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Enzalutamide fatigue

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https://www.readbyqxmd.com/read/27885457/-psma-targeted-radioligand-therapy-in-prostate-cancer
#1
M M Heck, M Retz, R Tauber, K Knorr, C Kratochwil, M Eiber
Radioligand therapy (RLT) directed against prostate-specific membrane antigen (PSMA) enables tumor-specific treatment directed against PSMA-overexpressing prostate cancer cells. Several PSMA ligands such as PSMA-617 or PSMA-I&T have been developed that can be labeled with β‑radiating lutetium-177. These are currently applied in compassionate use programs to treat metastatic castration-resistant prostate cancer (mCRPC). PSMA-directed RLT is currently being offered in several nuclear medicine departments throughout Germany...
November 24, 2016: Der Urologe. Ausg. A
https://www.readbyqxmd.com/read/27544669/enzalutamide-as-a-fourth-or-fifth-line-treatment-option-for-metastatic-castration-resistant-prostate-cancer
#2
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
https://www.readbyqxmd.com/read/27306820/-an-undeniable-case-of-optic-neuropathy-due-to-cabazitaxel
#3
Yusuke Noguchi, Yugo Kawashima, Hiroko Kawara, Masatomo Kaneko, Hiroo Nakauchi, Yoko Tokuyama
Cabazitaxelis a taxane-type antineoplastic agent used for treating prostate cancer. Although typical side effects include neutropenia and fatigue, no studies have investigated eye disorders as a possible side effect, and the details are not clear. Herein, we report our experience of an undeniable case of optic neuropathy caused by cabazitaxel. A 78-year-old man had been diagnosed with prostate cancer (cT3aN1M1b, stage IV) 3 years previously, with a treatment history of bicalutamide, leuprorelin, flutamide, docetaxel, abiraterone, and enzalutamide...
June 2016: Gan to Kagaku Ryoho. Cancer & Chemotherapy
https://www.readbyqxmd.com/read/26858312/phase-ib-study-of-enzalutamide-in-combination-with-docetaxel-in-men-with-metastatic-castration-resistant-prostate-cancer
#4
Michael J Morris, Dana E Rathkopf, William Novotny, Jacqueline A Gibbons, Amy C Peterson, Zakaria Khondker, Taoufik Ouatas, Howard I Scher, Mark T Fleming
PURPOSE: Preclinical evidence suggests that both docetaxel and enzalutamide target androgen receptor translocation and signaling. This phase Ib study assessed the safety, tolerability, and pharmacokinetics of docetaxel when administered with enzalutamide as first-line systemic chemotherapy in men with metastatic castration-resistant prostate cancer (mCRPC). EXPERIMENTAL METHODS: Docetaxel-naïve patients received 21-day cycles of docetaxel (75 mg/m(2)). Enzalutamide (160 mg/day) was administered daily starting on day 2 of cycle 1...
August 1, 2016: Clinical Cancer Research: An Official Journal of the American Association for Cancer Research
https://www.readbyqxmd.com/read/26774508/efficacy-and-safety-of-enzalutamide-versus-bicalutamide-for-patients-with-metastatic-prostate-cancer-terrain-a-randomised-double-blind-phase-2-study
#5
RANDOMIZED CONTROLLED TRIAL
Neal D Shore, Simon Chowdhury, Arnauld Villers, Laurence Klotz, D Robert Siemens, De Phung, Steve van Os, Nahla Hasabou, Fong Wang, Suman Bhattacharya, Axel Heidenreich
BACKGROUND: Enzalutamide is an oral androgen-receptor inhibitor that has been shown to improve survival in two placebo-controlled phase 3 trials, and is approved for patients with metastatic castration-resistant prostate cancer. The objective of the TERRAIN study was to compare the efficacy and safety of enzalutamide with bicalutamide in patients with metastatic castration-resistant prostate cancer. METHODS: TERRAIN was a double-blind, randomised phase 2 study, that recruited asymptomatic or minimally symptomatic men with prostate cancer progression on androgen-deprivation therapy (ADT) from academic, community, and private health-care provision sites across North America and Europe...
February 2016: Lancet Oncology
https://www.readbyqxmd.com/read/26722066/efficacy-and-safety-profile-of-enzalutamide-for-japanese-patients-with-castration-resistant-prostate-cancer
#6
Mutsushi Yamasaki, Takeshi Yuasa, Shinya Yamamoto, Tatsuro Hayashi, Masahiro Ogawa, Mizuaki Sakura, Hitoshi Masuda, Iwao Fukui, Junji Yonese
Enzalutamide is a novel, non-steroidal anti-androgen that was approved for the treatment of patients with castration-resistant prostate cancer (CRPC) in 2014 in Japan. To assess the potency of enzalutamide treatment in Japan, we performed a pilot retrospective study. Among 91 patients who received treatment in our Institution between May 2014 and July 2015, 51 patients with docetaxel-naïve CRPC (56.0%) underwent enzalutamide therapy. The median progression-free survival (PFS) and overall survival (OS) were 10...
January 2016: Anticancer Research
https://www.readbyqxmd.com/read/26510020/dna-repair-defects-and-olaparib-in-metastatic-prostate-cancer
#7
MULTICENTER STUDY
Joaquin Mateo, Suzanne Carreira, Shahneen Sandhu, Susana Miranda, Helen Mossop, Raquel Perez-Lopez, Daniel Nava Rodrigues, Dan Robinson, Aurelius Omlin, Nina Tunariu, Gunther Boysen, Nuria Porta, Penny Flohr, Alexa Gillman, Ines Figueiredo, Claire Paulding, George Seed, Suneil Jain, Christy Ralph, Andrew Protheroe, Syed Hussain, Robert Jones, Tony Elliott, Ursula McGovern, Diletta Bianchini, Jane Goodall, Zafeiris Zafeiriou, Chris T Williamson, Roberta Ferraldeschi, Ruth Riisnaes, Bernardette Ebbs, Gemma Fowler, Desamparados Roda, Wei Yuan, Yi-Mi Wu, Xuhong Cao, Rachel Brough, Helen Pemberton, Roger A'Hern, Amanda Swain, Lakshmi P Kunju, Rosalind Eeles, Gerhardt Attard, Christopher J Lord, Alan Ashworth, Mark A Rubin, Karen E Knudsen, Felix Y Feng, Arul M Chinnaiyan, Emma Hall, Johann S de Bono
BACKGROUND: Prostate cancer is a heterogeneous disease, but current treatments are not based on molecular stratification. We hypothesized that metastatic, castration-resistant prostate cancers with DNA-repair defects would respond to poly(adenosine diphosphate [ADP]-ribose) polymerase (PARP) inhibition with olaparib. METHODS: We conducted a phase 2 trial in which patients with metastatic, castration-resistant prostate cancer were treated with olaparib tablets at a dose of 400 mg twice a day...
October 29, 2015: New England Journal of Medicine
https://www.readbyqxmd.com/read/26468445/is-there-still-a-place-for-docetaxel-rechallenge-in-prostate-cancer
#8
Roberto Petrioli, Edoardo Francini, Giandomenico Roviello
Three-weekly docetaxel plus prednisone is the standard first-line cytotoxic treatment for patients with metastatic castrate-resistant prostate cancer (mCRPC). Today, several new treatment options are available for patients with tumor progression after first-line docetaxel: Abiraterone, enzalutamide, cabazitaxel, sipuleucel-T immunotherapy, and the radionuclide radium-223. However, despite the evolving scenario in CRPC treatment, the optimal sequencing of the innovative therapies remains unclear. The reintroduction of docetaxel at the occurrence of disease progression after a drug holiday (docetaxel rechallenge) was often proposed, and this chemotherapeutic agent showed to maintain antitumor activity in mCRPC patients...
October 10, 2015: World Journal of Clinical Oncology
https://www.readbyqxmd.com/read/25937426/commentary-on-enzalutamide-monotherapy-in-hormone-naive-prostate-cancer-primary-analysis-of-an-open-label-single-arm-phase-2-study-tombal-b-borre-m-rathenborg-p-werbrouck-p-van-poppel-h-heidenreich-a-iversen-p-braeckman-j-heracek-j-baskin-bey-e-ouatas-t-perabo
#9
COMMENT
Donald Trump
BACKGROUND: The androgen receptor inhibitor enzalutamide is approved for the treatment of metastatic castration-resistant prostate cancer that has progressed on docetaxel. Our aim was to assess the activity and safety of enzalutamide monotherapy in men with hormone-naive prostate cancer. METHODS: This trial is an ongoing open-label, single-arm, phase 2 study, done across 12 European sites. Men aged over 18 years with hormone-naive prostate cancer for whom hormone therapy was indicated, and who had noncastration levels of testosterone and prostate-specific antigen (PSA) of 2ng/mL or greater at screening, and an Eastern Cooperative Oncology Group score of 0, received oral enzalutamide 160mg/day...
May 2016: Urologic Oncology
https://www.readbyqxmd.com/read/25698064/long-term-safety-and-antitumor-activity-in-the-phase-1-2-study-of-enzalutamide-in-pre-and-post-docetaxel-castration-resistant-prostate-cancer
#10
Celestia S Higano, Tomasz M Beer, Mary-Ellen Taplin, Eleni Efstathiou, Mohammad Hirmand, David Forer, Howard I Scher
BACKGROUND: Given that some patients with castration-resistant prostate cancer (CRPC) have shown extended responses to the androgen receptor inhibitor enzalutamide, long-term safety of this drug is of interest. OBJECTIVE: To evaluate the long-term safety and antitumor activity of enzalutamide in CRPC patients. DESIGN, SETTING, AND PARTICIPANTS: This phase 1-2 study evaluated enzalutamide in 140 CRPC patients with and without prior chemotherapy...
November 2015: European Urology
https://www.readbyqxmd.com/read/25687533/long-term-efficacy-and-safety-of-enzalutamide-monotherapy-in-hormone-na%C3%A3-ve-prostate-cancer-1-and-2-year-open-label-follow-up-results
#11
Bertrand Tombal, Michael Borre, Per Rathenborg, Patrick Werbrouck, Hendrik Van Poppel, Axel Heidenreich, Peter Iversen, Johan Braeckman, Jiri Heracek, Edwina Baskin-Bey, Taoufik Ouatas, Frank Perabo, De Phung, Benoit Baron, Mohammad Hirmand, Matthew R Smith
BACKGROUND: Enzalutamide is an androgen receptor inhibitor with a demonstrated overall survival benefit in metastatic castration-resistant prostate cancer. A phase 2 study of enzalutamide monotherapy in patients with hormone-naïve prostate cancer (HNPC) showed a high response rate for the prespecified primary endpoint (ie, prostate-specific antigen [PSA] response at week 25), regardless of metastases at baseline, and favorable tolerability. OBJECTIVE: To determine the long-term efficacy and safety of enzalutamide monotherapy at 1 and 2 yr...
November 2015: European Urology
https://www.readbyqxmd.com/read/25687355/safety-and-effectiveness-of-enzalutamide-in-men-with-metastatic-castration-resistant-prostate-cancer
#12
REVIEW
Julie N Graff, Max J Gordon, Tomasz M Beer
INTRODUCTION: Enzalutamide (MDV3100) is a second-generation androgen receptor antagonist that improves survival in metastatic, castration-resistant prostate cancer (mCRPC). Alternatives include chemotherapy, radiation, immunotherapy and abiraterone. AREAS COVERED: The Phase I/II study showed early evidence of efficacy and determined that fatigue is the dose-limiting toxicity. Two randomized, placebo-controlled trials have demonstrated superiority of enzalutamide 160 mg by mouth daily over placebo in terms of overall survival, radiographic progression-free survival as well as a broad range of secondary and exploratory end points in men who had received previous chemotherapy (AFFIRM) and in those who were chemotherapy naive (PREVAIL)...
April 2015: Expert Opinion on Pharmacotherapy
https://www.readbyqxmd.com/read/25683285/safety-of-enzalutamide-in-patients-with-metastatic-castration-resistant-prostate-cancer-previously-treated-with-docetaxel-expanded-access-in-north-america
#13
MULTICENTER STUDY
Anthony M Joshua, Neal D Shore, Fred Saad, Kim N Chi, Carl A Olsson, Urban Emmenegger, Mark Scholz, William Berry, Som D Mukherjee, Eric Winquist, Naomi B Haas, Margaret A Foley, Carl Dmuchowski, Frank Perabo, Mohammad Hirmand, Nahla Hasabou, Dana Rathkopf
BACKGROUND: The open-label, single-arm enzalutamide expanded access program (EAP) in the United States and Canada evaluated the safety of enzalutamide in patients with metastatic castration-resistant prostate cancer (mCRPC) who had previously received docetaxel. METHODS: Patients (n = 507) received enzalutamide 160 mg/day until disease progression, intolerable adverse events (AEs), or commercial availability occurred. AEs and other safety variables were assessed on day 1, weeks 4 and 12, and every 12 weeks thereafter...
June 2015: Prostate
https://www.readbyqxmd.com/read/25642291/an-update-on-enzalutamide-in-the-treatment-of-prostate-cancer
#14
REVIEW
Axel S Merseburger, Gabriel P Haas, Christoph-A von Klot
Enzalutamide is an oral androgen receptor inhibitor that targets multiple steps in the androgen receptor signaling pathway. In the randomized phase III AFFIRM study, significant improvements in survival versus placebo were observed when enzalutamide was used as a treatment for patients with metastatic castration-resistant prostate cancer (mCRPC) following prior treatment with docetaxel. Additional benefits included significant delay in time to first skeletal-related event, and improvement in several measures of pain and health-related quality of life...
February 2015: Therapeutic Advances in Urology
https://www.readbyqxmd.com/read/25123978/enzalutamide-in-european-and-north-american-men-participating-in-the-affirm-trial
#15
RANDOMIZED CONTROLLED TRIAL
Axel S Merseburger, Howard I Scher, Joaquim Bellmunt, Kurt Miller, Peter F A Mulders, Arnulf Stenzl, Cora N Sternberg, Karim Fizazi, Mohammad Hirmand, Billy Franks, Gabriel P Haas, Johann de Bono, Ronald de Wit
OBJECTIVE: To explore any differences in efficacy and safety outcomes between European (EU) (n = 684) and North American (NA) (n = 395) patients in the AFFIRM trial (NCT00974311). PATIENTS AND METHODS: Phase III, double-blind, placebo-controlled, multinational AFFIRM trial in men with metastatic castration-resistant prostate cancer (mCRPC) after docetaxel. Participants were randomly assigned in a 2:1 ratio to receive oral enzalutamide 160 mg/day or placebo. The primary end point was overall survival (OS) in a post hoc analysis...
January 2015: BJU International
https://www.readbyqxmd.com/read/24881730/enzalutamide-in-metastatic-prostate-cancer-before-chemotherapy
#16
RANDOMIZED CONTROLLED TRIAL
Tomasz M Beer, Andrew J Armstrong, Dana E Rathkopf, Yohann Loriot, Cora N Sternberg, Celestia S Higano, Peter Iversen, Suman Bhattacharya, Joan Carles, Simon Chowdhury, Ian D Davis, Johann S de Bono, Christopher P Evans, Karim Fizazi, Anthony M Joshua, Choung-Soo Kim, Go Kimura, Paul Mainwaring, Harry Mansbach, Kurt Miller, Sarah B Noonberg, Frank Perabo, De Phung, Fred Saad, Howard I Scher, Mary-Ellen Taplin, Peter M Venner, Bertrand Tombal
BACKGROUND: Enzalutamide is an oral androgen-receptor inhibitor that prolongs survival in men with metastatic castration-resistant prostate cancer in whom the disease has progressed after chemotherapy. New treatment options are needed for patients with metastatic prostate cancer who have not received chemotherapy, in whom the disease has progressed despite androgen-deprivation therapy. METHODS: In this double-blind, phase 3 study, we randomly assigned 1717 patients to receive either enzalutamide (at a dose of 160 mg) or placebo once daily...
July 31, 2014: New England Journal of Medicine
https://www.readbyqxmd.com/read/24775726/practical-guide-to-the-use-of-enzalutamide
#17
REVIEW
Jean Hoffman-Censits, Wm Kevin Kelly
INTRODUCTION: We summarize the development, definitive trials, and practical use of enzalutamide for practicing urologists and medical oncologists. The care paradigm for patients with metastatic castration resistant prostate cancer (mCRPC) is a changing landscape, with the ongoing discovery of drivers of cancer progression yielding actionable targets for drug development. Since 2010, sipuleucel-T, cabazitaxel, abiraterone with prednisone, radium 223 and enzalutamide have been Food and Drug Administration approved based upon improvement in overall survival in men with mCRPC...
April 2014: Canadian Journal of Urology
https://www.readbyqxmd.com/read/24739897/enzalutamide-monotherapy-in-hormone-naive-prostate-cancer-primary-analysis-of-an-open-label-single-arm-phase-2-study
#18
MULTICENTER STUDY
Bertrand Tombal, Michael Borre, Per Rathenborg, Patrick Werbrouck, Hendrik Van Poppel, Axel Heidenreich, Peter Iversen, Johan Braeckman, Jiri Heracek, Edwina Baskin-Bey, Taoufik Ouatas, Frank Perabo, De Phung, Mohammad Hirmand, Matthew R Smith
BACKGROUND: The androgen receptor inhibitor enzalutamide is approved for the treatment of metastatic castration-resistant prostate cancer that has progressed on docetaxel. Our aim was to assess the activity and safety of enzalutamide monotherapy in men with hormone-naive prostate cancer. METHODS: This trial is an ongoing open-label, single-arm, phase 2 study, done across 12 European sites. Men aged over 18 years, with hormone-naive prostate cancer for whom hormone therapy was indicated, and who had non-castration levels of testosterone and prostate-specific antigen (PSA) of 2 ng/mL or greater at screening, and an Eastern Cooperative Oncology Group score of 0, received oral enzalutamide 160 mg/day...
May 2014: Lancet Oncology
https://www.readbyqxmd.com/read/24478320/improved-outcomes-in-elderly-patients-with-metastatic-castration-resistant-prostate-cancer-treated-with-the-androgen-receptor-inhibitor-enzalutamide-results-from-the-phase-iii-affirm-trial
#19
RANDOMIZED CONTROLLED TRIAL
C N Sternberg, J S de Bono, K N Chi, K Fizazi, P Mulders, L Cerbone, M Hirmand, D Forer, H I Scher
BACKGROUND: The randomized, double-blind phase III AFFIRM trial demonstrated that enzalutamide, an oral androgen receptor inhibitor, significantly prolonged overall survival (OS) [median 18.4 versus 13.6 months (hazard ratio, HR) 0.63 (95% confidence interval, CI, 0.53-0.75); P<0.001] compared with placebo in patients with metastatic castration-resistant prostate cancer who received prior docetaxel chemotherapy. PATIENTS AND METHODS: A post hoc analysis was carried out to assess the efficacy and safety of enzalutamide on outcomes in younger (<75 years) and elderly (≥75 years) patients in the AFFIRM population...
February 2014: Annals of Oncology: Official Journal of the European Society for Medical Oncology
https://www.readbyqxmd.com/read/24458946/enzalutamide-xtandi-for-patients-with-metastatic-resistant-prostate-cancer
#20
REVIEW
Lunawati L Bennett, April Ingason
OBJECTIVE: To review the pharmacology and pharmacokinetics, and to evaluate the clinical efficacy, safety, and place in therapy of enzalutamide for the treatment of castration-resistant prostate cancer (CRPC). DATA SOURCES: A literature search through PubMed (1984 to November 2013; English language) was performed using the following keywords: MDV3100, androgen deprivation therapy, enzalutamide, CRPC, and androgen receptor antagonist. Searches were limited to published studies in humans...
April 2014: Annals of Pharmacotherapy
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