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/m(2) 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.