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Enzalutamide fatigue

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https://www.readbyqxmd.com/read/29033099/custirsen-ogx-011-combined-with-cabazitaxel-and-prednisone-versus-cabazitaxel-and-prednisone-alone-in-patients-with-metastatic-castration-resistant-prostate-cancer-previously-treated-with-docetaxel-affinity-a-randomised-open-label-international-phase-3-trial
#1
Tomasz M Beer, Sebastien J Hotte, Fred Saad, Boris Alekseev, Vsevolod Matveev, Aude Fléchon, Gwenaelle Gravis, Florence Joly, Kim N Chi, Zafar Malik, Brent Blumenstein, Patricia S Stewart, Cindy A Jacobs, Karim Fizazi
BACKGROUND: Docetaxel and cabazitaxel improve overall survival compared with mitoxantrone in patients with metastatic castration-resistant prostate cancer. Custirsen (OGX011) is a second generation highly specific antisense oligonucleotide that inhibits the production of clusterin, an antiapoptotic protein that is upregulated in response to chemotherapy and that confers treatment resistance. We aimed to assess whether custirsen in combination with cabazitaxel and prednisone increases overall survival in patients with metastatic castration-resistant prostate cancer previously treated with docetaxel...
October 9, 2017: Lancet Oncology
https://www.readbyqxmd.com/read/28867562/long-term-anti-tumor-activity-and-safety-of-enzalutamide-monotherapy-in-hormone-na%C3%A3-ve-prostate-cancer-3-year-open-label-follow-up-results
#2
Bertrand Tombal, Michael Borre, Per Rathenborg, Patrick Werbrouck, Hendrik Van Poppel, Axel Heidenreich, Peter Iversen, Johan Braeckman, Jiri Heracek, Benoit Baron, Andrew Krivoshik, Mohammad Hirmand, Matthew R Smith
PURPOSE: A phase 2 study of enzalutamide monotherapy in patients with hormone-naïve prostate cancer demonstrated high prostate-specific antigen response rates at 25 weeks, 1 year and 2 years, with minimal effects on total body bone mineral density and favorable safety. This follow-up analysis evaluated enzalutamide's anti-tumor activity and safety at 3 years. MATERIALS AND METHODS: Sixty-seven patients with hormone-naïve prostate cancer and non-castrate testosterone (≥230 ng/dL) received enzalutamide 160 mg/day orally until disease progression or unacceptable toxicity in a single-arm analysis...
August 31, 2017: Journal of Urology
https://www.readbyqxmd.com/read/28844372/antitumour-activity-and-safety-of-enzalutamide-in-patients-with-metastatic-castration-resistant-prostate-cancer-previously-treated-with-abiraterone-acetate-plus-prednisone-for-%C3%A2-24-weeks-in-europe
#3
Johann S de Bono, Simon Chowdhury, Susan Feyerabend, Tony Elliott, Enrique Grande, Amal Melhem-Bertrandt, Benoit Baron, Mohammad Hirmand, Patrick Werbrouck, Karim Fizazi
BACKGROUND: Enzalutamide and abiraterone acetate plus prednisone, which target the androgen receptor axis, have expanded the treatment of advanced prostate cancer. Retrospective analyses suggest some cross-resistance between these two drugs when used sequentially, but robust, prospective studies have not yet been reported. OBJECTIVE: To fulfil a regulatory postregistration commitment by evaluating the efficacy and safety of enzalutamide in patients with metastatic castration-resistant prostate cancer (mCRPC) who progressed following abiraterone acetate plus prednisone treatment...
August 22, 2017: European Urology
https://www.readbyqxmd.com/read/28832175/-docetaxel-cabazitaxel-enzalutamide-versus-docetaxel-enzalutamide-in-patients-with-metastatic-castration-resistant-prostate-cancer
#4
I Richter, J Dvořák, J Bartoš
AIM: The aim of this retrospective study was to compare the efficacy of the sequence docetaxel-cabazitaxel-enzalutamide vs. docetaxel-enzalutamide in patients with metastatic castration-resistant prostate cancer. PATIENTS AND METHODS: Of the cohort of 35 patients, 11 were treated with the sequence docetaxel-cabazitaxel-enzalutamide and 24 were treated with the sequence docetaxel-enzalutamide. The doses were as follows: docetaxel, 75 mg/m2; cabazitaxel, 25 mg/m2; and enzalutamide, 160 mg/day...
2017: Klinická Onkologie: Casopis Ceské a Slovenské Onkologické Spolecnosti
https://www.readbyqxmd.com/read/28827103/efficacy-and-safety-of-enzalutamide-vs-bicalutamide-in-younger-and-older-patients-with-metastatic-castration-resistant-prostate-cancer-in-the-terrain-trial
#5
D Robert Siemens, Laurence Klotz, Axel Heidenreich, Simon Chowdhury, Arnauld Villers, Benoit Baron, Steve van Os, Nahla Hasabou, Fong Wang, Ping Lin, Neal D Shore
PURPOSE: Enzalutamide significantly prolonged median progression-free survival vs bicalutamide in chemotherapy naïve men with metastatic, castration resistant prostate cancer in the TERRAIN (Enzalutamide versus Bicalutamide in Castrate Men with Metastatic Prostate Cancer) trial. In this post hoc analysis we investigated the influence of age on the efficacy and safety of enzalutamide vs bicalutamide in this population. MATERIALS AND METHODS: Patients were randomized 1:1 to enzalutamide 160 mg per day or bicalutamide 50 mg per day...
August 19, 2017: Journal of Urology
https://www.readbyqxmd.com/read/28614882/-review-on-quality-of-life-in-crpc-patients
#6
Kurt Miller
Health-related quality of life (HRQoL) deteriorates rapidly in patients with advanced-stage cancer, with patients seriously disturbed by fatigue, sleep disorders, bone pain, constipation and other disease related symptoms. As treatment and prognosis continues to improve, reducing symptoms and improving quality of life with minimum of toxicities have become important therapeutic goals. The effectiveness of abiraterone acetate and enzalutamide in both prolonging life and improving quality of life in asymptomatic or mildly symptomatic patients with metastatic castrations-resistant prostate cancer (mCRPC) has been clinically proven...
May 2017: Aktuelle Urologie
https://www.readbyqxmd.com/read/28502694/phase-ii-trial-of-the-pi3-kinase-inhibitor-buparlisib-bkm-120-with-or-without-enzalutamide-in-men-with-metastatic-castration-resistant-prostate-cancer
#7
MULTICENTER STUDY
Andrew J Armstrong, Susan Halabi, Patrick Healy, Joshi J Alumkal, Carolyn Winters, Julie Kephart, Rhonda L Bitting, Carey Hobbs, Colleen F Soleau, Tomasz M Beer, Rachel Slottke, Kelly Mundy, Evan Y Yu, Daniel J George
BACKGROUND: Phosphatidylinositol-3-kinase (PI3K) and androgen receptor pathway activation is common in metastatic castration resistant prostate cancer (mCRPC). Buparlisib is an oral, pan-class I PI3 kinase inhibitor. METHODS: This was a multisite single arm phase II trial of buparlisib 100 mg ± enzalutamide daily in men with mCRPC whose disease progressed on or who were not candidates for docetaxel. The primary end-point was the rate of radiographic/clinical progression-free survival (PFS) at 6 months...
August 2017: European Journal of Cancer
https://www.readbyqxmd.com/read/28395931/impact-of-abiraterone-acetate-and-enzalutamide-on-symptom-burden-of-patients-with-chemotherapy-naive-metastatic-castration-resistant-prostate-cancer
#8
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
https://www.readbyqxmd.com/read/27942507/impact-of-enzalutamide-on-patient-related-outcomes-in-metastatic-castration-resistant-prostate-cancer-current-perspectives
#9
REVIEW
Jia Luo, Julie N Graff
Prostate cancer claims the lives of more than 25,000 men in the United States yearly, most from metastatic disease. In the past decade, several new medications have been approved for the treatment of metastatic prostate cancer including the antiandrogen enzalutamide. In addition, there has been mounting interest in evaluating health-related quality of life (QoL) in patients with cancer including new more detailed recommendations released by the Prostate Cancer Working Group 3 on how to evaluate patient-related outcomes in clinical trials...
2016: Research and Reports in Urology
https://www.readbyqxmd.com/read/27885457/-psma-targeted-radioligand-therapy-in-prostate-cancer
#10
REVIEW
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...
January 2017: 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
#11
MULTICENTER STUDY
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...
2016: Oncology
https://www.readbyqxmd.com/read/27306820/-an-undeniable-case-of-optic-neuropathy-due-to-cabazitaxel
#12
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
#13
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
#14
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
#15
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
#16
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
#17
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
#18
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
#19
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
#20
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
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