Biweekly cabazitaxel as post-docetaxel treatment for metastatic castration resistant prostate cancer (mCRPC): Findings from an early safety analysis of the Prosty II trial

Autor:	Mikko Taalikka, Pirkko-Liisa Kellokumpu-Lehtinen, Tapio Utriainen, Anna-Liisa Kautio, Marjaana Luukkaa, Petteri Hervonen, Vesa Kataja, Timo Marttila
Rok vydání:	2015
Předmět:	Oncology Cancer Research medicine.medical_specialty Performance status business.industry Neutropenia medicine.disease Surgery Prostate cancer Docetaxel Cabazitaxel Internal medicine medicine Clinical endpoint Dosing business Adverse effect medicine.drug
Zdroj:	Journal of Clinical Oncology. 33:276-276
ISSN:	1527-7755 0732-183X
Popis:	276 Background: Docetaxel (D) administered at 2-week intervals was better tolerated than the standard 3-week D in mCRPC. In addition, the overall survival was better with the 2-weekly D dosing in our Prosty I trial (Kellokumpu-Lehtinen et al. Lancet Oncol 2013;14:117-124). The aim of the Prosty II trial was to evaluate the safety of 2-weekly cabazitaxel (C) as post-docetaxel treatment for m CRPC. The safety of the first 40 patient (pts) is reported below. Methods: 40 pts were allocated to receive C 16 mg/m² i.v. d1 and d14 q4 wks. At baseline, WHO performance status was 0 in 33% of pts and 1 in 67% of pts and the median serum PSA level was 342 µg/L (range 3.7-2425)). The primary endpoint was safety. Study identifier: NCT01558219. Results: A total number of 144 cycles of C were administered. No prophylactic G-CSF was used. The most common Grade 3/4 adverse events (AE, expressed as % pts experienced Grade3 or Grade 4 AE) were neutropenia 12.5/2.5%, pain 12.5/0%, fatique 5/2.5%, anemia 5.0/0%, neutropenic infections 2.5/0%, leucopenia 2.5/0%, mucositis 2.5/0%, increase of alkaline phosphatase 5/0% and limb edema 2.5/0. In addition one Grade 4 pulmonary embolism and one intracerebral hemorrhage occurred. In one pt, cancer related bone fracture occurred during the second C cycle (Grade 4 AE). Altogether up to cycle 6 no AE was reported in 1 pt (2.5%), Grade 1 AE in 3 pts (7.5%), Grade 2 in 17 pts (42.5%), Grade 3 in 13 pts (32.5%) and Grade 4 in 5 pts (12.5%). Conclusions: Biweekly cabazitaxel seems to be well tolerated treatment for heavily pretreated advanced mCRPC patients.
Databáze:	OpenAIRE
Externí odkaz:	https://explore.openaire.eu/search/publication?articleId=doi_________::c3dc2f6871f7e732a32ce886f9b98c6a https://doi.org/10.1200/jco.2015.33.7_suppl.276 Zobrazit plný text záznamu