Neoadjuvant Docetaxel (Taxotere) Plus Cisplatin and 5-Flurouracil Followed by Concomitent Chemoradiotherapy in Patients with Locally Advanced Squamous Cell Carcinoma of the Head and Neck, INAS I. ABDELHALIM, NAWAL M. ELSAID, ELSAID M. ALI and BASHEER S. ATA
Abstract
Background: Concomitent chemoradiotherapy (CRT) has become the standard of care for patients with inoperable head and neck squamous cell carcinoma (HNSCC). More recently, induction chemotherapy (IC) has been adopted as an approach in the management of these patients. The primary objective of this study is to evaluate PFS (progression-free survival) after sequential therapy, (taxotere, cisplatin, and 5-FU induction therapy followed by concomitant CRT) in patients with locally advanced HNSCC. Secondary objectives include; overall response rate (ORR) to treatment, duration of response, overall survival (OS) and safety profile.
Patients and Methods: 30 patients with stage III-IV M0 HNSCC, Eastern Cooperative Oncology Group performance status (ECOG PS) of zero to one were prospectively treated with 3 courses of TPF induction chemotherapy followed by concomitant CRT. IC consisted of Docetaxel (Taxotere) 75mg/m2 day 1 followed by cisplatin 75mg/m2 day 1 and 5- Flurouracil 750mg/m2 day 1-5 continuous infusion, given every 3 weeks. Concomitent CRT started 4 weeks after the last cycle of chemotherapy with the goal of delivering a total dose of 66Gy concomitant with cisplatin 80mg/m2 for 2 cycles during RT.
Results: At a median follow-up period of 18 months (ranging from 8 to 30m), the median PFS was 15 months, the PFS was 46.7% and the OS was 53.3% while the median OS was not reached. The one year PFS and OS were 70% and 90% respectively. The overall response rate to treatment was 90%. Median duration of CR was 20 months and median duration of ORR was 15 months. The most common grade III toxicity during IC was neutropinic fever (13.3%).
Conclusions: Induction TPF is active, feasible, well tolerated, with acceptable toxicity and does not compromise the delivery of subsequent CRT in patients with ECOG PS of 0-1.