒性，但应考虑将IL-2用于适当选择的转移性肾细胞癌患者的初始治疗。(C)1995年，美国临床肿瘤学会。
Purpose: To determine the efficacy and toxicity of a high-dose interleukin-2 (IL-2) regimen in patients with metastatic renal cell carcinoma.Patients and Methods: Two hundred fifty-five assessable patients were entered onto seven phase II clinical trials. Proleukin (aldesleukin; Chiron Corp, Emeryville, CA) 600,000 or 720,000 IU/kg was administered by 15-minute intravenous (IV) infusion every 8 hours for up to 14 consecutive doses over 5 days as clinically tolerated with maximum support, including pressors. A second identical cycle of treatment was scheduled following 5 to 9 days of rest, and courses could be repeated every 6 to 12 weeks in stable or responding patients.Results: The overall objective response rate was 14% (90% confidence interval [CI], 10% to 19%), with 12 (5%) complete responses (CRs) and 24 (9%) partial responses (PRs). Responses occurred in all sites of disease, including bone, intact primary tumors, and visceral metastases, and in patients with large tumor burdens or bulky individual lesions. The median response duration for patients who achieved a CR has not been reached, but was 19.0 months for those who achieved a PR. Baseline Eastern Cooperative Oncology Group (ECOG) performance status (PS) was the only predictive prognostic factor for response to IL-2. While treatment was associated with severe acute toxicities, these generally reversed rapidly after therapy was completed. However, 4% of patients died of adverse events judged to be possibly or probably treatment-related.Conclusion: High-dose IL-2 appears to benefit some patients with metastatic renal cell carcinoma by producing durable CRs or PRs. Despite severe acute treatment-associated toxicities, IL-2 should be considered for initial therapy of patients with appropriately selected metastatic renal cell carcinoma. (C) 1995 by American Society of Clinical Oncology.