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Failure-free survival and radiotherapy in patients with newly diagnosed nonmetastatic prostate cancer
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(2016) Failure-free survival and radiotherapy in patients with newly diagnosed nonmetastatic prostate cancer. JAMA Oncology, 2 (3). pp. 348-357. doi:10.1001/jamaoncol.2015.4350 ISSN 2374-2437. An open access version can be found in:
Official URL: http://dx.doi.org/10.1001/jamaoncol.2015.4350
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.
Item Type: | Journal Article | ||||||
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Divisions: | Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School > Health Sciences > Cancer Research Unit Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School |
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Journal or Publication Title: | JAMA Oncology | ||||||
Publisher: | American Medical Association | ||||||
ISSN: | 2374-2437 | ||||||
Official Date: | March 2016 | ||||||
Dates: |
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Volume: | 2 | ||||||
Number: | 3 | ||||||
Page Range: | pp. 348-357 | ||||||
DOI: | 10.1001/jamaoncol.2015.4350 | ||||||
Status: | Peer Reviewed | ||||||
Publication Status: | Published | ||||||
Access rights to Published version: | Open Access (Creative Commons) | ||||||
Open Access Version: |
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