Journal of Clinical Oncology, Vol 13, 2620-2628, Copyright © 1995 by American Society of Clinical Oncology
Effect of granulocyte-macrophage colony-stimulating factor on oral mucositis in head and neck cancer patients after cisplatin, fluorouracil, and leucovorin chemotherapy
KH Chi, CH Chen, WK Chan, KC Chow, SY Chen, SH Yen, JY Chao, CY Chang and KY Chen
Cancer Center, Veterans General Hospital, Taipei, Taiwan, Republic of China.
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.
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