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Addition of docetaxel to hormonal therapy in low- and high-burden metastatic hormone sensitive prostate cancer: long-term survival results from the STAMPEDE trial.

Authors :
Clarke NW
Ali A
Ingleby FC
Hoyle A
Amos CL
Attard G
Brawley CD
Calvert J
Chowdhury S
Cook A
Cross W
Dearnaley DP
Douis H
Gilbert D
Gillessen S
Jones RJ
Langley RE
MacNair A
Malik Z
Mason MD
Matheson D
Millman R
Parker CC
Ritchie AWS
Rush H
Russell JM
Brown J
Beesley S
Birtle A
Capaldi L
Gale J
Gibbs S
Lydon A
Nikapota A
Omlin A
O'Sullivan JM
Parikh O
Protheroe A
Rudman S
Srihari NN
Simms M
Tanguay JS
Tolan S
Wagstaff J
Wallace J
Wylie J
Zarkar A
Sydes MR
Parmar MKB
James ND
Source :
Annals of oncology : official journal of the European Society for Medical Oncology [Ann Oncol] 2019 Dec 01; Vol. 30 (12), pp. 1992-2003.
Publication Year :
2019

Abstract

Background: STAMPEDE has previously reported that the use of upfront docetaxel improved overall survival (OS) for metastatic hormone naïve prostate cancer patients starting long-term androgen deprivation therapy. We report on long-term outcomes stratified by metastatic burden for M1 patients.<br />Methods: We randomly allocated patients in 2 : 1 ratio to standard-of-care (SOC; control group) or SOC + docetaxel. Metastatic disease burden was categorised using retrospectively-collected baseline staging scans where available. Analysis used Cox regression models, adjusted for stratification factors, with emphasis on restricted mean survival time where hazards were non-proportional.<br />Results: Between 05 October 2005 and 31 March 2013, 1086 M1 patients were randomised to receive SOC (n = 724) or SOC + docetaxel (n = 362). Metastatic burden was assessable for 830/1086 (76%) patients; 362 (44%) had low and 468 (56%) high metastatic burden. Median follow-up was 78.2 months. There were 494 deaths on SOC (41% more than the previous report). There was good evidence of benefit of docetaxel over SOC on OS (HR = 0.81, 95% CI 0.69-0.95, P = 0.009) with no evidence of heterogeneity of docetaxel effect between metastatic burden sub-groups (interaction P = 0.827). Analysis of other outcomes found evidence of benefit for docetaxel over SOC in failure-free survival (HR = 0.66, 95% CI 0.57-0.76, P < 0.001) and progression-free survival (HR = 0.69, 95% CI 0.59-0.81, P < 0.001) with no evidence of heterogeneity of docetaxel effect between metastatic burden sub-groups (interaction P > 0.5 in each case). There was no evidence that docetaxel resulted in late toxicity compared with SOC: after 1 year, G3-5 toxicity was reported for 28% SOC and 27% docetaxel (in patients still on follow-up at 1 year without prior progression).<br />Conclusions: The clinically significant benefit in survival for upfront docetaxel persists at longer follow-up, with no evidence that benefit differed by metastatic burden. We advocate that upfront docetaxel is considered for metastatic hormone naïve prostate cancer patients regardless of metastatic burden.<br /> (© The Author(s) 2019. Published by Oxford University Press on behalf of the European Society for Medical Oncology.)

Details

Language :
English
ISSN :
1569-8041
Volume :
30
Issue :
12
Database :
MEDLINE
Journal :
Annals of oncology : official journal of the European Society for Medical Oncology
Publication Type :
Academic Journal
Accession number :
31560068
Full Text :
https://doi.org/10.1093/annonc/mdz396