OBJECTIVE: To assess the safety and efficacy of abiraterone acetate (AA) in patients with mCRPC treated in a compassionate named patient programme (NPP).
PATIENTS AND METHODS: We retrospectively reviewed the clinical records of mCRPC patients treated with AA at the standard daily oral dose of 1,000 mg plus prednisone 10 mg/day in 19 Italian hospitals.
RESULTS: We assessed 265 mCRPC patients treated with AA. The most frequent (>1%) grade 3-4 toxicities were anemia (4.2%), fatigue (4.2%), and bone pain (1.5%). Median progression-free survival was seven months; median overall survival was 17 months after starting AA, and 35 months after the first docetaxel administration. Our study reproduced the clinical outcomes observed in the AA pivotal trial, including those relating to special populations such as the elderly, patients with a poor performance status, symptomatic patients, and patients with visceral metastases.
CONCLUSIONS: Our data show the safety and activity of AA when administered outside clinical trials, and confirm the findings of the post-docetaxel pivotal trial in the patients as a whole population and in special populations of specific interest.
Written by:
Caffo O, De Giorgi U, Fratino L, Lo Re G, Basso U, D Angelo A, Donini M, Verderame F, Ratta R, Procopio G, Campadelli E, Massari F, Gasparro D, Macrini S, Messina C, Giordano M, Alesini D, Zustovich F, Fraccon AP, Vicario G, Conteduca V, Maines F, Galligioni E. Are you the author?
Medical Oncology Department, Santa Chiara Hospital, Trento, Italy.
Reference: BJU Int. 2014 Jul 2. Epub ahead of print.
doi: 10.1111/bju.12857
PubMed Abstract
PMID: 24988879
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