5-Fluorouracil and Cisplatin (FP) with Concurrent Radiotherapy for Locally Advanced Head and Neck Cancer.

Abstract

The combination of chemotherapy and radiotherapy is emerging as the new standard modality for the treatment of locally advanced head and neck cancer, due to the inherent functional and cosmetic sequelae associated with its surgical management. Combination chemotherapy with 5-fluorouracil and cisplatin (FP) is one of the most active regimens for the head and neck cancer. Furthermore, both agents are known to act as radiosensitizer. This study was conducted to determine the efficacy, feasibility, and the toxicities of concurrent FP chemotherapy with radiotherapy. Patients with histologically proven locally advanced head and neck cancer (T3-4 or node positive) were enrolled in the study. Patients received 5-fluorouracil, 1,000 mg/m2/day, continuously for 4 days, and cisplatin, 75 mg/m2, on day 1. This regimen was given every four weeks. The radiotherapy (45 Gy) was started on day 1 of the first cycle, and administered in 25 fractions. Following a three-week interval, the radiotherapy was resumed on day 1 of the third cycle of chemotherapy, and administered in 15 fractions (27 Gy). Of the 31 eligible patients included, 28 were able to be evaluated for the tumor response. The response rate for the 28 patients was 93% (16 complete responses, 10 partial responses). Disease free survival for the 16 complete responders was 37 months (median, 1 ~41 months), with a median follow-up time of 31 months. The 1-, 2-, and 3-year survival rates were 82%, 69%, and 63%, respectively. Regarding the feasibility of this treatments, only nineteen patients (61%) received the complete courses of scheduled treatments. The median duration of admission for all patients was 39 days. Grade 3 or 4 stomatitis were observed in 25 patients (83%) and appeared as the dose limiting toxicity of this regimen. Although FP chemotherapy with concurrent radiotherapy is toxic, it is an effective and relatively feasible treatment for locally advanced head and neck cancer. The majority of patients experienced severe stomatitis, which appeared as the dose limiting toxicity of this regimen.