Enzalutamide Versus Abiraterone plus Prednisolone Before Chemotherapy for Castration-resistant Prostate Cancer: A Multicenter Randomized Controlled Trial

Izumi, Kouji; Shima, Takashi; Mita, Koji; Kato, Yuki; Kamiyama, Manabu; Inoue, Shogo; Tanaka, Nobumichi; Hoshi, Seiji; Okamura, Tomonori; Yoshio, Yuko; Enokida, Hideki; Chikazawa, Ippei; Kawai, Noriyasu; Hashimoto, Kimio; Fukushima, Takashi; Shigehara, Kazuyoshi; Takahara, Shizuko; Kadono, Yoshifumi; Mizokami, Atsushi

doi:10.1016/j.euros.2022.04.016

Cited by 8 publications

(6 citation statements)

References 28 publications

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“…13,14 A small, multicenter, randomized controlled trial that compared ABI and ENZ as first-line treatment for CRPC showed that men with ABI presented a higher rate of grade 3-5 AEs (21% vs 11%). 20 In our study, there was a higher reported incidence of fatigue in men receiving ENZ than in ABI (21.8% vs 8.1%, respectively). In addition, the cognitive impairment rate, including memory impairment, disturbance in attention, depression, and abnormal thinking, was higher in men receiving ENZ than ABI (2.9% vs 0.99%, respectively).…”

Section: Discussioncontrasting

confidence: 37%

Adverse Events of Abiraterone Acetate vs Enzalutamide

et al. 2023

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Introduction: This study aimed to highlight the comprehensive differences in adverse events between abiraterone and enzalutamide based on a big data data set. Methods:We downloaded adverse event data sets of abiraterone and enzalutamide from the Food and Drug Administration Adverse Event Reporting System database. We used the Medical Dictionary for Regulatory Activities to treat each adverse event as a preferred term and grouped it into the System Organ Class. Logistic regression analyses were performed to compare abiraterone and enzalutamide.Results: In total, we extracted 59,680 data sets. After exclusion by criteria, we included 26,015 reports on enzalutamide and 7,507 on abiraterone. Enzalutamide and abiraterone presented different toxicity profiles in most System Organ Classes. Overall, the reporting odds ratio indicated a higher incidence rate of serious adverse events for abiraterone than enzalutamide. Conclusions:In conclusion, our findings suggest that both drugs present a discrete and nonoverlapping toxicity profile that varies by System Organ Class and patient age. This data set confirms, for the most part, what has been reported in clinical trials as well as true real-world reports.

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Section: Discussioncontrasting

confidence: 37%

Adverse Events of Abiraterone Acetate vs Enzalutamide

et al. 2023

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“…The percentage of patients without PSA progression at 24 months was 59.7% and 55.0% in the ENZ and ABI arms, respectively. No significant difference was observed in TTPP between the two arms (hazard ratio [HR]: 0.56; 95% confidence interval [CI]: 0.21-1.50; p = 0.2196) [12]. The PSA response rate, defined as a ≥50% decline in the PSA level from baseline, was analyzed.…”

Section: Resultsmentioning

confidence: 99%

“…Nevertheless, no prospective randomized controlled trials investigating the superiority of ENZ and ABI as not sequential use but a single agent in metastatic and nonmetastatic CRPC have been conducted so far. Therefore, we performed a head-to-head investigator-initiated, multicenter, randomized controlled trial (The ENABLE Study for PCa) comparing ENZ and ABI as first-line endocrine therapies before chemotherapy in Japanese patients with CRPC, regardless of metastatic status [12]. The results showed that ENZ did not have any survival benefits compared with ABI.…”

Section: Introductionmentioning

confidence: 99%

Enzalutamide versus Abiraterone Plus Prednisolone for Nonmetastatic Castration-Resistant Prostate Cancer: A Sub-Analysis from the ENABLE Study for PCa

Mita,

Izumi,

Goriki

et al. 2024

Cancers

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Enzalutamide (ENZ) and abiraterone plus prednisolone (ABI) can improve the survival of patients with castration-resistant prostate cancer (CRPC). However, the agent that is more effective against nonmetastatic CRPC remains unclear. To evaluate the agent that can be used as the first-line treatment for CRPC, an investigator-initiated, multicenter, randomized controlled trial (ENABLE Study for PCa) including both metastatic and nonmetastatic CRPC was conducted in Japan. The prostate-specific antigen (PSA) response rate, overall survival, some essential survival endpoints, and safety of patients with nonmetastatic CRPC were also analyzed. In this subanalysis, 15 and 26 patients in the ENZ and ABI arms, respectively, presented with nonmetastatic CRPC. There was no significant difference in terms of the PSA response rate between the ENZ and ABI arms (80% and 64%, respectively; p = 0.3048). The overall survival did not significantly differ between the two arms (HR: 0.68; 95% CI: 0.22–2.14, p = 0.5260). No significant differences were observed in terms of radiographic progression-free survival and cancer-specific survival between the ENZ and ABI arms (HR: 0.81; 95% CI: 0.35–1.84; p = 0.6056 and HR: 0.72; 95% CI: 0.19–2.73; p = 0.6443, respectively). Only four and six patients in the ENZ and ABI arms, respectively, had ≥grade 3 adverse events. ABI and ENZ had similar efficacy and safety profiles in patients with nonmetastatic CRPC.

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“…While still in the drug discovery phase, it remains a promising therapeutic target due to its ability to bind only to CCR6 and its association with several immunological diseases. In addition, there have been reports that several AR‐axis targets are available for the treatment of prostate cancer, but there is no difference in efficacy 24 . Therefore, it is expected that developing drugs with entirely different points of action will satisfy unmet needs.…”

Section: Discussionmentioning

confidence: 99%

“…In addition, there have been reports that several AR‐axis targets are available for the treatment of prostate cancer, but there is no difference in efficacy. 24 Therefore, it is expected that developing drugs with entirely different points of action will satisfy unmet needs.…”

Section: Discussionmentioning

confidence: 99%

Suppression of androgen receptor signaling induces prostate cancer migration via activation of the CCL20–CCR6 axis

et al. 2022

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The suppression of androgen receptor (AR) expression exacerbates the migration potential of prostate cancer. This study identified a previously unrecognized regulation of the AR‐controlled pathway that promotes migration potential in prostate cancer cells. Prostate cancer cells that pass through a transwell membrane (mig cells) have a higher migration potential with a decreased AR expression than parental cells. In this study, we aimed to elucidate the mechanism of migration enhancement associated with the suppression of AR signaling. Expression of C–C motif ligand 20 (CCL20) is upregulated in mig cells, unlike in the parental cells. Knockdown of AR with small interfering RNA (siAR) in LNCaP and C4‐2B cells increased CCL20 secretion and enhanced the migration of cancer cells. Mig cells, CCL20‐treated cells, and siAR cells promoted cell migration with an enhancement of AKT phosphorylation and Snail expression, while the addition of a C–C chemokine receptor 6 (CCR6, the specific receptor of CCL20) inhibitor, anti‐CCL20 antibody, and AKT inhibitor suppressed the activation of AKT and Snail. With 59 samples of prostate cancer tissue, CCL20 secretion was profuse in metastatic cases despite low AR expression levels. Snail expression was associated with the expression of CCL20 and CCR6. A xenograft study showed that the anti‐CCL20 antibody significantly inhibited Snail expression, thereby suggesting a new therapeutic approach for castration‐resistant prostate cancer with the inhibition of the axis between CCL20 and CCR6.

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Enzalutamide Versus Abiraterone plus Prednisolone Before Chemotherapy for Castration-resistant Prostate Cancer: A Multicenter Randomized Controlled Trial

Cited by 8 publications

References 28 publications

Adverse Events of Abiraterone Acetate vs Enzalutamide

Adverse Events of Abiraterone Acetate vs Enzalutamide

Enzalutamide versus Abiraterone Plus Prednisolone for Nonmetastatic Castration-Resistant Prostate Cancer: A Sub-Analysis from the ENABLE Study for PCa

Suppression of androgen receptor signaling induces prostate cancer migration via activation of the CCL20–CCR6 axis

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