Umeda Masahiro, Ota Yoshihide, Kashiwabara Kosuke, Hayashi Naoki, Naito Mariko, Yamashita Toshinari, Mukai Hirofumi, Nakatsukasa Katsuhiko, Amemiya Takeshi, Watanabe Ken-Ichi, Hata Hironobu, Kikawa Yuichiro, Taniike Naoki, Yamanaka Takashi, Mitsunaga Sachiyo, Nakagami Kazuhiko, Adachi Moriyasu, Kondo Naoto, Shibuya Yasuyuki, Niikura Naoki
Department of Clinical Oral Oncology, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan.
Department of Oral and Maxillofacial Surgery, Tokai University School of Medicine, Tokyo, Japan.
Ann Transl Med. 2021 Apr;9(7):535. doi: 10.21037/atm-20-6488.
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.
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.
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.
Professional oral care may prevent oral mucositis and improve teeth/denture conditions in patients receiving everolimus and exemestane.
口腔黏膜炎是一种与癌症治疗相关的具有临床意义的不良事件；它会降低患者的生活质量，并可能导致治疗中断和预后较差。基于3级证据，癌症支持治疗多国协会黏膜炎症研究组和国际口腔肿瘤学会建议，对所有接受癌症化疗和放疗的患者进行口腔护理，尽管尚无大规模随机对照试验的数据支持口腔护理在预防口腔黏膜炎方面的疗效。因此，这项随机、对照、多中心、开放标签的III期研究旨在确定专业口腔护理是否能降低接受依维莫司和依西美坦治疗的雌激素受体阳性转移性乳腺癌患者的口腔黏膜炎发生率。
总共169例患者被随机分为专业口腔护理组（n = 82）和对照组（n = 87）。专业口腔护理组接受口腔健康指导、专业的机械牙齿和舌清洁、用苄索氯铵漱口水漱口，以及在出现1级黏膜炎时使用地塞米松软膏。对照组接受口腔健康指导和漱口。在给予依维莫司和依西美坦8周后，评估口腔状况（口腔评估指南标准）和口腔黏膜炎状况（不良事件通用术语标准功能和临床检查）。
根据不良事件通用术语标准功能和临床检查，专业口腔护理组任何级别的口腔黏膜炎和2级严重黏膜炎的发生率显著较低。两组之间的口腔评估指南总分、口腔评估指南总等级以及牙齿/假牙和黏膜的口腔评估指南评分存在显著差异。吞咽、嘴唇、牙齿/假牙、黏膜、舌头和唾液的口腔评估指南等级与口腔黏膜炎严重程度显著相关。
专业口腔护理可能预防接受依维莫司和依西美坦治疗的患者发生口腔黏膜炎，并改善牙齿/假牙状况。
