COMBINED POSTOPERATIVE RADIOTHERAPY AND WEEKLY CISPLATIN INFUSION FORLOCALLY ADVANCED HEAD AND NECK-CARCINOMA - FINAL REPORT OF A RANDOMIZED TRIAL

Purpose: To report the final results of a prospective randomized trial that aimed to evaluate efficacy and toxicity of concomitant postopera tive radiotherapy and Cisplatin infusion in patients with Stage III or IV squamous cell carcinoma of the head and neck and histological evid ence of extracapsular spread of tumor in lymph node metastase(s). Meth ods and Materials: Radiotherapy was delivered using a daily dose of 1. 7 Gy for the first 54 Gy and 1.8 to 2 Gy until the completion of the t reatment. Cisplatin 50 mg i.v. with forced hydratation was given or no t every week (i.e., seven to nine cycles) concurrently with radiothera py, A total of 44 patients were treated by irradiation only (RT group) and 39 by irradiation with chemotherapy (CM group). Results: The RT g roup displayed a higher rate of loco-regional failures as compared to CM group (41 vs. 23%; p = 0.08). The overall survival, the survival co rrected for deaths by intercurrent disease, and the disease-free survi val were better in CM group as compared to RT group with statistically significant differences. Survival without loco-regional treatment fai lure was better in the CM group, the difference being close to the lev el of significance (p = 0.05). Survival without distant metastases wer e comparable in the two therapeutic groups. Ten severe late complicati ons were observed, four in the RT group (17%) and six in the CM group (22%). Cox univariate analysis confirmed the importance of the therape utic modality in predicting the overall survival, the survival correct ed for deaths by intercurrent disease, and the disease-free survival. Conclusions: The present final report of this phase III study confirms preliminary results. The concomitant use of 50 mg weekly Cisplatin in fusion and postoperative radiation improved loco-regional control and survival. No significant increase of late radiation complications was observed in the CM group. Copyright (C) 1996 by Elsevier Science Inc.