Department of Hematology & Medical Oncology, Taussig Cancer Institute, Cleveland Clinic, 9500 Euclid Ave, Desk CA60, Cleveland, OH, 44195, USA.
Department of Medicine, Division of Medical Oncology, Duke University Medical Center, Durham, NC, USA.
J Immunother Cancer. 2018 Jan 29;6(1):9. doi: 10.1186/s40425-018-0319-9.
Nivolumab is approved for patients with metastatic renal cell carcinoma (mRCC) refractory to prior antiangiogenic therapy. The clinical activity of nivolumab in patients with non-clear cell RCC subtypes remains unknown as these patients were excluded from the original nivolumab trials.
Patients from 6 centers in the United States who received at least one dose of nivolumab for non-clear cell mRCC between 12/2015 and 06/2017 were identified. A retrospective analysis including patient characteristics, objective response rate according to RECIST v1.1 and treatment-related adverse events (TRAEs) was undertaken.
Forty-one patients were identified. Median age was 58 years (33-82), 71% were male, and majority had ECOG PS 0 (40%) or 1 (47%). Histology included 16 papillary, 14 unclassified, 5 chromophobe, 4 collecting duct, 1 Xp11 translocation and 1 MTSCC (mucinous tubular and spindle cell carcinoma). Among 35 patients who were evaluable for best response, 7 (20%) had PR and 10 (29%) had SD. Responses were observed in unclassified, papillary and collecting duct subtypes. In the entire cohort, median follow-up was 8.5 months and median treatment duration was 3.0 months. Median PFS was 3.5 months and median OS was not reached. Among responders, median time to best response was 5.1 months, and median duration of response was not reached as only 2 out of 7 responders had disease progression during follow-up. TRAEs of any grade were noted in 37% and most commonly included fatigue (12%), fever (10%) and rash (10%). Nivolumab treatments were postponed in 34% and discontinued in 15% of patients due to intolerance. No treatment-related deaths were observed.
Nivolumab monotherapy demonstrated objective responses and was well tolerated in a heterogeneous population of patients with non-clear cell mRCC. In the absence of other data in this treatment setting, this study lends support to the use of nivolumab for patients with metastatic non-clear cell renal cell carcinoma.
纳武利尤单抗获批用于既往抗血管生成治疗失败的转移性肾细胞癌（mRCC）患者。纳武利尤单抗在非透明细胞 RCC 亚型患者中的临床活性尚不清楚，因为这些患者被排除在最初的纳武利尤单抗试验之外。
在美国 6 家中心接受纳武利尤单抗治疗非透明细胞 mRCC 的至少 1 剂的患者被识别。对患者特征、根据 RECIST v1.1 评估的客观缓解率和治疗相关不良事件（TRAEs）进行了回顾性分析。
共确定了 41 名患者。中位年龄为 58 岁（33-82 岁），71%为男性，大多数 ECOG PS 为 0（40%）或 1（47%）。组织学包括 16 例乳头状、14 例未分类、5 例嫌色细胞癌、4 例集合管癌、1 例 Xp11 易位和 1 例 MTSCC（黏液管状和梭形细胞癌）。在 35 名可评估最佳反应的患者中，7 名（20%）有 PR，10 名（29%）有 SD。在未分类、乳头状和集合管亚型中观察到反应。在整个队列中，中位随访时间为 8.5 个月，中位治疗时间为 3.0 个月。中位 PFS 为 3.5 个月，中位 OS 未达到。在应答者中，最佳反应的中位时间为 5.1 个月，由于只有 7 名应答者中有 2 名在随访期间疾病进展，应答的中位持续时间未达到。任何级别的 TRAE 发生率为 37%，最常见的包括疲劳（12%）、发热（10%）和皮疹（10%）。由于不耐受，纳武利尤单抗治疗在 34%的患者中被推迟，在 15%的患者中被停止。未观察到与治疗相关的死亡。
纳武利尤单抗单药治疗在非透明细胞 mRCC 患者的异质性人群中表现出客观缓解且耐受良好。在这种治疗环境中缺乏其他数据的情况下，本研究支持将纳武利尤单抗用于转移性非透明细胞肾细胞癌患者。
