5-FLUOROURACIL DOSE INTENSIFICATION AND GRANULOCYTE-MACROPHAGE COLONY-STIMULATING FACTOR IN CISPLATIN-BASED CHEMOTHERAPY FOR RELAPSED SQUAMOUS-CELL CARCINOMA OF THE HEAD AND NECK - A PHASE-II STUDY

A previous phase I study showed that in a 5-day combination of cisplat in (CDDP) 20 mg/m(2)/day and 5-fluorouracil (5-FU) intravenous bolus, the maximum tolerable dose of 5-FU is 200 mg/m(2)/day without the use of growth factors and 300 mg/m(2)/day with recombinant human granulocy te-monocyte colony-stimulating factor (rhGM-CSF) support. In the prese nt phase II study, 26 patients with relapsed and/or metastatic squamou s cell carcinoma of the head and neck (SCCHN) were treated with CDDP, 20 mg/m(2)/day, and 5-FU, 300 mg/m(2)/day intravenous bolus, for 5 con secutive days every 3 weeks. Granulocyte-macrophage colony-stimulating factor, 5 mg/kg/day subcutaneously, was administered from days 8 to 1 9. All patients had previously undergone surgery and/or radiation trea tment. None had previously received chemotherapy. Mucositis (19% of th e patients) and thrombocytopenia (42%) were the most frequent, but gen erally mild, toxicities. Relevant, GM-CSF-related side effects were de tected in 12% of the patients. The median number of cycles delivered w as four. Three complete and five partial responses were recorded (31% overall response rate). Further investigation of this regimen is unwar ranted because of both its lack of improvement in antitumoral activity and the high costs incurred with the use of growth factors.