A randomized clinical trial on continuous 7-day-a-week postoperative radiotherapy in high-risk squamous cell head-and-neck cancer: a preliminary report on acute normal tissue reactions

Abstract

Purpose/Objective: To evaluate acute normal tissue reactions in patients treated with continuous accelerated postoperative irradiation (p-CAIR) vs. conventionally fractionated postoperative radiotherapy (p-CF). Materials/Methods: Between October 2001 and December 2002 100 patients with squamous cell cancer of the larynx, oral cavity, oropharynx or hypopharynx, after major surgical intervention, with high-risk pathologic features, and no gross residual disease were recruited for this trial. The patients were randomly assigned to receive 63 Gy in 1.8 Gy 7-day-a-week fractions over a period of 5 weeks (n=48), or 63 Gy in 1.8 Gy fractions given Monday to Friday over 7 weeks (n=52). Acute mucosal reactions were scored using Dische system. The supportive anti-inflammatory treatment was given when the severity score exceeded 10. Results: Ninety five patients complied to the assigned treatment. Two patients in the p-CAIR and 1 in the p-CF arm received <60 Gy because of deteriorating general performance and/or tumor progression; one patient died before radiotherapy was started, and one terminated radiotherapy due to psychosis. The average maximum Dische score in both arms of the trial was 11.9 (range 2–21) and was significantly higher in patients treated with p-CAIR, compared to p-CF (10.8 vs. 13.3, p<0.05). Patients with cancer of the oral cavity and oropharynx had higher average maximum Dische scores (p-CAIR:16.4 vs. p-CF:12.3) compared to cancer of the larynx or hypopharynx (p-CAIR:11.8 vs. p-CF:9.6). The average body weight loss during radiotherapy was the same in both arms of the trial (3.3%), but it varied depending on primary tumor site (2.7% larynx/hypoharynx vs. 4.4% other). The hematological toxicity was mild and similar in both arms of the trial. No consequential side toxicity of radiotherapy was observed. Conclusions: The acute normal tissue morbidity in the initial group of 48 patients randomly assigned to the p-CAIR schedule appears acceptable, and allows further recruitment into the trial. In both trial arms patients with cancer of the larynx or hypopharynx tolerated postoperative radiotherapy better than patients with cancer of the oral cavity or oropharynx.