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.

Japanese Journal of Clinical Oncology
Kazuhiro SuzukiHideyasu Matsuyama

Abstract

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. 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). 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 ...Continue Reading

References

Jan 17, 2009·Clinical Cancer Research : an Official Journal of the American Association for Cancer Research·Alain C MitaAnthony W Tolcher
Nov 16, 2010·Drugs of Today·B P Bouchet, C M Galmarini
Apr 17, 2013·Clinical Cancer Research : an Official Journal of the American Association for Cancer Research·Patricia VrignaudMarie-Christine Bissery
Jun 1, 2013·Annals of Oncology : Official Journal of the European Society for Medical Oncology·A BahlUNKNOWN TROPIC Investigators
Feb 4, 2014·Cancer Chemotherapy and Pharmacology·Hirofumi MukaiUNKNOWN TED 11576 investigators
Mar 27, 2015·International Journal of Clinical Oncology·Masahiro NozawaYoshiyuki Kakehi
Aug 28, 2015·International Journal of Urology : Official Journal of the Japanese Urological Association·Naohiro Fujimoto
Jun 4, 2017·International Journal of Urology : Official Journal of the Japanese Urological Association·Atsushi MizokamiHiroyuki Konaka
Jul 2, 2017·International Journal of Urology : Official Journal of the Japanese Urological Association·Yoshiyuki KakehiUNKNOWN committee for establishment of the evidenced-based clinical practice guideline for prostate cancer of the Japanese Urologica
Aug 16, 2017·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Mario EisenbergerJohann de Bono
May 10, 2018·International Journal of Urology : Official Journal of the Japanese Urological Association·Takahiro Kimura, Shin Egawa

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