Abstract
BackgroundTo examine the efficacy and safety of induction therapy with paclitaxel and bevacizumab followed by switch maintenance therapy with eribulin (ISMT) in Japanese patients with HER2-negative metastatic breast cancer (MBC).MethodsPatients, who had previously undergone a maximum of 2 regimens of chemotherapy, received 3 cycles of induction therapy with paclitaxel (90 mg/m2 intravenously on days 1, 8, and 15 followed by 1-week drug holiday) and bevacizumab (10 mg/kg intravenously after the completion of paclitaxel administration on days 1 and 15). Patients who had complete response, partial response, or stable disease underwent switch maintenance therapy with eribulin (1.4 mg/m2 intravenously on days 1 and 8 followed by 1-week drug holiday). The primary endpoint was time to treatment failure (TTF) for ISMT.ResultsFifty-one eligible patients (median age: 66 years; range: 35–74) were enrolled: 19 (37.3%) and 32 (62.7%) had stage IV and recurrence, respectively, 42 (82.4%) had visceral metastases, and 45 (88.2%) received eribulin—38 of whom showed disease progression, and 40 (78.4%) underwent post therapy. Median TTF was 9.2 months (95% confidence interval [CI]: 7.3–11.1), median progression-free survival was 10.7 months (95% CI: 9.6–11.8), and median overall survival was 20.0 months (95% CI: 16.0–24.0). Relative dose intensity was 97.7% (range: 33.3–100.0) for induction therapy and was 83.3% (range: 49.3–100.6%) for eribulin maintenance therapy. The most common adverse event was alopecia (51 [100%]) in induction therapy and was peripheral sensory neuropathy (37 [82.2%]) in eribulin maintenance therapy. Eribulin was effective with manageable tolerability.ConclusionsISMT may be a promising therapeutic option for patients with MBC.Trial registrationUMIN000015971. Registration date: January 1, 2015.
Highlights
To examine the efficacy and safety of induction therapy with paclitaxel and bevacizumab followed by switch maintenance therapy with eribulin (ISMT) in Japanese patients with human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer (MBC)
Approximately 90% of patients diagnosed with breast cancer undergo surgery for the treatment of their primary malignancy [1], and up to 5% of patients present with distal metastatic breast cancer (MBC) at the time of diagnosis [2]
Patient population Between January 23, 2015, and February 25, 2016, a total of 53 Japanese female patients with MBC were recruited to the present clinical study at 4 medical institutions in Japan
Summary
To examine the efficacy and safety of induction therapy with paclitaxel and bevacizumab followed by switch maintenance therapy with eribulin (ISMT) in Japanese patients with HER2-negative metastatic breast cancer (MBC). 90% of patients diagnosed with breast cancer undergo surgery for the treatment of their primary malignancy [1], and up to 5% of patients present with distal metastatic breast cancer (MBC) at the time of diagnosis [2]. Breast cancer recurs in about 40% of patients who underwent surgery [1], the residual recurrence-free survival rates at 5 and 10 years after adjuvant and neoadjuvant systemic therapy are 89 and 80%, respectively [3], and the median survival of patients with MBC is 28 months [4]. Treatments other than AT therapy are frequently selected when breast cancer progressed or recurred after AT therapy was conducted as pre- or postoperative chemotherapy.
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