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Eribulin plus trastuzumab safe, effective in HER-2–positive metastatic breast cancer
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SAN FRANCISCO — Eribulin mesylate plus trastuzumab demonstrated activity in patients with HER-2–positive metastatic breast cancer regardless of prior treatment with trastuzumab, according to phase 2 study results presented at the Breast Cancer Symposium.
Joyce O’Shaughnessy, MD, of the Texas Oncology Baylor Charles A. Sammons Cancer Center, and colleagues sought to evaluate whether prior trastuzumab (Herceptin, Genentech) affected the efficacy of eribulin mesylate (Halaven, Eisai) plus trastuzumab. Previous data indicated the combination conferred a 71% objective response rate as a first-line treatment.
Joyce O’Shaughnessy
The analysis included 52 patients (median age, 59.5 years) who had not undergone prior chemotherapy for metastatic breast cancer. Twenty-one patients had previously received trastuzumab and 31 had not. A median of 23 months had passed since previous treatment.
Patients received 1.4 mg/m2 IV eribulin mesylate on days 1 and 8 of a 21-day cycle. They also received an initial trastuzumab dose of 8 mg/kg, followed by 6-mg/kg doses on day 1 of each cycle. Median treatment duration was approximately 30 weeks.
Researchers reported similar rates of objective clinical response (62% vs. 77%) and clinical benefit (81% vs. 87%) between patients who had received prior trastuzumab and those who had not.
Median PFS was 12.2 months among those who had not received prior trastuzumab, and 11.5 months for those who had undergone prior trastuzumab treatment. The duration of response also was comparable between the cohorts (9.5 months for previous trastuzumab; 11.8 months for no trastuzumab).
Grade 3 to grade 4 adverse events (76% vs. 68%) and the rate of discontinuation due to adverse events (24% vs. 19%) were similar between patients who had and had not previously received trastuzumab. One patient without previous trastuzumab experienced a grade 5 adverse event.
“In this phase 2 single-arm trial in patients with HER-2–positive metastatic breast cancer, eribulin plus trastuzumab demonstrated activity and was well tolerated as a first-line treatment, irrespective of prior (neo)adjuvant trastuzumab treatment,” O’Shaughnessy and colleagues wrote.
For more information:
O’Shaughnessy J. Abstract #139. Presented at: Breast Cancer Symposium; Sept. 4-6, 2014, San Francisco.
Disclosure: The researchers report consultant/advisory, leadership, employment or speakers’ bureau roles with and research funding from ACORN Research, Amgen, Celldex, Eisai, Genentech, MedImmune, Novartis, Pfizer, Teva and Roche.