Queen Elizabeth II Health Sciences Centre, Halifax, Nova Scotia, Canada.
Division of Oncology, University of Alberta, Cross Cancer Institute, Edmonton, Alberta, Canada.
Clin Genitourin Cancer. 2022 Jun;20(3):210-218. doi: 10.1016/j.clgc.2021.12.003. Epub 2021 Dec 10.
Ipilimumab plus nivolumab was associated with a survival benefit in a phase III clinical trial of first-line treatment for metastatic renal cell carcinoma (mRCC). In this study, mRCC patients from the Canadian Kidney Cancer Information System (CKCis) database who received first-line ipilimumab plus nivolumab were analyzed to determine the safety and outcomes in a real-world setting.
Patients who received ipilimumab plus nivolumab as first-line therapy for mRCC in CKCis, were identified, and the amount of treatment received, discontinuation rates, and reasons for discontinuing treatment were determined. Toxicity data, including type and grade, were collected. Efficacy outcomes of interest included overall survival (OS), progression-free survival (PFS), and overall response rate (ORR).
The cohort included 195 patients, the majority with clear cell histology (74%). All 4 cycles of ipilimumab plus nivolumab were administered in 124 patients (64%). Progressive disease (n = 87; 45%) and toxicity (n = 36; 18%) were the most common causes for discontinuing treatment. Several patients (n = 18) did not receive all 4 doses of ipilimumab but received single agent nivolumab. The estimated median OS was 54.5 months (95% CI, 17.7 - NE) and 12-month OS was 72.2% (95% CI, 65.0 - 79.3). Median PFS was 7.4 months (95% CI 5.3 - 10.2) and ORR was 42.5%. Patients who received all 4 cycles of ipilimumab plus nivolumab had better ORR (50% vs. 28%) and a longer PFS and OS than those who received less than 4 cycles (P < .0001). Ninety-five AEs were documented in 72 patients who required dose reduction/change, with colitis being the most frequent.
In this real-world cohort of treatment-naïve mRCC patients, outcomes, and safety were comparable to previously reported clinical trial data.
依匹单抗联合纳武利尤单抗在转移性肾细胞癌（mRCC）一线治疗的 III 期临床试验中显示出生存获益。在这项研究中，分析了来自加拿大肾脏癌信息系统（CKCis）数据库的接受一线依匹单抗联合纳武利尤单抗治疗的 mRCC 患者，以确定真实环境中的安全性和结果。
确定了在 CKCis 中接受依匹单抗联合纳武利尤单抗作为一线 mRCC 治疗的患者，并确定了治疗的剂量、停药率以及停药的原因。收集了毒性数据，包括类型和等级。感兴趣的疗效结果包括总生存期（OS）、无进展生存期（PFS）和总缓解率（ORR）。
该队列包括 195 名患者，大多数为透明细胞组织学（74%）。124 名患者（64%）接受了全部 4 个周期的依匹单抗联合纳武利尤单抗治疗。进展性疾病（n=87；45%）和毒性（n=36；18%）是停止治疗的最常见原因。一些患者（n=18）未接受全部 4 剂依匹单抗，但接受了单药纳武利尤单抗治疗。估计中位 OS 为 54.5 个月（95%CI，17.7-NE），12 个月 OS 为 72.2%（95%CI，65.0-79.3）。中位 PFS 为 7.4 个月（95%CI，5.3-10.2），ORR 为 42.5%。接受全部 4 个周期依匹单抗联合纳武利尤单抗治疗的患者 ORR 更高（50%比 28%），PFS 和 OS 也更长，而接受少于 4 个周期治疗的患者则较低（P<.0001）。72 名需要剂量减少/改变的患者记录了 95 例不良事件，其中结肠炎最常见。
在这项未经治疗的 mRCC 患者的真实世界队列中，结果和安全性与先前报道的临床试验数据相当。
