Hyperfractionated, accelerated chemoradiation with concurrent mitomycin-C and cisplatin in locally advanced head and neck cancer, a phase I/II study.

BACKGROUND: To determine the outcome, acute and late toxicity in locally advanced head and neck cancer stage IVA with mitomycin-C (MMC), cisplatin (DDP) chemotherapy and hyperfractionated accelerated radiation therapy (C-HART). PATIENTS AND METHODS: Thirty-five patients, with squamous cell cancer of the oral cavity (20%), oropharynx (37%), hypopharynx (26%) and larynx (17%), received 30 Gy (2 Gy every day) followed by 1.4 Gy bid to a total of 70.6 Gy concurrently with MMC 10mg/m(2) (day 1 plus 36) and DDP 6 mg/m(2) given Mondays through Fridays during weeks 1-3. Median follow up was 19 months. RESULTS: C-HART was given as planned in 12 of 35 patients, with radiotherapy completed per protocol in 91%. Overall, patients received 70% of the intended dose of MMC and 91% of DDP. Mucositis CTC III/IV occurred in 27%, leucopenia CTC III/IV in 47%, and three early deaths were observed. Osteoradionecrosis occurred in 14% with cT4-tumours. At 3 years the locoregional control and survival rates were 60% and 46%, respectively. CONCLUSION: C-HART resulted in promising overall response with acceptable toxicity. Mucositis is a frequent, severe toxicity in patients treated with C-HART for head and neck cancer. While it appears that mucositis and hematological toxicity may lead to hospitalization and omitting of the second dose of mitomycin C, its impact on radiotherapy interruptions is marginal.