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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?2 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?2, 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 ).
SUBMITTER: Nakatsukasa K
PROVIDER: S-EPMC7791872 | biostudies-literature | 2021 Jan
REPOSITORIES: biostudies-literature
Nakatsukasa Katsuhiko K Niikura Naoki N Kashiwabara Kosuke K Amemiya Takeshi T Watanabe Ken-Ichi KI Hata Hironobu H Kikawa Yuichiro Y Taniike Naoki N Yamanaka Takashi T Mitsunaga Sachiyo S Nakagami Kazuhiko K Adachi Moriyasu M Kondo Naoto N Shibuya Yasuyuki Y Hayashi Naoki N Naito Mariko M Yamashita Toshinari T Umeda Masahiro M Mukai Hirofumi H Ota Yoshihide Y
BMC cancer 20210107 1
<h4>Background</h4>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 ...[more]