PMID- 27618249
OWN - NLM
STAT- MEDLINE
DCOM- 20170630
LR  - 20180305
IS  - 1464-410X (Electronic)
IS  - 1464-4096 (Linking)
VI  - 119
IP  - 5
DP  - 2017 May
TI  - Quality of life and pain relief in men with metastatic castration-resistant 
      prostate cancer on cabazitaxel: the non-interventional 'QoLiTime' study.
PG  - 731-740
LID - 10.1111/bju.13658 [doi]
AB  - OBJECTIVE: To examine health-related quality of life (QoL) in men with metastatic 
      castration-resistant prostate cancer (mCRPC) on cabazitaxel. PATIENTS AND 
      METHODS: Men with mCRPC receiving cabazitaxel (25 mg/m(2), every 3 weeks) and 10 
      mg/day oral prednis(ol)one were enrolled (2011-2014) in the non-interventional 
      prospective 'QoLiTime' study. Primary outcome was change in QoL (European 
      Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 
      30-item) with respect to prostate-specific antigen (PSA) response after four 
      cycles of cabazitaxel. Secondary outcomes included occurrence of adverse events 
      (AEs). RESULTS: Of 527 men, 348 received four cycles of cabazitaxel and 266 had 
      the necessary PSA level measurements. After four cycles, 92 (34.6%) men had a PSA 
      level decrease >/=50% (responders). QoL remained stable throughout the study (P = 
      0.62). Change in QoL did not differ between responders and non-responders (P = 
      0.69). Change in PSA level and global health status between baseline and four 
      cycles showed an inversely proportional relationship (correlation coefficient 
      -0.14; 95% confidence interval -0.26 to -0.01; P = 0.03), with increasing PSA 
      level corresponding to lower health status. Responders showed no change in 
      physical functioning vs baseline (-1.75, P = 0.12); non-responders showed a 
      reduction vs baseline (-7.00, P < 0.001) and responders (P = 0.05). Responders 
      showed an improvement in pain vs baseline (-7.61, P = 0.05) and vs non-responders 
      (P = 0.01). AEs occurred in 292 patients (55.4%), most commonly anaemia (16.5%), 
      fatigue (12.3%) and diarrhoea (11.8%). Neutropenia and febrile neutropenia were 
      reported in 3.8% and 3.6% of patients, respectively. CONCLUSION: 
      Prostate-specific antigen level response was associated with stable physical 
      functioning and improvement in pain. Symptom increases were seen in areas typical 
      of chemotoxicity, but QoL was maintained.
CI  - (c) 2016 The Authors BJU International (c) 2016 BJU International Published by John 
      Wiley & Sons Ltd.
FAU - Hofheinz, Ralf-Dieter
AU  - Hofheinz RD
AD  - University Hospital Mannheim, Mannheim, Germany.
FAU - Lange, Carsten
AU  - Lange C
AD  - Private Practice, Bernburg, Germany.
FAU - Ecke, Thorsten
AU  - Ecke T
AD  - Helios Hospital, Bad Saarow, Germany.
FAU - Kloss, Susanne
AU  - Kloss S
AD  - DRK Hospital, Luckenwalde, Germany.
FAU - Linsse, Burkhard
AU  - Linsse B
AD  - Sanofi-Aventis Deutschland GmbH, Berlin, Germany.
FAU - Windemuth-Kieselbach, Christine
AU  - Windemuth-Kieselbach C
AD  - Alcedis GmbH, Giessen, Germany.
FAU - Hammerer, Peter
AU  - Hammerer P
AD  - Academic Hospital Braunschweig, Braunschweig, Germany.
FAU - Al-Batran, Salah-Eddin
AU  - Al-Batran SE
AD  - Institute of Clinical Cancer Research, UCT - University Cancer Center, Frankfurt 
      am Main, Germany.
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20160930
PL  - England
TA  - BJU Int
JT  - BJU international
JID - 100886721
RN  - 0 (Taxoids)
RN  - 51F690397J (cabazitaxel)
RN  - EC 3.4.21.77 (Prostate-Specific Antigen)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Pain/etiology
MH  - Pain Management
MH  - Prospective Studies
MH  - Prostate-Specific Antigen/blood
MH  - Prostatic Neoplasms, Castration-Resistant/blood/complications/*drug therapy
MH  - *Quality of Life
MH  - Taxoids/*therapeutic use
OTO - NOTNLM
OT  - cabazitaxel
OT  - metastatic castration-resistant prostate cancer
OT  - prostate-specific antigen
OT  - quality of life
OT  - survival
EDAT- 2016/09/13 06:00
MHDA- 2017/07/01 06:00
CRDT- 2016/09/13 06:00
PHST- 2016/09/13 06:00 [pubmed]
PHST- 2017/07/01 06:00 [medline]
PHST- 2016/09/13 06:00 [entrez]
AID - 10.1111/bju.13658 [doi]
PST - ppublish
SO  - BJU Int. 2017 May;119(5):731-740. doi: 10.1111/bju.13658. Epub 2016 Sep 30.