Neoadjuvant combination of carboplatin and 5-FU in head and neck cancer: a randomized study.

A prospective, randomized, multicenter study of patients with oropharyngeal and pharyngolaryngeal tumors compared locoregional treatment alone with neoadjuvant chemotherapy with carboplatin/5-fluorouracil (5-FU) followed by locoregional treatment. The aim of the study was to evaluate the role of chemotherapy on survival and on the need for mutilating surgery. Since 1988, 219 patients (105 with oropharyngeal and 114 with pharyngolaryngeal tumors) have entered the study. All patients randomized to neoadjuvant chemotherapy received three cycles of carboplatin 400 mg/m2 day 1 and 5-FU 1 g/m2/d as a continuous infusion days 1 through 5 every 3 weeks. Neoadjuvant chemotherapy was given to 108 patients. The 268 evaluable courses induced a low rate of grade 3 or 4 toxicity. Four patients (3.6%) died of major complications. The complete response (CR) rate was 31%, which represented a decrease in mutilating surgery of 30%. (Patients with CRs had radiotherapy alone instead of radiosurgical treatment as originally planned.) The objective response rate was 61%. Survival curves for the chemotherapy and chemotherapy-naive groups were not significantly different. The rate of nodal recurrence was significantly higher in the chemotherapy group, however, and chemotherapy did not decrease the rate of second primary tumors or distant metastases. Thus, the justification for neoadjuvant chemotherapy may be a decreased rate of mutilating surgery. These preliminary results are encouraging, but follow-up is as yet too short to allow definite conclusions.

RCT Entities:   Population Interventions Outcomes