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Abiraterone response time

Silvana Giacinti, Paolo Carlini, Michela Roberto, Maria Bassanelli, Lidia Strigari, Francesco Pavese, Anna M Aschelter, Alessandra Felici, Maurizio Valeriani, Francesco Cognetti, Paolo Marchetti
Abiraterone acetate (AA) demonstrated its efficacy in the treatment of patients with metastatic castration resistance prostate cancer (mCRPC) in predocetaxel and postdocetaxel setting. However, we learn from pivotal studies that forms of primary and acquired resistance to this drug exist. Patient selection becomes so crucial to optimize treatment results. Potential predictive biomarkers have been identified but are not yet validated. In this scenario, clinical features and disease characteristics may still be of value in selecting patients for different treatments...
October 19, 2016: Anti-cancer Drugs
Sushil K Badrising, Vincent van der Noort, Paul Hamberg, Jules L L M Coenen, Maureen J Aarts, Inge M van Oort, Alfons J M van den Eertwegh, Maartje Los, H Pieter van den Berg, Hans Gelderblom, Suzan Vrijaldenhoven, Emile D Kerver, Theo van Voorthuizen, Igle J de Jong, John B Haanen, Andries M Bergman
OBJECTIVE: To evaluate the efficacy of enzalutamide (Enz) as fourth- or fifth-line treatment in men with metastasized castration-resistant prostate cancer (mCRPC), by analyzing a retrospective cohort of heavily pretreated patients. METHODS: We evaluated toxicity, overall survival (OS), progression-free survival (PFS) and time to prostate-specific antigen (PSA) progression data from 47 CRPC patients treated with fourth- or fifth-line Enz. RESULTS: All patients were treated with docetaxel and abiraterone acetate and 42 patients (89%) with cabazitaxel...
August 20, 2016: Oncology
Benjamin L Maughan, Brandon Luber, Rosa Nadal, Emmanuel S Antonarakis
BACKGROUND: There are no validated clinical decision tools to aid optimal treatment selection in men with metastatic castration-resistant prostate cancer (mCRPC). Frequently, abiraterone and enzalutamide are used prior to chemotherapy in mCRPC, given the more favorable safety profiles. However, there is no published data on clinical outcomes regarding best sequencing of these two agents. METHODS: A retrospective analysis of consecutive mCRPC patients treated with enzalutamide and abiraterone at Johns Hopkins was conducted...
August 16, 2016: Prostate
Johan Monbaliu, Martha Gonzalez, Apexa Bernard, James Jiao, Carlo Sensenhauser, Jan Snoeys, Hans Stieltjes, Inneke Wynant, Johan W Smit, Caly Chien
Abiraterone acetate, the prodrug of the cytochrome P450 C17 inhibitor abiraterone, plus prednisone is approved for treatment of metastatic castration-resistant prostate cancer. We explored whether abiraterone interacts with drugs metabolized by CYP2C8, an enzyme responsible for the metabolism of many drugs. Abiraterone acetate and abiraterone and its major metabolites, abiraterone sulfate and abiraterone sulfate N-oxide, inhibited CYP2C8 in human liver microsomes, with IC50 values near or below the peak total concentrations observed in patients with metastatic castration-resistant prostate cancer (IC50 values: 1...
October 2016: Drug Metabolism and Disposition: the Biological Fate of Chemicals
Dimitrios Papazoglou, Luciano Wannesson, Dominik Berthold, Richard Cathomas, Silke Gillessen, Christian Rothermundt, Loretta Hasler, Ralph Winterhalder, Andreas Barth, Walter Mingrone, Catrina Uhlmann Nussbaum, Lukas von Rohr, Philippe von Burg, Mathias Schmid, Jürg Richner, Sylvia Baumann, Reto Kühne, Frank Stenner, Sacha I Rothschild
BACKGROUND: Enzalutamide is a second-generation androgen receptor (AR) inhibitor that binds to and blocks the AR with higher affinity than previously available AR inhibitors. High activity has been proven in patients with metastatic castration-resistant prostate cancer (mCRPC) previously treated with docetaxel and in chemotherapy-naive patients with mCRPC. However, its activity in patients previously treated with other novel agents (for example, abiraterone and/or cabazitaxel), remains controversial...
June 23, 2016: Clinical Genitourinary Cancer
Tilman Todenhöfer, Arun Azad, Craig Stewart, Jian Gao, Bernhard J Eigl, Martin E Gleave, Anthony M Joshua, Peter C Black, Kim N Chi
PURPOSE: The expression of AR-V7 (androgen receptor splice variant) 7 in circulating tumor cells has been associated with resistance to abiraterone and enzalutamide in patients with metastatic castration resistant prostate cancer. We used a sensitive, whole blood reverse transcriptase-polymerase chain reaction assay that does not require circulating tumor cell enrichment to correlate outcomes of abiraterone with whole blood expression of AR-V7 and other prostate cancer associated transcripts...
July 17, 2016: Journal of Urology
Moritz Binder, Ben Y Zhang, David W Hillman, Rhea Kohli, Tanvi Kohli, Adam Lee, Manish Kohli
Treatment with abiraterone acetate and prednisone (AA/P) prolongs survival in metastatic castration-resistant prostate cancer (mCRPC) patients. We evaluated the genetic variation in CYP17A1 as predictive of response to AA/P. A prospective collection of germline DNA prior to AA/P initiation and follow-up of a mCRPC cohort was performed. Five common single-nucleotide polymorphisms (SNPs) in CYP17A1 identified using a haplotype-based tagging algorithm were genotyped. Clinical outcomes included biochemical response and time to biochemical progression on AA/P...
2016: International Journal of Molecular Sciences
David Lorente, David Olmos, Joaquin Mateo, Diletta Bianchini, George Seed, Martin Fleisher, Daniel C Danila, Penny Flohr, Mateus Crespo, Ines Figueiredo, Susana Miranda, Kurt Baeten, Arturo Molina, Thian Kheoh, Robert McCormack, Leon W M M Terstappen, Howard I Scher, Johann S de Bono
BACKGROUND: Treatment response biomarkers are urgently needed for castration-resistant prostate cancer (CRPC). Baseline and post-treatment circulating tumor cell (CTC) counts of ≥5 cells/7.5ml are associated with poor CRPC outcome. OBJECTIVE: To determine the value of a ≥30% CTC decline as a treatment response indicator. DESIGN, SETTING, AND PARTICIPANTS: We identified patients with a baseline CTC count ≥5 cells/7.5ml and evaluable post-treatment CTC counts in two prospective trials...
June 8, 2016: European Urology
Masahiko Nakayama, Hisanori Kobayashi, Tomihiro Takahara, Ryo Oyama, Keiichiro Imanaka, Kazutake Yoshizawa
BACKGROUND: Previous studies have demonstrated an association between prostate-specific antigen (PSA) kinetics and predictive value for treatment outcomes. Abiraterone acetate (AA) is a newly approved cytochrome-P450C17 inhibitor for treatment of metastatic castration-resistant prostate cancer (mCRPC), and few studies have evaluated PSA kinetics using AA so far. Results of a study evaluating PSA kinetics in the beginning of AA and enzalutamide responded chemotherapy-treated patients suggested different trends between the drugs...
2016: BMC Urology
Alan H Bryce, Emmanuel S Antonarakis
Constitutively-active ligand-independent splice variants of the androgen receptor are an adaptive response by prostate cancer cells to escape androgen deprivation therapy and novel androgen receptor-directed treatments. Androgen receptor splice variant 7 is the most common splice variant detected in clinical biospecimens, and emerging data now suggest that the presence of tumoral androgen receptor splice variant 7 might be indicative of primary and acquired resistance to next-generation androgen pathway inhibitors, such as abiraterone and enzalutamide...
August 2016: International Journal of Urology: Official Journal of the Japanese Urological Association
Wei Zhang, Teng-Yun Wu, Qi Chen, Xiao-Lei Shi, Guang-An Xiao, Lin Zhao, Chuan-Liang Xu, Tie Zhou, Ying-Hao Sun
This study was designed to evaluate the efficacy, tolerability, and sequential administration of abiraterone acetate (AA) and enzalutamide (Enz) for metastatic castration-resistant prostate cancer (mCRPC). A literature search was performed with PubMed, Embase, and Web of Science databases to identify relevant studies. Reviewed literature included published phase III trials of AA or Enz in mCRPC and studies regarding their sequential administration. Given the difference in control arms in AA (active comparator) and Enz (true placebo) randomized phase III studies, indirect comparisons between AA and Enz in mCRPC showed no statistically significant difference in overall survival in prechemotherapy and postchemotherapy settings (HR: 0...
May 20, 2016: Asian Journal of Andrology
Jacqueline Bogner, Kourosh Zolghadr, Ian Hickson, Tina Romer, Larisa Yurlova
The androgen receptor (AR) is an important target for drug therapies combating prostate cancer. However, various acquired mutations within the AR sequence often render this receptor resistant to treatment. Ligand-induced interaction between the N- and C-termini of the AR marks the initial step in the AR signaling cascade and can thus serve as an early read-out for analysis of potential antagonists of wt and mutant AR. To measure changes of the N/C interaction in the wt and mutant AR variants upon the addition of inhibitors, we applied our recently developed Fluorescent Two-Hybrid (F2H) assay...
May 9, 2016: Journal of Steroid Biochemistry and Molecular Biology
Jonathan Hung, Andrew R Taylor, George W Divine, Jason M Hafron, Clara Hwang
BACKGROUND: Abiraterone and enzalutamide are 2 novel androgen receptor (AR)-targeting therapies that improve survival in patients with metastatic castration-resistant prostate cancer. The factors that predict abiraterone and enzalutamide response are lacking. The objective of the present study was to determine whether the outcomes from primary androgen deprivation therapy (ADT) could predict the outcomes with subsequent novel AR-targeting therapies. MATERIALS AND METHODS: We identified 80 consecutive patients with metastatic castration-resistant prostate cancer treated with abiraterone or enzalutamide...
March 24, 2016: Clinical Genitourinary Cancer
Neeraj Agarwal, Anitha B Alex, James M Farnham, Shiven Patel, David Gill, Tyler H Buckley, Robert A Stephenson, Lisa Cannon-Albright
PURPOSE: Germline variations in genes involved in androgen biosynthesis and metabolic pathways may predict the response to abiraterone acetate in men with metastatic, castration refractory prostate cancer. The variations may serve as prognostic and predictive biomarkers to allow for more individualized therapy. MATERIALS AND METHODS: We evaluated 832 single nucleotide polymorphisms from the OmniExpress genotyping platform (Illumina®) in the boundaries of 61 candidate genes reported to be involved in the androgen metabolic pathway...
October 2016: Journal of Urology
Alexander W Wyatt, Arun A Azad, Stanislav V Volik, Matti Annala, Kevin Beja, Brian McConeghy, Anne Haegert, Evan W Warner, Fan Mo, Sonal Brahmbhatt, Robert Shukin, Stephane Le Bihan, Martin E Gleave, Matti Nykter, Colin C Collins, Kim N Chi
Importance: The molecular landscape underpinning response to the androgen receptor (AR) antagonist enzalutamide in patients with metastatic castration-resistant prostate cancer (mCRPC) is undefined. Consequently, there is an urgent need for practical biomarkers to guide therapy selection and elucidate resistance. Although tissue biopsies are impractical to perform routinely in the majority of patients with mCRPC, the analysis of plasma cell-free DNA (cfDNA) has recently emerged as a minimally invasive method to explore tumor characteristics...
May 5, 2016: JAMA Oncology
H Bonnefoi, T Grellety, O Tredan, M Saghatchian, F Dalenc, A Mailliez, T L'Haridon, P Cottu, S Abadie-Lacourtoisie, B You, M Mousseau, J Dauba, F Del Piano, I Desmoulins, F Coussy, N Madranges, J Grenier, F C Bidard, C Proudhon, G MacGrogan, C Orsini, M Pulido, A Gonçalves
BACKGROUND: Several expression array studies identified molecular apocrine breast cancer (BC) as a subtype that expresses androgen receptor (AR) but not estrogen receptor α. We carried out a multicentre single-arm phase II trial in women with AR-positive, estrogen, progesterone receptor and HER2-negative (triple-negative) metastatic or inoperable locally advanced BC to assess the efficacy and safety of abiraterone acetate (AA) plus prednisone. PATIENTS AND METHODS: Patients with a metastatic or locally advanced, centrally reviewed, triple-negative and AR-positive (≥10% by immunohistochemistry, IHC) BC were eligible...
May 2016: Annals of Oncology: Official Journal of the European Society for Medical Oncology
B A Teply, B Luber, S R Denmeade, E S Antonarakis
BACKGROUND: Prednisone and other corticosteroids can provide palliation and tumor responses in patients with prostate cancer. The combination of docetaxel and prednisone was the first treatment shown to prolong survival in men with metastatic castration-resistant prostate cancer (mCRPC). Since the approval of docetaxel in 2004, additional treatments are available, including abiraterone, which is also administered with prednisone. Therefore, patients are increasingly likely to have prednisone therapy several times throughout their disease course, and the contribution of prednisone to the efficacy of docetaxel is unknown...
March 2016: Prostate Cancer and Prostatic Diseases
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 Fizazi, T W Flaig, M Stöckle, H I Scher, J S de Bono, D E Rathkopf, C J Ryan, T Kheoh, J Li, M B Todd, T W Griffin, A Molina, C H Ohlmann
BACKGROUND: The usefulness of Gleason score (<8 or ≥8) at initial diagnosis as a predictive marker of response to abiraterone acetate (AA) plus prednisone in patients with metastatic castration-resistant prostate cancer (mCRPC) was explored retrospectively. PATIENTS AND METHODS: Initial diagnosis Gleason score was obtained in 1048 of 1195 (COU-AA-301, post-docetaxel) and 996 of 1088 (COU-AA-302, chemotherapy-naïve) patients treated with AA 1 g plus prednisone 5 mg twice daily by mouth or placebo plus prednisone...
April 2016: Annals of Oncology: Official Journal of the European Society for Medical Oncology
B Meller, F Bremmer, C O Sahlmann, S Hijazi, C Bouter, L Trojan, J Meller, P Thelen
BACKGROUND: Prostate-specific membrane antigen (PSMA) is a promising target for diagnostics and therapy of prostate carcinoma (PCa). Based on the hypothesis that PSMA expression can be modulated by variations in androgen deprivation therapy (ADT), we investigated the binding of a PSMA-directed radiopharmaceutical in vitro in order to get an insight of the interactions between altered premedication and PSMA expression before repetitive PSMA-directed PET/CT for therapy response and targeted therapy implementation...
December 2015: EJNMMI Research
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