ACCELERATED RADIOTHERAPY, CARBOGEN AND NICOTINAMIDE (ARCON) IN LOCALLY ADVANCED HEAD AND NECK-CANCER - A FEASIBILITY STUDY

Background and purpose: ARCON (Accelerated Radiotherapy, CarbOgen, Nic otinamide) achieves a large therapeutic gain in rodents. A phase I/II study was therefore undertaken to determine its feasibility in patient s with locally advanced head and neck cancer. Materials and methods: T he accelerated regime CHART was used in 35 patients given carbogen and /or nicotinamide with 11 small volume fractions. Eight patients receiv ed carbogen, 12 received nicotinamide and 15 were treated with ARCON. Treatment compliance, side-effects and acute mucositis were monitored in all cases. Results: All patients underwent CHART as intended. In th e 23 patients receiving carbogen, two failed to complete treatment. Co mpliance with nicotinamide was much lower. Out of 25 patients, only 52 % received 10-11 doses of the 80 mg/kg/day of the drug. The most commo n side-effect was nausea and vomiting, which responded to standard ant i-emetics in almost half of the patients. Historical comparisons with the CHART head and neck trials indicate that there was no increase in the severity of acute mucositis in any of these patients. Although the observation period is not sufficiently long to be definitive (median 20 months) there is no evidence of an increase in late normal tissue r eactions. Conclusions: ARCON using CHART as the radiotherapy protocol is feasible in patients with advanced head and neck cancer. However, w e are concerned about the low compliance rate in our patients, which i s far lower than that reported elsewhere. The implications are discuss ed together with identifying strategies for increasing compliance. (C) 1997 Elsevier Science Ireland Ltd.