Abstract 1373
Background
Anthracycline- or taxane-based regimens are the standard early-line chemotherapy for metastatic breast cancer. However, adverse effects of these treatments, such as neutropenia, peripheral neuropathy, edema, and alopecia, are a concern. The EMBRACE study has shown that eribulin is effective for metastatic breast cancer, even as a late-line treatment. The aim of this study was to investigate the usefulness of eribulin as first- or second-line treatment.
Methods
Patients with recurrent HER2-negative breast cancer who had received previous chemotherapy including both an anthracycline and a taxane were eligible for this phase II study. They were randomly allocated to receive eribulin or treatment of physician’s choice (TPC) as first- or second-line treatment. TPC was selected in advance from paclitaxel, docetaxel, nab-paclitaxel, and vinorelbine. The primary endpoint was progression-free survival (PFS). Secondary endpoints included time to treatment failure (TTF), response rate (RR), duration of response, and safety. (UMIN000009886).
Results
From May 2013 to January 2017, 72 patients were enrolled. The full analysis set comprised data from 58 patients (median age, 58 years; range, 33–82 years); 38 (65.5%) received first-line treatment and 20 (34.5%) received second-line treatment. 43 patients (74.1%) were ER- positive. The per protocol set comprised data from 57 patients. PFS, TTF, RR, and duration of response in both groups are shown in the table. The most common grade 3 or worse adverse events were neutropenia (6/27 [22.2%] in the eribulin group versus 5/31[16.1%] in the TPC group). The incidence of sensory neuropathy was low in both groups.Table: 317P
| Eribulin (n = 26) | TPC (n = 31) | p-value | ||
|---|---|---|---|---|
| PFS | Median(M) | 6.6(5.0-8.1) | 4.2(0.8-7.6) | 0.273 |
| TTF | Median(M) | 6.0(4.7-7.3) | 3.6(2.3-4.9) | 0.131 |
| Tumor response | CR | 0(0.0%) | 0(0.0%) | 0.190 |
| PR | 5(19.2%) | 6(19.4%) | ||
| SD | 16(61.5%) | 11(35.5%) | ||
| PD | 5(19.2%) | 13(41.9%) | ||
| ORR | 5(19.2%) | 6(19.4%) | ||
| Duration of response | Median(M) | 3.0(2.1-3.9) | 2.8(2.4-3.3) | 0.794 |
Conclusions
Eribulin was not shown to be superior to TPC in terms of efficacy. However, patients in the eribulin group had slightly longer PFS and TTF.
Clinical trial identification
UMIN000009886.
Legal entity responsible for the study
Japan Breast Cancer Research Group (JBCRG).
Funding
Japan Breast Cancer Research Group (JBCRG).
Editorial Acknowledgement
Disclosure
K. Aogi: Honoraria: Chugai, Eisai, Sanofi, AstraZeneca, Taiho, Daiichi Sankyo, Ono, Otsuka, Nihon Medi-physics, Terumo, Becton Dickinson and Company; Research funding: Chugai, Eisai, Takeda and Sanofi. S. Ohtani: Speakers bureau: Chugai and Eisai. H. Kawaguchi: Honoraria: Chugai, AstraZeneca, Eisai, Kyowa-Kirin, Novartis, Taiho, Pfizer and Nippon Chemiphar; Consulting or advisory role: Chugai and AstraZeneca; Speakers bureau: Chugai, AstraZeneca, Eisai, Kyowa-Kirin, Novartis, Taiho, Pfizer and Nippon Chemiphar. S. Morita: Honoraria: Eisai and Taiho; Research funding: Eisai. N. Masuda: Honoraria: Chugai, Takeda, Pfizer and AstraZeneca; Research funding: Chugai, AstraZeneca, Kyowa-Kirin, MSD, Novartis, Pfizer, Eli-Lilly. M. Toi: Honoraria: Novartis, MSD, Takeda, AstraZeneca, Eisai, Genomic Health, Chugai, Taiho, Bayer, Eli Lilly, Daiichi Sankyo, Kiowa-Kirin, C&C Research Laboratories, Yakult, Sanofi, Shimadzu, Pfizer; Consulting or advisory role: Daiichi Sankyo, Kiowa-Kirin and Taiho; Research funding: Taiho, Chugai, Shimadzu, Astellas Phama, AFI technology and C&C Research Laboratories. S. Ohno: Speakers bureau: Chugai Pharmaceutical, Eisai, Pfizer, Novartis, Taiho, Kyowa-Kirin, AstraZeneca. All other authors have declared no conflicts of interest.