Azienda Ospedaliera Universitaria di Modena, Modena, Italy.
AORN A. Cardarelli, Napoli, Italy.
PLoS One. 2018 Jul 6;13(7):e0199642. doi: 10.1371/journal.pone.0199642. eCollection 2018.
Results from phase III clinical trial CheckMate 025 have established nivolumab as the standard of care for treatment of metastatic renal-cell carcinoma (mRCC) after VEGF inhibitor failure; however, elderly patients are under-represented in the registration trial and little is known about the activity of nivolumab in this subgroup. The purpose of the Expanded Access Program was to provide nivolumab to patients with mRCC who had progressed despite treatment with other agents that were considered standard of care.
Nivolumab 3 mg/kg was administered intravenously every 2 weeks to a maximum of 24 months or until progression or unacceptable toxicity. The current analysis included all patients from the EAP Italian cohort who had received ≥1 dose of nivolumab. Adverse events (AEs) were monitored using Common Terminology Criteria for Adverse Events v4.0.
A total of 389 patients with advanced RCC were enrolled in the Italian cohort of the EAP and treated with nivolumab. Of these patients, 125 (32%) were at least 70 years of age and 70 (18%) were at least 75 years of age. Efficacy with nivolumab in the elderly patients was similar to that observed in the overall EAP population and in the CheckMate 025 trial. Safety was comparable between the elderly patients and the overall EAP population, and was consistent with what previously reported.
The final results suggest that elderly patients with pretreated metastatic RCC may benefit from therapy with nivolumab.
CheckMate 025 期临床试验的结果确立了纳武利尤单抗作为 VEGF 抑制剂治疗失败后转移性肾细胞癌（mRCC）的标准治疗方法；然而，在注册试验中，老年患者代表性不足，对这一亚组中纳武利尤单抗的活性知之甚少。扩展准入计划的目的是为那些在接受其他被认为是标准治疗的药物治疗后进展的 mRCC 患者提供纳武利尤单抗。
纳武利尤单抗 3 mg/kg 静脉输注，每 2 周 1 次，最长 24 个月或直至疾病进展或不可接受的毒性。目前的分析包括来自意大利 EAP 队列的所有接受了至少 1 剂纳武利尤单抗的患者。使用不良事件通用术语标准 4.0 监测不良事件（AE）。
EAP 意大利队列共纳入 389 例晚期 RCC 患者接受纳武利尤单抗治疗。这些患者中，125 例（32%）年龄至少为 70 岁，70 例（18%）年龄至少为 75 岁。老年患者的纳武利尤单抗疗效与总体 EAP 人群和 CheckMate 025 试验观察到的疗效相似。老年患者与总体 EAP 人群的安全性相当，与之前报道的结果一致。
最终结果表明，经治转移性 RCC 老年患者可能从纳武利尤单抗治疗中获益。
