Initial Evaluation of Nivolumab in Patients With Post-Operative Recurrence of Malignant Pleural Mesothelioma
Japanese Journal of Clinical Oncology 2020 May 28 [Link]
Akifumi Nakamura, Nobuyuki Kondo, Toru Nakamichi, Ayumi Kuroda, Masaki Hashimoto 1, Seiji Matsumoto 1, Takashi Yokoi 2, Kozo Kuribayashi, Takashi Kijima, Seiki Hasegawa
Background: 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.
Methods: 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.
Results: 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.
Conclusion: Nivolumab treatment in patients with post-operative recurrence of MPM seems safe and clinical efficacy.