Division of Thoracic Surgery, Department of Surgery, Hyogo College of Medicine, 1-1 Mukogawa-cho, Nishinomiya, Hyogo, 663-8501, Japan.
Division of Respiratory Medicine, Department of Thoracic Oncology, Hyogo College of Medicine, 1-1 Mukogawa-cho, Nishinomiya, Hyogo, 663-8501, Japan.
Jpn J Clin Oncol. 2020 Aug 4;50(8):920-925. doi: 10.1093/jjco/hyaa069.
Limited options exist for treating post-recurrence patients with malignant pleural mesothelioma (MPM). This study aimed to evaluate the efficacy and feasibility of nivolumab in patients with post-operative recurrence of MPM in a real-world setting.
This study included 35 patients with post-operative recurrence of MPM. Treatment consisted of 240-mg intravenous nivolumab administration every 2 weeks until progressive disease (PD) or serious adverse events (AEs). Additional post-treatment data were evaluated, including objective response rate (ORR), disease control rate (DCR), progression-free survival (PFS), post-treatment survival and AEs. Tumor response was assessed using the modified Response Evaluation Criteria in Solid Tumors. Survival analysis was performed using the Kaplan-Meier method. The feasibility analysis including AEs was performed with the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0.
Of the 35 patients who received nivolumab, median follow-up was 6 months. The median treatment duration was 3 months (range: 1-14 months), and median of 8 cycles (range: 2-32 cycles) was administered. Best overall responses were follows: 1 patient had complete response, 6 had partial response, 18 had stable disease and 8 had PD. The ORR was 20.0%, and the DCR was 77.1%. The median overall survival and PFS were 13.1 and 4.4 months, respectively. There were grade-3 AEs in four patients (11.4%). No grade-4 or -5 AEs were observed.
Nivolumab treatment in patients with post-operative recurrence of MPM seems safe and clinical efficacy.
恶性胸膜间皮瘤（MPM）术后复发患者的治疗选择有限。本研究旨在评估纳武利尤单抗在真实世界环境中治疗 MPM 术后复发患者的疗效和可行性。
本研究纳入了 35 例 MPM 术后复发患者。治疗方案为每 2 周静脉输注 240mg 纳武利尤单抗，直至疾病进展（PD）或出现严重不良事件（AE）。评估了治疗后的额外数据，包括客观缓解率（ORR）、疾病控制率（DCR）、无进展生存期（PFS）、治疗后生存时间和 AE。使用实体瘤反应评估标准（RECIST）1.1 评估肿瘤缓解情况。采用 Kaplan-Meier 法进行生存分析。使用美国国立癌症研究所不良事件通用术语标准（CTCAE）5.0 进行 AE 可行性分析。
35 例接受纳武利尤单抗治疗的患者中，中位随访时间为 6 个月。中位治疗持续时间为 3 个月（范围：1-14 个月），中位治疗周期为 8 个（范围：2-32 个）。最佳总体缓解情况为：1 例完全缓解，6 例部分缓解，18 例疾病稳定，8 例疾病进展。ORR 为 20.0%，DCR 为 77.1%。中位总生存期和 PFS 分别为 13.1 个月和 4.4 个月。4 例（11.4%）患者出现 3 级 AE，未观察到 4 级或 5 级 AE。
纳武利尤单抗治疗 MPM 术后复发患者似乎安全且具有临床疗效。
