Oral Care Evaluation to Prevent Oral Mucositis in Estrogen Receptor-Positive Metastatic Breast Cancer Patients Treated with Everolimus (Oral Care-BC): A Randomized Controlled Phase III Trial

被引:15
作者
Niikura, Naoki [1 ]
Nakatukasa, Katsuhiko [3 ]
Amemiya, Takeshi [4 ]
Watanabe, Ken-Ichi [5 ]
Hata, Hironobu [6 ]
Kikawa, Yuichiro [7 ]
Taniike, Naoki [8 ]
Yamanaka, Takashi [9 ]
Mitsunaga, Sachiyo [10 ]
Nakagami, Kazuhiko [11 ]
Adachi, Moriyasu [12 ]
Kondo, Naoto [13 ]
Shibuya, Yasuyuki [14 ]
Hayashi, Naoki [15 ]
Naito, Mariko [16 ]
Kashiwabara, Kosuke [17 ]
Yamashita, Toshinari [12 ]
Umeda, Masahiro [18 ]
Mukai, Hirofumi [19 ]
Ota, Yoshihide [2 ]
机构
[1] Tokai Univ, Sch Med, Dept Breast & Endocrine Surg, Tokyo, Japan
[2] Tokai Univ, Sch Med, Dept Dent & Oral & Maxillofacial Surg, Tokyo, Japan
[3] Kyoto Prefectural Univ Med, Dept Breast & Endocrine Surg, Kyoto, Japan
[4] Kyoto Prefectural Univ Med, Dept Dent & Oral & Maxillofacial Surg, Kyoto, Japan
[5] Hokkaido Canc Ctr, Dept Breast Surg, Sapporo, Hokkaido, Japan
[6] Hokkaido Canc Ctr, Dept Dent, Sapporo, Hokkaido, Japan
[7] Kobe City Med Ctr Gen Hosp, Dept Breast Surg, Kobe, Hyogo, Japan
[8] Kobe City Med Ctr Gen Hosp, Dept Dent & Oral & Maxillofacial Surg, Kobe, Hyogo, Japan
[9] Kanagawa Canc Ctr, Dept Breast & Endocrine Surg, Yokohama, Kanagawa, Japan
[10] Kanagawa Canc Ctr, Dept Dent & Oral & Maxillofacial Surg, Yokohama, Kanagawa, Japan
[11] Shizuoka Prefectural Gen Hosp, Dept Breast & Endocrine Surg, Shizuoka, Japan
[12] Shizuoka Prefectural Gen Hosp, Dept Oral & Maxillofacial Surg, Shizuoka, Japan
[13] Nagoya City Univ Hosp, Dept Breast & Endocrine Surg, Nagoya, Aichi, Japan
[14] Nagoya City Univ Hosp, Dept Dent & Oral & Maxillofacial Surg, Nagoya, Aichi, Japan
[15] St Lukes Int Hosp, Dept Breast Surg Oncol, Tokyo, Japan
[16] Hiroshima Univ, Grad Sch Biomed & Hlth Sci, Dept Oral Epidemiol, Hiroshima, Japan
[17] Univ Tokyo, Sch Publ Hlth, Dept Biostat, Tokyo, Japan
[18] Nagasaki Univ, Dept Clin Oral Oncol, Grad Sch Biomed Sci, Nagasaki, Japan
[19] Natl Canc Ctr Hosp East, Dept Breast & Med Oncol, Kashiwa, Chiba, Japan
基金
日本学术振兴会;
关键词
Oral care; Oral mucositis; Everolimus; Breast cancer; ECONOMIC OUTCOMES; THERAPY; MASCC/ISOO; MANAGEMENT; STOMATITIS; HEALTH;
D O I
10.1634/theoncologist.2019-0382
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
Background The incidence of oral mucositis (any grade) after everolimus treatment is 58% in the general population and 81% in Asian patients. This study hypothesized that professional oral care (POC) before everolimus treatment could reduce the incidence of everolimus-induced oral mucositis. Materials and Methods This randomized, multicenter, open-label, phase III study evaluated the efficacy of POC in preventing everolimus-induced mucositis. Patients were randomized into POC and control groups (1:1 ratio) and received everolimus with exemestane. Patients in the POC group underwent teeth surface cleaning, scaling, and tongue cleaning before everolimus initiation and continued to receive weekly POC throughout the 8-week treatment period. Patients in the control group brushed their own teeth and gargled with 0.9% sodium chloride solution or water. The primary endpoint was the incidence of all grades of oral mucositis. We targeted acquisition of 200 patients with a 2-sided type I error rate of 5% and 80% power to detect 25% risk reduction. Results Between March 2015 and December 2017, we enrolled 175 women from 31 institutions, of which five did not receive the protocol treatment and were excluded. Over the 8 weeks, the incidence of grade 1 oral mucositis was significantly different between the POC group (76.5%, 62 of 82 patients) and control group (89.7%, 78 of 87 patients; p = .034). The incidence of grade 2 (severe) oral mucositis was also significantly different between the POC group (34.6%, 28 of 82 patients) and control group (54%, 47 of 87 patients; p = .015). As a result of oral mucositis, 18 (22.0%) patients in the POC group and 28 (32.2%) in the control group had to undergo everolimus dose reduction. Conclusion POC reduced the incidence and severity of oral mucositis in patients receiving everolimus and exemestane. This might be considered as a treatment option of oral care for patients undergoing this treatment. Clinical trial identification number: NCT 02069093. Implications for Practice The Oral Care-BC trial that prophylactically used professional oral care (POC), available worldwide, did not show a greater than 25% difference in mucositis. The 12% difference in grade 1 or higher mucositis and especially the similar to 20% difference in grade 2 mucositis are likely clinically meaningful to patients. POC before treatment should be considered as a treatment option of oral care for postmenopausal patients who are receiving everolimus and exemestane for treatment of hormone receptor-positive, HER2-negative advanced breast cancer and metastatic breast cancer. However, POC was not adequate for prophylactic oral mucositis in these patients, and dexamethasone mouthwash prophylaxis is standard treatment before everolimus.
引用
收藏
页码:E223 / E230
页数:8
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