Phase II study on gemcitabine in recurrent and/or metastatic adenoid cystic carcinoma of the head and neck (EORTC 24982)

Background: This phase II study was conducted to determine the antitumour activity of gemcitabine in adenoid cystic carcinoma (ACC). Patients and methods: Patients with progressive and/or symptomatic, recurrent and/or metastatic ACC were treated with gemcitabine 1250 mg/m2 intravenous (i.v.) on days 1 and 8 of each 21-day cycle. Each cycle was repeated every 3 weeks in the absence of disease progression for a minimum of four cycles and a maximum of 12 cycles. Results: Among 21 ACC patients, there were no objective responses. Eleven patients had a stable disease, of which ten patients for more than 6 months, and eight had a progressive disease after 4 cycles. Gemcitabine was well tolerated by most patients. Conclusion: We conclude that gemcitabine is not an active drug in ACC.