Phase 2 study of eribulin in patients with previously treated advanced or metastatic soft tissue sarcoma.
Phase 2 study of eribulin in patients with previously treated advanced or metastatic soft tissue sarcoma.
复制标题
DOI：
10.1093/jjco/hyw175
复制
发表时间：
2017-02-01
影响因子：
2.4
通讯作者：
Isu K
中科院分区：
文献类型：
--
作者：
Kawai A;Araki N;Naito Y;Ozaki T;Sugiura H;Yazawa Y;Morioka H;Matsumine A;Saito K;Asami S;Isu K
这项2期研究调查了以前治疗过的日本晚期/转移性软组织肉瘤患者中的灯盏花素。埃布林显示出临床活性，并具有可管理的安全性。埃布林是一种微管动力学抑制剂，已被批准用于乳腺癌和软组织肉瘤患者的治疗。我们研究了灯盏花素治疗日本软组织肉瘤患者的疗效和安全性。这项开放标签、多中心、非随机的第二阶段研究纳入了日本患者，这些患者患有可测量的、高/中级别的晚期/转移性软组织肉瘤，并在晚期疾病之前接受≥1化疗。患者在21天周期的第1天和第8天，在2-5分钟内静脉注射甲磺酸淫羊藿苷1.4 mg/m2。主要终点是12周时的无进展率。次要终点包括总体存活率、无进展存活率和安全性。疗效分析按组织学(脂肪肉瘤或平滑肌肉瘤及其他亚型)分层。总体而言，52名患者入选，51名患者接受治疗。脂肪肉瘤/平滑肌肉瘤患者(n=35)与其他亚型患者(n=16)有相似的特征，只是女性比例较高(分别为63%和38%)，东部合作肿瘤组患者的表现状态为0(57%比44%)。脂肪肉瘤/平滑肌肉瘤患者12周的无进展率为60%，其他亚型为31%，总体为51%。脂肪肉瘤/平滑肌肉瘤患者的中位无进展生存期为5.5个月，其他亚型为2.0个月，总的无进展生存期为4.1个月。脂肪肉瘤/平滑肌肉瘤患者的中位总生存期为17.0个月，其他亚型的中位生存期为7.6个月，总的中位生存期为13.2个月。最常见的3-4级不良反应为中性粒细胞减少症(86%)、白细胞减少症(75%)、淋巴细胞减少症(33%)、贫血(14%)和发热中性粒细胞减少症(8%)。Eribuin在以前治疗过的日本晚期/转移性软组织肉瘤患者中显示出临床活性和可控的安全性。
This phase 2 study investigated eribulin in previously treated Japanese patients with advanced/metastatic soft tissue sarcoma. Eribulin showed clinical activity together with a manageable safety profile. Eribulin, a microtubule dynamics inhibitor, is approved for the treatment of patients with breast cancer and soft tissue sarcoma. We investigated the efficacy and safety of eribulin in Japanese patients with soft tissue sarcoma. This open-label, multicenter, nonrandomized, Phase 2 study enrolled Japanese patients with measurable, advanced/metastatic soft tissue sarcoma of high/intermediate grade and ≥1 prior chemotherapy for advanced disease. Patients received eribulin mesilate 1.4 mg/m2 intravenously over 2–5 minutes on Days 1 and 8 of a 21-day cycle. The primary endpoint was progression-free rate at 12 weeks. Secondary endpoints included overall survival, progression-free survival and safety. Efficacy analyses were stratified by histology (liposarcoma or leiomyosarcoma, and other subtypes). Overall, 52 patients were enrolled and 51 patients were treated. Patients with liposarcoma/leiomyosarcoma (n = 35) had similar characteristics to those with other subtypes (n = 16), except for a higher proportion of women (63% vs 38%, respectively) and patients with Eastern Cooperative Oncology Group performance status 0 (57% vs 44%). Progression-free rate at 12 weeks was 60% in liposarcoma/leiomyosarcoma patients, 31% in other subtypes and 51% overall. Median progression-free survival was 5.5 months in liposarcoma/leiomyosarcoma patients, 2.0 months in other subtypes and 4.1 months overall. Median overall survival was 17.0 months in liposarcoma/leiomyosarcoma patients, 7.6 months in other subtypes and 13.2 months overall. The most common Grade 3–4 adverse events were neutropenia (86%), leukopenia (75%), lymphopenia (33%), anemia (14%) and febrile neutropenia (8%). Eribulin showed clinical activity with a manageable safety profile in previously treated Japanese patients with advanced/metastatic soft tissue sarcoma.
登录
查看更多内容
影响因子：
8.4
作者：
Eisenhauer, E. A.;Therasse, P.;Verweij, J.
通讯作者：
Verweij, J.
影响因子：
2.9
作者：
Smith, Jennifer A.;Wilson, Leslie;Jordan, Mary Ann
通讯作者：
Jordan, Mary Ann
影响因子：
51.1
作者：
Kawai, Akira;Araki, Nobuhito;Takahashi, Shunji
通讯作者：
Takahashi, Shunji
影响因子：
8.4
作者：
Van Glabbeke, M;Verweij, J;Nielsen, OS
通讯作者：
Nielsen, OS
影响因子：
50.5
作者：
Casali, Paolo G.;Blay, Jean-Yves;Wardelmann, Eva
通讯作者：
Wardelmann, Eva