http://www.therapeuticsdaily.com/new...e&channelID=28
Eribulin Mesylate Demonstrated Anti-Tumor Activity in Heavily Pretreated Patients With Advanced Breast Cancer
Eisai Europe Ltd. The investigational chemotherapeutic agent eribulin mesylate (E7389) demonstrated activity in a heavily pretreated population of women with locally advanced or metastatic breast cancer, according to results of a multi-center Phase II clinical trial. The study also suggests that eribulin mesylate has a manageable tolerability profile, with a low incidence of Grade 3 (severe) and no Grade 4 (disabling or life-threatening) neuropathy. These data (abstract #1084) will be presented at the 44th Annual Meeting of the American Society of Clinical Oncology (ASCO) on Monday, June 2 from 2 to 6 p.m. at S Hall A1 of McCormick Place.
Study 211 is a Phase II, open-label, single-arm study evaluating the efficacy and safety of eribulin mesylate in patients with locally advanced or metastatic breast cancer who had received an anthracycline, a taxane and capecitabine as prior therapy, and who were refractory to their last chemotherapy regimen, as documented by progression on or within six months of that therapy.
Of 299 patients enrolled in the study, 291 were treated with eribulin mesylate. The median age of those patients was 56 years (range: 26-80 years). Eribulin mesylate was administered at a dose of 1.4mg/m2 as a 2- to 5-minute intravenous infusion on Days 1 and 8 of a 21-day cycle. Patients received a median of four cycles of eribulin mesylate (range 1-27). No premedication to prevent hypersensitivity was required.
Two-hundred sixty-nine patients met the key inclusion criteria. In patients who received a median of four cycles of eribulin mesylate, Overall Response Rate (ORR) by Independent Review (IR) was 9.3% (all Partial Responses (PR); 95% confidence interval (CI): 6.1%-13.4%). Investigator-assessed ORR was 14.1% (1 CR; 95% CI: 10.2%-18.9%). Nearly half (46.5%) the patients had stable disease (SD) after treatment with eribulin mesylate. The clinical benefit rate (CBR, defined as CR+PR+SD equal to or more than 6 months) was 17.1% (95% CI: 12.8%-22.1%).
The median duration of response was 4.2 months (126 days, range: 42(1)-258 days; 95% CI: 86-147). Median progression-free survival (PFS) was 2.6 months (79 days, range: 1*-397 days), and the median overall survival (OS) rate was 10.3 months (315 days, range: 19-604 days; 95% CI: 279-350). The six-month PFS and OS rates were 16.0% (95% CI: 8.6-17.0) and 72.3%, respectively (95% CI: 66.9-77.6).
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