Abstract
BackgroundThe 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.MethodsBetween 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.ResultsThere 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.ConclusionsPOC 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 registrationThe 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).
Highlights
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)
Oral Care-BC was a phase 3 multicenter randomized clinical trial that assessed the effectiveness of professional oral care (POC) in preventing oral mucositis in patients treated with EVE and EXE for hormone-receptor-positive HER2-negative metastatic breast cancer
Univariate analysis for progression-free survival (PFS) showed that Body mass index (BMI) ≥ 25 mg/m2 was associated with a significantly shorter PFS (HR: 1.85; 95% CI, 1.16–2.96, P = 0.010) and the presence of visceral disease (HR: 1.98; 95% CI 1.27–3.08, P = 0.002) was associated with a significantly shorter PFS
Summary
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). We compared outcomes for estrogen receptor-positive metastatic breast cancer patients who received POC to those who had not, and evaluated clinical prognostic factors. Oral Care-BC was a phase 3 multicenter randomized clinical trial that assessed the effectiveness of professional oral care (POC) in preventing oral mucositis in patients treated with EVE and EXE for hormone-receptor-positive HER2-negative metastatic breast cancer. We hypothesized that POC might have a good prognostic effect in patients treated with EVE This is the first randomized trial to compare POC with a control to evaluate its effectiveness in reducing oral mucositis
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