Genomic classifier identifies men with adverse pathology after radical prostatectomy who benefit from adjuvant radiation therapy.

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Abstract

The optimal timing of postoperative radiotherapy (RT) after radical prostatectomy (RP) is unclear. We hypothesized that a genomic classifier (GC) would provide prognostic and predictive insight into the development of clinical metastases in men receiving post-RP RT and inform decision making.

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Adjuvant radiotherapy for pathological T3N0M0 prostate cancer significantly reduces risk of metastases and improves survival: long-term followup of a randomized clinical trial.

Ian Thompson, Catherine M Tangen, Jorge Paradelo … (2009)

Extraprostatic disease will be manifest in a third of men after radical prostatectomy. We present the long-term followup of a randomized clinical trial of radiotherapy to reduce the risk of subsequent metastatic disease and death. A total of 431 men with pT3N0M0 prostate cancer were randomized to 60 to 64 Gy adjuvant radiotherapy or observation. The primary study end point was metastasis-free survival. Of 425 eligible men 211 were randomized to observation and 214 to adjuvant radiation. Of those men under observation 70 ultimately received radiotherapy. Metastasis-free survival was significantly greater with radiotherapy (93 of 214 events on the radiotherapy arm vs 114 of 211 events on observation; HR 0.71; 95% CI 0.54, 0.94; p = 0.016). Survival improved significantly with adjuvant radiation (88 deaths of 214 on the radiotherapy arm vs 110 deaths of 211 on observation; HR 0.72; 95% CI 0.55, 0.96; p = 0.023). Adjuvant radiotherapy after radical prostatectomy for a man with pT3N0M0 prostate cancer significantly reduces the risk of metastasis and increases survival.

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Postoperative radiotherapy after radical prostatectomy for high-risk prostate cancer: long-term results of a randomised controlled trial (EORTC trial 22911).

Michel Bolla, Hein Van Poppel, Bertrand Tombal … (2012)

We report the long-term results of a trial of immediate postoperative irradiation versus a wait-and-see policy in patients with prostate cancer extending beyond the prostate, to confirm whether previously reported progression-free survival was sustained. This randomised, phase 3, controlled trial recruited patients aged 75 years or younger with untreated cT0-3 prostate cancer (WHO performance status 0 or 1) from 37 institutions across Europe. Eligible patients were randomly assigned centrally (1:1) to postoperative irradiation (60 Gy of conventional irradiation to the surgical bed for 6 weeks) or to a wait-and-see policy until biochemical progression (increase in prostate-specific antigen >0·2 μg/L confirmed twice at least 2 weeks apart). We analysed the primary endpoint, biochemical progression-free survival, by intention to treat (two-sided test for difference at α=0.05, adjusted for one interim analysis) and did exploratory analyses of heterogeneity of effect. This trial is registered with ClinicalTrials.gov, number NCT00002511. 1005 patients were randomly assigned to a wait-and-see policy (n=503) or postoperative irradiation (n=502) and were followed up for a median of 10·6 years (range 2 months to 16·6 years). Postoperative irradiation significantly improved biochemical progression-free survival compared with the wait-and-see policy (198 [39·4%] of 502 patients in postoperative irradiation group vs 311 [61·8%] of 503 patients in wait-and-see group had biochemical or clinical progression or died; HR 0·49 [95% CI 0·41-0·59]; p<0·0001). Late adverse effects (any type of any grade) were more frequent in the postoperative irradiation group than in the wait-and-see group (10 year cumulative incidence 70·8% [66·6-75·0] vs 59·7% [55·3-64·1]; p=0.001). Results at median follow-up of 10·6 years show that conventional postoperative irradiation significantly improves biochemical progression-free survival and local control compared with a wait-and-see policy, supporting results at 5 year follow-up; however, improvements in clinical progression-free survival were not maintained. Exploratory analyses suggest that postoperative irradiation might improve clinical progression-free survival in patients younger than 70 years and in those with positive surgical margins, but could have a detrimental effect in patients aged 70 years or older. Ligue Nationale contre le Cancer (Comité de l'Isère, Grenoble, France) and the European Organisation for Research and Treatment of Cancer (EORTC) Charitable Trust. Copyright © 2012 Elsevier Ltd. All rights reserved.

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Pivotal Evaluation of the Accuracy of a Biomarker Used for Classification or Prediction: Standards for Study Design

Margaret S Pepe, Ziding Feng, Holly Janes … (2008)

Research methods for biomarker evaluation lag behind those for evaluating therapeutic treatments. Although a phased approach to development of biomarkers exists and guidelines are available for reporting study results, a coherent and comprehensive set of guidelines for study design has not been delineated. We describe a nested case–control study design that involves prospective collection of specimens before outcome ascertainment from a study cohort that is relevant to the clinical application. The biomarker is assayed in a blinded fashion on specimens from randomly selected case patients and control subjects in the study cohort. We separately describe aspects of the design that relate to the clinical context, biomarker performance criteria, the biomarker test, and study size. The design can be applied to studies of biomarkers intended for use in disease diagnosis, screening, or prognosis. Common biases that pervade the biomarker research literature would be eliminated if these rigorous standards were followed.

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Journal

Journal ID (iso-abbrev): J. Clin. Oncol.

Title: Journal of clinical oncology : official journal of the American Society of Clinical Oncology

ISSN (Electronic): 1527-7755

ISSN (Print): 0732-183X

Publication date (Electronic): Mar 10 2015

Volume: 33

Issue: 8

Affiliations

[1 ] Robert B. Den, Edouard J. Trabulsi, Adam P. Dicker, Costas D. Lallas, and Leonard G. Gomella, Sidney Kimmel Medical College at Thomas Jefferson University, Philadelphia, PA; Firas Abdollah, Vattikuti Urology Institute, Henry Ford Hospital, Detroit; Felix Y. Feng, University of Michigan, Ann Arbor, MI; R. Jeffrey Karnes, Mayo Clinic, Rochester, MN; and Kasra Yousefi, Voleak Choeurng, and Elai Davicioni, GenomeDx Biosciences, Vancouver, British Columbia, Canada. Robert.Den@jefferson.edu.

[2 ] Robert B. Den, Edouard J. Trabulsi, Adam P. Dicker, Costas D. Lallas, and Leonard G. Gomella, Sidney Kimmel Medical College at Thomas Jefferson University, Philadelphia, PA; Firas Abdollah, Vattikuti Urology Institute, Henry Ford Hospital, Detroit; Felix Y. Feng, University of Michigan, Ann Arbor, MI; R. Jeffrey Karnes, Mayo Clinic, Rochester, MN; and Kasra Yousefi, Voleak Choeurng, and Elai Davicioni, GenomeDx Biosciences, Vancouver, British Columbia, Canada.

Article

Publisher Item ID: JCO.2014.59.0026

DOI: 10.1200/JCO.2014.59.0026

PubMed ID: 25667284

SO-VID: 489d4460-807d-4e34-b9f3-3605d4dc4c48

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Genomic classifier identifies men with adverse pathology after radical prostatectomy who benefit from adjuvant radiation therapy.

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Most cited references 33

Adjuvant radiotherapy for pathological T3N0M0 prostate cancer significantly reduces risk of metastases and improves survival: long-term followup of a randomized clinical trial.

Postoperative radiotherapy after radical prostatectomy for high-risk prostate cancer: long-term results of a randomised controlled trial (EORTC trial 22911).

Pivotal Evaluation of the Accuracy of a Biomarker Used for Classification or Prediction: Standards for Study Design

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