Chemotherapy of advanced head and neck cancer: Updated results of a randomized trial of the order of administration of sequential methotrexate and 5‐fluorouracil

Publisher Website
Google Scholar
Abstract
One hundred and twenty‐seven patients with advanced or recurrent squamous cell carcinoma of the head and neck (HNC) were randomized to treatment with methotrexate (MTX) followed 1 hour later by 5‐fluorouracil (5‐FU) (sequence MF), or 5‐fluorouracil followed after 1 hour by methotrexate (sequence FM). One hundred and seventeen patients were evaluable for response. There was no significant difference in response rates between the MF and FM sequences. Overall, 8 patients (6.8%) achieved complete response (CR) and 46 (39.3%) partial response (PR). In 95 previously untreated patients, the overall response rate (CR + PR) was 50%, compared with 31% for previously treated patients (P = 0.02). Survival duration significantly favored the FM sequence in univariate analyses (P = 0.04). Stepwise multivariate Cox model analysis showed that poor performance status (Eastern Cooperative Oncology Group) at study entry (P < 0.001) and prior radiotherapy (P = 0.03) were significant adverse predictors for survival. When allowance was made for these factors, a survival difference in favor of the FM sequence remained (P = 0.003). Sequential MTX followed 1 hour later by 5‐FU is not recommended for treatment of HNC.