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Real-world and abiraterone

Alexander Liede, Sally Wade, Jan Lethen, Rohini K Hernandez, Douglas Warner, Amy P Abernethy, Antonio Finelli
PURPOSE: This observational study of oncologic clinical practices was designed to describe real-world patterns of use of emerging therapies (abiraterone acetate, cabazitaxel, enzalutamide, radium-223, sipuleucel-T) in patients with castration-resistant prostate cancer and to characterize their concomitant use with denosumab or zoledronic acid. METHODS: A retrospective cohort study was conducted using a database of electronic health records from oncology practices across the United States...
January 24, 2018: Clinical Therapeutics
Alessia Cavo, Alessandra Rubagotti, Elisa Zanardi, Chiara Fabbroni, Linda Zinoli, Antonio Di Meglio, Eleonora Arboscello, Andrea Bellodi, Paolo Spallarossa, Carlo Cattrini, Carlo Messina, Francesco Boccardo
Background: The aim of this work was to to evaluate the incidence and risk factors of adverse events (AEs), focusing on cardiovascular events (CVEs) and hypokalemia, in patients treated with abiraterone acetate (AA) and prednisone (PDN) outside clinical trials, and their association with survival outcomes. Methods: This was a retrospective cohort study of 105 patients treated from 2011 to 2016. Incidence of AEs was descriptively summarized in the whole cohort and by subgroup (pre- versus post-docetaxel)...
2018: Therapeutic Advances in Medical Oncology
Hideaki Miyake, Takayuki Sugiyama, Ryota Aki, Yuto Matsushita, Keita Tamura, Daisuke Motoyama, Toshiki Ito, Atsushi Otsuka
BACKGROUND: The objective of the present study was to assess the oncologic outcomes of patients receiving second-line therapy against metastatic castration-resistant prostate cancer (mCRPC). PATIENTS AND METHODS: The present study included 222 consecutive mCRPC patients with progression during initial androgen receptor-axis-targeted agent (ARATA) therapy with either abiraterone acetate (AA) or enzalutamide (Enz). Of these 222 patients, 108 subsequently received an alternative ARATA (AA-to-Enz, n = 49; Enz-to-AA, n = 59) and 114 received docetaxel (DTX; AA-to-DTX, n = 54; Enz-to-DTX, n = 60)...
December 6, 2017: Clinical Genitourinary Cancer
Ajay S Behl, Lorie A Ellis, Dominic Pilon, Yongling Xiao, Patrick Lefebvre
BACKGROUND: The efficacy of and overall survival associated with metastatic castration-resistant prostate cancer (CRPC) treatments rely on patients' consistent adherence to the recommended dosage regimens. OBJECTIVES: To evaluate treatment patterns and patient adherence to abiraterone acetate or enzalutamide therapy in real-world practice, and to examine the factors that may be associated with medication dose reduction in patients with metastatic CRPC. METHODS: Retrospective analyses were conducted using the Truven Health MarketScan research databases among patients with metastatic CRPC who initiated treatment with abiraterone acetate or enzalutamide between October 1, 2012, and December 31, 2014 (index date)...
September 2017: American Health & Drug Benefits
William K Oh, Raymond Miao, Francis Vekeman, Jennifer Sung, Wendy Y Cheng, Marjolaine Gauthier-Loiselle, Ravinder Dhawan, Mei Sheng Duh
It is unclear how treatment sequencing for metastatic castration-resistant prostate cancer (mCRPC) affects real-world patient outcomes. We assessed treatment sequences, patient characteristics and overall survival (OS) in post-docetaxel mCRPC patients. mCRPC patients receiving second-line cabazitaxel or androgen receptor-targeted therapy (ART; abiraterone/enzalutamide) post-docetaxel were identified using electronic medical records. OS was assessed from second-line therapy initiation using Cox regressions adjusting for: metastases; prostate-specific antigen (PSA); hemoglobin; alkaline phosphatase (ALP); albumin; second-line therapy initiation year...
August 10, 2017: Medical Oncology
Dominic Pilon, Ajay S Behl, Lorie A Ellis, Marie-Noëlle Robitaille, Patrick Lefebvre, Nancy A Dawson
BACKGROUND: Central nervous system (CNS) events are frequently reported among patients with advanced prostate cancer as a consequence of the treatments used in this patient population. OBJECTIVE: To assess the incidence of CNS events in patients with advanced prostate cancer who initiated treatment with abiraterone acetate, bicalutamide, enzalutamide, or chemotherapy. METHODS: The Truven Health MarketScan Research databases were used to retrospectively identify patients with prostate cancer who initiated treatment with abiraterone acetate, enzalutamide, bicalutamide, or chemotherapy after September 1, 2012 (ie, the index date)...
May 2017: American Health & Drug Benefits
Joice Rocha, Armen G Aprikian, Marie Vanhuyse, Fabio L Cury, Jason Hu, Noémie Prévost, Alice Dragomir
BACKGROUND: Abiraterone acetate was introduced in Quebec in 2012 for the treatment of metastatic castration-resistant prostate cancer (mCRPC) in patients who had received chemotherapy with docetaxel. This study describes abiraterone use in the early postapproval period and its clinical effectiveness in Quebec, for both patients who had received docetaxel chemotherapy and those who could not receive docetaxel therapy owing to medical reasons. METHODS: A retrospective cohort study was conducted using Quebec public health care administrative databases...
January 2017: CMAJ Open
S Salem, M Komisarenko, N Timilshina, L Martin, R Grewal, S Alibhai, A Finelli
AIMS: Treatments and disease burden of metastatic castration-resistant prostate cancer (mCRPC) considerably affect a patient's quality of life. However, patient-reported symptom burden data are still largely insufficient. This study sought to compare the self-reported symptom burden of men with chemotherapy-naive (CN) mCRPC treated with abiraterone acetate (AA) or enzalutamide (EZ) in routine clinical practice. MATERIALS AND METHODS: Between 2011 and 2015, 189 CN-mCRPC patients who had received AA (n = 76) or EZ (n = 113) at the Princess Margaret Cancer Centre were included...
September 2017: Clinical Oncology: a Journal of the Royal College of Radiologists
David Gill, David Gaston, Erin Bailey, Andrew Hahn, Sumati Gupta, Julia Batten, Anitha Alex, Kenneth Boucher, David Stenehjem, Neeraj Agarwal
BACKGROUND: Abiraterone acetate has been approved for metastatic castration-resistant prostate cancer (mCRPC). Coadministration with prednisone has been recommended to prevent the toxicity from secondary mineralocorticoid excess, such as hypertension, hypokalemia, and edema. However, the use of prednisone is often not desired by patients because of the potential for detrimental effects of long-term therapy with corticosteroids, especially in those with comorbidities such as diabetes or who have received previous immunotherapeutic agents...
August 2017: Clinical Genitourinary Cancer
Elisabetta Malangone-Monaco, Kathleen Foley, Helen Varker, Kathleen L Wilson, Scott McKenzie, Lorie Ellis
PURPOSE: The purpose of this study was to examine, using a US electronic medical records (EMR) database, the clinical characteristics and real-world treatment sequences in men with advanced prostate cancer who initiated treatment with abiraterone acetate or enzalutamide. METHODS: This retrospective, observational study evaluated adult male patients with a diagnosis of prostate cancer (International Classification of Diseases, Ninth Revision, Clinical Modification code 185) in the EMR database between July 1, 2011, and March 31, 2014, who had initiated first-line treatment with abiraterone acetate or enzalutamide between September 1, 2012, and March 31, 2014...
August 2016: Clinical Therapeutics
Mallika Dhawan, Charles J Ryan
Abiraterone and enzalutamide are in widespread clinical use because of their favorable safety and efficacy. Nonetheless, even with newer agents, resistance develops overtime. In this review, we discuss mechanisms of resistance to these newer agents as well as novel therapeutic agents. We also review the literature to help clinicians decide which agent to begin with and when to stop or switch androgen receptor agents.
August 2016: Urologic Oncology
Hideaki Miyake, Takuto Hara, Tomoaki Terakawa, Seiichiro Ozono, Masato Fujisawa
BACKGROUND: The objective of the present study was to comprehensively compare the clinical outcomes between abiraterone acetate (AA) and enzalutamide (Enz) in Japanese patients with docetaxel-naive metastatic castration-resistant prostate cancer (mCRPC). PATIENTS AND METHODS: The present study retrospectively included 280 consecutive mCRPC patients, consisting of 113 and 167 who had received AA and Enz, respectively, without previous treatment with docetaxel. RESULTS: Of the several baseline characteristics examined, some parameters, including performance status (PS), prostate-specific antigen (PSA) value, and incidence of lymph node metastasis, significantly favored the Enz over the AA group...
April 2017: Clinical Genitourinary Cancer
Edoardo Francini, Christopher J Sweeney
UNLABELLED: For >6 yr, docetaxel with prednisone was the only treatment with survival benefits for metastatic castration-resistant prostate cancer (mCRPC). More recently, in clinical practice, abiraterone acetate has been commonly administered prior to docetaxel for the treatment of mCRPC. Our study aimed to review the activity of docetaxel after prior abiraterone. To this end, we analyzed all retrospective reports in the literature describing the overall survival (OS) of mCRPC patients treated with docetaxel after previous abiraterone...
September 2016: European Urology
Johanna Svensson, Emelie Andersson, Ulf Persson, Thomas Edekling, Anna Ovanfors, Göran Ahlgren
OBJECTIVE: In a randomized clinical trial (COU-AA-301), abiraterone acetate (Zytiga(®)) was shown to be superior to prednisone in the treatment of metastatic castration-resistant prostate cancer (mCRPC). However, the value of abiraterone treatment for patients with mCRPC in clinical practice in Sweden is not known. The aim of this study was to compare the outcomes and treatment patterns of abiraterone treatment in a Swedish observational study to those of the pivotal clinical trial, thereby discussing the external validity of the postchemotherapy clinical trial from a Swedish perspective...
August 2016: Scandinavian Journal of Urology
Darren M C Poon, Kuen Chan, S H Lee, T W Chan, Henry Sze, Eric K C Lee, Daisy Lam, Michelle F T Chan
BACKGROUND: There is much interest in confirming whether the efficacy of abiraterone acetate (AA) demonstrated within the trial setting is reproducible in routine clinical practice. We report the clinical outcome of metastatic castration-resistant prostate cancer (mCRPC) patients treated with AA in real-life clinical practice. METHODS: The clinical records of mCRPC patients treated with AA from all 6 public oncology centers in Hong Kong between August 2011 and December 2014 were reviewed...
March 22, 2016: BMC Urology
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
Thomas W Flaig, Ravi C Potluri, Yvette Ng, Mary B Todd, Maneesha Mehra
Despite increasing drug treatment options for metastatic castration-resistant prostate cancer (mCRPC) patients, real-world treatment data are lacking. We conducted retrospective analyses of commercial claims and electronic medical record (EMR) databases to understand how treatment patterns for mCRPC have changed in a US-based real-world population. Truven Health Analytics MarketScan(®) (2000-2013) and EMR (2004-2013) databases were used to identify patients with an index prostate cancer diagnosis (ICD-9 codes 185X or 233...
February 2016: Cancer Medicine
Susumu Kunisawa, Chihiro Tange, Kojiro Shimozuma
Previous cost-effectiveness analyses (CEAs) of abiraterone for castration-resistant prostate cancer (CRPC) patients have not shown favorable results for this new drug. These CEAs were generally conducted based on models used in clinical trials, where comparisons were made with patients given placebos. However, details on any other therapies provided to the comparison groups were not analyzed. These additional therapies should be considered when conducting CEAs to ensure better applications to clinical practice and policymaking...
2015: SpringerPlus
L Dearden, P Musingarimi, N Shalet, D Demuth, L Garcia Alvarez, A Muthutantri, A Venerus, R Lasry, M Hankins, T Maher
No abstract text is available yet for this article.
November 2015: Value in Health: the Journal of the International Society for Pharmacoeconomics and Outcomes Research
A D Smith, C Olson, B Lyons, D Tran, D F Blackburn
Metastatic castration-resistant prostate cancer is now commonly treated with abiraterone, an orally administered chronic medication. Although abiraterone has certain advantages over docetaxel-based therapy, patients are now responsible for ensuring optimal adherence to their medication. To our knowledge, adherence to abiraterone in a real-world setting has never been described. The objective of the present study was to measure adherence to abiraterone among the first patients to receive the drug in Saskatchewan...
February 2015: Current Oncology
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