Five-year Survival Prediction and Safety Outcomes with Enzalutamide in Men with Chemotherapy-naïve Metastatic Castration-resistant Prostate Cancer from the PREVAIL Trial

Armstrong, Andrew J.; Lin, Po-Han; Tombal, Bertrand; Saad, Fred; Higano, Celestia S.; Joshua, Anthony M.; Parli, Teresa; Rosbrook, Brad; Os, Steve van; Beer, Tomasz M.

doi:10.1016/j.eururo.2020.04.061

Cited by 108 publications

(87 citation statements)

References 27 publications

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“…In the PREVAIL study, which was terminated early due to the clear superiority of pre-docetaxel E treatment in terms of rPFS (20 months vs. 5.4 months) over placebo. Median OS was 35.3 and 31.3 months in the treatment and placebo arms, respectively 10 . In our study, E given in post-docetaxel and pre-docetaxel settings revealed a rPFS of 11 months and 17 months, an OS of 26 months and 29 months, respectively.…”

Section: Discussionmentioning

confidence: 99%

Comparison of real-life data of abiraterone acetate and enzalutamide in metastatic castration-resistant prostate cancer

Demirci

Bilir

Gülbağcı

et al. 2021

Sci Rep

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To compare enzalutamide (E) and abiraterone acetate (AA) in terms of efficacy, survival and to characterize prognostic factors affecting survival in metastatic castration-resistant prostate cancer (mCRPC) patients. A total of 250 patients treated with E or AA in 5 centers were included. The number of patients with no prostate specific antigen (PSA) decline was higher in the AA group than that in the E group, and the proportion of patients with a PSA decline of ≥ 50% was higher in the E group (p = 0.020). Radiological progression free survival (rPFS) and overall survival (OS) were significantly longer in the E group when compared to that in the AA group (p < 0.001 and p = 0.027, respectively). In the E group, rPFS was significantly longer than that in the AA group in both pre- and post-docetaxel settings (p = 0.010 and p = 0.003, respectively). OS was similar in the pre-docetaxel setting; but in the post-docetaxel setting, E group had a significantly longer OS than the AA group (p = 0.021). In the multivariate analysis performed in the whole patient group, we found that good prognostic factors for rPFS were E treatment, being ≥ 75 years and a PSA decline of ≥ 50% while there was no factor affecting OS. With longer OS and PFS, E seems to be more suitable for mCRPC patients in the post-docetaxel setting than AA.

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Section: Discussionmentioning

confidence: 99%

Comparison of real-life data of abiraterone acetate and enzalutamide in metastatic castration-resistant prostate cancer

Demirci

Bilir

Gülbağcı

et al. 2021

Sci Rep

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“…E was approved to be used in the pre-docetaxel setting with the PREVAIL study, which was terminated early, as pre-docetaxel E treatment demonstrated a clear superiority in rPFS (20 months vs. 5.4 months) over placebo. In the placebo arm, 167 patients had crossed over to receive E. At a median follow-up of 69 months, median OS was 35.3 and 31.3 months in the treatment arm and placebo arm, respectively 10 . In our study, E given in post-docetaxel and predocetaxel settings revealed a rPFS of 11 months and 17 months, an OS of 26 months and 29 months, respectively.…”

Section: Discussionmentioning

confidence: 99%

Comparison of the oncological outcomes of abiraterone acetate and enzalutamide in metastatic castration-resistant prostate cancer: A multicenter real-life data

Demirci¹,

Bilir²,

Gülbağcı³

et al. 2021

Preprint

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Background: To compare enzalutamide (E) and abiraterone acetate (AA) in terms of efficacy, survival and prognostic factors affecting survival in metastatic castration-resistant prostate cancer (mCRPC) patients. Methods: A total of 250 patients treated with E or AA in 5 centers were included.Results: The number of patients with no prostate specific antigen (PSA) decline was higher in the AA group than that in the E group, and the proportion of patients with a PSA decline of ≥50% was higher in the E group (p = 0.020). The rate of progression in the AA group (82.2%) was significantly higher than that in the E group (p <0.001). Radiological progression free survival (rPFS) and overall survival (OS) were significantly longer in the E group when compared to that in the AA group (p <0.001 and p = 0.027, respectively). In the E group, rPFS was significantly longer than that in the AA group in both pre- and post-docetaxel settings (p=0.010 and p=0.003, respectively). OS was similar in the pre-docetaxel setting; but in the post-docetaxel setting, E group had a significantly longer OS than the AA group(p=0.021). In the multivariate analysis performed in the whole patient group, we found that good prognostic factors for rPFS were E treatment, being ≥75 years and a PSA decline of ≥50% while there was no factor affecting OS. Conclusion: With longer OS and PFS, E seems to be more suitable for mCRPC patients in the post-docetaxel setting than AA.

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“…EMBARK is designed to provide further evidence to address whether treatment intensification by enzalutamide in the disease continuum (prior to the onset of metastasis or symptoms) is associated with improved metastasis-free survival (MFS) for men with high-risk nmCSPC and rising PSA concentrations after definitive therapy ( figure 1 ). Treatment with enzalutamide has shown robust effects across the prostate cancer continuum, including in patients with mCSPC (ARCHES 18 and ENZAMET 21 ), patients with nmCRPC (PROSPER) 22 23 and patients with metastatic castration-resistant prostate cancer (PREVAIL 24–26 [chemotherapy naïve] and AFFIRM 27 [postchemotherapy]), supporting the expectation of a significant treatment effect in men with nmCSPC. This phase 3 randomised study will determine whether administration of enzalutamide plus LHRHa or enzalutamide monotherapy is more effective than placebo plus LHRHa earlier along the prostate cancer continuum for patients with high-risk nmCSPC and rising PSA levels after local therapy.…”

Section: Introductionmentioning

confidence: 86%

A phase 3 randomised study of enzalutamide plus leuprolide and enzalutamide monotherapy in high-risk non-metastatic hormone-sensitive prostate cancer with rising PSA after local therapy: EMBARK study design

et al. 2021

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IntroductionLimited data from controlled clinical trials are available for men who experience biochemical recurrence after definitive therapy for prostate cancer. In the absence of overt metastases, patients with non-metastatic castration-sensitive prostate cancer (nmCSPC) often receive androgen deprivation therapy (ADT). There is no standard-of-care consensus on optimal ADT timing, although most men are treated prior to metastases, especially those with high-risk features (Gleason score 8–10 or prostate-specific antigen doubling time (PSADT) <9–12 months). Given data that ADT plus novel hormonal agents improve survival in men with metastatic CSPC, there is a desire to evaluate these agents earlier in the disease course. The main objective of EMBARK is the comparative assessment of enzalutamide plus leuprolide (luteinising hormone-releasing hormone agonist (LHRHa)) or enzalutamide monotherapy versus monotherapy LHRHa to improve metastasis-free survival (MFS) in patients with high-risk nmCSPC PSA recurrence after definitive therapy.Methods and analysisEMBARK is a randomised, phase 3 study of high-risk patients with nmCSPC, a PSADT of ≤9 months and a screening PSA of ≥2 ng/mL above the nadir after radiotherapy (RT) or ≥1 ng/mL after radical prostatectomy (RP) with or without postoperative RT. Men (n=1050) are randomised 1:1:1 to enzalutamide 160 mg/day plus LHRHa or placebo plus LHRHa (double-blind arms) or enzalutamide monotherapy (open-label arm). Treatment is suspended at week 37 if PSA concentrations are <0.2 ng/mL and reinstated if levels rise to ≥2.0 ng/mL with RP or ≥5.0 ng/mL without RP. Patients with PSA ≥0.2 ng/mL at week 37 continue until treatment discontinuation criteria are met. The primary endpoint is MFS comparing enzalutamide plus LHRHa versus placebo plus LHRHa.Ethics and disseminationThe study is conducted under the guiding principles of the World Medical Association Declaration of Helsinki. The results will be disseminated at research conferences and in peer-reviewed journals.Trial registration numberNCT02319837.

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Five-year Survival Prediction and Safety Outcomes with Enzalutamide in Men with Chemotherapy-naïve Metastatic Castration-resistant Prostate Cancer from the PREVAIL Trial

Cited by 108 publications

References 27 publications

Comparison of real-life data of abiraterone acetate and enzalutamide in metastatic castration-resistant prostate cancer

Comparison of real-life data of abiraterone acetate and enzalutamide in metastatic castration-resistant prostate cancer

Comparison of the oncological outcomes of abiraterone acetate and enzalutamide in metastatic castration-resistant prostate cancer: A multicenter real-life data

A phase 3 randomised study of enzalutamide plus leuprolide and enzalutamide monotherapy in high-risk non-metastatic hormone-sensitive prostate cancer with rising PSA after local therapy: EMBARK study design

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