内容紹介
Therapeutic Effect of Rebamipide for Oral Mucositis Associated with FEC Therapy for Breast Cancer
Summary
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.
要旨
がん化学療法で生じる口腔粘膜炎の支持療法薬は確立されていない。2007年9月～2008年8月にFEC100療法を施行した乳癌患者91例の,口腔粘膜炎のGrade変化をretrospectiveに調査した。当院では,rebamipide製剤(ムコスタ®)の粘膜保護作用に期待し,口腔粘膜炎発症次コース以降にrebamipideの連日投与を試行しており,その効果を中心に検討した。年齢中央値55(32～76)歳,FEC4コース中43例(47%)に口腔粘膜炎を認めた。対象の91例は,FEC4コース中rebamipide非投与のA群49例,FEC開始前からrebamipideを投与されたB群14例,口腔粘膜炎発症後rebamipideを投与したC群28例に分類された。口腔粘膜炎発症率はrebamipide投与の有無をFEC開始時点で区切り検討し,B群5例(36%),A+C群38例(49%)であった(p=0.3472)。GradeはB群(G1; 4例,G2; 1例),A+C群(G1; 20例,G2+G3; 18例)であった(p=0.2467)。C群は25例(89%)で次コースのGrade低下,17例(61%)で発症なく(G0),15例(54%)で最終コースまで継続して口腔粘膜炎の発症を認めなかった。これらの結果から,rebamipideの治療効果がうかがえた。有意差は認めなかったが,rebamipideで口腔粘膜炎の発症予防や症状軽減を図れる可能性があり,新たな支持療法薬として期待できそうである。口腔粘膜炎に対しては,口腔ケアを基本に多職種によるチーム介入と同時に,今後rebamipideの予防効果に関して前向きランダム化試験を行い,検証を進めたい。
目次
Summary
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.
要旨
がん化学療法で生じる口腔粘膜炎の支持療法薬は確立されていない。2007年9月～2008年8月にFEC100療法を施行した乳癌患者91例の,口腔粘膜炎のGrade変化をretrospectiveに調査した。当院では,rebamipide製剤(ムコスタ®)の粘膜保護作用に期待し,口腔粘膜炎発症次コース以降にrebamipideの連日投与を試行しており,その効果を中心に検討した。年齢中央値55(32～76)歳,FEC4コース中43例(47%)に口腔粘膜炎を認めた。対象の91例は,FEC4コース中rebamipide非投与のA群49例,FEC開始前からrebamipideを投与されたB群14例,口腔粘膜炎発症後rebamipideを投与したC群28例に分類された。口腔粘膜炎発症率はrebamipide投与の有無をFEC開始時点で区切り検討し,B群5例(36%),A+C群38例(49%)であった(p=0.3472)。GradeはB群(G1; 4例,G2; 1例),A+C群(G1; 20例,G2+G3; 18例)であった(p=0.2467)。C群は25例(89%)で次コースのGrade低下,17例(61%)で発症なく(G0),15例(54%)で最終コースまで継続して口腔粘膜炎の発症を認めなかった。これらの結果から,rebamipideの治療効果がうかがえた。有意差は認めなかったが,rebamipideで口腔粘膜炎の発症予防や症状軽減を図れる可能性があり,新たな支持療法薬として期待できそうである。口腔粘膜炎に対しては,口腔ケアを基本に多職種によるチーム介入と同時に,今後rebamipideの予防効果に関して前向きランダム化試験を行い,検証を進めたい。