EFFECT OF TOPICAL ORAL G-CSF ON ORAL MUCOSITIS - A RANDOMIZED PLACEBO-CONTROLLED TRIAL

Oral mucositis is a dose-limiting toxicity of intensive chemotherapy, It is caused directly by the cytotoxic effect of chemotherapeutic agen ts and indirectly by sustained neutropenia. Severe oral mucositis is a n important predisposing factor for life-threatening septic complicati ons during aplasia, It also reduces quality of life. At present, no ef fective causal prophylaxis or treatment against oral mucositis is esta blished. We performed a prospective randomised placebo-controlled tria l using topical oral r-metHuG-CSF (filgrastim) in high-grade lymphoma patients treated according to the B-NHL protocol, which contains high- dose methotrexate and causes severe oral mucositis (WHO grades I-IV) i n >50% of patients. Between August 1996 and July 1997, a total of 32 c hemotherapy cycles were documented in eight patients (four male, four female). Mucosal erythema and ulceration were recorded. All patients a ssessed their oral pain and impact on swallowing daily, using a subjec tive scale from no to maximal discomfort (1-10), In addition, oral muc ositis was assessed according to the WHO score. Filgrastim was adminis tered in 16 cycles as a viscous mouthrinse (carboxymethylcellulose 2%, oleum citrii) 4 x 120 mu g/day from days 10 to 16, Sixteen cycles wer e given to control patients, of these 14 with placebo, and another two cycles with no treatment, Severe mucositis (WHO grade III/IV) was doc umented in 21 of 32 cycles (65.5%), A difference of borderline signifi cance was observed for the reduction of maximum severity of oral mucos itis between G-CSF vs placebo (P = 0.058), with a reduction of WHO gra de IV of 50% (four G-CSF vs eight control). The number of days in hosp ital was reduced significantly in the G-CSF group (P = 0.02), In concl usion, topical oral G-CSF mouthrinses may be beneficial to reduce oral mucositis.