Randomized clinical trial of post-operative radiotherapy versus concomitant carboplatin and radiotherapy for head and neck cancers with lymph node involvement

Background and purposePost-operative radiotherapy is indicated for the treatment of head and neck cancers. In vitro, chemotherapy potentiates the cytotoxic effects of radiation. We report the results of a randomized trial testing post-operative radiotherapy alone versus concomitant carboplatin and radiotherapy for head and neck cancers with lymph node involvement.Materials and methodsThe study involved patients undergoing curative-intent surgery for head and neck cancers with histological evidence of lymph node involvement. Patients were randomly assigned to receive radiotherapy alone (54–72 Gy, 30–40 fractions, 6–8 weeks) or identical treatment plus concomitant Carboplatin (50 mg/m2 administered by IV infusion twice weekly).ResultsBetween February 1994 and June 2002, 144 patients were included. With a median follow-up of 106 months (95% confidence interval (CI) [92–119]), the 2-year rate of loco-regional control was 73% (95% CI: 0.61–0.84) in the combined treatment group and 68% (95% CI: 0.57–0.80) in the radiotherapy group (p = 0.26). Overall survival did not differ significantly between groups (hazard ratio for death, 1.05; 95% CI: 0.69–1.60; p = 0.81).ConclusionsTwice-weekly administration of carboplatin concomitant to post-operative radiotherapy did not improve local control or overall survival rates in this population of patients with node-positive head and neck cancers.