Quality of life and pain relief in men with metastatic castration-resistant prostate cancer on cabazitaxel: the non-interventional 'QoLiTime' study.

Abstract

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/m², 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.

• Authors: Ralf-Dieter Hofheinz, Carsten Lange, Thorsten Ecke, Susanne Kloss, Burkhard Linsse, Christine Windemuth-Kieselbach, Peter Hammerer, Salah-Eddin Al-Batran
• Journal: BJU international (BJU Int) Vol. 119 Issue 5 Pg. 731-740 (05 2017) ISSN: 1464-410X [Electronic] England
• PMID: 27618249 (Publication Type: Journal Article, Research Support, Non-U.S. Gov't)
• Copyright: © 2016 The Authors BJU International © 2016 BJU International Published by John Wiley & Sons Ltd.

Chemical References

• Taxoids
• cabazitaxel
• Prostate-Specific Antigen

Topics

• Adult
• Aged
• Aged, 80 and over
• Humans
• Male
• Middle Aged
• Pain (etiology)
• Pain Management
• Prospective Studies
• Prostate-Specific Antigen (blood)
• Prostatic Neoplasms, Castration-Resistant (blood, complications, drug therapy)
• Quality of Life
• Taxoids (therapeutic use)