Rodriguez Cristina P, Martins Renato G, Baik Christina, Chow Laura Q, Santana-Davila Rafael, Goulart Bernardo H, Lee Sylvia, Eaton Keith D
Division of Medical Oncology, Department of Medicine, University of Washington, Seattle, WA.
Fred Hutchinson Cancer Research Center, Seattle, WA.
Head Neck. 2018 Mar;40(3):584-589. doi: 10.1002/hed.25020. Epub 2017 Dec 28.
This study examined the microtubule inhibitor eribulin in recurrent/metastatic salivary gland cancers (RMSGCs), a disease where no therapeutic standard exists.
This phase II clinical trial treated patients with progressive recurrent/metastatic salivary gland cancers with eribulin 1.4 mg/m i.v. on days 1 and 8 of a 21-day cycle until disease progression/unacceptable toxicities. The primary endpoint was the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 objective response rate.
Between May 2012 and August 2015, 29 patients were enrolled in this study. The median age was 63 years (range 34-75 years) and 20 of the subjects were men (69%). The most common histologies were adenoid cystic carcinoma (ACC; n = 11) and adenocarcinoma (n = 4). Neutropenia was the most common toxicity (grade 3; n = 5; 17% and grade 4 n = 3; 10%). The objective responses were observed in 3 of 29 patients (10%), 20 of 29 patients (69%) demonstrated a decrement in tumor size, and disease control was observed in 26 of 29 patients (90%).
Although the objective responses to eribulin were uncommon, disease control was observed in the majority of patients.
本研究考察了微管抑制剂艾瑞布林在复发/转移性唾液腺癌（RMSGCs）中的疗效，该病尚无治疗标准。
本II期临床试验采用艾瑞布林1.4mg/m²静脉注射，在21天周期的第1天和第8天给药，治疗病情进展的复发/转移性唾液腺癌患者，直至疾病进展或出现不可接受的毒性。主要终点为实体瘤疗效评价标准（RECIST）1.1版的客观缓解率。
2012年5月至2015年8月期间，29例患者入组本研究。中位年龄为63岁（范围34 - 75岁），20例受试者为男性（69%）。最常见的组织学类型为腺样囊性癌（ACC；n = 11）和腺癌（n = 4）。中性粒细胞减少是最常见的毒性反应（3级；n = 5；17%，4级n = 3；10%）。29例患者中有3例（10%）观察到客观缓解，29例患者中有20例（69%）肿瘤大小减小，29例患者中有26例（90%）观察到疾病控制。
尽管艾瑞布林的客观缓解不常见，但大多数患者观察到疾病控制。
