Meeting
2016 Genitourinary Cancers Symposium
NRG Oncology/RTOG 9601, a phase III trial in prostate cancer patients: Anti-androgen therapy (AAT) with bicalutamide during and after salvage radiation therapy (RT) following radical prostatectomy (RP) and an elevated PSA.
Authors
William U. Shipley
Massachusetts General Hospital, Harvard Medical School, Boston, MA
William U. Shipley , Stephanie L. Pugh , Himu R. Lukka , Pierre Major , Niall M. Heney , David A. Grignon , Oliver Sartor , Malti Patel , Jean-Paul Bahary , Anthony L. Zietman , Thomas Michael Pisansky , Kenneth Lee Zeitzer , Colleen Anne Lawton , Felix Yi-Chung Feng , Richard Dana Lovett , Alexander G. Balogh , Luis Souhami , Seth A. Rosenthal , Kevin Kerlin , Howard M. Sandler
Organizations
Massachusetts General Hospital, Harvard Medical School, Boston, MA, Statistical Center, Radiation Therapy Oncology Group, Philadelphia, PA, Juravinski Cancer Centre, Hamilton, ON, Canada, McMaster University, Juravinski Cancer Centre, Hamilton Health Sciences, Hamilton, ON, Canada, Massachusetts General Hospital, Boston, MA, Indiana University Medical School, Indianapolis, IN, Tulane University School of Medicine, New Orleans, LA, McMaster University, Hamilton, ON, Canada, Department of Radiation Oncology, Centre Hospitalier de l'Université de Montréal, Montreal University, Montreal, QC, Canada, Mayo Clinic, Rochester, MN, Albert Einstein Medical Center, Philadelphia, PA, Medical College of Wisconsin, Milwaukee, WI, University of Michigan, Ann Arbor, MI, Rutland Regional Medical Center, Rutland, VT, Tom Baker Cancer Center, Calgary, AB, Canada, Department of Radiation Oncology, McGill University Health Centre, Montreal, QC, Canada, Sutter Cancer Center, Sacramento, CA, Southeast Cancer Control Consortium, Goldsboro, NC, Cedars-Sinai Medical Center, Los Angeles, CA
Research Funding
NIH
Background: Previous reports suggested that AAT when combined with salvage RT following RP in patients may improve prostate cancer control outcomes. Methods: Post-RP patients with pT3pN0 or with pT2pN0 and positive margins who had or developed elevated PSA levels from 0.2 to 4.0 ng/ml were randomized on a phase III, double-blind, trial of RT + placebo (64.8 Gy in 36 fractions of 1.8 Gy) vs. RT + AAT (24 months bicalutamide, 150 mg daily) during and after RT. The primary end-point was overall survival. Trial design required 725 patients and provided 80% power to detect a reduction in death rate by at least 28.5% and a 1-sided significance level of 0.046. Results: From 3/98 to 3/03, 761 eligible patients (median age 65) were randomized to RT + AAT (384) or RT + placebo (377). 248 patients (33%) were pT2pN0 and 513 (67%) were pT3pN0. 671 (88%) had a PSA nadir after RP of < 0.5 ng/ml. 649 (85%) had an entry PSA value of <1.6, 112 patients (15%) had an entry PSA of 1.6-4. Median follow up was 12.6 years. Actuarial overall survival at 10 years was 82% for RT plus AAT and 78% for RT + placebo and a hazard ratio of 0.75 (95% CI: 0.58-0.98) with a 1-sided p value of 0.018 (2-sided p = 0.036). The 12-year incidence of PC central-reviewed deaths were 2.3% for RT + AAT and 7.5% for RT + placebo ( p< 0.001).The cumulative incidence of metastatic PC at 12 years was less in the RT + AAT arm, 14% (51 patients), vs. 23% (83 patients) in the RT + placebo arm (p < 0.001). Subgroup analyses of the relative benefits of the addition of AAT to RT are planned and will be presented. Late grade III and IV toxicity were similar in the AAT and placebo arms. The combined grade III and IV toxicities for RT + AAT and RT + placebo were: bladder 7.0% vs. 6.7%, bowel 2.7% vs. 1.6%. Gynecomastia differed significantly by treatment arm, 70% vs. 11%. Conclusions: 24 months of AAT using 150mg bicalutamide daily during and after salvage RT significantly improved long term overall survival and reduced the incidence of metastatic PC and PC death. Support: NCI grants U10CA21661, U10CA180868, U10CA180822, and U10CA37422 and AstraZeneca. Clinical trial information: NCT00002874
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Abstract Details
Session Type
Poster Session
Session Title
Poster Session A: Prostate Cancer
Track
Prostate Cancer,Prostate Cancer
Sub Track
Prostate Cancer - Localized Disease
Clinical Trial Registration Number
NCT00002874
Citation
J Clin Oncol 34, 2016 (suppl 2S; abstr 3)
DOI
10.1200/jco.2016.34.2_suppl.3
Abstract #
3
Poster Bd #
A3
Abstract Disclosures
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