James, Nicholas D;
Ingleby, Fiona C;
Clarke, Noel W;
Amos, Claire;
Attard, Gerhardt;
Brawley, Christopher D;
Chowdhury, Simon;
... Sydes, Matthew R; + view all
(2022)
Docetaxel for nonmetastatic prostate cancer: long-term survival outcomes in the STAMPEDE randomized controlled trial.
JNCI Cancer Spectrum
, 6
(4)
, Article pkac043. 10.1093/jncics/pkac043.
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Abstract
BACKGROUND: STAMPEDE previously reported adding upfront docetaxel improved overall survival for prostate cancer patients starting long-term androgen deprivation therapy (ADT). We report long-term results for non-metastatic patients using, as primary outcome, metastatic progression-free survival (mPFS), an externally-demonstrated surrogate for overall survival. METHODS: Standard-of-care (SOC) was ADT+/-radical prostate radiotherapy (RT). 460 SOC and 230 SOC+Doc were randomized 2:1. Standard survival methods and intention-to-treat were used. Treatment effect estimates were summarized from adjusted Cox regression models, switching to restricted mean survival time (RMST) if non-proportional (non-PH) hazards. mPFS (new metastases, skeletal-related events or prostate cancer death) had 70% power (α = 0.05) for HR = 0.70. Secondary outcome measures included overall survival, failure-free survival (FFS) and progression-free survival (PFS: mPFS, locoregional progression). RESULTS: Median follow-up was 6.5 yr with 142 mPFS events on SOC (3 yr and 54% increases over previous report). There was no good evidence of an advantage to SOC+Doc on mPFS (HR = 0.89, 95%CI : 0.66-1.19, P = .43); with 5 yr mPFS 82% (95%CI : 78%-87%) SOC+Doc vs. 77% (95%CI : 73%-81%) SOC. Secondary outcomes showed evidence SOC+Doc improved FFS (HR = 0.70, 95%CI 0.55-0.88, P = .002) and PFS (non-PH P = .033, RMST difference = 5.8 m, 95%CI : 0.5-11.2, P = .031), but no good evidence of overall survival benefit (125 SOC deaths; HR = 0.88, 95%CI : 0.64-1.21, P = .442). There was no evidence SOC+Doc increased late toxicity: post-1yr, 29% SOC and 30% SOC+Doc G3-5 toxicity. CONCLUSIONS: There is robust evidence SOC+Doc improved FFS and PFS (previously shown to increase Quality-Adjusted-Life-Years), without excess late toxicity, which did not translates into benefit for longer-term outcomes. This may influence patient management in individual cases. TRIAL IDENTIFICATION: NCT00268476.
| Type: | Article |
|---|---|
| Title: | Docetaxel for nonmetastatic prostate cancer: long-term survival outcomes in the STAMPEDE randomized controlled trial |
| Location: | England |
| Open access status: | An open access version is available from UCL Discovery |
| DOI: | 10.1093/jncics/pkac043 |
| Publisher version: | https://doi.org/10.1093/jncics/pkac043 |
| Language: | English |
| Additional information: | © The Author(s) 2022. Published by Oxford University Press. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted reuse, distribution, and reproduction in any medium, provided the original work is properly cited. |
| UCL classification: | UCL UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences > Inst of Clinical Trials and Methodology > MRC Clinical Trials Unit at UCL UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences > Inst of Clinical Trials and Methodology UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences |
| URI: | https://discovery.ucl.ac.uk/id/eprint/10153003 |
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