Abstract

The combination chemotherapy regimen of eribulin (ERI) and trastuzumab (TRA)—the ERI-TRA regimen—has been shown to be highly tolerable for patients with recurrent or metastatic human epidermal growth factor receptor 2 (HER2)-positive breast cancer. However, no sufficient clinical evidence is available for the long-term safety profile of the regimen. We report on three patients in the Phase I combination study of the regimen, for whom the regimen could be conducted over the long term. Patient #1 was a 68-year-old woman and underwent the regimen until cycle 23. Patient #2 was a 61-year-old woman and underwent the regimen until cycle 27. Patient #3 was a 59-year-old woman and underwent the regimen until cycle 22. All these patients had undergone TRA-based combination therapy before the onset of the regimen. Any new categories of adverse events did not occur in association with the long-term combination chemotherapy. Neutropenia experienced by these patients was reversible and easily manageable by dose adjustment (interruption/delay and reduction). Neither increase in the risk of cardiomyopathy nor the worsening of peripheral neuropathy greater than grade 1 was found. The present regimen was suggested to be a novel chemotherapeutic option for patients with HER2-positive recurrent or metastatic breast cancer. The fact that the long-term ERI-TRA regimen was successfully conducted for these patients can be supplementary clinical information that is beneficial for clinical oncologists.

Highlights

  • The combination chemotherapy regimen of eribulin (ERI) and trastuzumab (TRA)—the ERI-TRA regimen—has been shown to be highly tolerable for patients with recurrent or metastatic human epidermal growth factor receptor 2 (HER2)-positive breast cancer

  • We hereby report on three Japanese patients with HER2positive metastatic breast cancer for whom this regiment was continued after the cutoff date (August 2, 2013) in the Phase I combination study and in whom subsequent 9-month follow-up revealed that the total number of the chemotherapy cycles had exceeded 20

  • At the onset of the Phase I combination study in 2011, the preferred first-line chemotherapy regimens recommended by the National Comprehensive Cancer Network (NCCN) [3]—which combined TRA with one and/or two anticancer drugs, e.g., PTX [4, 5], DTX [6,7,8,9,10], capecitabine [CAPE] [7, 11, 12], and vinorelbine [VNR] [10, 13, 14]—were conducted for patients with HER2-positive recurrent or metastatic breast cancer

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Summary

Introduction

The combination chemotherapy regimen of eribulin (ERI) and trastuzumab (TRA)—the ERI-TRA regimen—has been shown to be highly tolerable for patients with recurrent or metastatic human epidermal growth factor receptor 2 (HER2)-positive breast cancer. We report on three patients in the Phase I combination study of the regimen, for whom the regimen could be conducted over the long term.

Results
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