754O - Impact of node status and radiotherapy on failure-free survival in patients with newly diagnosed non-metastatic prostate cancer: Data from >690 pat...

Date 28 September 2014
Event ESMO 2014
Session Genitourinary tumours, prostate 1
Topics Prostate Cancer
Pathology/Molecular Biology
Surgery and/or Radiotherapy of Cancer
Presenter Chris Parker
Citation Annals of Oncology (2014) 25 (suppl_4): iv255-iv279. 10.1093/annonc/mdu336
Authors N. James1, M. Spears2, N.W. Clarke3, M. Sydes2, C. Parker4, D. Dearnaley5, J.M. Russell6, A. Ritchie2, G. Thalmann7, J.S. De Bono8, G. Attard9, C. Amos2, M.K. Parmar2, M. Mason10
  • 1Warwick Medical School, University of Warwick, CV4 7AL - Coventry/GB
  • 2Mrc Ctu At Ucl, UCL, WC2B 6NH - London/GB
  • 3Department Of Urology, Hope Hospital, The Christie NHS Foundation Trust, Salford/GB
  • 4Dept Of Clinical Oncology And Radiotherapy, Royal Marsden Hospital, Sutton/GB
  • 5Academic Radiotherapy, The Royal Marsden NHS Foundation Trust and Institute of Cancer Research ICR, SM25PT - Sutton/GB
  • 6Beatson Oncology Centre, Beatson West of Scotland Cancer Centre, Glasgow/GB
  • 7Department Of Urology, University of Bern, Bern/CH
  • 8Academic Unit Of Radiotherapy & Oncology, The Royal Marsden NHS Foundation Trust and The Institute of Cancer Research ICR, SM25PT - Sutton/GB
  • 9Icr, The Royal Marsden NHS Foundation Trust and Institute of Cancer Research ICR, SM25PT - Sutton/GB
  • 10Section Of Clinical Oncology, Velindre Cancer Centre Velindre Hospital, Cardiff/GB

Abstract

Aim

The natural history of patients (pts) with newly diagnosed high-risk non-metastatic (M0) prostate cancer receiving androgen deprivation therapy (ADT) either alone or with standard of care radiotherapy (RT) at 6 to 9 months is not well documented. Further, no RCT has tested RT in N + M0 patients; none are planned. The STAMPEDE RCT (NCT00268476; MRC PR08; CRUK/06/019) includes such pts & allows exploratory multivariate analysis of radical RT's impact. We report data from trial pts. We hypothesised that planning RT in N + M0 pts improves survival outcomes.

Methods

Newly diagnosed pts with confirmed M0 disease in the control arm (standard of care = ADT planned for >2yr), diagnosed <6 months pre-randomisation & on ADT for 0-12 weeks already, were identified from trial records in Jan-2014. RT is encouraged in this group, but only mandated for N0M0 pts since Nov-2011. We report failure-free survival (FFS), driven by PSA failure, & overall survival (OS); split by nodal involvement & reported RT status. Standard survival analysis methods were used, adjusting for age & PSA.

Results

5272 men were recruited Oct-2005 to Jan-2014, including a cohort of 694 M0 pts with newly diagnosed disease allocated to the control arm: median age 66yr (IQR 61-71), median time from diagnosis to randomisation 2.6m (IQR 2.0-3.3) & median PSA 42ng/ml (IQR 17-88) at diagnosis. By Jan-2014, there were 34 deaths; 25 from prostate cancer. Median follow-up is short, but 2yr OS is 95% (95%CI 92, 97) & 2yr FFS is 79% (95%CI 75, 83). Median FFS is 63 months; 79% (94/119) report PSA failure-only as first FFS event. Time to FFS is worse in N+ pts (HR 1.87, 95%CI 1.29-2.72). Baseline characteristics were comparable by planned RT status, but N0M0 pts planned for RT had lower PSA at diagnosis & more WHO PS = 0. The Table shows that FFS outcomes clearly favour the planned use of RT.

Group N.Pts 2-year FFS (95% CI) Adjusted HR (95% CI)
N0M0 not planned for RT 59 69% (56% - 79%) Reference
N0M0 planned for RT 121 94% (88% - 97%) 0.33 (0.18-0.62)
N + M0 not planned for RT 71 55% (41% - 67%) Reference
N + M0 planned for RT 84 85% (75% - 91%) 0.45 (0.25-0.80)

Conclusions

2 year survival is encouraging in M0 pts & higher than originally expected. Our prospectively-collected, non-randomised data strongly support routine use of RT with ADT in N0M0 pts (consistent with MRC PR07/NCIC PR.3 & SPCG7) and suggest the advantage may extend to N + M0 pts.

Disclosure

All authors have declared no conflicts of interest.