Moffitt Cancer Center, Tampa, FL, USA.
Cancer Research Foundation of NY, Chappaqua, NY, USA.
J Immunother Cancer. 2019 Mar 27;7(1):84. doi: 10.1186/s40425-019-0567-3.
Prognostic scoring systems are used to estimate the risk of mortality from metastatic renal cell carcinoma (mRCC). Outcomes from different therapies may vary within each risk group. These survival algorithms have been applied to assess outcomes in patients receiving T-cell checkpoint inhibitory immunotherapy and tyrosine kinase inhibitor therapy, but have not been applied extensively to patients receiving high dose interleukin-2 (HD IL-2) immunotherapy.
Survival of 810 mRCC patients treated from 2006 to 2017 with high dose IL-2 (aldesleukin) and enrolled in the PROCLAIM registry data base was assessed utilizing the International Metastatic RCC Database Consortium (IMDC) risk criteria. Median follow-up is 23.4 months (mo.) (range 0.2-124 mo.). Subgroup evaluations were performed by separating patients by prior or no prior therapy, IL-2 alone, or therapy subsequent to IL-2. Some patients were in two groups. We will focus on the 356 patients who received IL-2 alone, and evaluate outcome by risk factor categories.
Among the 810 patients, 721 were treatment-naïve (89%) and 59% were intermediate risk. Overall, of the 249 patients with favorable risk, the median overall survival (OS) is 63.3 mo. and the 2-year OS is 77.6%. Of 480 patients with intermediate risk, median OS is 42.4 mo., 2-year OS 68.2%, and of 81 patients with poor risk, median OS 14 mo., 2-year OS 40.4%. Among those who received IL-2 alone (356 patients), median OS is 64.5, 57.6, and 14 months for favorable, intermediate and poor risk categories respectively. Two year survival among those treated only with HD IL-2 is 73.4, 63.7 and 39.8%, for favorable, intermediate and poor risk categories respectively.
Among mRCC patients treated with HD IL-2, all risk groups have median and 2-year survival consistent with recent reports of checkpoint or targeted therapies for mRCC. Favorable and intermediate risk (by IMDC) patients treated with HD IL-2 have longer OS compared with poor risk patients, with most durable OS observed in favorable risk patients. Favorable risk patients treated with HD IL-2 alone have a 2-year OS of 74%. These data continue to support a recommendation for HD IL-2 for patients with mRCC who meet eligibility criteria.
PROCLAIM, NCT01415167 was registered with ClinicalTrials.gov on August 11, 2011, and initiated for retrospective data collection until 2006, and prospective data collection ongoing since 2011.
预后评分系统用于估计转移性肾细胞癌（mRCC）患者的死亡风险。不同治疗方法的结果可能在每个风险组内有所不同。这些生存算法已被应用于评估接受 T 细胞检查点抑制免疫疗法和酪氨酸激酶抑制剂治疗的患者的结局，但尚未广泛应用于接受高剂量白细胞介素-2（HD IL-2）免疫疗法的患者。
利用国际转移性肾细胞癌数据库联盟（IMDC）风险标准评估了 2006 年至 2017 年间接受高剂量 IL-2（白细胞介素 2）和 aldesleukin）治疗的 810 例 mRCC 患者的生存情况，并纳入 PROCLAIM 登记数据库。中位随访时间为 23.4 个月（mo.）（范围 0.2-124 mo.）。通过将患者分为既往治疗或无既往治疗、单独使用 IL-2 或 IL-2 后继治疗，进行亚组评估。有些患者分属于两个组。我们将重点关注 356 例单独接受 IL-2 治疗的患者，并根据风险因素类别评估结局。
在 810 例患者中，721 例为初治（89%），59%为中危。总体而言，249 例预后良好的患者中，中位总生存期（OS）为 63.3 mo.，2 年 OS 为 77.6%。480 例中危患者的中位 OS 为 42.4 mo.，2 年 OS 为 68.2%，81 例预后不良的患者的中位 OS 为 14 mo.，2 年 OS 为 40.4%。在单独接受 IL-2 治疗的 356 例患者中，预后良好、中危和预后不良的患者的中位 OS 分别为 64.5、57.6 和 14 个月。仅接受 HD IL-2 治疗的患者的 2 年生存率分别为预后良好、中危和预后不良患者的 73.4%、63.7%和 39.8%。
在接受 HD IL-2 治疗的 mRCC 患者中，所有风险组的中位生存期和 2 年生存率与 mRCC 患者最近报告的检查点或靶向治疗一致。接受 HD IL-2 治疗的中危和预后良好（按 IMDC 分类）患者的 OS 比预后不良患者长，预后良好患者的 OS 最持久。单独接受 HD IL-2 治疗的预后良好患者的 2 年 OS 为 74%。这些数据继续支持为符合条件的 mRCC 患者推荐使用 HD IL-2。
PROCLAIM，NCT01415167 于 2011 年 8 月 11 日在 ClinicalTrials.gov 上注册，于 2006 年开始进行回顾性数据收集，2011 年开始进行前瞻性数据收集。
