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首页> 外文期刊>Journal of immunotherapy >Adjuvant low-dose interleukin-2 (IL-2) plus interferon-α (IFN-α) in operable renal cell carcinoma (RCC): A phase III, randomized, multicentre trial of the italian oncology group for clinical research (GOIRC)
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Adjuvant low-dose interleukin-2 (IL-2) plus interferon-α (IFN-α) in operable renal cell carcinoma (RCC): A phase III, randomized, multicentre trial of the italian oncology group for clinical research (GOIRC)

机译：辅助性小剂量白介素2（IL-2）和干扰素-α（IFN-α）在可手术肾细胞癌（RCC）中的应用：意大利肿瘤临床研究组（GOIRC）的一项III期随机多中心试验

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There is currently no standard therapy to reduce the recurrence rate after surgery for renal cell carcinoma (RCC). The aim of this study was to assess efficacy and safety of adjuvant treatment with low doses of interleukin-2 (IL-2)+interferon-a (IFN-α) in operable RCC. The patients were randomized 1:1 to receive a 4-week cycle of low-dose IL-2+IFN-α or observation after primary surgery for RCC. Treatment cycles were repeated every 4 months for the first 2 years and every 6 months for the subsequent 3 years. The primary endpoint was recurrence-free survival (RFS); safety; and overall survival (OS) were secondary endpoints. ClinicalTrials.gov registration number was NCT00502034. 303/310 randomized patients (156 in the immunotherapy arm and 154 in the observation group) were evaluable at the intention-to-treat analyses. The 2 arms were well balanced. At a median follow-up of 52 months (range, 12-151 mo), RFS, and OS were similar, with an estimated hazard ratio (HR) of 0.84 [95% confidence interval (CI), 0.54-1.31; P=0.44] and of 1.07 (95% CI, 0.64-1.79; P=0.79), respectively in the 2 groups. Unplanned, subgroup analysis showed a positive effect of the treatment for patients with age 60 years and younger, pN0, tumor grades 1-2, and pT3a stage. Among patients with the combined presence of ≥2 of these factors, immunotherapy had a positive effect on RFS (HR=0.44; 95% CI, 0.24-0.82; P≤0.01), whereas patients with <2 factors in the treatment arm exhibited a significant poorer OS (HR=2.27; 95% CI, 1.03-5.03 P=0.037). Toxicity of immunotherapy was mild and limited to World Health Organization grade 1-2 in most cases. Adjuvant immunotherapy with IL-2+IFN-α showed no RFS or OS improvement in RCC patients who underwent radical surgery. The results of subset analysis here presented are only hypothesis generating.
机译：目前尚无标准疗法可降低肾细胞癌（RCC）手术后的复发率。这项研究的目的是评估在可手术的RCC中小剂量白介素2（IL-2）+干扰素-α（IFN-α）辅助治疗的有效性和安全性。患者按1：1的比例随机分配，接受4周低剂量IL-2 +IFN-α的治疗或接受RCC初次手术后的观察。在最初的2年中，每4个月重复一次治疗周期，在随后的3年中，每6个月重复一次。主要终点是无复发生存期（RFS）。安全;和总生存期（OS）是次要终点。 ClinicalTrials.gov的注册号为NCT00502034。 303/310名随机患者（免疫治疗组156名，观察组154名）在意向性治疗分析中可评估。 2个手臂平衡良好。中位随访52个月（范围12-151 mo），RFS和OS相似，估计危险比（HR）为0.84 [95％置信区间（CI），0.54-1.31; [P = 0.44]和2组分别为1.07（95％CI，0.64-1.79; P = 0.79）。未经计划的亚组分析显示，该疗法对60岁及以下，pN0、1-2级肿瘤和pT3a分期的患者具有积极作用。在这些因素的总和≥2的患者中，免疫疗法对RFS有积极作用（HR = 0.44; 95％CI，0.24-0.82;P≤0.01），而治疗组中<2个因素的患者表现出一定的敏感性。 OS明显较差（HR = 2.27; 95％CI，1.03-5.03 P = 0.037）。免疫疗法的毒性很小，在大多数情况下限于世界卫生组织1-2级。在接受根治性手术的RCC患者中，IL-2 +IFN-α的辅助免疫疗法未显示RFS或OS改善。这里介绍的子集分析结果仅是假设的产生。

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