Phase II trial of sorafenib in advanced salivary adenoid cystic carcinoma of the head and neck.

Abstract

Background There is a need to improve the systemic treatment of advanced adenoid cystic carcinoma (ACC). Response rates to chemotherapy are poor and preliminary investigations of molecularly targeted agents have been disappointing. We evaluate sorafenib, an oral multi-kinase inhibitor, which has an attractive targeting profile for this disease. Materials and Methods In a single-arm phase II trial, patients with unresectable locally recurrent and/or metastatic ACC were treated with sorafenib 400mg bid. Results 23 patients, median age 51 years were recruited from 2009-2011. Median progression-free and overall survivals were 11.3 and 19.6 months, respectively. Progression-free survivals at 6 and 12 months were 69.3% and 46.2%, respectively. Sorafenib was only reasonably well tolerated and 13 (57%) patients experienced grade 3 toxicity. Conclusions Sorafenib showed modest activity in ACC with a 12 month progression-free survival of 46.2%. Sorafenib 400mg bid was associated with significant toxicity and taken together with limited effectiveness cannot be enthusiastically recommended for further evaluation. Head Neck, 2013.