ABIRATERONE- A SINGLE-CENTRE EXPERIENCE
Author(s)
Raposo JP1, Barros CT2, Caetano FR3
1Fundação Champalimaud, Lisboa, 11, Portugal, 2Pharmacy Faculty, University of Lisbon, Lisbon, Portugal, 3Fundação Champalimaud, Lisbon, Portugal
OBJECTIVES: Abiraterone is approved for metastatic castration-resistant prostate cancer (mCRPC) in patients who have progressed after a docetaxel regimen and those that were on androgen deprivation therapy and not eligible for chemotherapy. This study aims to contribute with real-world data on Abiraterone overall survival (OS) and PSA response between two groups of patients: exposed and not exposed to previous docetaxel chemotherapy. Furthermore, safety profile was also evaluated in both groups. METHODS: Retrospective cohort chart review study over a 5 year period (January 2013 to January 2018). RESULTS: One hundred and twenty patients were enrolled in the study with a median age of 78 years (range: 48-96). Sixty three patients (52.5%) were not exposed to docetaxel chemotherapy and 47.5% (n=57) were exposed. Comparing the two groups of patients it was observed that those that were not exposed to docetaxel had a significant PSA response rate (63.3% vs 40.0%; p= 0.01). The median overall survival was 29 ± 6.5 [95% CI 16.2-41.8] months for the docetaxel exposed group and 32.5 ± 4.0 [95% CI 24.6-40.4] for the not exposed docetaxel group (log–rank test p value = 0.125). In both groups 80% (n= 96) of patients had documented adverse events, being the most common asthenia 26.7% and peripheral edema 22,5%. CONCLUSIONS: Our study indicates that although not reaching statistical significance, those patients that were not exposed to prior docetaxel chemotherapy had an improved overall survival. It was also observed that the PSA response rate was better indicating improved prognosis. The adverse events were not serious or life-threatening. No new safety signals were identified.
Conference/Value in Health Info
2018-11, ISPOR Europe 2018, Barcelona, Spain
Value in Health, Vol. 21, S3 (October 2018)
Code
PIH13
Topic
Epidemiology & Public Health
Topic Subcategory
Safety & Pharmacoepidemiology
Disease
Reproductive and Sexual Health