Docetaxel, cisplatin and gemcitabine as first line for patients with advanced/metastatic head and neck cancer

Abstract

5586 Background: Docetaxel, cisplatin and gemcitabine are active drugs in head and neck cancer. A phase II study was conducted to evaluate the activity of their combination in patients with relapsed or metastatic H&N cancer. Methods: Twenty-seven patients have been entered with median age 65, performance status (WHO) 0:15, 1:8, 2:4. Eighteen (67%) pts had local disease, 14 (52%) lymph nodes, 9 (33%) lung, 2 (7%) pleura and 2 (7%) bone metastases. Cisplatin (80mg/m2) was administered on d1, docetaxel (80mg/m2) on d15 and gemcitabine (1100mg/m2) on d1 and d15 every 4 weeks. Results: Among 21 patients evaluable for response there were 1CR and 6PRs for an ORR 33% (95% CI 22.4–55.1). The median duration of response was 8.9 months, the median TTP 6 months and the estimated median survival 8.1 months. A total of 107 cycles have been administered with a median of 4 cycles/pt. Nineteen (18%) cycles were delayed, dose reduction was performed in 16 (15%) and rhG-CSF support was administered in 60 (56%) cycles. Toxicities included one (4%) pt with grII febrile neutropenia, 11 (41%) pts with gr3/4 neutropenia, one (4%) gr3 anemia, and one (4%) of each gr3 mucositis, asthenia and vomiting. After a median follow up of 6 months (range 1–29.5), seven (26%) patients have died all due to disease progression. Conclusions: The combination of docetaxel with cisplatin and gemcitabine has modest activity and manageable toxicity in patients with relapsed or metastatic H&N carcinomas. No significant financial relationships to disclose.