Enzalutamide monotherapy in hormone-naive prostate cancer: primary analysis of an open-label, single-arm, phase 2 study

Tombal, Bertrand; Borre, Michael; Rathenborg, Per; Werbrouck, Patrick; Poppel, Hendrik Van; Heidenreich, Axel; Iversen, Peter; Braeckman, Johan; Heráček, Jiří; Baskin-Bey, Edwina S.; Ouatas, Taoufik; Perabo, Frank; Phung, De; Hirmand, Mohammad; Smith, Matthew R.

doi:10.1016/s1470-2045(14)70129-9

Cited by 77 publications

(75 citation statements)

References 27 publications

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“…Furthermore, new antiandrogen drug (enzalutamide) has higher affinity than bicalutamide [16]. Tombal et al reported the good efficacy and safety of enzalutamide monotherapy [17]. So, enzaltamide may lower PSA significantly compared to bicalutamide and flutamide on the use of antiandrogen drugs as monotherapy.…”

Section: Discussionmentioning

confidence: 99%

A Randomized Control Trial Comparing the Efficacy of Antiandrogen Monotherapy: Flutamide vs. Bicalutamide

et al. 2015

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The study aims to compare serial changes in prostate-specific antigen (PSA), testosterone, dehydroepiandrosterone (DHEA), and androstenedione in patients treated with either of the antiandrogen agents, bicalutamide or flutamide, using a randomized controlled study. Patients had to meet the following inclusion criteria: (1) presence of histopathologically confirmed prostate cancer, (2) prostate cancer treatment naive, (3) no current treatment with luteinizing hormone-releasing hormone (LH-RH) agonist for sexual interest and physical capacity, (4) clinical stage T1-cT3N0M0, (5) Gleason score ≤ 7, and (6) Cooperative Oncology Group performance status 0-1. Patients were randomly allocated to two groups: flutamide and bicalutamide monotherapy group 1:1. PSA levels were significantly decreased in both groups at 4 weeks. PSA levels were significantly lower in the bicalutamide group compared with the flutamide group at 4 and 8 weeks. Testosterone levels in the bicalutamide group were significantly higher than the baseline levels between 4 and 24 weeks of treatment. Testosterone levels in the flutamide group were significantly increased at 4 and 12 weeks and returned to baseline levels at 16 and 24 weeks. DHEA levels in the bicalutamide group were unchanged from baseline at 4 and 24 weeks. However, DHEA levels in the flutamide group were decreased at 24 weeks. Androstenedione levels increased slightly in both groups, but the increase did not reach statistical significance. PSA, testosterone, and DHEA levels significantly differed between bicalutamide and flutamide monotherapy.

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Section: Discussionmentioning

confidence: 99%

A Randomized Control Trial Comparing the Efficacy of Antiandrogen Monotherapy: Flutamide vs. Bicalutamide

et al. 2015

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“…In an openlabel, single-arm, phase 2 study of enzalutamide monotherapy (160 mg/day for 25 weeks) in 67 patients with localized, locally advanced or metastatic prostate cancer who had not received hormone or chemotherapy, significant PSA responses in 92.5 % of patients was obtained. PSA response was achieved rapidly, and PSA control was maintained in patients completing 49 weeks of treatment [6]. However, a determination of the final duration of activity and efficacy in comparison with standard ADT will require comparative clinical trials and longer follow-up.…”

Section: New Hormonal Treatments In Hormone-sensitive Diseasementioning

confidence: 99%

“…AR and c-Myb transcriptional activity shared processes including DNA damage response (DDR), i.e., BRCA1, TOPBP1, and XRCC3. MYB (which encodes c-Myb) silencing suppressed prostate cancer growth and decreased metastasis in preclinical models [6] and sensitize prostate cancer cells to PARP inhibitors [9].…”

Section: Novel Molecular Targets For Prostate Cancermentioning

confidence: 99%

New advances in genitourinary cancer: evidence gathered in 2014

Suárez

Puente

Gallardo³

et al. 2015

Cancer Metastasis Rev

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This review provides updated information published in 2014 regarding advances and major achievements in genitourinary cancer. Sections include the best in prostate cancer, renal cancer, bladder cancer, and germ cell tumors. In the field of prostate cancer, data related to treatment approach of hormone-sensitive disease, castrate-resistant prostate cancer, mechanisms of resistance, new drugs, and molecular research are presented. In relation to renal cancer, relevant aspects in the treatment of advanced renal cell carcinoma, immunotherapy, and molecular research, including angiogenesis and von Hippel-Lindau gene, molecular biology of non-clear cell histologies, and epigenetics of clear renal cell cancer are described. New strategies in the management of muscle-invasive localized bladder cancer and metastatic disease are reported as well as salient findings of biomolecular research in urothelial cancer. Some approaches intended to improve outcomes in poor prognosis patients with metastatic germ cell cancer are also reported. Results of clinical trials in these areas are discussed.

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“…2,3 Recently, enzalutamide has also been assessed as a monotherapy in castration-naive (without androgen deprivation therapy) prostate cancer. 4 Restless legs syndrome (RLS) is a sensorimotor disorder characterized by an urge to move legs and other parts of the body accompanied by a marked sense of discomfort. 5 Besides an idiopathic, most probably genetically determined form, there are secondary forms that can be caused by a variety of medical conditions including iron deficiency, renal insufficiency, thyroid dysfunction, and sensory polyneuropathy.…”

Section: Introductionmentioning

confidence: 99%

Restless Legs Syndrome—An Emerging Potential Side Effect of Enzalutamide: Report of 2 Cases

Desax

Hundsberger

Rothermundt

et al. 2015

Clinical Genitourinary Cancer

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Enzalutamide monotherapy in hormone-naive prostate cancer: primary analysis of an open-label, single-arm, phase 2 study

Cited by 77 publications

References 27 publications

A Randomized Control Trial Comparing the Efficacy of Antiandrogen Monotherapy: Flutamide vs. Bicalutamide

A Randomized Control Trial Comparing the Efficacy of Antiandrogen Monotherapy: Flutamide vs. Bicalutamide

New advances in genitourinary cancer: evidence gathered in 2014

Restless Legs Syndrome—An Emerging Potential Side Effect of Enzalutamide: Report of 2 Cases

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