Abstract 1901
Background
Eribulin mesylate has been approved for advanced or metastatic breast cancers subjected to at least two previous chemotherapy regimens. The present multicenter, phase II, single-arm study assessed the efficacy and safety of a first-line regimen of eribulin plus trastuzumab for untreated advanced or metastatic HER2-positive breast cancer.
Methods
Enrolled patients received eribulin (1.4 mg/m2 intravenously; I.V.) on days 1 and 8 of each 21-day cycle, an initial trastuzumab dose (8 mg/kg I.V.) on day 1, and 6 mg/kg of trastuzumab on day 1 of each subsequent cycle. The primary endpoint was the RR. The secondary endpoints were PFS, OS, DOR, and safety. Twenty-eight patients (median age: 62.5 years) received a median of 12 (range: 2–53) cycles of eribulin plus trastuzumab.
Results
The RR was 53.6% (CR, 4; PR, 11) with a median PFS of 344 days. The clinical benefit rate was 64.0%. Grade 3/4 adverse events were observed in 12 (42.9%) patients. For details, neutropenia in 8 (28.6%) patients, peripheral neuropathy in 2 (7.1%) patient, interstitial pneumonia in 1 (3.6%) patient, ALT elevation in 1 (3.6%) patient, osteonecrosis of the jaw in 1 (3.6%) patient, and fatigue in 1 (3.6%) patient. The patient with osteonecrosis received denosumab, too. No symptomatic congestive heart failure was observed.
Conclusions
Combination therapy of eribulin plus trastuzumab is acceptable in efficacy and safety, and a capable option for first-line advanced or recurrent HER2-positive breast cancer.
Clinical trial identification
UMIN000009890.
Legal entity responsible for the study
Translational Reseach Informatics Center, Kobe, Japan.
Funding
Has not received any funding.
Editorial Acknowledgement
Editage edited English language.
Disclosure
All authors have declared no conflicts of interest.
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