Japanese phase I study of cabazitaxel in metastatic castration-resistant prostate cancer

Nozawa, Masahiro; Mukai, Hirofumi; Takahashi, Shunji; Uemura, Hiroji; Kosaka, Takeo; Onozawa, Yusuke; Miyazaki, Jun; Suzuki, Kazuhiro; Okihara, Koji; Arai, Yoichi; Kamba, Tomomi; Kato, Masashi; Nakai, Yasutomo; Furuse, Hiroshi; Kume, Haruki; Ide, Hisamitsu; Kitamura, Hiroshi; Yokomizo, Akira; Kimura, Takahiro; Tomita, Yoshihiko; Ohno, Keiji; Kakehi, Yoshiyuki

doi:10.1007/s10147-015-0820-9

Cited by 37 publications

(56 citation statements)

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“…28 In a phase 1 study of cabazitaxel in Japanese patients previously treated with chemotherapy, 29.3% of 41 patients had a PSA response. 29 Whereas in the overall study population, just 3.5% of placebo-treated patients had a confirmed PSA response, and 21.2% of placebo-treated Japanese patients (seven of 33) had a confirmed PSA response. This might be a result of the use of concomitant corticosteroids, which occurred in five of seven placebo-treated patients, but just five of 17 enzalutamide-treated patients with a confirmed PSA response.…”

Section: Discussionmentioning

confidence: 87%

Enzalutamide in Japanese patients with chemotherapy‐naïve, metastatic castration‐resistant prostate cancer: A post‐hoc analysis of the placebo‐controlled PREVAIL trial

et al. 2016

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Objectives: To evaluate the treatment effects, safety and pharmacokinetics of enzalutamide in Japanese patients. Methods: This was a post-hoc analysis of the phase 3, double-blind, placebocontrolled PREVAIL trial. Asymptomatic or mildly symptomatic chemotherapy-na€ ıve patients with metastatic castration-resistant prostate cancer progressing on androgen deprivation therapy were randomized one-to-one to 160 mg/day oral enzalutamide or placebo until discontinuation on radiographic progression or skeletal-related event and initiation of subsequent antineoplastic therapy. Coprimary end-points were centrally assessed radiographic progression-free survival and overall survival. Secondary endpoints were investigator-assessed radiographic progression-free survival, time to initiation of chemotherapy, time to prostate-specific antigen progression, prostatespecific antigen response (≥50% decline) and time to skeletal-related event.Results: Of 1717 patients, 61 were enrolled in Japan (enzalutamide, n = 28; placebo, n = 33); hazard ratios (95% confidence interval) of 0.30 for centrally assessed radiographic progression-free survival (0.03-2.95), 0.59 for overall survival (0.20-1.8), 0.46 for time to chemotherapy (0.22-0.96) and 0.36 for time to prostate-specific antigen progression (0.17-0.75) showed the treatment benefit of enzalutamide over the placebo. Prostate-specific antigen responses were observed in 60.7% of enzalutamide-treated men versus 21.2% of placebo-treated men. Plasma concentrations of enzalutamide were higher in Japanese patients: the geometric mean ratio of Japanese/non-Japanese patients was 1.126 (90% confidence interval 1.018-1.245) at 13 weeks. Treatment-related adverse events grade ≥3 occurred in 3.6% of enzalutamide-and 6.1% of placebo-treated Japanese patients. Conclusion: Treatment effects and safety in Japanese patients were generally consistent with the overall results from PREVAIL.

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Section: Discussionmentioning

confidence: 87%

Enzalutamide in Japanese patients with chemotherapy‐naïve, metastatic castration‐resistant prostate cancer: A post‐hoc analysis of the placebo‐controlled PREVAIL trial

et al. 2016

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“…Cabazitaxel was approved worldwide for the treatment of patients with mCRPC previously treated with a docetaxel-containing regimen [4–7]. In a phase I study of cabazitaxel in patients with mCRPC in Japan that enrolled patients up to the age of 74 years, PK parameters, safety and tolerability in Japanese patients were found to be comparable to results of previous studies in Caucasian patients, and the MTD was identified as 25 mg/m 2 [8, 9]. However the safety and antitumor activity in higher-age patients more than 74 years have not been fully characterized yet.…”

Section: Introductionmentioning

confidence: 82%

“…Cabazitaxel was the first agent demonstrating a survival benefit in Western CRPC patients progressing during or after docetaxel [1, 8, 9]. A phase I cabazitaxel study in Japan demonstrated the safety and the efficacy of PSA-PFS [8, 9].…”

Section: Discussionmentioning

confidence: 99%

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No significant impact of patient age and prior treatment profile with docetaxel on the efficacy of cabazitaxel in patient with castration-resistant prostate cancer

Kosaka

Hongo

Watanabe

et al. 2018

Cancer Chemother Pharmacol

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BackgroundThe correlation of the oncological outcomes of docetaxel and cabazitaxel in Japanese metastatic castration-resistant prostate cancer (mCRPC) patients has not been unclear.Materials and methodsThis study included a total of 47 consecutive Japanese mCRPC patients treated with cabazitaxel and assessed the prognostic significance of cabazitaxel, focusing on patient age and the correlation of efficacy between docetaxel and cabazitaxel.ResultsProstate-specific antigen (PSA) decline was observed in 27 patients (57.4%), including 19 (40.0%) achieving the response defined by PSA decline ≥ 30%. The median overall survival (OS) periods after the introduction of cabazitaxel was 16.1 months. Twenty (42.6%) were judged to have responded to cabazitaxel with a PSA decrease ≥ 30% from the baseline. A 30% PSA response to cabazitaxel was achieved in 4 (50.0%) patients with ≧ 75 years (n = 8) and 16 (41.0%) patients with less than 75 years (n = 39). There was no significant correlation between the PSA response and patients’ age (p = 0.707). A 30% PSA response to cabazitaxel was achieved in 13 (46.4%) and 7 (36.8%) patients with and without that to docetaxel, respectively. A 30% PSA response to cabazitaxel was achieved in 5 (16.6%) and 7 (41.2%) patients who had treated with less than 10 cycles docetaxel or 10 ≦ cycles, respectively. Univariate and multivariate analyses revealed that there were no significant correlation of patient age (p = 0.537), the response to prior docetaxel therapy (p = 0.339) or cycles of docetaxel therapy (p = 0.379) with shorter OS.ConclusionThese results indicate that the introduction of cabazitaxel for Japanese mCRPC patients could result in oncological outcomes without any association with patient’s age and the profiles of previous docetaxel therapy.Electronic supplementary materialThe online version of this article (10.1007/s00280-018-3698-1) contains supplementary material, which is available to authorized users.

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“…Similar results were obtained in other studies of Asian men with mCRPC, including phase II studies of abiraterone acetate and prednisolone, in which 43% to 60% of Asian patients had a PSA response. [32,33] Similarly, in studies of cabazitaxel in Japanese [34] and Korean, [35] patients with mCRPC previously treated with chemotherapy, PSA responses were achieved by 29% and 32% of patients, respectively.…”

Section: Discussionmentioning

confidence: 99%

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

Choi²,

Lee

et al. 2017

Medicine

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Japanese phase I study of cabazitaxel in metastatic castration-resistant prostate cancer

Cited by 37 publications

References 13 publications

Enzalutamide in Japanese patients with chemotherapy‐naïve, metastatic castration‐resistant prostate cancer: A post‐hoc analysis of the placebo‐controlled PREVAIL trial

Enzalutamide in Japanese patients with chemotherapy‐naïve, metastatic castration‐resistant prostate cancer: A post‐hoc analysis of the placebo‐controlled PREVAIL trial

No significant impact of patient age and prior treatment profile with docetaxel on the efficacy of cabazitaxel in patient with castration-resistant prostate cancer

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

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