Brief Report: Real-World Toxicity and Survival of Combination Immunotherapy in Pleural Mesothelioma-RIOMeso
- Author(s)
- McNamee, N; Harvey, C; Gray, L; Khoo, T; Lingam, L; Zhang, B; Nindra, U; Yip, PY; Pal, A; Clay, T; Arulananda, S; Itchins, M; Pavlakis, N; Kao, S; Bowyer, S; Chin, V; Warburton, L; Pires da Silva, I; John, T; Solomon, B; Alexander, M; Nagrial, A;
- Details
- Publication Year 2024-04,Volume 19,Issue #4,Page 636-642
- Journal Title
- Journal of Thoracic Oncology
- Publication Type
- Research article
- Abstract
- BACKGROUND: Australia has one of the highest rates of asbestos-associated diseases. Mesothelioma remains an area of unmet need with a 5-year overall survival of 10%. First-line immunotherapy with ipilimumab and nivolumab is now a standard of care for unresectable pleural mesothelioma following the CheckMate 743 trial, with supportive data from the later line single-arm MAPS2 trial. RIOMeso evaluates survival and toxicity of this regimen in real-world practice. METHODS: Demographic and clinicopathologic data of Australian patients treated with ipilimumab and nivolumab in first- and subsequent-line settings for pleural mesothelioma were collected retrospectively. Survival was reported using the Kaplan-Meier method and compared between subgroups with the log-rank test. Toxicity was investigator assessed using Common Terminology Criteria for Adverse Events version 5.0. RESULTS: A total of 119 patients were identified from 11 centers. The median age was 72 years, 83% were male, 92% had Eastern Cooperative Oncology Group less than or equal to 1, 50% were past or current smokers, and 78% had known asbestos exposure. In addition, 50% were epithelioid, 19% sarcomatoid, 14% biphasic, and 17% unavailable. Ipilimumab and nivolumab were used first line in 75% of patients. Median overall survival (mOS) was 14.5 months (95% confidence interval [CI]: 13.0-not reached [NR]) for the entire cohort. For patients treated first line, mOS was 14.5 months (95% CI: 12.5-NR) and in second- or later-line patients was 15.4 months (95% CI: 11.2-NR). There was no statistically significant difference in mOS for epithelioid patients compared with nonepithelioid (19.1 mo [95% CI: 15.4-NR] versus 13.0 mo [95% CI: 9.7-NR], respectively, p = 0.064). Furthermore, 24% of the patients had a Common Terminology Criteria for Adverse Events grade greater than or equal to 3 adverse events, including three treatment-related deaths. Colitis was the most frequent adverse event. CONCLUSIONS: Combination immunotherapy in real-world practice has poorer survival outcomes and seems more toxic compared with clinical trial data. This is the first detailed report of real-world survival and toxicity outcomes using ipilimumab and nivolumab treatment of pleural mesothelioma.
- Publisher
- Elsevier
- Keywords
- Humans; Male; Aged; Female; Nivolumab/adverse effects; Ipilimumab/adverse effects; Retrospective Studies; *Lung Neoplasms/drug therapy/etiology; Australia; *Mesothelioma, Malignant; *Mesothelioma/drug therapy/etiology; *Pleural Neoplasms/drug therapy/etiology; Immunotherapy/adverse effects; *Asbestos; Antineoplastic Combined Chemotherapy Protocols/adverse effects; Immunotherapy; Pleural mesothelioma; Real-world; Toxicity
- Department(s)
- Medical Oncology; Pharmacy
- Publisher's Version
- https://doi.org/10.1016/j.jtho.2023.11.014
- Terms of Use/Rights Notice
- Refer to copyright notice on published article.
Creation Date: 2024-07-16 07:55:49
Last Modified: 2024-07-16 07:59:12