A PROSPECTIVE PHASE-II TRIAL OF CONCOMITANT CHEMOTHERAPY AND RADIOTHERAPY WITH DELAYED ACCELERATED FRACTIONATION-IN UNRESECTABLE TUMORS OF THE HEAD AND NECK

Background. Our study is a prospective evaluation of unresectable mali gnant cancers of the head and neck treated with concomitant chemothera py and radiotherapy (RT) using delayed accelerated fractionation (conc omitant boost). Methods: Between January 1988 and March 1995, 82 patie nts with unresectable cancers of the head and neck were enrolled in th is phase II study. Of these, 52 patients were treated and followed for a minimum of 3 years and are the subject of this analysis. All patien ts had T4 lesions and were stage IV according to the American Joint Co mmittee on Staging Criteria (AJCC). Patients received RT with accelera ted fractionation to a total of 70 Gy in 6 weeks using a concomitant-b oost technique. Concomitant cis platin (100 mg/M-2) was given on days 1 and 22 of RT. Twenty-seven patients received mitomycin-C (7.5 mg/M-2 ) on days 1 and 22, and 1 patient received mitomycin-C on day 1. In ad dition, 27 patients received adjuvant chemotherapy with cis platin and vinblastine. The mean follow-up was 45 months (range, 36-72 months). The minimum follow-up for surviving patients is 3 years. Results. At 3 years, the local control rate was 58%. Three-year local control rates for paranasal sinus, nasopharynx, oropharynx, and larynx/hypopharynx were 78%, 78%, 64%, and 100%, respectively. For all patients, the dist ant-metastasis-free survival was 56%, and the overall survival rate wa s 36%. Patients with oral cavity cancers experienced worse overall sur vival versus other sites, 0% versus 47% (p = .03). Salivary cancers al so showed worse survival versus other sites, 0% versus 47%, but was no t statistically significant. Severe acute complications occurred in 34 % of patients. Treatment-related toxicity also resulted in the death o f 2 patients. Severe late complications occurred in 7% of patients. Co nclusions. Treatment of this poor prognostic group of patients with ag gressive chemotherapy and RT produced surprisingly good local control and survival. (C) 1998 John Wiley & Sons, Inc.