Clinical and Safety Profile of High-Dose Interleukin-2 Treatment in Elderly Patients with Metastatic Melanoma and Renal Cell Carcinoma
Clinical and Safety Profile of High-Dose Interleukin-2 Treatment in Elderly Patients with Metastatic Melanoma and Renal Cell Carcinoma
复制标题
高剂量白细胞介素 2 治疗老年转移性黑色素瘤和肾细胞癌患者的临床和安全性概况
作者：
J. Clark;B. Kelley;J. Titze;H. Fung;J. Maciejewski;S. Nathan;E. Rich;S. Basu;H. Kaufman
目的：大剂量白细胞介素-2（IL-2）是治疗转移性黑色素瘤和肾细胞癌（RCC）的有效免疫疗法，但在老年患者中禁用。本研究评估了高剂量IL-2在≥65岁转移性黑色素瘤和RCC患者中的安全性和疗效。研究方法：使用前瞻性收集的2009年至2012年间接受高剂量IL-2治疗的104名连续黑色素瘤或RCC患者的临床数据库，比较≥65岁患者与年轻患者的临床结局和不良事件。结果：≥65岁22例（21%），<65岁82例（79%）。在治疗周期1期间，老年患者的平均IL-2剂量数较低（7.2 vs. 8.6，p = 0.012）。各年龄组的给药模式无其他差异。在年轻患者中，选择性心脏、体质、血液学、代谢和肾脏毒性的发生率较高（p < 0.05）。总体而言，客观缓解率和生存率不受年龄的影响，尽管老年患者的部分缓解率较高（p = 0.04）。结论：IL-2在≥65岁的患者中是安全的，具有相当的疗效。年龄不应被视为其他合格患者接受IL-2治疗的禁忌症。
Objective: High-dose interleukin-2 (IL-2) is effective immunotherapy for the treatment of metastatic melanoma and renal cell carcinoma (RCC) but has been contraindicated in elderly patients. This study assessed the safety and therapeutic efficacy of high-dose IL-2 in patients ≥65 years of age with metastatic melanoma and RCC. Methods: A prospectively collected clinical database of 104 consecutive melanoma or RCC patients treated with high-dose IL-2 between 2009 and 2012 was used to compare clinical outcomes and adverse events in patients ≥65 years of age with those of younger patients. Results: There were 22 (21%) patients ≥65 years and 82 (79%) patients <65 years of age. The mean number of IL-2 doses was lower in older patients during cycle 1 of treatment (7.2 vs. 8.6, p = 0.012). There were no other differences in dosing pattern by age group. There was a higher rate of selected cardiac, constitutional, hematologic, metabolic and renal toxicities in younger patients (p < 0.05). Overall, objective responses and survival were not affected by age, though older patients had a higher partial response rate (p = 0.04). Conclusions: IL-2 is safe and has comparable therapeutic effectiveness in patients ≥65 years. Age should not be considered a contraindication to treatment with IL-2 in otherwise eligible patients.
DOI：
10.1056/nejmoa1012863
发表时间：
2011-06-02
期刊：
The New England journal of medicine
影响因子：
--
作者：
Schwartzentruber DJ;Lawson DH;Richards JM;Conry RM;Miller DM;Treisman J;Gailani F;Riley L;Conlon K;Pockaj B;Kendra KL;White RL;Gonzalez R;Kuzel TM;Curti B;Leming PD;Whitman ED;Balkissoon J;Reintgen DS;Kaufman H;Marincola FM;Merino MJ;Rosenberg SA;Choyke P;Vena D;Hwu P
通讯作者：
Hwu P