No guidelines for supportive
drug therapy have been established for
oral mucositis occurring during
cancer chemotherapy. We retrospectively examined the progression of
oral mucositis in 91 patients with
breast cancer who received the
5-fluorouracil,
epirubicin, and
cyclophosphamide (FEC)-100 regimen between September 2007 and August 2008. Daily
rebamipide was administered to patients with
oral mucositis as per hospital protocol to evaluate the hypothesized preventive and mucosal protective effects of
rebamipide(Mucosta®).
Oral mucositis was observed in 43 patients (47%)during 4 courses of FEC. The median age of the patients was 55 years(range, 32-76 years). Of the 91 patients, 49 patients who did not receive
rebamipide during the 4 FEC courses were classified as group A, 14 patients who received
rebamipide before the start of FEC were classified as group B, and 28 patients who received
rebamipide after developing
oral mucositis were classified as group C. The incidence of
oral mucositis at the start of FEC with or without
rebamipide administration was observed in 5 patients in group B (36%) and 38 patients in groups A and C (49%) (p=0.3472). The
mucositis grade was G1 in 4 patients and G2 in 1 patient in group B, and G1 in 20 patients and G2 plus G3 in 18 patients in groups A and C (p=0.2467). In group C, the grade decreased in 25 patients (89%) and did not occur (G0) in 17 patients (61%) during the next course, and 15 patients (54%) continued to the final course without any occurrence of
mucositis. These results suggest that
rebamipide is effective for the treatment of
oral mucositis. Although significant differences were not observed in the groups,
rebamipide has the potential to prevent development of
oral mucositis and alleviate its symptoms, and seems promising as a new supportive
drug therapy. We hope to verify the preventive and protective effects of
rebamipide by conducting a prospective, randomized trial while treating
oral mucositis with basic oral care and appropriate interventions provided by a multidisciplinary team.