دورية أكاديمية
Genomic Classifier Performance in Intermediate-Risk Prostate Cancer: Results From NRG Oncology/RTOG 0126 Randomized Phase 3 Trial.
| العنوان: | Genomic Classifier Performance in Intermediate-Risk Prostate Cancer: Results From NRG Oncology/RTOG 0126 Randomized Phase 3 Trial. |
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| المؤلفون: | Spratt DE; Department of Radiation Oncology, University Hospitals Seidman Cancer Center, Cleveland, Ohio. Electronic address: Daniel.Spratt@uhhospitals.org., Liu VYT; Veracyte, Inc, South San Francisco, California., Michalski J; Department of Radiation Oncology, Washington University, St. Louis, Missouri., Davicioni E; Veracyte, Inc, South San Francisco, California., Berlin A; Princess Margaret Cancer Centre, Cancer Clinical Research Unit, Toronto, Ontario, Canada., Simko JP; Department of Pathology, UCSF Medical Center-Mount Zion, San Francisco, California., Efstathiou JA; Department of Radiation Oncology, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts., Tran PT; Department of Pathology, University of Maryland, Baltimore, Maryland., Sandler HM; Department of Radiation Oncology, Cedars-Sinai Medical Center, Los Angeles, California., Hall WA; Department of Radiation Oncology, Medical College of Wisconsin, Milwaukee, Wisconsin., Thompson DJS; Veracyte, Inc, South San Francisco, California., Parliament MB; Division of Radiation Oncology, Cross Cancer Institute, Edmonton, Alberta, Canada., Dayes IS; Division of Radiation Oncology, Hamilton Regional Cancer Centre, Ontario, Canada., Correa RJM; Department of Oncology, London Regional Cancer Program, Ontario, Canada., Robertson JM; Department of Radiation Oncology, Beaumont Health CCOP, Royal Oak, Michigan., Gore EM; Department of Radiation Oncology, Milwaukee VA Medical Center, Milwaukee, Wisconsin., Doncals DE; Division of Radiation Oncology, Akron City Hospital, Akron, Ohio., Vigneault E; Department of Radiation Oncology, CHU de Quebec Universite Laval, Quebec, Canada., Souhami L; Department of Radiation Oncology, Cedars Cancer Centre, McGill University, Quebec, Canada., Karrison TG; NRG Oncology Statistics and Data Management Center, Philadelphia, Pennsylvania., Feng FY; Department of Radiation Oncology, University of California San Francisco, San Francisco, California. |
| المصدر: | International journal of radiation oncology, biology, physics [Int J Radiat Oncol Biol Phys] 2023 Oct 01; Vol. 117 (2), pp. 370-377. Date of Electronic Publication: 2023 May 02. |
| نوع المنشور: | Clinical Trial, Phase III; Randomized Controlled Trial; Journal Article; Research Support, Non-U.S. Gov't; Research Support, N.I.H., Extramural |
| اللغة: | English |
| بيانات الدورية: | Publisher: Elsevier, Inc Country of Publication: United States NLM ID: 7603616 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1879-355X (Electronic) Linking ISSN: 03603016 NLM ISO Abbreviation: Int J Radiat Oncol Biol Phys Subsets: MEDLINE |
| أسماء مطبوعة: | Publication: New York, NY : Elsevier, Inc Original Publication: Elmsford, N. Y., Pergamon Press. |
| مواضيع طبية MeSH: | Prostatic Neoplasms*/genetics , Prostatic Neoplasms*/radiotherapy, Male ; Humans ; Prostate-Specific Antigen ; Androgen Antagonists ; Retrospective Studies ; Neoplasm Grading ; Genomics ; Disease Progression |
| مستخلص: | Purpose: Intermediate-risk prostate cancer is a heterogeneous disease state with diverse treatment options. The 22-gene Decipher genomic classifier (GC) retrospectively has shown to improve risk stratification in these patients. We assessed the performance of the GC in men with intermediate-risk disease enrolled in NRG Oncology/RTOG 01-26 with updated follow-up. Methods and Materials: After National Cancer Institute approval, biopsy slides were collected from NRG Oncology/RTOG 01-26, a randomized phase 3 trial of men with intermediate-risk prostate cancer randomized to 70.2 Gy versus 79.2 Gy of radiation therapy without androgen deprivation therapy. RNA was extracted from the highest-grade tumor foci to generate the locked 22-gene GC model. The primary endpoint for this ancillary project was disease progression (composite of biochemical failure, local failure, distant metastasis, prostate cancer-specific mortality, and use of salvage therapy). Individual endpoints were also assessed. Fine-Gray or cause-specific Cox multivariable models were constructed adjusting for randomization arm and trial stratification factors. Results: Two-hundred fifteen patient samples passed quality control for analysis. The median follow-up was 12.8 years (range, 2.4-17.7). On multivariable analysis, the 22-gene GC (per 0.1 unit) was independently prognostic for disease progression (subdistribution hazard ratio [sHR], 1.12; 95% confidence interval [CI], 1.00-1.26; P = .04), biochemical failure (sHR, 1.22; 95% CI, 1.10-1.37; P < .001), distant metastasis (sHR, 1.28; 95% CI, 1.06-1.55; P = .01), and prostate cancer-specific mortality (sHR, 1.45; 95% CI, 1.20-1.76; P < .001). Ten-year distant metastasis in GC low-risk patients was 4% compared with 16% for GC high-risk patients. In patients with lower GC scores, the 10-year difference in metastasis-free survival rate between arms was -7%, compared with 21% for higher GC patients (P-interaction = .04). Conclusions: This study represents the first validation of a biopsy-based gene expression classifier, assessing both its prognostic and predictive value, using data from a randomized phase 3 trial of intermediate-risk prostate cancer. Decipher improves risk stratification and can aid in treatment decision-making in men with intermediate-risk disease. (Copyright © 2023 Elsevier Inc. All rights reserved.) |
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| معلومات مُعتمدة: | U10 CA180868 United States CA NCI NIH HHS; UG1 CA189867 United States CA NCI NIH HHS; R21 CA274500 United States CA NCI NIH HHS; UG1 CA233234 United States CA NCI NIH HHS; U24 CA196067 United States CA NCI NIH HHS; R01 CA240991 United States CA NCI NIH HHS; U01 CA257638 United States CA NCI NIH HHS; U10 CA180822 United States CA NCI NIH HHS |
| سلسلة جزيئية: | ClinicalTrials.gov NCT00033631 |
| المشرفين على المادة: | EC 3.4.21.77 (Prostate-Specific Antigen) 0 (Androgen Antagonists) |
| تواريخ الأحداث: | Date Created: 20230503 Date Completed: 20230904 Latest Revision: 20240530 |
| رمز التحديث: | 20240530 |
| مُعرف محوري في PubMed: | PMC10949135 |
| DOI: | 10.1016/j.ijrobp.2023.04.010 |
| PMID: | 37137444 |
| قاعدة البيانات: | MEDLINE |
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Full Text Finder | تدمد: | 1879-355X |
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| DOI: | 10.1016/j.ijrobp.2023.04.010 |