Phase II trial of eribulin mesylate in recurrent or metastatic salivary gland malignancies

BackgroundThis study examined the microtubule inhibitor eribulin in recurrent/metastatic salivary gland cancers (RMSGCs), a disease where no therapeutic standard exists. MethodsThis phase II clinical trial treated patients with progressive recurrent/metastatic salivary gland cancers with eribulin 1.4 mg/m(2) 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. ResultsBetween 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%). ConclusionAlthough the objective responses to eribulin were uncommon, disease control was observed in the majority of patients.