Final analysis of intergroup randomized phase III study of androgen deprivation therapy (ADT) plus radiation therapy (RT) in locally advanced prostate cancer (CaP) (NCIC-CTG, SWOG, MRC-UK, INT: T94-0110)

Autor: Mahesh K. B. Parmar, Malcolm David Mason, Michael Brundage, Richard A Cowan, Karen Sanders, John Anderson, Charles Hayter, Ncic-Ctg Pr, Peter Kirkbride, Gregory P. Swanson, Matthew R. Sydes, Padraig Warde, Jinka Sathya, Bingshu E. Chen, J. Hetherington, E. Kostashuk, Jim Barber, Wendy R. Parulekar, Andrea Hiltz, Mary Gospodarowicz, Mrc Uk Pr Investigators
Rok vydání: 2012
Předmět:
Zdroj: Journal of Clinical Oncology. 30:4509-4509
ISSN: 1527-7755
0732-183X
DOI: 10.1200/jco.2012.30.15_suppl.4509
Popis: 4509 Background: Data from the SPCG-7 study and interim analysis of this trial have demonstrated an overall survival (OS) benefit for RT when added to ADT. We present the protocol specified final analysis of PR3/PR07. Methods: Patients with locally advanced (T3/T4, N0/NX, n=1057) or organ-confined prostate cancer (T2,N0/NX, with either PSA > 40 μg/l or PSA > 20 μg/l and Gleason > 8, n=144) were randomized to lifelong ADT (bilateral orchiectomy or LHRH agonist) or ADT + RT (65-69 Gy to prostate + seminal vesicles with or without 45Gy to pelvic nodes). The primary outcome measure was OS; secondary outcomes included disease-specific survival (DSS), time to disease progression and quality of life. Final analysis was planned after 421 deaths. Results: 1,205 patients were randomized from 1995-2005, 602 to ADT alone and 603 to ADT+RT (well balanced with respect to baseline characteristics). The median follow-up is 8.0 years and 465 patients have died (260 ADT, 205 ADT+RT). Adding RT to ADT significantly reduced the risk of death (Hazard Ratio 0.70, 95% CI 0.57-0.85, p=0.001). 199 patients died of disease and/or treatment (134 on ADT alone and 65 on ADT+RT). Competing risk analysis demonstrated that patients on the ADT alone arm had a significantly higher chance of dying of disease related causes than those treated with ADT+RT (10 year cumulative disease specific death rates 15% with ADT+ RT, 26% with ADT alone, p grade II proctitis, 0.3% ADT alone, 1.0% ADT+RT; mean change EORTC Rectal symptoms -0.3 ADT vs 1.7 ADT + RT, p=0.54). Conclusions: Mature data indicate a sustained and substantial overall survival and disease specific survival benefit for ADT+RT in the management of patients with locally advanced prostate cancer with minimal increase in late treatment toxicity. The benefits of combined modality treatment should be discussed with all patients. Supported by NCI-US Grant CA077202, CCSRI Grants #14469 and # 015469, UK Medical Research Council Grant G9805643, UK National Cancer Research Network.
Databáze: OpenAIRE
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