Dataset Information

Safety and efficacy of cabazitaxel in 660 patients with metastatic castration-resistant prostate cancer in real-world settings: results of a Japanese post-marketing surveillance study.

ABSTRACT: OBJECTIVE:To evaluate the real-world safety and efficacy of cabazitaxel in Japanese patients with metastatic castration-resistant prostate cancer (mCRPC) previously treated with a docetaxel-containing regimen. METHODS:This prospective multicenter observational study registered all patients with mCRPC treated with cabazitaxel following its launch in Japan in September 2014. Patient enrollment continued until at least 500 patients were enrolled. Adverse drug reactions (ADRs) were evaluated according to CTCAE ver. 4.0. Efficacy endpoints were assessed for up to 1 year, and included prostate specific antigen (PSA) response rates (defined as a decrease of ?30% or ?50% from baseline), overall survival (OS), and time to treatment failure (TTF). RESULTS:A total of 660 mCRPC patients were enrolled across 316 centers by June 2016. Frequent ADRs (any grade) were neutropenia (49.1%), febrile neutropenia (18.0%) and anemia (15.0%). Most ADRs occurred in cycle 1. Neutropenia and febrile neutropenia were significantly less frequent in patients who received prophylactic granulocyte colony-stimulating factor. The PSA response rates for decrease of ?30% or ?50% from baseline were 28.1% and 17.5%, respectively, in patients with baseline PSA of ?5 ng/ml. Median OS and TTF were 319 days (95% confidence interval: 293.0-361.0) and 116 days (95% confidence interval: 108.0-135.0), respectively. CONCLUSIONS:This study of cabazitaxel in 660 Japanese patients treated in real-world settings, the largest study of cabazitaxel to date, demonstrated a safety profile that was generally consistent with those of pivotal clinical studies. Cabazitaxel was also effective in terms of the PSA response, OS, and TTF.

SUBMITTER: Suzuki K

PROVIDER: S-EPMC6933873 | biostudies-literature | 2019 Dec

REPOSITORIES: biostudies-literature

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Safety and efficacy of cabazitaxel in 660 patients with metastatic castration-resistant prostate cancer in real-world settings: results of a Japanese post-marketing surveillance study.

Suzuki Kazuhiro K Matsubara Nobuaki N Kazama Hirotaka H Seto Takeshi T Tsukube Shoko S Matsuyama Hideyasu H

Japanese journal of clinical oncology 20191201 12

<h4>Objective</h4>To evaluate the real-world safety and efficacy of cabazitaxel in Japanese patients with metastatic castration-resistant prostate cancer (mCRPC) previously treated with a docetaxel-containing regimen.<h4>Methods</h4>This prospective multicenter observational study registered all patients with mCRPC treated with cabazitaxel following its launch in Japan in September 2014. Patient enrollment continued until at least 500 patients were enrolled. Adverse drug reactions (ADRs) were ev ...[more]

PMID: 31361807

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Project description:BackgroundThe CARD trial was conducted in patients with metastatic castration-resistant prostate cancer (mCRPC) who had received docetaxel and experienced disease progression within 1 year on an androgen receptor-axis-targeted therapy (ARAT). Subsequent treatment with cabazitaxel had improved clinical outcomes compared with an alternative ARAT. This study aims to confirm the effectiveness of cabazitaxel in real-world patients in Japan and compare their characteristics with those of patients from the CARD trial.MethodsThis was a post-hoc analysis of a nationwide post-marketing surveillance registering all patients who were prescribed cabazitaxel in Japan between September 2014 and June 2015. Included patients had received docetaxel and ≤ 1 year of an ARAT (abiraterone or enzalutamide) prior to receiving cabazitaxel or an alternative ARAT, as their third-line therapy. The primary effectiveness endpoint was the time to treatment failure (TTF) of the third-line therapy. Patients were matched (1:1) from the cabazitaxel and second ARAT arms based on propensity score (PS).ResultsOf the 535 patients analysed, 247 received cabazitaxel and 288 the alternative ARAT as their third-line therapy, of which, 91.3% (n = 263/288) received abiraterone and 8.7% (n = 25/288) received enzalutamide as their second third-line ARAT. Patients in the cabazitaxel and second ARAT arms had TNM classification of M1 or MX in 73.3% and 68.1%, Gleason score of 8-10 in 78.5% and 79.2% and mean (standard deviation) serum PSA levels of 483 (1370) and 594 (1241) ng/mL, respectively. Initial cabazitaxel dose was ≤ 20 mg/m2 in 61.9% (n = 153/247) of the patients in the cabazitaxel arm. The median TTF (95% confidence interval [CI]) of the third-line therapy was 109 (94-128) days for cabazitaxel and 58 (57-66) days for the second ARAT, with a hazard ratio (95% CI) of 0.339 (0.279-0.413) favouring cabazitaxel. Similar results were obtained after PS-matching, with a hazard ratio (95% CI) of 0.323 (95% CI 0.258-0.402) favouring cabazitaxel.ConclusionsConsistent with the CARD trial, cabazitaxel demonstrated superior effectiveness over a second alternative ARAT in a real-world patient population in Japan, despite the population having more advanced disease status and a lower dose of cabazitaxel being more frequently administered, than in the CARD trial.

Project description:IntroductionGolimumab is a human monoclonal antibody that inhibits tumor necrosis factor-α (TNF-α). Inhibition of TNF-α by golimumab inhibits the inflammatory response, thereby modulating the immune response in immune-mediated inflammatory diseases. Although the efficacy of golimumab has been demonstrated in randomized controlled trials (RCTs), various patient populations, such as those at high risk of infection, including those with latent tuberculosis and various comorbidities, or on co-administered medications, were excluded from the RCTs. Therefore, safety cannot be sufficiently evaluated by RCTs in the patient group with heterogenous characteristics. The aim of this study was to assess the safety and effectiveness of golimumab in patients with rheumatoid arthritis (RA), psoriatic arthritis (PsA), and ankylosing spondyloarthritis (AS) in a real-world setting in Korea.MethodsWe conducted an open-label, prospective, non-interventional study as post-marketing surveillance. Safety was evaluated by collecting and recording adverse events, and effectiveness was evaluated by assessing disease activity using DAS28-CRP, DAS28-ESR, ACR20, and ASAS20 outcome measures. Multiple logistic regression was performed to identify factors associated with the incidence of adverse events, and changes in disease activity scores from baseline were analyzed using the Wilcoxon signed-rank test.ResultsA total 673 patients were enrolled, of whom 621 were included in the safety analysis. During the study, 97 adverse drug reactions (ADRs) were reported in 62 patients (10.0%). The most frequently reported ADRs were related to infection, including nasopharyngitis (0.8%), upper respiratory tract infection (0.6%), and herpes zoster (0.5%). The mean (± standard deviation) changes from baseline in global disease activity at weeks 12 and 24 were - 3.37 ± 2.529 and - 3.68 ± 2.404, respectively, with statistical significance. In those patients with RA, 72.5 and 47.0% of individuals had a good response based on DAS28-CRP and DAS28-ESR outcomes at week 24. At week 24, 71.4% of patients with PsA had an ACR20 response and 72.9% of patients with AS had an ASAS20 response.ConclusionIn the real-world setting, golimumab was safe and effective in Korean patients with RA, PsA, and AS.

Dataset Information

Safety and efficacy of cabazitaxel in 660 patients with metastatic castration-resistant prostate cancer in real-world settings: results of a Japanese post-marketing surveillance study.

Publications

Safety and efficacy of cabazitaxel in 660 patients with metastatic castration-resistant prostate cancer in real-world settings: results of a Japanese post-marketing surveillance study.

Similar Datasets

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