M. Karthaus et al., EFFECT OF TOPICAL ORAL G-CSF ON ORAL MUCOSITIS - A RANDOMIZED PLACEBO-CONTROLLED TRIAL, Bone marrow transplantation, 22(8), 1998, pp. 781-785
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.