Effect of a genomic classifier on adjuvant treatment decision-making among patients with high-risk pathology at radical prostatectomy: Results from the multicenter prospective PRO-IMPACT study.

Authors

null

John L. Gore

University of Washington, Seattle, WA

John L. Gore , Marguerite Du Plessis , Maria Santiago-Jimenez , Kasra Yousefi , Darby J. S. Thompson , David Y. T. Chen , William R. Clark , Michael E. Franks , Lawrence Ivan Karsh , Adam S. Kibel , Hyung Lae Kim , Brian R. Lane , Yair Lotan , William Thomas Lowrance , Paul Maroni , Scott David Perrapato , Edouard John Trabulsi , Robert J. Waterhouse Jr., Elai Davicioni , Daniel W. Lin

Organizations

University of Washington, Seattle, WA, GenomeDx Biosciences, Inc., Vancouver, BC, Canada, EMMES Canada, Burnaby, BC, Canada, Fox Chase Cancer Center, Philadelphia, PA, Alaska Clinical Research Center, Anchorage, AK, Virginia Urology, Richmond, VA, The Urology Center of Colorado, Denver, CO, Brigham and Women's Hospital, Boston, MA, Cedars-Sinai Medical Center, Los Angeles, CA, Spectrum Health Medical Group, Grand Rapids, MI, UT Southwestern Medical Center, Dallas, TX, Huntsman Cancer Hospital, Institute, University of Utah, Salt Lake City, UT, University of Colorado, Denver Medical Campus, Denver, CO, University of Vermont Medical Center, Burlington, VT, Thomas Jefferson University, Philadelphia, PA, Carolina Urology Partners, Gastonia, NC

Research Funding

Pharmaceutical/Biotech Company

Background: The decision to provide adjuvant therapy to men with high risk pathology after radical prostatectomy (RP) is confounded by tremendous uncertainty. We prospectively evaluated the impact of a previously validated genomic classifier (the Decipher test, henceforth referred to as GC) which predicts metastasis risk after RP, on urologists’ decision-making for adjuvant treatment. Methods: 150 adjuvant patients were enrolled into the study by 43 urologists; 19 community and academic practices. Patients with pathologic T3 staging (pT3) or positive surgical margin (SM+) after RP were included. Physicians provided a management recommendation prior to obtaining GC and again upon receiving results. Patients completed validated surveys on decision quality and PCa-related anxiety. Results: Results were available for 141 patients. Median patient age at RP was 64 years; 66% and 51% had pT3 and SM+ pathology, respectively. The median 5-year predicted probability of metastasis by GC was 5.0% (interquartile range [IQR] 2.2%-10.7%). GC classified 48%, 20% and 32% of men as low-, intermediate- and high-risk, respectively. Pre-GC, observation was recommended for 88%; 12% received a recommendation for adjuvant radiation therapy (ART). Post-GC, 18% (95% CI 12-26%) of treatment recommendations changed, including 9% of low-risk and 31% of high-risk patients. Decisional Conflict Scale (DCS) scores decreased (indicating higher decision quality) after exposure to GC results (median DCS pre-GC 25 [IQR 10-44], median DCS post-GC 20 [IQR ], p < 0.001). GC results were associated with the decision to pursue ART in multivariable logistic regression (OR 1.47; 95% CI 1.18-1.83). Conclusions: Observation is the predominantly prescribed management strategy among PCa patients with high risk features at RP. Knowledge of GC results was associated with treatment decision-making among these patients: patients at low risk for metastasis had higher rates of observation recommendations and patients at high risk had higher rates of ART recommendations. Decision quality was improved for patients exposed to GC results. Clinical trial information: NCT02080689

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Abstract Details

Meeting

2016 ASCO Annual Meeting

Session Type

Poster Session

Session Title

Genitourinary (Prostate) Cancer

Track

Genitourinary Cancer—Prostate, Testicular, and Penile

Sub Track

Epidemiology/Outcomes

Clinical Trial Registration Number

NCT02080689

Citation

J Clin Oncol 34, 2016 (suppl; abstr 5053)

DOI

10.1200/JCO.2016.34.15_suppl.5053

Abstract #

5053

Poster Bd #

310

Abstract Disclosures