Androgen Suppression Plus Radiation Versus Radiation Alone for Patients With Stage D1/Pathologic Node-Positive Adenocarcinoma of the Prostate: Updated Results Based on National Prospective Randomized Trial Radiation Therapy Oncology Group 85-31
- 1 February 2005
- journal article
- clinical trial
- Published by American Society of Clinical Oncology (ASCO) in Journal of Clinical Oncology
- Vol. 23 (4) , 800-807
- https://doi.org/10.1200/jco.2005.08.141
Abstract
Purpose: To update the effect of immediate androgen suppression in conjunction with standard external-beam irradiation versus radiation alone on a group of histologically lymph node-positive patients with adenocarcinoma of the prostate. Materials and Methods: A national prospective randomized trial (Radiation Therapy Oncology Group 85-31) of standard external-beam irradiation plus immediate androgen suppression versus external-beam irradiation alone was initiated in 1985 for patients with locally advanced adenocarcinoma of the prostate. One hundred seventy-three patients in this trial had histologically involved lymph nodes. Ninety-eight patients received radiation plus immediate androgen suppression (luteinizing hormone–releasing hormone [LHRH] agonist), whereas 75 patients received radiation alone with hormonal manipulation instituted at the time of relapse. Results: With a median follow-up of 6.5 years for all patients and 9.5 years for living patients, estimated progression-free survival with prostate-specific antigen (PSA) level less than 1.5 ng/mL at 5 and 9 years was 54% and 10%, respectively, for patients who received immediate LHRH agonist versus 33% and 4% for patients who received radiation alone with hormonal manipulation instituted at time of relapse (P < .0001). Multivariate analysis revealed radiation therapy and immediate hormonal manipulation as having a statistically significant impact on all end points analyzed: absolute survival, disease-specific failure, metastatic failure, and biochemical control with PSA less than 4 ng/mL and less than 1.5 ng/mL. Conclusion: Pending the results of randomized trials, patients with adenocarcinoma of the prostate who have pathologically involved pelvic lymph nodes (pathologic node-positive or clinical stage D1) should be considered for external-beam irradiation plus immediate hormonal manipulation rather than radiation alone with hormone manipulation at the time of relapse.Keywords
This publication has 13 references indexed in Scilit:
- The randomization and stratification of patients to clinical trialsPublished by Elsevier ,2004
- Phase III radiation therapy oncology group (RTOG) trial 86-10 of androgen deprivation adjuvant to definitive radiotherapy in locally advanced carcinoma of the prostateInternational Journal of Radiation Oncology*Biology*Physics, 2001
- Addition of radiation therapy to androgen ablation improves outcome for subclinically node-positive prostate cancerUrology, 2001
- Updated results of the phase III Radiation Therapy Oncology Group (RTOG) trial 85-31 evaluating the potential benefit of androgen suppression following standard radiation therapy for unfavorable prognosis carcinoma of the prostateInternational Journal of Radiation Oncology*Biology*Physics, 2001
- Common toxicity criteria: version 2.0. an improved reference for grading the acute effects of cancer treatment: impact on radiotherapyInternational Journal of Radiation Oncology*Biology*Physics, 2000
- Immediate Hormonal Therapy Compared with Observation after Radical Prostatectomy and Pelvic Lymphadenectomy in Men with Node-Positive Prostate CancerNew England Journal of Medicine, 1999
- Androgen suppression plus radiation versus radiation alone for patients with D1 (pN+) adenocarcinoma of the prostate (results based on a national prospective randomized trial, RTOG 85-31)International Journal of Radiation Oncology*Biology*Physics, 1997
- Combined hormonal and radiation therapy for lymph node-positive prostate cancerUrology, 1995
- A Class of $K$-Sample Tests for Comparing the Cumulative Incidence of a Competing RiskThe Annals of Statistics, 1988
- Nonparametric Estimation from Incomplete ObservationsJournal of the American Statistical Association, 1958