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

Publikation

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

Wissenschaftlicher Artikel/Review - 01.03.2016

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

Zitation

James N, Elliott T, Matheson D, O'Sullivan J, Pudney D, Srihari N, Wallace J, Barber J, Syndikus I, Parmar M, Sydes M, Engeler D, Birtle A, Spears M, Clarke N, Dearnaley D, Mason M, Parker C, Ritchie A, Russell J, Schiavone F, Attard G, de Bono J. Failure-Free Survival and Radiotherapy in Patients With Newly Diagnosed Nonmetastatic Prostate Cancer: Data From Patients in the Control Arm of the STAMPEDE Trial. JAMA Oncol 2016; 2:348-57.

Art

Wissenschaftlicher Artikel/Review (Englisch)

Zeitschrift

JAMA Oncol 2016; 2

Veröffentlichungsdatum

01.03.2016

eISSN (Online)

2374-2445

Seiten

348-57

Kurzbeschreibung/Zielsetzung

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.