Masahiro Umeda1, Yoshihide Ota2, Kosuke Kashiwabara3, Naoki Hayashi4, Mariko Naito5, Toshinari Yamashita6, Hirofumi Mukai7, Katsuhiko Nakatsukasa8, Takeshi Amemiya9, Ken-Ichi Watanabe10, Hironobu Hata11, Yuichiro Kikawa12, Naoki Taniike13, Takashi Yamanaka6, Sachiyo Mitsunaga14, Kazuhiko Nakagami15, Moriyasu Adachi16, Naoto Kondo17, Yasuyuki Shibuya18, Naoki Niikura19. 1. Department of Clinical Oral Oncology, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan. 2. Department of Oral and Maxillofacial Surgery, Tokai University School of Medicine, Tokyo, Japan. 3. Data Science Office, Clinical Research Promotion Center, The University of Tokyo Hospital, Tokyo, Japan. 4. Department of Breast Surgical Oncology, St. Luke's International Hospital, Tokyo, Japan. 5. Department of Oral Epidemiology, Graduate School of Biomedical and Health Sciences, Hiroshima University, Hiroshima, Japan. 6. Department of Breast and Endocrine Surgery, Kanagawa Cancer Center, Kanagawa, Japan. 7. Department of Breast and Medical Oncology, National Cancer Center Hospital East, Chiba, Japan. 8. Department of Breast and Endocrine Surgery, Kyoto Prefectural University of Medicine, Kyoto, Japan. 9. Department of Dentistry and Oral and Maxillofacial Surgery, Kyoto Prefectural University of Medicine, Kyoto, Japan. 10. Department of Breast Surgery, Hokkaido Cancer Center, Hokkaido, Japan. 11. Department of Dentistry and Oral Surgery, Hokkaido Cancer Center, Hokkaido, Japan. 12. Department of Breast Surgery, Kobe City Medical Center General Hospital, Kobe, Japan. 13. Department of Dentistry and Oral and Maxillofacial Surgery, Kobe City Medical Center General Hospital, Kobe, Japan. 14. Department of Dentistry and Oral and Maxillofacial Surgery, Kanagawa Cancer Center, Kanagawa, Japan. 15. Department of Breast and Endocrine Surgery, Shizuoka General Hospital, Shizuoka, Japan. 16. Department of Oral and Maxillofacial Surgery, Shizuoka General Hospital, Shizuoka, Japan. 17. Department of Breast and Endocrine Surgery, Nagoya City University Hospital, Nagoya, Japan. 18. Department of Oral and Maxillofacial Surgery, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan. 19. Department of Breast and Endocrine Surgery, Tokai University School of Medicine, Tokyo, Japan.
Abstract
BACKGROUND: Oral mucositis is a clinically significant adverse event linked to cancer therapy; it reduces the quality of life of patients and may result in the discontinuation of treatment and a poorer prognosis. Based on level 3 evidence, the Mucositis Study Group of Multinational Association for Supportive Care in Cancer and the International Society of Oral Oncology recommend oral care for all patients receiving cancer chemotherapy and radiotherapy, although no data from large-scaled randomized controlled trials support the efficacy of oral care in preventing oral mucositis. Therefore, this randomized, controlled, multicenter, open-label, phase III study sought to determine whether professional oral care reduces oral mucositis in everolimus and exemestane-treated estrogen receptor-positive metastatic breast cancer patients. METHODS: Altogether, 169 patients were randomized into the professional oral care (n=82) and control (n=87) groups. The professional oral care group received oral health instruction, professional mechanical tooth and tongue cleaning, gargling with a benzethonium chloride mouthwash, and dexamethasone ointment when grade 1 mucositis manifested. The control group received oral health instruction and gargling. Eight weeks after the everolimus and exemestane administration, the oral status (Oral Assessment Guide criteria) and oral mucositis status (Common Terminology Criteria for Adverse Events functional and clinical examinations) were evaluated. RESULTS: The incidence of oral mucositis of any grade and grade 2 severe mucositis was significantly lower in the professional oral care group, based on the Common Terminology Criteria for Adverse Events functional and clinical examinations. The total Oral Assessment Guide score, total Oral Assessment Guide grade, and Oral Assessment Guide score of teeth/dentures and mucous membranes were significantly different between the two groups. The Oral Assessment Guide grade for swallow, lip, teeth/dentures, mucous membrane, tongue, and saliva significantly correlated to oral mucositis severity. CONCLUSIONS: Professional oral care may prevent oral mucositis and improve teeth/denture conditions in patients receiving everolimus and exemestane. 2021 Annals of Translational Medicine. All rights reserved.
BACKGROUND: Oral mucositis is a clinically significant adverse event linked to cancer therapy; it reduces the quality of life of patients and may result in the discontinuation of treatment and a poorer prognosis. Based on level 3 evidence, the Mucositis Study Group of Multinational Association for Supportive Care in Cancer and the International Society of Oral Oncology recommend oral care for all patients receiving cancer chemotherapy and radiotherapy, although no data from large-scaled randomized controlled trials support the efficacy of oral care in preventing oral mucositis. Therefore, this randomized, controlled, multicenter, open-label, phase III study sought to determine whether professional oral care reduces oral mucositis in everolimus and exemestane-treated estrogen receptor-positive metastatic breast cancer patients. METHODS: Altogether, 169 patients were randomized into the professional oral care (n=82) and control (n=87) groups. The professional oral care group received oral health instruction, professional mechanical tooth and tongue cleaning, gargling with a benzethonium chloride mouthwash, and dexamethasone ointment when grade 1 mucositis manifested. The control group received oral health instruction and gargling. Eight weeks after the everolimus and exemestane administration, the oral status (Oral Assessment Guide criteria) and oral mucositis status (Common Terminology Criteria for Adverse Events functional and clinical examinations) were evaluated. RESULTS: The incidence of oral mucositis of any grade and grade 2 severe mucositis was significantly lower in the professional oral care group, based on the Common Terminology Criteria for Adverse Events functional and clinical examinations. The total Oral Assessment Guide score, total Oral Assessment Guide grade, and Oral Assessment Guide score of teeth/dentures and mucous membranes were significantly different between the two groups. The Oral Assessment Guide grade for swallow, lip, teeth/dentures, mucous membrane, tongue, and saliva significantly correlated to oral mucositis severity. CONCLUSIONS: Professional oral care may prevent oral mucositis and improve teeth/denture conditions in patients receiving everolimus and exemestane. 2021 Annals of Translational Medicine. All rights reserved.
Entities:
Keywords:
Benzethonium; breast neoplasm; dexamethasone; everolimus; exemestane
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