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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.
- Source :
-
Japanese journal of clinical oncology [Jpn J Clin Oncol] 2019 Dec 27; Vol. 49 (12), pp. 1157-1163. - Publication Year :
- 2019
-
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.<br />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).<br />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.<br />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.<br /> (© The Author(s) 2019. Published by Oxford University Press.)
- Subjects :
- Aged
Aged, 80 and over
Antineoplastic Agents adverse effects
Asian People
Docetaxel therapeutic use
Drug-Related Side Effects and Adverse Reactions epidemiology
Drug-Related Side Effects and Adverse Reactions prevention & control
Granulocyte Colony-Stimulating Factor therapeutic use
Humans
Kallikreins metabolism
Male
Middle Aged
Product Surveillance, Postmarketing
Prospective Studies
Prostate-Specific Antigen metabolism
Prostatic Neoplasms, Castration-Resistant pathology
Safety
Taxoids adverse effects
Treatment Outcome
Antineoplastic Agents therapeutic use
Prostatic Neoplasms, Castration-Resistant drug therapy
Taxoids therapeutic use
Subjects
Details
- Language :
- English
- ISSN :
- 1465-3621
- Volume :
- 49
- Issue :
- 12
- Database :
- MEDLINE
- Journal :
- Japanese journal of clinical oncology
- Publication Type :
- Academic Journal
- Accession number :
- 31361807
- Full Text :
- https://doi.org/10.1093/jjco/hyz108