Phase II study of eribulin mesylate (E7389) in patients with metastatic castration-resistant prostate cancer stratified by prior taxane therapy - Abstract

Drug Development Unit, Royal Marsden Hospital/Institute of Cancer Research, Sutton, UK.

 

Treatment options remain limited for patients with castration-resistant prostate cancer (CRPC). We evaluated eribulin mesylate (E7389), a nontaxane halichondrin B analog microtubule inhibitor, in patients with metastatic CRPC with or without previous taxane exposure.

Men with histologically proven CRPC, with or without prior taxane exposure, were enrolled in an open-label, single-arm phase II trial. Patients received eribulin mesylate 1.4 mg/m2 as a 2- to 5-min i.v. bolus infusion on days 1 and 8 of a 21-day cycle. The primary efficacy end point was prostate-specific antigen (PSA) response rate.

In total, 108 patients were assessable for safety (50 were taxane-pretreated) and 105 for efficacy in the per-protocol population. The median age of patients was 71 years and median number of cycles was 4. PSA decreases of ≥50% were achieved in 22.4% and 8.5% of taxane-naive and taxane-pretreated patients, respectively. The most common grade 3/4 adverse event was neutropenia, seen in 22.4% of chemo-naive and 40% of taxane-pretreated men. Grade 3 peripheral neuropathy occurred in none of the taxane-naive patients and 6.0% of taxane-pretreated patients.

Eribulin mesylate demonstrated activity and a relatively favorable toxicity profile in metastatic CRPC.

Written by:
de Bono JS, Molife LR, Sonpavde G, Maroto JP, Calvo E, Cartwright TH, Loesch DM, Feit K, Das A, Zang EA, Wanders J, Agoulnik S, Petrylak DP.   Are you the author?

Reference: Ann Oncol. 2011 Sep 7. Epub ahead of print.
doi: 10.1093/annonc/mdr380

PubMed Abstract
PMID: 21903605

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