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Eribulin in pretreated metastatic breast cancer patients: results of the TROTTER trial—a multicenter retrospective study of eribulin in real life

机译:预处理过的转移性乳腺癌患者中的依立布林:TROTTER试验结果–现实生活中埃立布林的多中心回顾性研究

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摘要

This retrospective multicenter analysis was aimed to evaluate clinical activity and tolerability of eribulin in pretreated metastatic breast cancer patients in clinical practice. Patients treated with eribulin from January 2012 to July 2013 were enrolled in the observational study from 10 italian hospitals. Tumor and toxicity evaluation were performed according to Agenzia Italiana Farmaco. One-hundred and thirteen patients were included in the study. Median age 62 years old. 71.7 % of the patients had visceral involvement and the majority had a burden of disease involving two or more organs with a median number of 2 (1–6). The median number of previous chemotherapy regimens for advanced disease was 3 (1–10). Median number of eribulin cycles was 4 (1–27). Overall response rate was 24 % (95 % CI 16.0–31.8). Clinical benefit rate, was 35.4 % (95 % CI 26.6–44.2). At a median follow-up of 29.6 months (8.3–41.9) the median progression free survival was 3.3 months (0.6–26.7; 95 % CI 2.4–4.2), and the median overall survival 11.6 months (0.6–33.3; 95 % CI 8.7–14.5). No correlation was recorded between subtypes in terms of ORR and CBR. Toxicity was manageable. Main common grade 3–4 toxicities were neutropenia (19.4 %), febrile neutropenia (0.9 %), asthenia (3.5 %), abnormal liver function test (1.8 %), stomatitis (0.9 %). Our results confirm that treatment with eribulin is feasible and safe in real-world patients.
机译:这项回顾性多中心分析旨在评估临床实践中经过预处理的转移性乳腺癌患者中eribulin的临床活性和耐受性。从2012年1月至2013年7月用eribulin治疗的患者入选了10家意大利医院的观察性研究。根据Agenzia Italiana Farmaco进行肿瘤和毒性评估。这项研究纳入了一百三十一例患者。中位年龄62岁。 71.7%的患者有内脏受累,大多数患者的疾病负担涉及两个或多个器官,中位数为2(1-6)。先前针对晚期疾病的化疗方案的中位数为3(1-10)。 eribulin周期的中位数为4(1-27)。整体回应率为24%(95%CI 16.0-31.8)。临床受益率为35.4%(95%CI 26.6-44.2)。在29.6个月(8.3-41.9)的中位随访中,无进展中位生存期为3.3个月(0.6-26.7; 95%CI 2.4-4.2),中位总生存期为11.6个月(0.6-33.3; 95%CI) 8.7–14.5)。在ORR和CBR方面,亚型之间未发现相关性。毒性是可控的。主要的3-4级常见毒性反应是中性粒细胞减少症(19.4%),发热性中性粒细胞减少症(0.9%),乏力(3.5%),肝功能异常(1.8%),口腔炎(0.9%)。我们的结果证实,在现实世界中的患者中,用eribulin治疗是可行且安全的。

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