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Phase II trial of biweekly administration with eribulin after three cycles of induction therapy in hormone receptor-positive, HER2-negative metastatic breast cancer (JACCRO BC-03)

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Breast Cancer Research and Treatment Aims and scope Submit manuscript

Abstract

Purpose

Metastatic breast cancer (MBC) is usually incurable; treatment aims to maximize patients’ function and quality of life (QOL). Eribulin is a standard treatment in patients with MBC pretreated with anthracycline and taxane; however, the best administration schedule is unknown.

Methods

In this prospective phase II trial of patients with luminal MBC, we administered biweekly eribulin to patients who completed a three-cycle induction treatment.

Results

Sixty patients with hormone-receptor-positive and HER2-negative MBC were enrolled; 40 obtained stable disease (SD) or better efficacy after induction therapy, after which they were switched to biweekly maintenance administration. The median progression-free survival (PFS) in patients who switched to maintenance therapy was 15.21 weeks (95% CI 9.71–22.14), starting on the first day of maintenance therapy. Overall survival (OS) in patients who switched to maintenance therapy was 21.39 months (95% CI 18.89–32.89). PFS and OS in the whole population starting from the registration date were 19.00 weeks (95% CI 17.00–25.00) and 21.52 months (95% CI 16.23–24.25), respectively. PFS from the enrollment date for patients who received maintenance therapy was 25.29 weeks (95% CI 19.14–32.14). Patients who achieved complete response or partial response during induction therapy had significantly longer PFS compared to patients with SD.

Conclusion

The efficacy of biweekly administration of eribulin at maintenance was nonsignificant. However, less frequent visits are convenient, and reduced dose intensity improves safety. Biweekly administration, besides dose reduction, could be an acceptable option for patients who are unable to maintain a standard regimen.

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Data availability

The datasets generated during and/or analyzed during the current study are not publicly available because of no planning in the study protocol but are available from the corresponding author on reasonable request.

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Acknowledgements

We thank the patients, their families, investigators, institutions involved in this study, and the members of the JACCRO Data Center and Support Office. We also thank Yasuhiro Fujiwara, Kohei Akazawa and Toru Takebayashi for the independent data and safety monitoring committee.

Funding

This study was funded by Eisai and supported by JACCRO.

Author information

Authors and Affiliations

  1. Department of Breast Medical Oncology, Cancer Institute Hospital of JFCR, Tokyo, Japan

    Kokoro Kobayashi & Yoshinori Ito

  2. Department of Breast and Endocrine Surgery, Nagoya University Graduate School of Medicine, Nagoya, Japan

    Norikazu Masuda

  3. Department of Surgery, Breast Oncology, NHO Osaka National Hospital, Osaka, Japan

    Norikazu Masuda

  4. Department of Medical Oncology, Mie University Hospital, Tsu, Japan

    Toshiro Mizuno

  5. Department of Respiratory Medicine, Juntendo University Graduate School of Medicine, Tokyo, Japan

    Kayo Miura

  6. Breast Center, Seirei Yokohama Hospital, Yokohama, Japan

    Yutaka Tokuda

  7. Department of Breast and Endocrine Surgery, Graduate School of Medicine, Osaka University, Suita, Japan

    Tetsuhiro Yoshinami

  8. Department of Breast Surgery, Matsuyama Red Cross Hospital, Matsuyama, Japan

    Hidetoshi Kawaguchi

  9. Department of Breast Surgery, Hiroshima City Hiroshima Citizens Hospital, Hiroshima, Japan

    Shoichiro Ohtani

  10. Department of Breast Oncology, Saitama Medical University International Medical Center, Hidaka, Japan

    Toshiaki Saeki

  11. Department of Breast Surgery, Graduate School of Medicine, Kyoto University Hospital, Kyoto, Japan

    Masakazu Toi

  12. Graduate School of Mathematical Sciences, The University of Tokyo, Tokyo, Japan

    Masahiro Takeuchi

Authors
  1. Kokoro Kobayashi
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  2. Norikazu Masuda
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  3. Toshiro Mizuno
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  4. Kayo Miura
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  5. Yutaka Tokuda
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  6. Tetsuhiro Yoshinami
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  7. Hidetoshi Kawaguchi
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  8. Shoichiro Ohtani
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  10. Masakazu Toi
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Contributions

Material preparation and data collection were conducted by KK, YI, TY, YT, SM, TM and HK performed data analysis and interpretation. MT was responsible for statistical analysis. The first draft of the manuscript was written by KK and YI and all the authors collaborated in the preparation, review, and approval of the manuscript and agreed to the decision to submit this manuscript for publication.

Corresponding author

Correspondence to Kokoro Kobayashi.

Ethics declarations

Conflict of interest

KK has received honoraria from Pfizer, Eisai, Eli lily, Chugai, Taiho, Novartis, AstraZeneca. NM has received honoraria from Chugai, Pfizer, AstraZeneca and Eli Lilly. NM’s institution received grants from Chugai, Eli Lilly, AstraZeneca, Pfizer, Daiichi Sankyo, MSD, Eisai, Novartis, Sanofi, Kyowa Kirin, Nippon Kayaku and Ono; and has been involved in the Japan Breast Cancer Research Group (JBCRG) and Japanese Breast Cancer Society (JBCS) as a board of directors. TM has received honoraria from Chugai, Pfizer, Eisai, MSD, Ono, Daiichi Sankyo, Eli Lilly and AstraZeneca. TY has received Consulting fee from Eisai; and honoraria from Chugai, Eli Lilly, Kyowa Kirin, Daiichi Sankyo, MSD, Pfizer, Novartis, Eisai and Astra Zeneca. HK has received honoraria from Pfizer, Chugai, Astra Zeneca, Eisai, Kyowa Kirin, Novartis, Maruho, Eli Lilly, Taiho, Daiichi Sankyo and Nippon Kayaku. SO has received honoraria from Lilly, Chugai, Pfizer and Daiichi Sankyo. TS has received honoraria from Taiho, Daiichi Sankyo, Chugai, Pfizer, and Eli Lilly. MT has received research grant from Chugai, Takeda, Pfizer, Taiho, JBCRG, Kyoto Breast Cancer Research Network (KBCRN), Eisai, Eli Lilly and companies, Daiichi Sankyo, AstraZeneca, Astellas, Shimadzu, Yakult Honsha, Nippon Kayaku, AFI technology, Luxonus, Shionogi, GL Science, Sanwa Shurui; honoraria from Chugai, Takeda, Pfizer, Kyowa Kirin, Taiho, Eisai, Daiichi Sankyo, AstraZeneca, Eli Lilly and companies, MSD, Exact Science, Novartis, Shimadzu, Yakult, Nippon Kayaku, Devicore Medical Japan and Sysmex; advisory board member of Daiichi Sankyo, Eli Lilly and companies, BMS, Athenex Oncology, Bertis, Terumo and Kansai Medical Net; has been involved in JBCRG as the board of directors, KBCRN as the board of directors, OOTR as the board of directors and JBCS as the Chairman of the board of directors; and associate editor of British Journal of Cancer, Scientific Reports, Breast Cancer Research and Treatment, Cancer Science, Frontiers in Women’s Cancer, Asian Journal of Surgery and Asian Journal of Breast Surgery. YI has received research funding from Chugai, MSD, Eli Lilly, Daiichi Sankyo and AstraZeneca. The other authors declare no conflict of interest.

Ethical approval

The study was conducted in compliance with the Japanese guidelines and the Declaration of Helsinki. The study was approved by the institutional review boards of all participating institutions. Written informed consent was obtained from all patients.

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Kobayashi, K., Masuda, N., Mizuno, T. et al. Phase II trial of biweekly administration with eribulin after three cycles of induction therapy in hormone receptor-positive, HER2-negative metastatic breast cancer (JACCRO BC-03). Breast Cancer Res Treat 201, 409–415 (2023). https://doi.org/10.1007/s10549-023-07030-x

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