Secondary endpoints analysis in patients with estrogen receptor-positive metastatic breast cancer treated with everolimus and exemestane enrolled in Oral Care-BC
Katsuhiko Nakatsukasa,
Naoki Niikura,
Kosuke Kashiwabara,
Takeshi Amemiya,
Ken-ichi Watanabe,
Hironobu Hata,
Yuichiro Kikawa,
Naoki Taniike,
Takashi Yamanaka,
Sachiyo Mitsunaga,
Kazuhiko Nakagami,
Moriyasu Adachi,
Naoto Kondo,
Yasuyuki Shibuya,
Naoki Hayashi,
Mariko Naito,
Toshinari Yamashita,
Masahiro Umeda,
Hirofumi Mukai,
Yoshihide Ota
Affiliations
Katsuhiko Nakatsukasa
Department of Endocrine and Breast Surgery, Kyoto Prefectural University of Medicine
Naoki Niikura
Department of Breast and Endocrine Surgery, Tokai University School of Medicine
Kosuke Kashiwabara
Department of Biostatistics, School of Public Health, The University of Tokyo
Takeshi Amemiya
Department of Dentistry and Oral and Maxillofacial Surgery, Kyoto Prefectural University of Medicine
Ken-ichi Watanabe
Department of Breast Surgery, Hokkaido Cancer Center
Hironobu Hata
Department of Dentistry, Hokkaido Cancer Center
Yuichiro Kikawa
Department of Breast Surgery, Kobe City Medical Center General Hospital
Naoki Taniike
Department of Dentistry and Oral and Maxillofacial Surgery, Kobe City Medical Center General Hospital
Takashi Yamanaka
Department of Breast and Endocrine Surgery, Kanagawa Cancer Center
Sachiyo Mitsunaga
Department of Dentistry and Oral and Maxillofacial Surgery, Kanagawa Cancer Center
Kazuhiko Nakagami
Department of Breast and Endocrine Surgery, Shizuoka General Hospital
Moriyasu Adachi
Department of Oral and Maxillofacial Surgery, Shizuoka General Hospital
Naoto Kondo
Department of Breast and Endocrine Surgery, Nagoya City University Hospital
Yasuyuki Shibuya
Department of Dentistry and Oral and Maxillofacial Surgery, Nagoya City University Hospital
Naoki Hayashi
Department of Breast Surgical Oncology, St. Luke’s International Hospital
Mariko Naito
Department of Oral Epidemiology, Graduate School of Biomedical and Health Sciences Hiroshima University
Toshinari Yamashita
Department of Breast and Endocrine Surgery, Kanagawa Cancer Center
Masahiro Umeda
Department of Clinical Oral Oncology, Nagasaki University Graduate School of Biomedical Sciences
Hirofumi Mukai
Department of Breast and Medical Oncology, National Cancer Center Hospital East
Yoshihide Ota
Department of Dentistry and Oral and Maxillofacial Surgery, Tokai University School of Medicine
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) 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 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 ).
