Efficacy and safety of nivolumab with ipilimumab for recurrent malignant pleural mesothelioma after primary surgical intervention

• Published in: International journal of clinical oncology 2023-03, Vol.28 (3), p.409-415
• Main Authors: Nakamura, Akifumi, Hashimoto, Masaki, Kondo, Nobuyuki, Matsumoto, Seiji, Kuroda, Ayumi, Minami, Toshiyuki, Kitajima, Kazuhiro, Kuribayashi, Kozo, Kijima, Takashi, Hasegawa, Seiki
• Format: Article
• Language: English
• Subjects: Antineoplastic Combined Chemotherapy Protocols; Cancer Research; Disease control; Humans; Ipilimumab - adverse effects; Ipilimumab - therapeutic use; Medicine; Medicine & Public Health; Mesothelioma; Mesothelioma, Malignant - chemically induced; Mesothelioma, Malignant - drug therapy; Neutropenia; Nivolumab - adverse effects; Oncology; Original Article; Patients; Progression-Free Survival; Solid tumors; Surgery; Surgical Oncology; Survival Analysis; Terminology
• ISSN: 1341-9625; 1437-7772
• DOI: 10.1007/s10147-023-02292-3

Background Treatment of recurrent malignant pleural mesothelioma (MPM) remains challenging. Our study examined the efficacy, tolerability, and safety of nivolumab with ipilimumab treatment for recurrent MPM after primary curative-intent surgery. Methods Treatment comprised 360 mg nivolumab every 3 weeks and 1 mg/kg of ipilimumab every 6 weeks, both administered intravenously. Both were discontinued for progressive disease or serious adverse events (AEs). Additional post-treatment data were evaluated, including objective response rate (ORR), disease control rate (DCR), post-treatment survival, progression-free survival (PFS), and AEs. Tumor response was assessed using the modified Response Evaluation Criteria in Solid Tumors (RECIST 1.1). Survival analysis was estimated using a Kaplan–Meier plot. Feasibility analysis was performed using the National Cancer Institute Common Terminology Criteria for AEs version 5.0. Results Forty-one patients received nivolumab with ipilimumab for recurrent MPM after primary curative-intent surgery (median follow-up, 10.4 months; median treatment, 5.1 months). Overall, 18 patients exhibited partial response, 13 exhibited stable disease, and 10 had documented progressive disease. ORR and DCR were 43.9 and 75.6%, respectively. The 12-month post-treatment survival rate and PFS rate were 74.2 and 40.0%, respectively (median survival, not calculated; median PFS, 7.3 months). Further, 47 AEs were reported in 29 patients (70.7%), including grade 3–4 AEs in 14 patients (34.1%). Grade 4 hepatobiliary disorders were observed in 2 patients and grade 4 neutropenia was observed in 1. Conclusion Nivolumab with ipilimumab treatment in patients with recurrent MPM after primary surgical treatment may be clinically efficacious, although serious AEs may be frequently observed.