恶性胸膜间皮瘤患者接受伊匹单抗和 Nivolumab 联合疗法作为一线或二线治疗的实际效果

IF 3 Q2 ONCOLOGY

JTO Clinical and Research Reports Pub Date : 2024-10-15 DOI:10.1016/j.jtocrr.2024.100735

Sabine Schmid MD , Lisa Holer MSc , Katrin Gysel MSc , Kira-Lee Koster MD , Sacha I. Rothschild MD , Laura A. Boos MD , Lorenz Frehner MD , Sabine Cardoso Almeida MD , Christian Britschgi MD, PhD , Yannis Metaxas MD , Michael Mark MD , Patrizia Froesch MD , Wolf-Dieter Janthur MD , Anna Allemann MD , Christine Waibel MD , Catherine Von der Mühll-Schill MD , Martin Früh MD , Laetitia A. Mauti MD, PhD

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引用次数: 0

摘要

目的在CheckMate-743取得积极成果的基础上，伊匹单抗和尼夫单抗（ipi-nivo）联合治疗恶性胸膜间皮瘤（MPM）的一线（1L）疗法已成为标准疗法。此外，根据MAPS2的结果，接受过1L铂/培美曲塞化疗的患者通常会被考虑接受二线或三线（2L+）ipi-nivo治疗。在此，我们报告了瑞士 MPM 患者接受 ipi-nivo 治疗的实际生存率和安全性结果。收集的基线特征包括年龄、性别、组织学、程序性死亡配体 1 表达、东部合作肿瘤学组（Eastern Cooperative Oncology Group）表现状态（ECOG PS）以及先前/后续疗法。结果在2017年11月至2023年3月期间接受ipi-nivo治疗的109名MPM患者中（中位随访16.6个月），75%为上皮样组织学，9%为双相组织学，16%为肉瘤样组织学。43%的患者接受了伊匹单抗联合尼妥珠单抗的1L治疗，57%的患者接受了2L+治疗。1L 的客观反应率为 21%，2L+ 的客观反应率为 15%。中位无进展生存期分别为6.5个月和2.8个月。从开始接受ipi-nivo治疗起，1L患者的中位总生存期（OS）为12.6个月，2L+患者的中位总生存期（OS）为6.9个月。根据年龄和程序性死亡配体1表达的不同，OS没有差异。然而，ECOG PS 为 2 或以上的患者的中位 OS 明显低于 ECOG PS 为 0 至 1 的患者（2.4 个月对 11.9 个月，p < 0.001）。65名患者（62%）发生了与ipi-nivo治疗相关的任何级别的治疗相关不良事件（TRAE）。结论在这组接受 ipi-nivo 治疗的 MPM 患者中，实际生存结果不如 CheckMate-743 和 MAPS2 试验报告的结果，但安全性结果相似。

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Real-World Outcomes of Patients With Malignant Pleural Mesothelioma Receiving a Combination of Ipilimumab and Nivolumab as First- or Later-Line Treatment

Objectives

On the basis of the positive results of CheckMate-743, first-line (1L) treatment of malignant pleural mesothelioma (MPM) with the combination of ipilimumab and nivolumab (ipi-nivo) has become a standard-of-care. Furthermore, patients who received 1L platinum/pemetrexed chemotherapy are often considered for second or further-line (2L+) ipi-nivo on the basis of MAPS2 results. Here we report on real-world survival and safety outcomes of ipi-nivo for patients with MPM in Switzerland.

Methods

Twelve cancer centers contributed data to this retrospective cohort. Baseline characteristics including age, sex, histology, programmed death-ligand 1 expression, Eastern Cooperative Oncology Group performance status (ECOG PS), and previous/subsequent therapies were collected. The efficacy and safety outcomes were assessed by local investigators.

Results

Of the 109 patients with MPM treated with ipi-nivo between November 2017 and March 2023 (median follow-up of 16.6 months) 75% had epithelioid, 9% biphasic, and 16% sarcomatoid histology. The median age was 72 years; 91% were males, and 83% had an ECOG PS of 0 to 1. Ipilimumab in combination with nivolumab was given as 1L in 43% and as 2L+ treatment in 57% of patients. The objective response rate was 21% in 1L and 15% in 2L+. Median progression-free survival was 6.5 and 2.8 months, respectively. Median overall survival (OS) from the start of ipi-nivo was 12.6 months for 1L and 6.9 months for 2L+. No differences in OS were observed depending on age and programmed death-ligand 1 expression. Nevertheless, the median OS was significantly worse in patients with an ECOG PS of 2 or higher than those with an ECOG PS of 0 to 1 (2.4 versus 11.9 months, p < 0.001). Treatment-related adverse events (TRAEs) of any grade related to ipi-nivo treatment occurred in 65 patients (62%). The highest-grade TRAE was 1 to 2 in 58% of these patients and 3 or higher in 42% Treatment discontinuation due to a TRAE occurred in 22% of patients.

Conclusion

In this real-world cohort of patients with MPM treated with ipi-nivo survival outcomes were inferior to those reported in the CheckMate-743 and MAPS2 trials, whereas safety outcomes were similar.

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