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Publication Detail
Docetaxel for nonmetastatic prostate cancer: long-term survival outcomes in the STAMPEDE randomized controlled trial
  • Publication Type:
    Journal article
  • Authors:
    James ND, Ingleby FC, Clarke NW, Amos C, Attard G, Brawley CD, Chowdhury S, Cross W, Dearnaley DP, Gilbert DC, Gillessen S, Jones RJ, Langley RE, Macnair A, Malik ZI, Mason MD, Matheson DJ, Millman R, Parker CC, Rush HL, Russell JM, Au C, Ritchie AWS, Mestre RP, Ahmed I, Birtle AJ, Brock SJ, Das P, Ford VA, Gray EK, Hughes RJ, Manetta CB, McLaren DB, Nikapota AD, O'Sullivan JM, Perna C, Peedell C, Protheroe AS, Sundar S, Tanguay JS, Tolan SP, Wagstaff J, Wallace JB, Wylie JP, Zarkar A, Parmar MKB, Sydes MR
  • Publisher:
    Oxford University Press (OUP)
  • Publication date:
  • Journal:
    JNCI Cancer Spectrum
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  • Issue:
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  • Notes:
    © 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.
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.
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