Department of Thoracic Oncology and Respiratory Medicine, Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital, Bunkyo, Japan.
Department of Thoracic Oncology, National Cancer Center Hospital, Chuo, Japan.
Thorac Cancer. 2021 Jun;12(11):1668-1672. doi: 10.1111/1759-7714.13892. Epub 2021 Apr 8.
Treatment options for malignant pleural mesothelioma (MPM) are limited. Anthracyclines are considered key drugs for treating MPM. However, their use is limited by severe cardiac toxicities. Amrubicin (AMR) is a next-generation anthracycline that is commonly used to treat lung cancer. Here, we conducted a phase II trial of this drug in patients with previously treated MPM.
Eligible patients with MPM having adequate organ function and a performance status of 0-2 were enrolled after disease progression following pemetrexed/platinum therapy. Patients received 35 mg/m AMR on days 1-3 every three weeks until tumor progression or the appearance of unacceptable toxicities. The primary endpoint was the objective response rate. Median progression-free survival (PFS), overall survival (OS), number of treatment cycles, and adverse events were evaluated as secondary endpoints.
This trial was discontinued because of low accrual. From September 2013 to July 2018, five patients with MPM were enrolled. Stable disease (SD) was observed in three patients (60%), and progressive disease was noted in two patients (40%). The median PFS was 2.4 (range, 1.2-11.2) months, and the median OS was 9.1 (range, 6.2-22.0) months. The median number of treatment cycles was three (range, 2-11). Grade 1/2 toxicities were observed in all patients. Grade 3/4 neutropenia was observed in four patients (80%), but there were no cases of febrile neutropenia.
Despite the absence of the responders, the observation of SD in three patients suggests that AMR could have potential for treating MPM.
恶性胸膜间皮瘤（MPM）的治疗选择有限。蒽环类药物被认为是治疗 MPM 的关键药物。然而，由于严重的心脏毒性，其应用受到限制。氨柔比星（AMR）是一种常用于治疗肺癌的新一代蒽环类药物。在这里，我们对先前接受过治疗的 MPM 患者进行了这项药物的 II 期试验。
在培美曲塞/铂类化疗后疾病进展的情况下，纳入了有足够器官功能和表现状态为 0-2 的 MPM 患者。患者每 3 周接受 35mg/m2 AMR 治疗，连续 3 天，直到肿瘤进展或出现不可接受的毒性。主要终点是客观缓解率。中位无进展生存期（PFS）、总生存期（OS）、治疗周期数和不良事件作为次要终点进行评估。
由于入组人数少，该试验被终止。从 2013 年 9 月至 2018 年 7 月，共纳入了 5 例 MPM 患者。3 例（60%）患者观察到疾病稳定（SD），2 例（40%）患者观察到疾病进展。中位 PFS 为 2.4（范围，1.2-11.2）个月，中位 OS 为 9.1（范围，6.2-22.0）个月。中位治疗周期数为 3（范围，2-11）。所有患者均观察到 1/2 级毒性。4 例（80%）患者观察到 3/4 级中性粒细胞减少症，但无发热性中性粒细胞减少症病例。
尽管没有应答者，但 3 例患者观察到 SD，提示 AMR 可能具有治疗 MPM 的潜力。
