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
Summary
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.
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