Methotrexate, 5-fluorouracil and leucovorin in patients with advanced head and neck cancer

Twenty six patients with advanced stage IV head and neck cancer were treated with combination chemotherapy. Creatinine clearance was measured before each chemotherapy cycle. Patients were hydrated and alkalinized. The chemotherapy regimen was methotrexate (MTX) 150 mg/m² iv bolus followed by MTX 150 mg/m² infused over 4 hrs. 5-Fluorouracil (5FU) 900 mg/m² was given iv bolus 7 hrs after MTX was started. Leucovorin (LV) 22.5 mg was given iv or po every 6 hrs for 8 doses beginning 24 hrs after MTX. Treatment cycles were repeated every 1~4 weeks, most often every 3 weeks as toxicity permitted. Median cycles were 2.5 per patients with a range of 1 to 13. Toxicities encountered were leucopenia 69% (less than 2,000/μl 19%), mucositis 38% (severe 8%), alopecia 23%, thrombocytopenia 15% and transient elevation of transaminases 12%. Of 25 patients evaluable for response, there were 4 PR, 2 MR and 3 NC. The PR lasted 10, 20, 25 and 32+ weeks and MR 10 and 28 weeks. Three NC lasting 12+, 20+, and 52 weeks had a decrease in pain and improvement in quality of life. Median survival of all patients was, however, 15 weeks and one year survival was only 8%. Both MTX and 5FU are active single agents for this diseases. This exact regimen was shown to be active in patients with metastatic colon cancer. Although there is no evidence for improved overall survival, few patients benefited from the treatment.