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Randomized Controlled Trial
. 2016 Mar;2(3):348-57.
doi: 10.1001/jamaoncol.2015.4350.

Failure-Free Survival and Radiotherapy in Patients With Newly Diagnosed Nonmetastatic Prostate Cancer: Data From Patients in the Control Arm of the STAMPEDE Trial

Nicholas D James  1 , Melissa R Spears  2 , Noel W Clarke  3 , David P Dearnaley  4 , Malcolm D Mason  5 , Christopher C Parker  4 , Alastair W S Ritchie  2 , J Martin Russell  6 , Francesca Schiavone  2 , Gerhardt Attard  4 , Johann S de Bono  4 , Alison Birtle  7 , Daniel S Engeler  8 , Tony Elliott  9 , David Matheson  10 , Joe O'Sullivan  11 , Delia Pudney  12 , Narayanan Srihari  13 , Jan Wallace  14 , Jim Barber  5 , Isabel Syndikus  15 , Mahesh K B Parmar  2 , Matthew R Sydes  2 ; STAMPEDE Investigators
Affiliations
Randomized Controlled Trial

Failure-Free Survival and Radiotherapy in Patients With Newly Diagnosed Nonmetastatic Prostate Cancer: Data From Patients in the Control Arm of the STAMPEDE Trial

Nicholas D James et al. JAMA Oncol. 2016 Mar.

Erratum in

  • Error in Corresponding Author Address.
    [No authors listed] [No authors listed] JAMA Oncol. 2016 Feb;2(2):279. doi: 10.1001/jamaoncol.2016.0032. JAMA Oncol. 2016. PMID: 26869005 No abstract available.

Abstract

Importance: The natural history of patients with newly diagnosed high-risk nonmetastatic (M0) prostate cancer receiving hormone therapy (HT) either alone or with standard-of-care radiotherapy (RT) is not well documented. Furthermore, no clinical trial has assessed the role of RT in patients with node-positive (N+) M0 disease. The STAMPEDE Trial includes such individuals, allowing an exploratory multivariate analysis of the impact of radical RT.

Objective: To describe survival and the impact on failure-free survival of RT by nodal involvement in these patients.

Design, setting, and participants: Cohort study using data collected for patients allocated to the control arm (standard-of-care only) of the STAMPEDE Trial between October 5, 2005, and May 1, 2014. Outcomes are presented as hazard ratios (HRs) with 95% CIs derived from adjusted Cox models; survival estimates are reported at 2 and 5 years. Participants were high-risk, hormone-naive patients with newly diagnosed M0 prostate cancer starting long-term HT for the first time. Radiotherapy is encouraged in this group, but mandated for patients with node-negative (N0) M0 disease only since November 2011.

Exposures: Long-term HT either alone or with RT, as per local standard. Planned RT use was recorded at entry.

Main outcomes and measures: Failure-free survival (FFS) and overall survival.

Results: A total of 721 men with newly diagnosed M0 disease were included: median age at entry, 66 (interquartile range [IQR], 61-72) years, median (IQR) prostate-specific antigen level of 43 (18-88) ng/mL. There were 40 deaths (31 owing to prostate cancer) with 17 months' median follow-up. Two-year survival was 96% (95% CI, 93%-97%) and 2-year FFS, 77% (95% CI, 73%-81%). Median (IQR) FFS was 63 (26 to not reached) months. Time to FFS was worse in patients with N+ disease (HR, 2.02 [95% CI, 1.46-2.81]) than in those with N0 disease. Failure-free survival outcomes favored planned use of RT for patients with both N0M0 (HR, 0.33 [95% CI, 0.18-0.61]) and N+M0 disease (HR, 0.48 [95% CI, 0.29-0.79]).

Conclusions and relevance: Survival for men entering the cohort with high-risk M0 disease was higher than anticipated at study inception. These nonrandomized data were consistent with previous trials that support routine use of RT with HT in patients with N0M0 disease. Additionally, the data suggest that the benefits of RT extend to men with N+M0 disease.

Trial registration: clinicaltrials.gov Identifier: NCT00268476; ISRCTN78818544.

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Figures

Figure 1
Figure 1. Cohort Selection for Full M0 Cohort and Patient Selection for the Radiotherapy Analysis, in N0M0 and N+M0 Subcohorts
Figure 2
Figure 2. Failure-Free Survival for Reported Radical Radiotherapy Status, in N0M0 and N+M0 Subcohorts
See this image and copyright information in PMC

Comment in

References

    1. James ND, Sydes MR, Clarke NW, et al. STAMPEDE: Systemic Therapy for Advancing or Metastatic Prostate Cancer—a multi-arm multi-stage randomised controlled trial. Clin Oncol (R Coll Radiol) 2008;20(8):577–581. - PubMed
    1. James ND, Sydes MR, Mason MD, et al. STAMPEDE investigators Celecoxib plus hormone therapy versus hormone therapy alone for hormone-sensitive prostate cancer: first results from the STAMPEDE multiarm, multistage, randomised controlled trial. Lancet Oncol. 2012;13(5):549–558. - PMC - PubMed
    1. Sydes MR, James ND, Mason MD, et al. Flexible trial design in practice—dropping and adding arms in STAMPEDE: a multi-arm multi-stage randomised controlled trial. Trials. 2011;12(suppl 1):A3. - PMC - PubMed
    1. Sydes MR, Parmar MK, James ND, et al. Issues in applying multi-arm multi-stage methodology to a clinical trial in prostate cancer: the MRC STAMPEDE Trial. Trials. 2009;10:39. - PMC - PubMed
    1. Sydes MR, Parmar MK, Mason MD, et al. Flexible trial design in practice—stopping arms for lack-of-benefit and adding research arms mid-trial in STAMPEDE: a multi-arm multi-stage randomized controlled trial. Trials. 2012;13:168. - PMC - PubMed

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