Phase II trial of a paclitaxel-carboplatin combination in recurrent squamous cell carcinoma of the head and neck

Objective: Twenty-seven patients with recurrent squamous cell carcinoma of the head and neck were entered in a multicenter study to determine the effi cacy of the paclitaxel-carboplatin association. Methods: Standard eligibili ty criteria applied, i.e. measurable disease, and chemotherapy given as ind uction treatment or concomitant chemoradiotherapy was allowed if completed more than 6 months prior to the study. Every 21 days, paclitaxel 175 mg/m(2 ) and carboplatin AUC 6 were administered. The patient group included 3 fem ales and 24 males with a median age of 61 years (range 39-75 years). Result s: All patients were assessable for toxicity and 24 for responses. Main gra de 3-4 toxicities were: neutropenia (62.9%), febrile neutropenia (18.5%), a nemia (11.1%), thrombocytopenia (14.8%), mucositis (7.4%) and vomiting (7.4 %). Among the intent-to-treat population, 29.6% of patients had an objectiv e response, with a median response duration of 4.2 months (range 1-5.7 mont hs). Stable and progressive disease were observed in 11.1 and 48.1% of pati ents, respectively. The median overall survival was 7.2 months (range 0.5-1 0.9 months). Conclusion: From these data, paclitaxel-carboplatin seems to h ave an activity in recurrent squamous cell carcinoma of the head and neck, but the high level of toxicity highlights the need to search for a safer ch emotherapy combination. Copyright (C) 2001 S. Karger AG, Basel.