Post hoc analyses of East Asian patients from the randomized placebo-controlled PREVAIL trial of enzalutamide in patients with chemotherapy-naïve, metastatic castration-resistant prostate cancer

Kim, Choung Soo; Choi, Young Deuk; Lee, Sang Eun; Lee, Hyun Moo; Ueda, Takeshi; Yonese, Junji; Fukushima, Takashi; Chiong, Edmund; Lau, Weber Kam On; Abhyankar, Sarang; Theeuwes, A.; Tombal, Bertrand; Beer, Tomasz M.; Kimura, Go

doi:10.1097/md.0000000000007223

Cited by 15 publications

(25 citation statements)

References 29 publications

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“…Compared with the results of the PREVAIL trial, which focused on treatment of mCRPC before chemotherapy, the number of treatment regimens before ENZ treatment in our trial tended to be relatively high. Kim et al reported that 40% of East Asian patients, and 21% of patients in the overall population of the PREVAIL trial, had received at least two prior antiandrogen therapies . Overall, 52.7% of patients in our pre‐DOC group had received at least two prior antiandrogen therapies.…”

Section: Discussionmentioning

confidence: 76%

An exploratory retrospective multicenter study of prognostic factors in mCRPC patients undergoing enzalutamide treatment: Focus on early PSA decline and kinetics at time of progression

Miyazawa

Sekine

Shimizu³

et al. 2019

The Prostate

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Background Recent studies have shown that an early prostate‐specific antigen (PSA) response to androgen receptor‐targeting agents in metastatic castration‐resistant prostate cancer (mCRPC) is associated with a better prognosis. We analyzed the early PSA response to enzalutamide (ENZ) by measuring the PSA doubling time (PSADT) and PSA velocity (PSAV) while monitoring oncologic outcomes and survival in Japanese patients. Methods We analyzed a total of 241 patients with mCRPC who were treated with ENZ. The patients’ median age was 75 ± 7.9 years (range, 53‐93 years). There were 171 (71%) predocetaxel cases, and 70 (29%) post docetaxel cases. PSA‐progression‐free survival (PFS) and overall survival (OS) were assessed according to Prostate Cancer Working Group 2 criteria. This study was approved by the Institutional Review Board of Gunma University Hospital (No. 1595). Results We observed 77 good response (GR; case in which PSA remained low after treatment) cases (31.9%), 125 acquired resistance (AR; decline in PSA after treatment followed by progression) cases (51.9%), and 39 primary resistance (PR; lack of decline in PSA) cases (16.2%). Predocetaxel, PSA‐PFS, and OS were significantly higher compared with post docetaxel (PSA‐PFS: 47.0 vs 13.4 weeks, P < .001; OS: not yet reached vs 80.7 weeks, P < .001). Multivariate analysis of prognostic factors, including PSA response at 4 weeks, was performed using Cox regression analysis. ECOG PS (0 vs 1‐2), hemoglobin (Hb; ≥ 12.2 vs < 12.2 g/dL), time to CRPC ( ≥ 12 vs < 12 m), docetaxel treatment history (no vs yes), and a PSA reduction of 50% at 4 weeks were significant predictors of OS (all, P < .05). In cases of AR (n = 125), multivariate analysis showed that PSA kinetic factors, such as PSADT and PSAV (ng/mL/m), Hb, time to CRPC, PSADT ( ≥ 2 vs < 2 m), and PSAV ( < 20 vs ≥ 20 ng/mL/m), were all predictive of OS following PSA‐progression (P < .05). Conclusions Our study has demonstrated that PSA dynamics after ENZ administration may be a useful prognostic factor for mCRPC patients.

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Section: Discussionmentioning

confidence: 76%

An exploratory retrospective multicenter study of prognostic factors in mCRPC patients undergoing enzalutamide treatment: Focus on early PSA decline and kinetics at time of progression

Miyazawa

Sekine

Shimizu³

et al. 2019

The Prostate

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“…This includes a higher percentage of patients with a Gleason score of ≥8 and a higher percentage with bone disease (likely a result of less frequent PSA testing). However, PREVAIL also found lower median PSA levels and fewer patients with soft tissue disease and bone pain in the East Asian population .…”

Section: Management Of Advanced Prostate Cancer In the Apac Regionmentioning

confidence: 88%

“…Studies in Asian populations (China, Malaysia, Thailand) suggest no difference in safety data for abiraterone or enzalutamide compared with data from global studies. The APAC APCCC 2018 panellists agreed with the APCCC 2017 conclusions that clinical factors, such as performance status, symptoms, comorbidities, disease site, and extent of disease, are important in influencing choice and sequence of treatment.…”

Section: The Apac Apccc 2018 Outcomesmentioning

confidence: 97%

“…Differences in genetics, environment, lifestyle, diet, and culture are all likely to influence the management of advanced prostate cancer in the APAC region. Some of these differences are highlighted in recent post hoc analyses of data from the PREVAIL trial in different population groups . Whilst numbers are small, differences in the East Asian patients compared with the overall study population included more common upper respiratory tract infection, urinary frequency, falls, and decreased appetite.…”

Section: Management Of Advanced Prostate Cancer In the Apac Regionmentioning

confidence: 99%

Section: Management Of Advanced Prostate Cancer In the Apac Regionmentioning

confidence: 99%

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Management of patients with advanced prostate cancer in the Asia Pacific region: ‘real‐world’ consideration of results from the Advanced Prostate Cancer Consensus Conference (APCCC) 2017

et al. 2018

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As the field continues to evolve, collaboration across the APAC region will be important to facilitate relevant research and collection and appraisal of data relevant to APAC populations. In the meantime, the APAC APCCC 2018 meeting highlighted the critical importance of a multidisciplinary team-based approach to treatment planning and care, delivery of best-practice care by clinicians with appropriate expertise, and the importance of patient information and support for informed patient choice.

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Enzalutamide versus flutamide for castration-resistant prostate cancer after combined androgen blockade therapy with bicalutamide: a retrospective study

et al. 2019

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Background: Alternative anti-androgen therapy (AAT) with flutamide after combined androgen blockade (CAB) therapy with bicalutamide for metastatic prostate cancer is common. However, no studies have compared enzalutamide without AAT with enzalutamide after AAT with flutamide as treatment for castration-resistant prostate cancer (CRPC). We aimed to compare the efficacies of flutamide and enzalutamide for CRPC. Methods: In our hospital, 55 patients were diagnosed with CRPC after CAB therapy and administered flutamide or enzalutamide between May 2014 and December 2017. Patients with flutamide failure were administered enzalutamide. We evaluated the prostate-specific antigen (PSA) best response with initial therapy, 2) PSA progression-free survival with initial therapy (PSA-PFS), 3) PSA best response with enzalutamide therapy, 4) PSA-PFS of enzalutamide therapy, and 5) overall survival (OS). Results: As first-line therapy, patients were administered enzalutamide (n = 29) or flutamide (n = 26). In the flutamide group, 18 patients showed disease progression and were administered enzalutamide. PSA best response was statistically higher in the enzalutamide group. PSA-PFS was significantly longer in the enzalutamide group (hazard ratio (HR) 0.42, 95% confidence interval (CI) 0.19-0.92, p = 0.024). However, there was no significant difference in PSA best response with enzalutamide therapy and PSA-PFS between the first-and second-line enzalutamide therapies (HR 0.80, 95% CI 0.33-1.94, p = 0.62). There was no 4 significant difference in OS between enzalutamide and flutamide groups (HR1.85, 95% CI 0.53-6.42, p = 0.33). Conclusions: AAT with subsequent flutamide after CAB therapy with bicalutamide may be suitable for some CRPC patients.

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Post hoc analyses of East Asian patients from the randomized placebo-controlled PREVAIL trial of enzalutamide in patients with chemotherapy-naïve, metastatic castration-resistant prostate cancer

Abstract: Supplemental Digital Content is available in the text

Cited by 15 publications

References 29 publications

An exploratory retrospective multicenter study of prognostic factors in mCRPC patients undergoing enzalutamide treatment: Focus on early PSA decline and kinetics at time of progression

An exploratory retrospective multicenter study of prognostic factors in mCRPC patients undergoing enzalutamide treatment: Focus on early PSA decline and kinetics at time of progression

Management of patients with advanced prostate cancer in the Asia Pacific region: ‘real‐world’ consideration of results from the Advanced Prostate Cancer Consensus Conference (APCCC) 2017

Enzalutamide versus flutamide for castration-resistant prostate cancer after combined androgen blockade therapy with bicalutamide: a retrospective study

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