Abstract
Simple SummaryTo investigate a possible treatment strategy for hormone receptor (HR)-positive, HER2-negative advanced and/or metastatic breast cancer (AMBC), we investigated the clinical usefulness of adding capecitabine to maintenance endocrine therapy after induction chemotherapy and the efficacy of reinduction chemotherapy. Patients who had received bevacizumab–paclitaxel induction therapy and did not have progressive disease were randomized to receive maintenance therapy with endocrine therapy alone (group E; n = 46) or endocrine therapy plus capecitabine (group EC; n = 44). The median progression-free survival (PFS) under maintenance therapy (primary endpoint) was significantly longer in group EC than in group E (11.1 vs. 4.3 months; hazard ratio, 0.53; p < 0.01). At 24 months from the induction therapy start, the overall survival (OS) rate was significantly higher in group EC than in group E (83.5% vs. 62.3%; p = 0.02). Therefore, the addition of capecitabine to maintenance endocrine therapy may be a beneficial option after induction chemotherapy for HR-positive, HER2-negative AMBC patients.Optimal treatment strategies for hormone receptor (HR)-positive, HER2-negative advanced and/or metastatic breast cancer (AMBC) remain uncertain. We investigated the clinical usefulness of adding capecitabine to maintenance endocrine therapy after induction chemotherapy and the efficacy of reinduction chemotherapy. Patients who had received bevacizumab–paclitaxel induction therapy and did not have progressive disease (PD) were randomized to maintenance therapy with endocrine therapy alone (group E) or endocrine plus capecitabine (1657 mg/m2/day on days 1–21, q4w) (group EC). In case of PD after maintenance therapy, patients received bevacizumab–paclitaxel reinduction therapy. Ninety patients were randomized. The median progression-free survival (PFS) under maintenance therapy (primary endpoint) was significantly longer in group EC (11.1 {95% CI, 8.0–11.8} months) than in group E (4.3 {3.6–6.0} months) (hazard ratio, 0.53; p < 0.01). At 24 months from the induction therapy start, the overall survival (OS) was significantly longer in group EC than in group E (hazard ratio, 0.41; p = 0.046). No difference was found in the time to failure of strategy (13.9 and 16.6 months in groups E and EC, respectively). Increased capecitabine-associated toxicities in group EC were tolerable. Addition of capecitabine to maintenance endocrine therapy may be a beneficial option after induction chemotherapy for HR-positive, HER2-negative AMBC patients.
Highlights
The aim of treatment for advanced and/or metastatic breast cancer (AMBC) is to prolong patients’ survival and improve their quality of life (QOL) by controlling disease symptoms
The median progression-free survival (PFS) of bevacizumab–paclitaxel reinduction therapy tended to be longer in group E than in group endocrine therapy plus capecitabine (EC); no significant difference was found between the groups (9.1 months, 95% CI 6.7–11.3 months, and 7.8 months, 95% CI 5.5–9.5 months, respectively; log-rank p = 0.053) (Figure 3)
We evaluated two maintenance therapies in patients with HRpositive, human epidermal growth factor receptor 2 (HER2)-negative AMBC to determine the clinical usefulness of the addition of capecitabine to maintenance endocrine therapy, as compared with endocrine therapy alone, in patients who had received bevacizumab–paclitaxel induction therapy
Summary
The aim of treatment for advanced and/or metastatic breast cancer (AMBC) is to prolong patients’ survival and improve their quality of life (QOL) by controlling disease symptoms. Bevacizumab has been shown to significantly increase progression-free survival (PFS) and improve the response rate when combined with docetaxel [8,9] or paclitaxel [10,11] in AMBC patients. In Japan, weekly paclitaxel plus bevacizumab is widely used as one of the standard therapy regimens for HER2-negative metastatic breast cancer [12]. A longer duration of first-line chemotherapy is associated with prolonged PFS and overall survival (OS) [13], so intensive treatment tends to be continued until disease progression or intolerable toxicity in daily clinical practice, while AEs need to be minimized to maintain patients’ QOL
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