Safety and clinical outcomes of patients treated with abiraterone acetate after docetaxel: Results of the Italian Named Patient Programme

Orazio Caffo, Ugo De Giorgi, Lucia Fratino, Giovanni Lo Re, Umberto Basso, Alessandro D'Angelo, Maddalena Donini, Francesco Verderame, Raffaele Ratta, Giuseppe Procopio, Enrico Campadelli, Francesco Massari, Donatello Gasparro, Sveva Macrini, Caterina Messina, Monica Giordano, Daniele Alesini, Fable Zustovich, Anna P. Fraccon, Giovanni VicarioVincenza Conteduca, Francesca Maines, Enzo Galligioni

Research output: Contribution to journalArticle

Abstract

Objective To assess the safety and efficacy of abiraterone acetate (AA) in patients with metastatic castration-resistant prostate cancer (mCRPC) treated in a compassionate named patient programme (NPP). Patients and Methods We retrospectively reviewed the clinical records of patients with mCRPC treated with AA at the standard daily oral dose of 1000-mg plus prednisone 10-mg/day in 19 Italian hospitals. Results We assessed 265 patients with mCRPC treated with AA. The most frequent (>1%) grade 3-4 toxicities were anaemia (4.2%), fatigue (4.2%), and bone pain (1.5%). The median progression-free survival was 7 months; median overall survival was 17 months after starting AA, and 35 months after the first docetaxel administration. Our study reproduced the clinical outcomes reported 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.

Original languageEnglish
Pages (from-to)764-771
Number of pages8
JournalBJU International
Volume115
Issue number5
DOIs
Publication statusPublished - May 1 2015

Keywords

  • abiraterone acetate
  • castration-resistant prostate cancer
  • compassionate programme
  • pre-treated patients
  • safety

ASJC Scopus subject areas

  • Urology
  • Medicine(all)

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    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, A. P., ... Galligioni, E. (2015). Safety and clinical outcomes of patients treated with abiraterone acetate after docetaxel: Results of the Italian Named Patient Programme. BJU International, 115(5), 764-771. https://doi.org/10.1111/bju.12857