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DI-007 Efficacy study of abiraterone in metastatic castration-resistant prostate cancer after docetaxel
  1. MA Arias Moya,
  2. E Castillo Bazán,
  3. FJ Bécares Martínez,
  4. EV Tortajada Esteban,
  5. M Bonilla Porras,
  6. M Hernández Segurado
  1. Hospital Universitario Fundación Jimenez Diaz, Pharmacy, Madrid, Spain

Abstract

Background Abiraterone was established in a randomised placebo-controlled multicentre phase 3 clinical study for patients who had received prior docetaxel (n = 1195). The median overall survival (OS) was 14.8 vs.10.9 months for abiraterone and placebo, respectively. The median progression-free survival (PFS) was 5.6 months vs. 3.6 months.

Purpose To compare the OS and PFS characteristics of patients who received abiraterone in metastatic castration-resistant prostate cancer (mCRPC) after docetaxel in our hospital with those of patients in the phase 3 clinical study (CS).

Materials and methods Retrospective observational study, including all patients who received abiraterone from marketing to April 2013. Data collected: ECOG performance status, haematological, hepatic, renal and heart function before treatment, time to progression with docetaxel, PFS and OS.

Results We investigated 6 patients.

  • Time to progression with docetaxel was less than six months in all patients.

  • 100% of patients had ECOG ≤2.

  • Hepatic function was correct in all patients

  • Only one had poor renal and haematological function before treatment, with GFR = 39 ml/min and haemoglobin < 9.

  • Heart function was only studied in four patients who had FEVI > 50%.

In April 2013, four patients had died and one patient had stopped treatment after progression.

  • The median OS was 1.9 months (n = 4).

  • The median PFS was 2.9 months (n = 5).

Another patient is still being treated since March 2012.

Five patients met the inclusion and exclusion criteria of CS (except serum testosterone levels that could not be verified due to the lack of analytical data). The patient who did not meet the CS exclusion criteria had brain metastasis, his OS and PFS was 20 days.

Conclusions Although most of the patients met the inclusion criteria, OS and PFS results were much lower than those of the CS.

Since February 2013 it has been mandatory in our hospital that only patients who meet the CS inclusion and exclusion criteria begin treatment.

No conflict of interest.

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