Final results of a phase II single-institutional trial with hyperfractionated radiation therapy (HFX) and four-weekly continuous cisplatin in locally advanced head and neck carcinoma.

Background: To evaluate the efficacy and toxicity of hyperfractionated radiation therapy and continuous infusion of cisplatin on weeks 1 and 5 in locally advanced head and neck carcinoma.

Methods: There were 53 patients: 3 (5.7 %) T2 patients, 31 T3 patients (58.4 %), and 19 T4 patients (35.8 %). Forty-one patients (77.4 %) were N-positive. According to the AJCC, 40 (75.4 %) patients had stage IV and the rest stage III. Treatment consisted of hyperfractionated radiation therapy, 120 cGy bid to a dose of 76.8-81.6 Gy, and cisplatin 20 mg/m(2)/day administered by continuous infusion over 120 h during days 1-5 and 21-25 of radiation therapy.

Results: Tumor response and toxicity There were 40 (75.5 %) complete responses, 6 partial responses (11.3 %), and 5 (9.4 %) non-responses or progression. Two patients were non-evaluable for response due to toxic death. All patients had some acute toxicity grade, the most frequent being mucositis (grade 3-4 in 33 patients) and epithelitis (grade 3-4 in 30 patients). Regarding late toxicity, only 2/24 long-term survivors had tracheostomy, and none of them needed enteral nutrition. Survival and local control With a median follow-up of 66 months, the 5-year overall survival rate for all the series was 49.1 % (95 % CI 58.9-39.3 %) with a median survival duration of 32.83 months. Five-year local control was 68.4 % (95 % CI 81.3-55.5 %).

Conclusions: Hyperfractionated radiation therapy and continuous infusion of cisplatin during weeks 1 and 5 are an active treatment in patients with LAHNC. Nevertheless, new strategies are necessary to increase the local control rates and reduce the incidence of distant metastasis and second tumors.