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Clinical Trial
. 2017 Jun 1;98(2):296-303.
doi: 10.1016/j.ijrobp.2017.02.004. Epub 2017 Feb 12.

Duration of Androgen Deprivation in Locally Advanced Prostate Cancer: Long-Term Update of NRG Oncology RTOG 9202

Affiliations
Clinical Trial

Duration of Androgen Deprivation in Locally Advanced Prostate Cancer: Long-Term Update of NRG Oncology RTOG 9202

Colleen A F Lawton et al. Int J Radiat Oncol Biol Phys. .

Abstract

Purpose: Trial RTOG 9202 was a phase 3 randomized trial designed to determine the optimal duration of androgen deprivation therapy (ADT) when combined with definitive radiation therapy (RT) in the treatment of locally advanced nonmetastatic adenocarcinoma of the prostate. Long-term follow-up results of this study now available are relevant to the management of this disease.

Methods and materials: Men (N=1554) with adenocarcinoma of the prostate (cT2c-T4, N0-Nx) with a prostate-specific antigen (PSA) <150 ng/mL and no evidence of distant metastasis were randomized (June 1992 to April 1995) to short-term ADT (STAD: 4 months of flutamide 250 mg 3 times per day and goserelin 3.6 mg per month) and definitive RT versus long-term ADT (LTAD: STAD with definitive RT plus an additional 24 months of monthly goserelin).

Results: Among 1520 protocol-eligible and evaluable patients, the median follow-up time for this analysis was 19.6 years. In analysis adjusted for prognostic covariates, LTAD improved disease-free survival (29% relative reduction in failure rate, P<.0001), local progression (46% relative reduction, P=.02), distant metastases (36% relative reduction, P<.0001), disease-specific survival (30% relative reduction, P=.003), and overall survival (12% relative reduction, P=.03). Other-cause mortality (non-prostate cancer) did not differ (5% relative reduction, P=.48).

Conclusions: LTAD and RT is superior to STAD and RT for the treatment of locally advanced nonmetastatic adenocarcinoma of the prostate and should be considered the standard of care.

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Conflict of interest statement

Conflicts of interest: Dr. Sandler reports grants from ACR-RTOG, during the conduct of the study; consulting fees from Sanofi, Medivation, Clovis Oncology, Janssen, Ferring, and Blue Earth Diagnostics, speaking fees from Varian outside the submitted work.

Figures

Figure 1
Figure 1
Disease-free survival (A), distant metastasis (B), death from prostate cancer (C), and overall survival (death from any cause) (D) by treatment group. Plots in panels A and D are Kaplan-Meier curves; plots in panels B and C are (1 – cumulative incidence estimator). P-values are from unadjusted logrank tests. See Table 2 for adjusted hazard ratios and p-values.
Figure 2
Figure 2
Disease-free survival (A), distant metastasis (B), death from prostate cancer (C), and overall survival (death from any cause) (D) by treatment group for patients with Gleason score 8- 10 and N0/NX nodal status. Plots in panels A and D are Kaplan-Meier curves; plots in panels B and C are (1 – cumulative incidence estimator). P-values are from unadjusted logrank tests. See Table 3 for adjusted hazard ratios and p-values.
Figure 3
Figure 3
Cumulative incidence of grade 3 or greater genitourinary (GU) late toxicity (A) and gastrointestinal (GI) late toxicity (B). P-value is from Gray’s test.

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