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Presidential Symposium 2

1922 - Radiotherapy (RT) to the primary tumour for men with newly-diagnosed metastatic prostate cancer (PCa): Survival results from STAMPEDE (NCT00268476)

Date

21 Oct 2018

Session

Presidential Symposium 2

Presenters

Chris Parker

Authors

C.C. Parker1, N.D. James2, C. Brawley3, N.W. Clarke4, G. Attard5, S. Chowdhury6, W. Cross7, D.P. Dearnaley8, C.E. Gilson3, R. Jones9, M.D. Mason10, R. Millman11, S. Gillessen12, C. Eswar13, J. Gale14, J. Lester10, D. Sheehan15, A. Tran16, M.K. Parmar3, M.R. Sydes3

Author affiliations

  • 1 Urology, The Institute of Cancer Research/Royal Marsden NHS Foundation Trust, SM2 5PT - Sutton/GB
  • 2 Clinical Trials Unit, Queen Elizabeth-University Hospital Birmingham NHS Foundation Trust, B15 2TH - Birmingham/GB
  • 3 Mrc Clinical Trials Unit At Ucl, Institute of Clinical Trials and Methodology-UCL, WC2B6NH - London/GB
  • 4 Ngs Foundation Trust, The Christie and Salford Royal Hospitals, Manchester/GB
  • 5 Medical Oncology, The Institute of Cancer Research and The Royal Marsden, SM2 5NG - London/GB
  • 6 -, Guy's and St. Thomas' Hospital NHS Trust, SE1 9RT - London/GB
  • 7 Department Of Urology, LIMM - Leeds Institute of Molecular Medicine, LS9 7TF - Leeds/GB
  • 8 -, The Institute of Cancer Research (ICR), SW7 3RP - London/GB
  • 9 Institute Of Cancer Sciences, University of Glasgow, Glasgow/GB
  • 10 -, Velindre Cancer Centre Velindre Hospital, CF14 2TL - Cardiff/GB
  • 11 Clinical Trials Unit, Medical Research Council - MRC Clinical Trials Unit, NW1 2DA - London/GB
  • 12 Department Of Oncology/hematology  , Kantonsspital St. Gallen, 9007 - St. Gallen/CH
  • 13 -, The Clatterbridge Cancer Centre, L9 7AL - Liverpool/GB
  • 14 -, St. Mary's Hospital Portsmouth Oncology Centre, PO3 6AD - Portsmouth/GB
  • 15 Exeter Oncology Centre, Royal Devon and Exeter Hospital, EX2 5DW - Devon/GB
  • 16 -, The Christie NHS Foundation Trust, M20 4BX - Manchester/GB
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Abstract 1922

Background

Local treatment of the prostate might not only improve local control but also slow progression of metastatic disease. We hypothesised that RT to the prostate would improve overall survival in men presenting with metastatic PCa & that survival benefit would be greater in men with lower metastatic burden.

Methods

STAMPEDE, a multi-arm multi-stage platform protocol, included a randomised phase III comparison to test this hypothesis. Standard-of-care (SOC) was lifelong androgen deprivation therapy (ADT), with early docetaxel permitted from 2016. Stratified randomisation within 12 wk on ADT allocated pts 1:1 to SOC or SOC+RT. Men allocated to RT had daily (55Gy/20f/4wk) or weekly (36Gy/6f/6wk) schedules, started ≤8wk after randomisation or docetaxel. The primary outcome measure (OM) was death from any cause; secondary OMs included failure-free survival (FFS). 90% power & 2.5% 1 sided α for hazard ratio (HR) 0.75 required ~267 control arm deaths. Analyses used Cox proportional hazards & flexible parametric models. Directionally pre-specified subgroup analysis tested effects by metastatic burden at entry.

Results

2061 men with newly-diagnosed M1 PCa were randomised Jan 2013 - Sep 2016. Randomised groups were well balanced: median age 68 yr; median PSA 97ng/ml; 18% early docetaxel; metastatic burden: 40% lower, 54% higher, 6% unknown. Prostate RT improved FFS (HR=0.76, 95%CI 0.68, 0.84) but not overall survival (HR=0.92, 95%CI 0.80, 1.06). Subgroup analysis showed improved overall survival for prostate RT in 819 men with lower metastatic burden (HR=0.68, 95%CI 0.52, 0.90) but not in 1120 men with higher metastatic burden (HR=1.07, 95%CI 0.90, 1.28). RT was well-tolerated during (5% Grd3-4 SOC+ RT) & after treatment (Grd3-4 <1% SOC, 4% SOC+RT).

Conclusions

Radiotherapy to the prostate did not improve survival for unselected patients with newly-diagnosed metastatic prostate cancer, but, in a pre-planned analysis, did improve survival in men with a lower metastatic burden. Therefore, prostate radiotherapy should be a standard treatment option for men with oligometastatic disease.

Clinical trial identification

NCT00268476

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