Katsuhiko Nakatsukasa1, Naoki Niikura2, Kosuke Kashiwabara3, Takeshi Amemiya4, Ken-Ichi Watanabe5, Hironobu Hata6, Yuichiro Kikawa7, Naoki Taniike8, Takashi Yamanaka9, Sachiyo Mitsunaga10, Kazuhiko Nakagami11, Moriyasu Adachi12, Naoto Kondo13, Yasuyuki Shibuya14, Naoki Hayashi15, Mariko Naito16, Toshinari Yamashita9, Masahiro Umeda17, Hirofumi Mukai18, Yoshihide Ota19. 1. Department of Endocrine and Breast Surgery, Kyoto Prefectural University of Medicine, 465 Kajii-cho, Kawaramachi-hirokoji, Kamigyo-ku, Kyoto City, 602-8566, Japan. kacchan@koto.kpu-m.ac.jp. 2. Department of Breast and Endocrine Surgery, Tokai University School of Medicine, Tokyo, Japan. 3. Department of Biostatistics, School of Public Health, The University of Tokyo, Tokyo, Japan. 4. Department of Dentistry and Oral and Maxillofacial Surgery, Kyoto Prefectural University of Medicine, Kyoto, Japan. 5. Department of Breast Surgery, Hokkaido Cancer Center, Sapporo, Japan. 6. Department of Dentistry, Hokkaido Cancer Center, Sapporo, Japan. 7. Department of Breast Surgery, Kobe City Medical Center General Hospital, Kobe, Japan. 8. Department of Dentistry and Oral and Maxillofacial Surgery, Kobe City Medical Center General Hospital, Kobe, Japan. 9. Department of Breast and Endocrine Surgery, Kanagawa Cancer Center, Yokohama, Japan. 10. Department of Dentistry and Oral and Maxillofacial Surgery, Kanagawa Cancer Center, Yokohama, Japan. 11. Department of Breast and Endocrine Surgery, Shizuoka General Hospital, Shizuoka, Japan. 12. Department of Oral and Maxillofacial Surgery, Shizuoka General Hospital, Shizuoka, Japan. 13. Department of Breast and Endocrine Surgery, Nagoya City University Hospital, Nagoya, Japan. 14. Department of Dentistry and Oral and Maxillofacial Surgery, Nagoya City University Hospital, Nagoya, Japan. 15. Department of Breast Surgical Oncology, St. Luke's International Hospital, Tokyo, Japan. 16. Department of Oral Epidemiology, Graduate School of Biomedical and Health Sciences Hiroshima University, Hiroshima, Japan. 17. Department of Clinical Oral Oncology, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan. 18. Department of Breast and Medical Oncology, National Cancer Center Hospital East, Kashiwa, Japan. 19. Department of Dentistry and Oral and Maxillofacial Surgery, Tokai University School of Medicine, Tokyo, Japan.
Abstract
BACKGROUND: The Oral Care BC-trial reported that professional oral care (POC) reduces the incidence and severity of oral mucositis in patients receiving everolimus (EVE) andexemestane (EXE). However, the effect of POC on clinical response among patients receiving EVE and EXE was not established. We compared outcomes for estrogen receptor-positive metastatic breast cancer patients who received POC to those who had not, and evaluated clinical prognostic factors. All patients simultaneously received EVE and EXE. METHODS:Between May 2015 and Dec 2017, 174 eligible patients were enrolled in the Oral Care-BC trial. The primary endpoint was the comparative incidence of grade 1 or worse oral mucositis, as evaluated for both the groups over 8 weeks by an oncologist. The secondary endpoints were progression-free survival (PFS) and overall survival (OS). Data were collected after a follow-up period of 13.9 months. RESULTS: There were no significant differences in PFS between the POC and Control Groups (P = 0.801). A BMI < 25 mg/m2 and non-visceral metastasis were associated with longer PFS (P = 0.018 and P = 0.003, respectively) and the use of bone modifying agents (BMA) was associated with shorter PFS (P = 0.028). The PFS and OS between the POC and control groups were not significantly different in the Oral-Care BC trial. CONCLUSIONS:POC did not influence the prognosis of estrogen receptor-positive metastatic breast cancer patients. Patients with non-visceral metastasis, a BMI < 25 mg/m2, and who did not receive BMA while receiving EVE and EXE may have better prognoses. TRIAL REGISTRATION: The study protocol was registered online at the University Hospital Medical Information Network (UMIN), Japan (protocol ID 000016109), on January 5, 2015 and at ClinicalTrials.gov ( NCT02376985 ).
RCT Entities:
BACKGROUND: The Oral Care BC-trial reported that professional oral care (POC) reduces the incidence and severity of oral mucositis in patients receiving everolimus (EVE) and exemestane (EXE). However, the effect of POC on clinical response among patients receiving EVE and EXE was not established. We compared outcomes for estrogen receptor-positive metastatic breast cancerpatients who received POC to those who had not, and evaluated clinical prognostic factors. All patients simultaneously received EVE and EXE. METHODS: Between May 2015 and Dec 2017, 174 eligible patients were enrolled in the Oral Care-BC trial. The primary endpoint was the comparative incidence of grade 1 or worse oral mucositis, as evaluated for both the groups over 8 weeks by an oncologist. The secondary endpoints were progression-free survival (PFS) and overall survival (OS). Data were collected after a follow-up period of 13.9 months. RESULTS: There were no significant differences in PFS between the POC and Control Groups (P = 0.801). A BMI < 25 mg/m2 and non-visceral metastasis were associated with longer PFS (P = 0.018 and P = 0.003, respectively) and the use of bone modifying agents (BMA) was associated with shorter PFS (P = 0.028). The PFS and OS between the POC and control groups were not significantly different in the Oral-Care BC trial. CONCLUSIONS: POC did not influence the prognosis of estrogen receptor-positive metastatic breast cancerpatients. Patients with non-visceral metastasis, a BMI < 25 mg/m2, and who did not receive BMA while receiving EVE and EXE may have better prognoses. TRIAL REGISTRATION: The study protocol was registered online at the University Hospital Medical Information Network (UMIN), Japan (protocol ID 000016109), on January 5, 2015 and at ClinicalTrials.gov ( NCT02376985 ).
Entities:
Keywords:
Breast cancer; Everolimus; Oral care; Oral care-BC; Progression-free survival
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