Phase II study of eribulin mesylate (E7389) in patients with metastatic castration-resistant prostate cancer stratified by prior taxane therapy
Por:
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
Publicada:
1 may 2012
Resumen:
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/m(2) 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.
Filiaciones:
de Bono, JS:
Royal Marsden Hosp, Inst Canc Res, Med Sect, Drug Dev Unit, Sutton SM2 5PT, Surrey, England
Sonpavde, G:
Texas Oncol, Houston, TX USA
US Oncol, Houston, TX USA
Maroto, JP:
Santa Creu St Pau Hosp, Dept Med Oncol, Barcelona, Spain
Calvo, E:
Vall Hebron Hosp, Dept Med Oncol, Barcelona, Spain
Cartwright, TH:
US Oncol, Houston, TX USA
Ocala Oncol, Ocala, FL USA
Loesch, DM:
Caris Life Sci, Irving, TX USA
Feit, K:
Eisai Inc, Woodcliff Lake, NJ USA
Das, A:
Genentech Inc, San Francisco, CA 94080 USA
Zang, EA:
Eisai Inc, Woodcliff Lake, NJ USA
Wanders, J:
Eisai Ltd, Hatfield, Herts, England
Agoulnik, S:
Eisai Inc, Andover, MA USA
Petrylak, DP:
Columbia Univ, Med Ctr, Herbert Irving Comprehens Canc Ctr, Dept Med,Sect Med Oncol, New York, NY USA
Bronze
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