Effect of granulocyte-macrophage colony-stimulating factor on oral mucositis in head and neck cancer patients after cisplatin, fluorouracil, and leucovorin chemotherapy.

• DOI: 10.1200/jco.1995.13.10.2620
• Publication Date: 2017-02-23T13:10:26Z
• Authors: K H Chi; C H Chen; W K Chan; K C Chow; S Y Chen; S H Yen; J Y Chao; C Y Chang; K Y Chen
• Keywords: Adult; Male; Analysis of Variance; Stomatitis; Cross-Over Studies; Leucovorin; Mouth Mucosa; Granulocyte-Macrophage Colony-Stimulating Factor; Middle Aged; Hematologic Diseases; 3. Good health; 03 medical and health sciences; 0302 clinical medicine; Head and Neck Neoplasms; Antineoplastic Combined Chemotherapy Protocols; Carcinoma, Squamous Cell; Humans; Female; Fluorouracil; Prospective Studies; Cisplatin; Aged

PURPOSE To evaluate prospectively the efficacy of granulocyte-macrophage colony-stimulating factor (GM-CSF) in the reduction of chemotherapy-induced oral mucositis. PATIENTS AND METHODS Twenty patients with stage IV squamous cell carcinoma of head and neck were studied. Two-cycles (periods) of identical doses of cisplatin, fluorouracil (5-FU), and leucovorin (PFL) chemotherapy with cisplatin 20 mg/m2/d, 5-FU 800 mg/m2/d, leucovorin 90 mg/m2/d by 96-hour continuous intravenous infusion every 3 weeks were given to each patient. After PFL chemotherapy, GM-CSF 4 micrograms/kg subcutaneously from days 5 to 14 or no therapy was given by a randomized self-controlled crossover study design. Oral mucositis was graded with modified Radiation Therapy Oncology Group criteria. RESULTS In the first cycle of PFL chemotherapy, GM-CSF significantly reduced the incidence, mean duration, and mean area under the curve (AUC) of severe oral gross mucositis (grade > or = 3) compared with no therapy. These beneficial effects continued into the second cycle of PFL chemotherapy after crossover to no GM-CSF. The incidence of severe mucositis was reduced when GM-CSF was given in the second cycle of PFL. Analysis of variance indicated significant direct GM-CSF treatment effects on the mean AUC of gross/functional scores and duration of moderate gross mucositis (grade > or = 2) over both periods. There was a significant period effect in favor of giving GM-CSF in the first cycle of chemotherapy. CONCLUSION GM-CSF can significantly reduce the severity and duration of chemotherapy-induced oral mucositis after PFL chemotherapy.