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

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.

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

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.

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

Failure-free survival (FFS) and overall survival.

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]).

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.

clinicaltrials. gov Identifier: NCT00268476; ISRCTN78818544.

JAMA oncology. 2015 Nov 25 [Epub ahead of print]

Nicholas D James, Melissa R Spears, Noel W Clarke, David P Dearnaley, Malcolm D Mason, Christopher C Parker, Alastair W S Ritchie, J Martin Russell, Francesca Schiavone, Gerhardt Attard, Johann S de Bono, Alison Birtle, Daniel S Engeler, Tony Elliott, David Matheson, Joe O'Sullivan, Delia Pudney, Narayanan Srihari, Jan Wallace, Jim Barber, Isabel Syndikus, Mahesh K B Parmar, Matthew R Sydes, STAMPEDE Investigators

Warwick Medical School, University of Warwick, Coventry, United Kingdom2University Hospitals Birmingham NHS Foundation Trust, The Medical School, University of Birmingham, Birmingham, United Kingdom. , Medical Research Council Clinical Trials Unit, University College, London, United Kingdom. , Department of Urology, Christie NHS Foundation Trust, Manchester, United Kingdom. , Institute of Cancer Research and Royal Marsden NHS Foundation Trust, London, United Kingdom. , Velindre Hospital, Cardiff, United Kingdom. , Institute of Cancer Research and Royal Marsden NHS Foundation Trust, London, United Kingdom. , Medical Research Council Clinical Trials Unit, University College, London, United Kingdom. , Institute of Cancer Sciences, University of Glasgow, Glasgow, United Kingdom. , Medical Research Council Clinical Trials Unit, University College, London, United Kingdom. , Institute of Cancer Research and Royal Marsden NHS Foundation Trust, London, United Kingdom. , Institute of Cancer Research and Royal Marsden NHS Foundation Trust, London, United Kingdom. , Royal Preston Hospital, Preston, United Kingdom. , Cantonal Hospital St Gallen, St Gallen, Switzerland. , Greater Manchester Group, Manchester, United Kingdom. , Leeds Beckett University, Leeds, United Kingdom. , Belfast City Hospital, Belfast, United Kingdom. , Singleton Hospital, Swansea, United Kingdom. , Royal Shrewsbury Hospital, Shrewsbury, United Kingdom. , Beatson West of Scotland Cancer Centre, Glasgow, United Kingdom. , Velindre Hospital, Cardiff, United Kingdom. , CCO Liverpool Warrington Aintree, Liverpool, United Kingdom. , Medical Research Council Clinical Trials Unit, University College, London, United Kingdom. , Medical Research Council Clinical Trials Unit, University College, London, United Kingdom.

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