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Phase II trial of eribulin in patients who do not achieve pathologic complete response (pCR) following neoadjuvant chemotherapy

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Breast Cancer Research and Treatment Aims and scope Submit manuscript

Abstract

Purpose

Women with residual invasive breast cancer at the primary site or axillary lymph nodes following neoadjuvant chemotherapy have a high risk of recurrence. Eribulin improves survival in patients with metastatic breast cancer who progress after anthracycline and taxane therapy. This phase 2 trial assessed the efficacy of postoperative eribulin in breast cancer patients who did not achieve a pCR following standard neoadjuvant chemotherapy.

Methods

Women with localized breast cancer who had residual invasive cancer following ≥ 4 cycles of standard anthracycline and/or taxane-containing neoadjuvant chemotherapy received adjuvant eribulin treatment. HER2-positive patients also received trastuzumab for 1 year. Adjuvant hormonal therapy and locoregional radiotherapy were administered as per institutional guidelines. Primary endpoint was the 2-year DFS rate. Three patient cohorts were analyzed: TNBC (Cohort A), HR+/HER2− (Cohort B), and HER2+ (Cohort C).

Results

One hundred twenty-six patients (Cohort A-53, Cohort B-42, and Cohort C-31) were enrolled. Neoadjuvant chemotherapy included a taxane and an anthracycline in 70%. Eribulin was well tolerated; 84% of patients received the planned 6 cycles. After a median follow-up of 28 months, the 24-month DFS rates were 56% (95% CI 42, 69), 83% (95% CI 67, 91), and 73% (95% CI 53, 86) for Cohorts A, B, and C, respectively. The most common grade 3/4 treatment-related adverse events were neutropenia (26%), leukopenia (13%), and neuropathy (7%).

Conclusion

Administration of adjuvant eribulin after neoadjuvant chemotherapy was feasible and well tolerated. The 24-month DFS rate did not reach the study target levels in any of the cohorts and was similar to DFS previously described in these cohorts following neoadjuvant chemotherapy alone.

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Funding

This study was supported in part by grants from Eisai.

Author information

Authors and Affiliations

  1. Sarah Cannon Research Institute, Nashville, TN, USA

    Denise A. Yardley, Nancy Peacock, Brooke Daniel, Betrand Anz, Mythili Shastry, Johanna Pasek, Laura M. DeBusk & John D. Hainsworth

  2. Tennessee Oncology, PLLC, Nashville, TN, USA

    Denise A. Yardley, Nancy Peacock & John D. Hainsworth

  3. Tennessee Oncology, PLLC, Chattanooga, TN, USA

    Brooke Daniel & Betrand Anz

  4. Florida Hospital Cancer Institute, Orlando, FL, USA

    David C. Molthrop Jr & Sonalee K. Shroff

  5. The Center for Cancer and Blood Disorders, Fort Worth, TX, USA

    Robyn Young

  6. Family Cancer Center, Memphis, TN, USA

    Aleksander Jankov

  7. Cancer Research Consortium of West Michigan, Grand Rapids, MI, USA

    Amy Vander Woude

  8. Sarah Cannon Research Institute, 250 25th Avenue North, Suite 100, Nashville, TN, 37203, USA

    Denise A. Yardley

Authors
  1. Denise A. Yardley
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  2. Nancy Peacock
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Contributions

Study was design was performed by DAY, MS, and JH. Data collection was performed by DAY, NP, BD, BA, DCM, SS, RY, AJ, and AVW. Data analysis was performed by DAY, MS, JP, LMD, and JH and this was then reviewed by the remaining authors. All authors read and approved the final manuscript.

Corresponding author

Correspondence to Denise A. Yardley.

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Conflict of interest

DAY reports consulting/advisory role funding paid to the institute from Novartis, Genentech/Roche, Daiichi Sankyo, Eisai, Celgene, Biotheranostocs, Nanostring Technologies, Bristol-Myers Squibb; research funding grants paid to the institution from AstraZeneca, Genentech/Roche, Syndax, Novartis, MedImmune, Lilly, Medivation, Pfizer, Eisai, Tesaro, Macrogenics, Abbvie, Immunomedics, Daiichi Sankyo, Merck, Clovis Oncology, Oncothyreon, InventisBio; speaker’s bureau funding from Novartis, Genentech/Roche; travel/accommodations/expenses from Novartis and Genentech/Roche, all outside the submitted work. JDH reports research funding grants paid to the institution from Genetech and Astellas. The other authors have no conflicts of interest to report.

Ethical approval

All procedures performed in studies involving human participants were in accordance with the ethical standards of the FDA (ClinicalTrials.gov NCT01401959) and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.

Informed consent

Informed consent was obtained from all individual participants included in the study.

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Yardley, D.A., Peacock, N., Daniel, B. et al. Phase II trial of eribulin in patients who do not achieve pathologic complete response (pCR) following neoadjuvant chemotherapy. Breast Cancer Res Treat 180, 647–655 (2020). https://doi.org/10.1007/s10549-020-05563-z

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  • DOI: https://doi.org/10.1007/s10549-020-05563-z

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