Multi-institutional prospective observational study of the effectiveness of eribulin in first-line or second-line chemotherapy for HER2-negative hormone-resistant advanced or metastatic breast cancer: The KBCRN A001: E-SPEC Study

Abstract PurposeTo investigate the survival impact of eribulin use in first-line and second-line chemotherapy for patients with endocrine-resistant advanced or metastatic breast cancer (AMBC) in the real-world clinical setting. MethodsThis multi-institutional prospective cohort study enrolled patients with triple-negative AMBC or estrogen receptor (ER)-positive AMBC refractory to at least one previous endocrine therapy selected at the physician’s discretion. The overall survival from the start of first-line (OS1) and second-line chemotherapy (OS2) were assessed. Adjusted hazard ratio (HR) between eribulin and the other regimens (oral 5-fluorouracil [5-FU] and anthracycline/taxane) was calculated using a stratified proportional hazards model that included prespecified prognostic factors. ResultsOf the 201 patients enrolled, 180 were included in the final analysis. Baseline patient characteristics were quite diverse among regimens. The median OS1 was 2.25, 3.49, and 2.62 years for eribulin (n=46), oral 5-FU (n=57), and anthracycline/taxane (n=71), and the median OS2 was 1.75, 2.33, and 1.69 years for eribulin (n=70), oral 5-FU (n=26), and anthracycline/taxane (n=44), respectively. First-line eribulin had a worse adjusted HR for OS than the other regimens in the ER-negative cohort; second-line oral 5-FU had a better adjusted HR for OS than eribulin in the ER-positive cohort. There was no significant difference between regimens in the other subgroups.ConclusionsEribulin and anthracycline/taxane resulted in similar point estimates for OS, while oral 5-FU led to relatively longer survival. Adjusted HRs differed based on treatment line and ER status. However, caution should be exercised when interpreting the results due to the heterogamies in patient background.Trial registration number and date of registrationClinical Trials.gov (NCT 02551263), July 22, 2015.

Download Full-text

Eribulin in combination with bevacizumab as second-line treatment for HER2–negative metastatic breast cancer progressing after first-line therapy with paclitaxel and bevacizumab: a multicenter, phase II, single arm trial (GIM11-BERGI)

10.21203/rs.3.rs-57677/v1 ◽

2020 ◽

Author(s):

CARMINE DE ANGELIS ◽

Dario Bruzzese ◽

Antonio Bernardo ◽

Editta Baldini ◽

Luigi Leo ◽

...

Keyword(s):

Breast Cancer ◽

Quality Of Life ◽

Metastatic Breast Cancer ◽

Metastatic Breast ◽

Line Treatment ◽

Second Line ◽

First Line ◽

Second Line Chemotherapy ◽

Line Chemotherapy

Abstract Background: Currently, there is no standard second-line chemotherapy-based treatment for patients with HER2-negative metastatic breast cancer (MBC). Continued VEGF inhibition with bevacizumab is an option in patients progressing to first-line bevacizumab and chemotherapy. Eribulin is a non-taxane microtubule dynamics inhibitor with a unique mechanism of action that has been shown to exert beneficial effects in the tumor microenvironment and on neoangiogenesis. We evaluated the efficacy and safety of eribulin plus bevacizumab in a novel second-line chemotherapy scheme in patients progressing after first-line paclitaxel and bevacizumab.Methods: This is a multicenter, single-arm, Simon's two-stage, phase II study. Patients with HER2-negative MBC progressing to paclitaxel and bevacizumab received eribulin (1.23 mg/m2 intravenously on days 1 and 8 of each 21-day cycle) plus bevacizumab (10 mg/kg every 2 weeks or 15 mg/kg every 3 weeks intravenously), as second-line chemotherapy. The primary endpoint was the overall response rate, considered as the sum of partial (PR) and complete response (CR) based on the best overall response (BORR).Results: Fifty-eight (95.1%) of the 61 patients enrolled in the study were evaluable for efficacy. The BORR was 24.6% (95% confidence intervals [CI], 14.5% to 37.3%). The CBR (i.e. the CR + PR + SD response that persisted for more than 24 weeks) was 32.8% (95% CI, 21.3% to 46.0%). The median progression-free survival was 6.2 months (95% CI, 4.0 to 7.8 months). Overall, adverse events (AEs) were clinically manageable and the most common were fatigue (9.9% of all AEs), paresthesia (6.5% of all AEs) and neutropenia (6.2% of all AEs). Moreover, 49.5% of AEs were related to eribulin, 7.7% to bevacizumab, and 11.8% to both drugs. Quality of life was well preserved in most patients.Conclusions: The results of this study suggest that continuing bevacizumab in combination with eribulin, beyond first line treatment with bevacizumab and paclitaxel is a reasonable therapeutic option for patients with HER2-negative MBC that exerts its effect without detrimentally affecting quality of life.Trial registration: clinicalTrial.gov: NCT02175446. Registered 26, June 2014. https://clinicaltrials.gov/ct2/show/NCT02175446

Download Full-text