(ChemotherapyAdvisor) – Eribulin safety and time to treatment failure in real-world clinical settings are comparable to those identified in previous clinical trials, according to an analysis reported during the 2013 Breast Cancer Symposium in San Francisco, CA.
“Time to treatment failure with eribulin was comparable regardless of triple-negative status and prior exposure to anthracyclines,” reported biostatistician George Dranitsaris of Augmentium Pharma Consulting in Toronto, Ontario, Canada, and coauthors.
Despite important advances in metastatic breast cancer (MBC) treatment, patients with triple-negative tumors remain “a therapeutic challenge,” the researchers noted.
Eribulin is the newest cytotoxic to gain regulatory approval for MBC in the United States. The team analyzed its real-world safety and efficacy data for eribulin among treatment-naïve patients with breast cancer and previously-treated patients with breast cancer.
“Eribulin was administered after a median of three prior lines of chemotherapy (range, 0 to 15),” they reported. “The drug was delivered as a single agent in 79 (88%) of 90 patients at the clinically approved dosage of 1.4 mg/m2 on days 1 and 8 of a 21-day cycle.”
Over a mean treatment duration of 2.9 months (range, 0-14.2 months), patients were administered a median of four cycles (range, 1-16 cycles) of eribulin.
“Seventeen (18.9%) of 90 patients were identified as triple-negative and 57 (63.3%) of 90 had received prior anthracycline treatment,” the coauthors noted.
The median time to treatment failure was 4 months (range, 2.3-5.6 months) in all patients. The most common dose-limiting toxicities included neutropenia (32%), anemia (31%), neuropathy (21%), and febrile neutropenia (8.9%), they reported.
“There were no significant differences in time to treatment failure by triple-negative status (P=0.49) and prior exposure to anthracyclines (P=0.15),” they noted.
Despite the relatively small sample size, these real-world findings were consistent with previous clinical trial reports, the coauthors noted.