556 Abiraterone acetate improves overall survival in chemotherapy-naïve metastatic castration-resistant prostate cancer (mCRPC): Impact of crossover and baseline prognostic factors in the COU-AA-302 final analysis

2015 ◽  
Vol 14 (2) ◽  
pp. e556-e556a
Author(s):  
P.F.A. Mulders ◽  
M.R. Smith ◽  
K. Fizazi ◽  
F. Saad ◽  
C.N. Sternberg ◽  
...  

Medicine ◽  
2016 ◽  
Vol 95 (31) ◽  
pp. e4308 ◽  
Author(s):  
Jacob Farnebo ◽  
Agnes Wadelius ◽  
Per Sandström ◽  
Sten Nilsson ◽  
Hans Jacobsson ◽  
...  






2018 ◽  
Vol 17 (14) ◽  
pp. e2865
Author(s):  
C. Melo Alvim Moreira ◽  
A. Mansinho ◽  
R. Paiva ◽  
R. Brás ◽  
P. Semedo ◽  
...  


2012 ◽  
Vol 30 (15_suppl) ◽  
pp. e15195-e15195
Author(s):  
Carsten Henning Ohlmann ◽  
Michael Stöckle ◽  
David A. Pfister ◽  
Axel Heidenreich ◽  
Axel S. Merseburger ◽  
...  

e15195 Background: Abiraterone acetate (AA) plus prednisone (P) has demonstrated an improved survival of patients with castration-resistant prostate cancer (CRPC) compared to placebo plus P in a large phase III trial. In Germany, patients were able to receive AA within a compassionate-use program (CUP). Here, we report the first results of the program. Methods: Patients were eligible for the CUP if they progressed on or after at least one cytotoxic chemotherapy regimens. For CUP entry, patients were considered to have disease progression if they had radiographic evidence of disease progression in soft tissue or bone with or without PSA-progression and ongoing androgen deprivation. Patients received AA 1000mg daily plus prednisone 5mg BID until progression of disease or unacceptable toxicity. Results: Between 02-05/2011, 398 patients were registered for the CUP in Germany. Data from 191/350 (47.9%) of the patients treated at 10 different sites were available for evaluation of efficacy. Median age was 70.72yrs (52.35-87.61) and patients received a median of 1 (1-4) chemotherapy lines prior to CUP entry. Median PSA at baseline was 220.5 ng/ml (0.47-4245); 168 (88%) of patients presented with bone metastasis. With regard to efficacy, 64/191 (33.5%) of the patients showed an unconfirmed PSA-response ≥50%. At a median follow-up of 5.3 months, 51/191 (26.7%) patients had died, resulting in a median PSA-progression free and overall survival of 8.3 and 10.61 months, respectively. In a subset of patients (71/191, 37.2%) data regarding objective response was available with 25/71 (35.2%) achieving an objective response. Data from 114 pts. revealed fatigue (20.3%), hot flushes (15.8%), edema (10.6%), elevated liver enzymes (8.0%) and asthenia (7.9%) being the most frequent toxicities (any grade). Conclusions: Treatment of CRPC patients with AA outside controlled clinical trials leads to considerable PSA- and objective response rates with a favourable toxicity profile, comparable to the results from COU-AA-301 registration trial. Due to the short median follow-up, conclusions regarding PSA-progression free and overall survival may not be drawn.



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