Universität zu Köln

Cash, Hannes ORCID: 0000-0002-1064-5633, Steiner, Ursula, Heidenreich, Axel, Klotz, Theodor, Albers, Peter, Melchior, Sebastian, Martus, Peter, Fuller, Florian, Magheli, Ahmed, Hinz, Stefan, Kempkensteffen, Carsten and Miller, Kurt (2018). Intermittent vs continuous docetaxel therapy in patients with metastatic castration-resistant prostate cancer - a phase III study (PRINCE). BJU Int., 122 (5). S. 774 - 783. HOBOKEN: WILEY. ISSN 1464-410X

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Abstract

ObjectivePatient and MethodsTo investigate non-inferiority of intermittent docetaxel compared to continuous docetaxel in patients with metastatic castration-resistant prostate cancer (mCRPC). The investigator initiated randomised phase III study included 187 chemotherapy-naive patients with mCRPC who were allocated to two treatment arms: intermittent docetaxel and continuous docetaxel. Docetaxel was applied in both arms as weekly (35mg/m(2)) or 3-weekly (75mg/m(2)). The primary endpoint was 1-year survival, which was tested for non-inferiority (margin = 0.125). The secondary endpoints were: overall survival (OS), progression-free survival (PFS), median time to treatment failure (TTF), and toxicity. ResultsConclusionOf 156 eligible patients, 78 were allocated to each arm. Theintermittent treatment met the non-inferiority criteria for 1-year survival (two-sided 95% confidence interval, -0.12, 18, P = 0.022), but not for OS, according to the result of a post hoc analysis. The differences between the study arms in PFS and TTF were not significant. The median (range) treatment holiday in the intermittent arm was 110 (13-486) days, or 38% of the overall treatment duration. Safety profiles of both study arms were comparable. The main limitation of this study was that the planned number of patients could not be recruited. Intermittent docetaxel chemotherapy was non-inferior to continuous therapy for 1-year survival; non-inferiority in regard to OS was not reached.

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Cash, Hannes UNSPECIFIED orcid.org/0000-0002-1064-5633 UNSPECIFIED Steiner, Ursula UNSPECIFIED UNSPECIFIED UNSPECIFIED Heidenreich, Axel UNSPECIFIED UNSPECIFIED UNSPECIFIED Klotz, Theodor UNSPECIFIED UNSPECIFIED UNSPECIFIED Albers, Peter UNSPECIFIED UNSPECIFIED UNSPECIFIED Melchior, Sebastian UNSPECIFIED UNSPECIFIED UNSPECIFIED Martus, Peter UNSPECIFIED UNSPECIFIED UNSPECIFIED Fuller, Florian UNSPECIFIED UNSPECIFIED UNSPECIFIED Magheli, Ahmed UNSPECIFIED UNSPECIFIED UNSPECIFIED Hinz, Stefan UNSPECIFIED UNSPECIFIED UNSPECIFIED Kempkensteffen, Carsten UNSPECIFIED UNSPECIFIED UNSPECIFIED Miller, Kurt UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-168333
DOI:	10.1111/bju.14239
Journal or Publication Title:	BJU Int.
Volume:	122
Number:	5
Page Range:	S. 774 - 783
Date:	2018
Publisher:	WILEY
Place of Publication:	HOBOKEN
ISSN:	1464-410X
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language MITOXANTRONE PLUS PREDNISONE; CHEMOTHERAPY; MEN; GUIDELINES; SURVIVAL; ARM Multiple languages Urology & Nephrology Multiple languages
Refereed:	Yes
URI:	http://kups.ub.uni-koeln.de/id/eprint/16833