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Volume 65, Issue 5, Pages 875-883 (May 2014)
Efficacy and Safety of Abiraterone Acetate in an Elderly Patient Subgroup (Aged 75 and Older) with Metastatic Castration-resistant Prostate Cancer After Docetaxel-based Chemotherapy Peter F.A. Mulders, Arturo Molina, Michael Marberger, Fred Saad, Celestia S. Higano, Kim N. Chi, Jinhui Li, Thian Kheoh, Christopher M. Haqq, Karim Fizazi European Urology Volume 65, Issue 5, Pages (May 2014) DOI: /j.eururo Copyright © Terms and Conditions
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Fig. 1 Study design. BID=twice daily; HR=hazard ratio; ITT=intention to treat; mCRPC=metastatic castration-resistant prostate cancer; OS=overall survival; PSA=prostate-specific antigen; rPFS=radiographic progression-free survival; TTPP=time to PSA progression. * Patients treated with previous ketoconazole or more than two prior chemotherapy regimens were excluded. OS was defined as time from randomisation to death from any cause; TTPP was defined as a 25% increase over the nadir PSA value, as defined by the PSA Working Group criteria [34]; PSA response was defined as the proportion of patients achieving ≥50% decrease in PSA from pretreatment baseline PSA value confirmed after ≥4 wk; rPFS was determined based on imaging evaluation according to modified Response Evaluation Criteria in Solid Tumours or by bone scan; baseline lymph node size must be ≥2.0cm to be considered a target lesion; progression on bone scans with two or more new lesions not consistent with tumour flare, confirmed on a second scan ≥6 wk later that shows one additional new lesion or more. European Urology , DOI: ( /j.eururo ) Copyright © Terms and Conditions
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Fig. 2 Patient disposition. Safety population includes all patients who were randomised in the study and received study medication. AA=abiraterone acetate; P=prednisone; PL=placebo. * As of September 20, 2010. European Urology , DOI: ( /j.eururo ) Copyright © Terms and Conditions
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Fig. 3 Primary and secondary end points. (A) Overall survival by age group; (B) time to prostate-specific antigen (PSA) progression by age group; (C) radiographic progression-free survival by age group. CI=confidence interval; HR=hazard ratio. European Urology , DOI: ( /j.eururo ) Copyright © Terms and Conditions
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