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abiraterone post docetaxel

Charles Van Praet, Sylvie Rottey, Fransien Van Hende, Gino Pelgrims, Wim Demey, Filip Van Aelst, Wim Wynendaele, Thierry Gil, Peter Schatteman, Bertrand Filleul, Denis Schallier, Jean-Pascal Machiels, Dirk Schrijvers, Els Everaert, Lionel D'Hondt, Patrick Werbrouck, Joanna Vermeij, Jeroen Mebis, Marylene Clausse, Marika Rasschaert, Joanna Van Erps, Jolanda Verheezen, Jan Van Haverbeke, Jean-Charles Goeminne, Nicolaas Lumen
BACKGROUND: Abiraterone acetate (AA) increases overall survival (OS) in patients with metastatic castration-resistant prostate cancer (mCRPC) previously treated with docetaxel. However, survival time varies substantially between individuals. Our goal was to identify prognostic factors that better estimate OS. MATERIALS AND METHODS: This is a retrospective multicentric analysis of 368 patients with mCRPC starting AA with prednisone after docetaxel. Cox proportional hazards statistics were applied...
February 1, 2017: Clinical Genitourinary Cancer
D Keizman, M O Fosboel, H Reichegger, A Peer, E Rosenbaum, M-C Desax, V Neiman, P M Petersen, J Mueller, R Cathomas, M Gottfried, H Dresler, D Sarid, W Mermershtain, K Rouvinov, J Mortensen, S Gillessen, G Daugaard, A Omlin
BACKGROUND: The imaging response to radium-223 therapy is at present poorly described. We aimed to describe the imaging response to radium-223 treatment. METHODS: We retrospectively evaluated the computed tomography (CT) and bone scintigraphy response of metastatic castration-resistant prostate cancer (CRPC) patients treated with radium-223, in eight centers in three countries. RESULTS: A total of 130 patients were included, the majority (n=84, 65%) received radium-223 post docetaxel...
February 28, 2017: Prostate Cancer and Prostatic Diseases
Akhil Chopra, Mina Georgieva, Gilberto Lopes, Chong Ming Yeo, Benjamin Haaland
BACKGROUND: To perform a comparative effectiveness analyses between enzalutamide and abiraterone acetate in both the pre-docetaxel and post-docetaxel settings based on published phase III randomized trials. METHODS: The primary measure of efficacy was the posterior probability that enzalutamide outperforms abiraterone acetate (AA) with prednisone in terms of overall survival (OS) on average. Indirect meta-estimates were generated from four randomized studies in the context of a Bayesian hierarchical model with study-specific efficacy estimates meta-analyzed on the log scale...
May 2017: Prostate
Anil Kapoor, Christopher Wu, Bobby Shayegan, Adrian P Rybak
Docetaxel-based chemotherapy has been the standard of care for metastatic castration-resistant prostate cancer (mCRPC) since 2004. Over the past few years, there has been a significant paradigm shift in the treatment landscape of this disease. A deeper understanding of prostate cancer biology, along with the development of novel agents has created hope towards treating chemotherapy-naïve and resistant disease. Following the implementation of docetaxel as the first-line therapy for mCRPC, five novel therapies have demonstrated survival benefit in mCRPC...
November 2016: Canadian Urological Association Journal, Journal de L'Association des Urologues du Canada
Rana R McKay, Lillian Werner, Matthew Fiorillo, Jennifer Roberts, Elisabeth I Heath, Glenn J Bubley, Robert Bruce Montgomery, Mary-Ellen Taplin
BACKGROUND: Galeterone is a multi-targeted agent with activity as a CYP17 inhibitor, androgen receptor antagonist, and also causes androgen receptor degradation. It has shown meaningful anti-tumor activity with a well-tolerated safety profile in patients with castration-resistant prostate cancer (CRPC) in phase I and II studies; however, the efficacy of currently approved CRPC therapies after treatment with galeterone is unknown. In this study, we evaluate prostate specific antigen (PSA) response of non-protocol therapies following galeterone in a subset of patients treated on the Androgen Receptor Modulation Optimized for Response (ARMOR) 2 study...
October 27, 2016: Clinical Genitourinary Cancer
Cristian Lolli, Orazio Caffo, Emanuela Scarpi, Michele Aieta, Vincenza Conteduca, Francesca Maines, Emanuela Bianchi, Francesco Massari, Antonello Veccia, Vincenzo E Chiuri, Gaetano Facchini, Ugo De Giorgi
Background: A systemic immune-inflammation index (SII) based on neutrophil (N), lymphocyte (L), and platelet (P) counts has shown a prognostic impact in several solid tumors. The aim of this study is to evaluate the prognostic role of SII in metastatic castration-resistant prostate cancer (mCRPC) patients treated with abiraterone post docetaxel. Patients and Methods: We retrospectively reviewed consecutive mCRPC patients treated with abiraterone after docetaxel in our Institutions. X-tile 3.6.1 software, cut-off values of SII, neutrophil-to-lymphocyte ratio (NLR) defined as N/L and platelets-to-lymphocyte ratio (PLR) as P/L...
2016: Frontiers in Pharmacology
Benjamin Kearns, Abdullah Pandor, Matt Stevenson, Jean Hamilton, Duncan Chambers, Mark Clowes, John Graham, M Satish Kumar
As part of its single technology appraisal (STA) process, the National Institute for Health and Care Excellence (NICE) invited the company that manufactures cabazitaxel (Jevtana(®), Sanofi, UK) to submit evidence for the clinical and cost effectiveness of cabazitaxel for treatment of patients with metastatic hormone-relapsed prostate cancer (mHRPC) previously treated with a docetaxel-containing regimen. The School of Health and Related Research Technology Appraisal Group at the University of Sheffield was commissioned to act as the independent Evidence Review Group (ERG)...
April 2017: PharmacoEconomics
Yoko Yamada, Nobuaki Matsubara, Ken-Ichi Tabata, Takefumi Satoh, Naoto Kamiya, Hiroyoshi Suzuki, Takashi Kawahara, Hiroji Uemura, Akihiro Yano, Satoru Kawakami
BACKGROUND: Both abiraterone acetate (AA) and enzalutamide are promising agents for patients with pre- and post-chemotherapy metastatic castration-resistant prostate cancer (mCRPC). Several retrospective analysis suggested clinical cross-resistance between these agents in patients previously treated with docetaxel. However, data on the antitumor activity of AA as a second androgen receptor-targeting new agent after the failure of enzalutamide in chemotherapy-naive mCRPC patients is unavailable...
October 18, 2016: BMC Research Notes
Chad R Ritch, Michael S Cookson
Docetaxel based chemotherapy showed survival benefit and emerged as the mainstay of treatment for castration resistant prostate cancer (CRPC) in 2004. However, therapeutic options have expanded rapidly since 2011. The spectrum of new agents is broad and includes drugs that target the androgen axis (enzalutamide, abiraterone), immunotherapy (sipuleucel-T), bone seeking radionuclides (radium-223), and second line chemotherapy (cabazitaxel). In addition, new agents have been developed to reduce skeletal related events (denosumab)...
October 17, 2016: BMJ: British Medical Journal
Che-Kai Tsao, John Sfakianos, Bobby Liaw, Kiev Gimpel-Tetra, Margaret Kemeny, Linda Bulone, Mohammad Shahin, William Kyu Oh, Matthew David Galsky
LESSONS LEARNED: The safety and activity findings of abiraterone acetate plus prednisone treatment in black men with mCRPC were similar to results from previously conducted studies with largely white populations.Poor trial accrual continues to be a challenge in black men with mCRPC and further efforts are needed to address such underrepresentation. BACKGROUND: Self-identified black men have higher incidence and mortality from prostate cancer in the United States compared with white men but are dramatically underrepresented in clinical trials exploring novel therapies for metastatic castration-resistant prostate cancer (mCRPC)...
December 2016: Oncologist
G Sonpavde, G R Pond, A J Templeton, E D Kwon, J S De Bono
BACKGROUND: Despite palliative benefits and PSA responses, the objective clinical impact of daily oral prednisone (P) for metastatic castration-resistant prostate cancer (mCRPC) is unknown. We performed a pooled analysis of control arms of randomized trials that either did or did not administer single-agent P to evaluate its impact on overall survival (OS) and toxicities. METHODS: Individual patient data from control arms of randomized trials of men with mCRPC who received placebo or P+placebo post docetaxel were eligible for analysis...
September 27, 2016: Prostate Cancer and Prostatic Diseases
Johann S de Bono, Matthew R Smith, Fred Saad, Dana E Rathkopf, Peter F A Mulders, Eric J Small, Neal D Shore, Karim Fizazi, Peter De Porre, Thian Kheoh, Jinhui Li, Mary B Todd, Charles J Ryan, Thomas W Flaig
BACKGROUND: Treatment patterns for metastatic castration-resistant prostate cancer (mCRPC) have changed substantially in the last few years. In trial COU-AA-302 (chemotherapy-naïve men with mCRPC), abiraterone acetate plus prednisone (AA) significantly improved radiographic progression-free survival and overall survival (OS) when compared to placebo plus prednisone (P). OBJECTIVE: This post hoc analysis investigated clinical responses to docetaxel as first subsequent therapy (FST) among patients who progressed following protocol-specified treatment with AA, and characterized subsequent treatment patterns among older (≥75 yr) and younger (<75 yr) patient subgroups...
July 8, 2016: European Urology
Matthew Smith, Johann De Bono, Cora Sternberg, Sylvestre Le Moulec, Stéphane Oudard, Ugo De Giorgi, Michael Krainer, Andries Bergman, Wolfgang Hoelzer, Ronald De Wit, Martin Bögemann, Fred Saad, Giorgio Cruciani, Antoine Thiery-Vuillemin, Susan Feyerabend, Kurt Miller, Nadine Houédé, Syed Hussain, Elaine Lam, Jonathan Polikoff, Arnulf Stenzl, Paul Mainwaring, David Ramies, Colin Hessel, Aaron Weitzman, Karim Fizazi
PURPOSE: Cabozantinib is an inhibitor of kinases, including MET and vascular endothelial growth factor receptors, and has shown activity in men with previously treated metastatic castration-resistant prostate cancer (mCRPC). This blinded phase III trial compared cabozantinib with prednisone in patients with mCRPC. PATIENTS AND METHODS: Men with progressive mCRPC after docetaxel and abiraterone and/or enzalutamide were randomly assigned at a two-to-one ratio to cabozantinib 60 mg once per day or prednisone 5 mg twice per day...
September 1, 2016: Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology
Gaetano Facchini, Orazio Caffo, Cinzia Ortega, Carmine D'Aniello, Marilena Di Napoli, Sabrina C Cecere, Chiara Della Pepa, Anna Crispo, Francesca Maines, Fiorella Ruatta, Gelsomina Iovane, Salvatore Pisconti, Maurizio Montella, Massimiliano Berretta, Sandro Pignata, Carla Cavaliere
BACKGROUND: Abiraterone Acetate (AA) is approved for the treatment of mCRPC after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated and for treatment of mCRPC progressed during or after docetaxel-based chemotherapy regimen. The aim of this study is to evaluate the role of early PSA decline for detection of therapy success or failure in mCRPC patients treated with AA in post chemotherapy setting. PATIENTS AND METHODS: We retrospectively evaluated 87 patients with mCRPC treated with AA...
2016: Frontiers in Pharmacology
Elena Verzoni, Ugo De Giorgi, Lisa Derosa, Orazio Caffo, Francesco Boccardo, Gaetano Facchini, Luca Porcu, Fabio De Vincenzo, Alberto Zaniboni, Vincenzo Emanuele Chiuri, Lucia Fratino, Daniele Santini, Vincenzo Adamo, Rocco De Vivo, Angelo Dinota, Caterina Messina, Riccardo Ricotta, Claudia Caserta, Claudio Scavelli, Marina Susi, Alfredo Tartarone, Giuseppe Surace, Alessandra Mosca, Michele Bruno, Sandro Barni, Paolo Grassi, Giuseppe Procopio
We aimed to identify clinical predictors of long-term response to abiraterone (defined as >12 months drug exposure) in a retrospective cohort of metastatic castration-resistant prostate cancer patients treated in post-docetaxel setting at 24 Italian centers. The Cox proportional hazards model was used to analyze the association between clinical features and the duration of drug exposure. Results were expressed as hazard ratios (HR) with associated 95% confidence intervals (CI). A total of 143 patients met the inclusion criteria...
June 28, 2016: Oncotarget
Fred Saad, Eric Winquist, Stacey Hubay, Scott Berry, Hazem Assi, Eric Levesque, Nathalie Aucoin, Piotr Czaykowski, Jean-Baptiste Lattouf, Karine Alloul, John Stewart, Srikala S Sridhar
INTRODUCTION: In the TROPIC study, cabazitaxel improved overall survival in abiraterone-naïve metastatic castration-resistant prostate cancer (mCRPC) patients post-docetaxel. To evaluate cabazitaxel in routine clinical practice, an international, single-arm trial was conducted. Efficacy, safety, and quality of life (QoL) data were collected from Canadian patients enrolled. Overall survival and progression-free survival were not collected as part of this study. Importantly, prior abiraterone use was obtained and its impact on clinical parameters was examined...
March 2016: Canadian Urological Association Journal, Journal de L'Association des Urologues du Canada
Yinghao Sun, Qing Zou, Zhongquan Sun, Changling Li, Chuanjun Du, Zhiwen Chen, Yuxi Shan, Yiran Huang, Jie Jin, Zhang Qun Ye, Liping Xie, Guowen Lin, Yi Feng, Peter De Porre, Weiping Liu, Dingwei Ye
OBJECTIVES: To evaluate the efficacy and safety of abiraterone acetate-prednisone versus placebo-prednisone in Asian metastatic castration-resistant prostate cancer patients who have failed docetaxel-based chemotherapy. METHODS: In this double-blind, phase 3 study from China, 214 patients were randomized (2:1) to abiraterone acetate 1000 mg once daily plus prednisone 5 mg twice daily and placebo plus prednisone 5 mg twice daily in 28-day treatment cycles. RESULTS: Abiraterone acetate-prednisone treatment significantly decreased prostate-specific antigen progression risk by 49%, with longer median time to prostate-specific antigen progression of 5...
May 2016: International Journal of Urology: Official Journal of the Japanese Urological Association
Zafeiris Zafeiriou, Anuradha Jayaram, Adam Sharp, Johann S de Bono
In recent years, the therapeutic options for treating men with metastatic castration-resistant prostate cancer have increased substantially. The hormonal treatments abiraterone acetate and enzalutamide, the chemotherapeutics docetaxel and cabazitaxel, the radiopharmaceutical alpharadin and the immunotherapeutic Sipuleucel-T have entered the field. Additionally, corticosteroids, which are used extensively, have documented activity but no documented survival benefit. Physicians treating patients with metastatic prostate cancer immediately after castration resistance develops currently have at least four different options to choose from for the first treatment...
March 2016: Drugs
Charles Van Praet, Sylvie Rottey, Fransien Van Hende, Gino Pelgrims, Wim Demey, Filip Van Aelst, Wim Wynendaele, Thierry Gil, Peter Schatteman, Bertrand Filleul, Dennis Schallier, Jean-Pascal Machiels, Dirk Schrijvers, Els Everaert, Lionel D'Hondt, Patrick Werbrouck, Joanna Vermeij, Jeroen Mebis, Marylene Clausse, Marika Rasschaert, Joanna Van Erps, Jolanda Verheezen, Jan Van Haverbeke, Jean-Charles Goeminne, Nicolaas Lumen
BACKGROUND: Abiraterone acetate (AA) is licensed for treating metastatic castration-resistant prostate cancer (mCRPC). Real-world data on oncological outcome after AA are scarce. The current study assesses efficacy and safety of AA in mCRPC patients previously treated with docetaxel who started treatment during the Belgian compassionate use program (January 2011-July 2012). PATIENTS AND METHODS: Records from 368 patients with mCRPC from 23 different Belgian hospitals who started AA 1000mg per day with 10mg prednisone or equivalent were retrospectively reviewed (September 2013-December 2014)...
June 2016: Urologic Oncology
K N Chi, T Kheoh, C J Ryan, A Molina, J Bellmunt, N J Vogelzang, D E Rathkopf, K Fizazi, P W Kantoff, J Li, A A Azad, B J Eigl, D Y C Heng, A M Joshua, J S de Bono, H I Scher
BACKGROUND: Few prognostic models for overall survival (OS) are available for patients with metastatic castration-resistant prostate cancer (mCRPC) treated with recently approved agents. We developed a prognostic index model using readily available clinical and laboratory factors from a phase III trial of abiraterone acetate (hereafter abiraterone) in combination with prednisone in post-docetaxel mCRPC. PATIENTS AND METHODS: Baseline data were available from 762 patients treated with abiraterone-prednisone...
March 2016: Annals of Oncology: Official Journal of the European Society for Medical Oncology
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