title: 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.
abstract: A previous phase I study showed that in a 5-day combination of cisplatin (CDDP) 20 mg/m2/day and 5-fluorouracil (5-FU) intravenous bolus, the maximum tolerable dose of 5-FU is 200 mg/m2/day without the use of growth factors and 300 mg/m2/day with recombinant human granulocyte-monocyte colony-stimulating factor (rhGM-CSF) support. In the present phase II study, 26 patients with relapsed and/or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated with CDDP, 20 mg/m2/day, and 5-FU, 300 mg/m2/day intravenous bolus, for 5 consecutive days every 3 weeks. Granulocyte-macrophage colony-stimulating factor, 5 mg/kg/day subcutaneously, was administered from days 8 to 19. All patients had previously undergone surgery and/or radiation treatment. None had previously received chemotherapy. Mucositis (19% of the patients) and thrombocytopenia (42%) were the most frequent, but generally mild, toxicities. Relevant, GM-CSF-related side effects were detected in 12% of the patients. The median number of cycles delivered was four. Three complete and five partial responses were recorded (31% overall response rate). Further investigation of this regimen is unwarranted because of both its lack of improvement in antitumoral activity and the high costs incurred with the use of growth factors.
authors.affiliation: Department of Medical Oncology I, National Institute for Cancer Research, Genoa, Italy.
authors.forename: M
authors.initials: M
authors.lastname: Merlano
authors.forename: M
authors.initials: M
authors.lastname: Benasso
authors.forename: G M
authors.initials: GM
authors.lastname: Numico
authors.forename: M
authors.initials: M
authors.lastname: Danova
authors.forename: A
authors.initials: A
authors.lastname: Santelli
authors.forename: F
authors.initials: F
authors.lastname: Ameli
authors.forename: F
authors.initials: F
authors.lastname: Blengio
authors.forename: I
authors.initials: I
authors.lastname: Ricci
authors.forename: M
authors.initials: M
authors.lastname: Rosso
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy*; D002945:Cisplatin / Q000008:administration & dosage; D004305:Dose-Response Relationship, Drug; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D016178:Granulocyte-Macrophage Colony-Stimulating Factor / Q000627:therapeutic use*; D006258:Head and Neck Neoplasms / Q000188:drug therapy*; D006801:Humans; D007970:Leukopenia / Q000139:chemically induced; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy*; D011994:Recombinant Proteins / Q000627:therapeutic use; D016019:Survival Analysis; D013921:Thrombocytopenia / Q000139:chemically induced
chemical_list: D011994:Recombinant Proteins; D016178:Granulocyte-Macrophage Colony-Stimulating Factor; D002945:Cisplatin; D005472:Fluorouracil