Prospective Evaluation of Supplemental External Beam Radiation Therapy With Palladium-103 Prostate Brachytherapy: Long-Term Results of the 44/20/0 Trials.

Autor:	King MT; Department of Radiation Oncology, Dana-Farber Cancer Institute and Brigham and Women's Hospital, Boston, Massachusetts. Electronic address: martin_king@dfci.harvard.edu., Merrick GS; Urologic Research Institute, Sarasota, Florida; Bethany College, Bethany, West Virginia., Galbreath RW; Urologic Research Institute, Sarasota, Florida; Ohio University Eastern, St. Clairsville, Ohio., Fiano R; Urologic Research Institute, Sarasota, Florida., Butler WM; Urologic Research Institute, Sarasota, Florida., Wallner KE; Department of Radiation Oncology, University of Washington, Seattle, Washington., Orio PF; Department of Radiation Oncology, Dana-Farber Cancer Institute and Brigham and Women's Hospital, Boston, Massachusetts.
Jazyk:	angličtina
Zdroj:	Practical radiation oncology [Pract Radiat Oncol] 2024 Oct 22. Date of Electronic Publication: 2024 Oct 22.
DOI:	10.1016/j.prro.2024.10.005
Abstrakt:	Purpose: The 44/20 and 20/0 randomized trials evaluated whether different external beam radiation therapy (EBRT) dosing regimens prior to brachytherapy affected biochemical failure (BF). We report long-term outcomes of both trials and evaluate whether biological equivalent dose (BED) was associated with reduced BF in the combined trial cohort. Methods and Materials: Both trials enrolled patients with clinical T1c to T2b, Gleason scores 7 to 9, and/or a pretreatment prostate-specific antigen (PSA) 10 to 20 ng/mL disease. The 44/20 trial randomized patients to 44 Gy EBRT with 90 Gy palladium (Pd)-103 versus 20 Gy EBRT with 115 Gy Pd-103. The subsequent 20/0 trial randomized patients to the 20 Gy arm versus monotherapeutic 125 Gy Pd-103. For each trial, univariate Fine-Gray analysis evaluated whether the treatment arm was associated with BF for the entire cohort and the unfavorable intermediate-risk (UIR) subgroup. For the combined trial cohort, multivariate Fine-Gray analysis evaluated whether BED was associated with BF while adjusting for clinical factors. Results: There were 247 analyzable patients in the 44/20 trial. At a median follow-up of 13.7 years, there were no differences in BF for the entire cohort (subdistribution hazard ratio [sHR] 0.99; 95% CI, 0.43, 2.276; P = .97) or the UIR subgroup (sHR 0.72; 95% CI, 0.25, 2.08; P = .55). There were 383 analyzable patients in the 20/0 trial. At a median follow-up of 10.4 years, there were no differences in BF for the entire cohort (sHR 0.42; 95% CI, 0.13-1.80; P = .15) or the UIR subgroup (sHR 0.81; 95% CI, 0.16-4.03; P = .80). For the combined cohort (630 patients), BED was not associated with BF (1.00; 95% CI, 0.98-1.02; P = .88) on multivariate analyses while adjusting for androgen deprivation therapy utilization, 4-tiered National Comprehensive Cancer Network category, and year of treatment. Conclusions: Brachytherapy monotherapy should be a standard-of-care treatment for clinically localized, intermediate-risk prostate cancer, including UIR disease. Competing Interests: Disclosures Martin King has received research funding from Palette Life Sciences, Bayer Healthcare, and AstraZeneca, outside of the submitted work. Gregory Merrick has served as a consultant for Theragenics, outside of the submitted work. Robert Galbreath has received a grant from Theragenics for statistical analysis of the submitted work. Peter Orio has received research funding, consulting fees, and stock for Palette Life Sciences, outside of the submitted work. (Copyright © 2024 American Society for Radiation Oncology. Published by Elsevier Inc. All rights reserved.)
Databáze:	MEDLINE
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