THE SECOG TRIALS IN ADVANCED HEAD AND NECK CANCER 1. COMPARISON OF SEQUENTIALLY AND SYNCHRONOUSLY TIMED REGIMENS AND THE ROLE OF 5 FLUOROURACIL

Two randomised trials have resulted in the recruitment of 463 with advanced (stage 3 or 4) squamous cell carcinoma of the head and neck. The first SECOG trial compared the scheduling of radiotherapy with combination chemotherapy in patients with previously untreated disease. The 2x2 factorial design used also allowed comparison of a 3 drug regimen (VBM) with the addition of 5FU (VBMF). No difference in either disease-free survival (DPS) or overall survival has been demonstrated between those treated synchronously or sequentially. Overall 5 year survival was 31.7%. Patients randomised to 5FU in addition to VBM had significantly prolonged DPS and overall survival, with an estimated reduction in mortality of 76% (95%confidence interval 59-95%).