A randomized phase III study of cisplatin with or without methotrexate for recurrent squamous cell carcinoma of the head and neck. A Northern California Oncology Group study.
Eighty patients with recurrent squamous cell cancer of the head and neck were randomized to cisplatin (80 mg/m2) every 3 weeks or cisplatin plus weekly methotrexate (250 mg/m2) with leucovorin. The overall response rate to cisplatin was 18%, with 10% complete responses. The overall response to the combination was 33% with 18% complete responses (P = 0.11). There was no difference in response duration, time to progression, or survival. There was no difference in renal toxicity between the 2 arms (creatinine greater than 2 mg/dl in 6% of the patients). There was significantly more leukopenia (64%), thrombocytopenia (18%), anemia (18%), and mucositis (33%) in the combination arm. This combination of two of the best agents for head and neck cancer did not improve response, but resulted in added toxicity.
D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002140:California; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy*; D002945:Cisplatin / Q000008:administration & dosage / Q000627:therapeutic use*; D002986:Clinical Trials as Topic; D004359:Drug Therapy, Combination; D005260:Female; D006258:Head and Neck Neoplasms / Q000188:drug therapy*; D006801:Humans; D002955:Leucovorin / Q000008:administration & dosage; D008297:Male; D008727:Methotrexate / Q000008:administration & dosage; D009364:Neoplasm Recurrence, Local; D011336:Probability; D011897:Random Allocation
D002945:Cisplatin; D002955:Leucovorin; D008727:Methotrexate