Genitourinary Cancer

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SU_34_2342 - Comparative effectiveness of Surgery versus Radiation Therapy for NCCN High and Very High Risk Prostate Cancer

Sunday, October 21
1:15 PM - 2:45 PM
Location: Innovation Hub, Exhibit Hall 3

Comparative effectiveness of Surgery versus Radiation Therapy for NCCN High and Very High Risk Prostate Cancer
J. D. Tward1, R. Petragallo2, T. Farr2, and D. C. Shrieve3; 1Huntsman Cancer Institute, University of Utah, Salt Lake City, UT, 2Huntsman Cancer Institute, salt lake city, UT, 3Huntsman Cancer Hospital, University of Utah, Salt Lake City, UT

Purpose/Objective(s): To compare oncologic outcomes of surgery versus radiation for men with high and very-high risk prostate cancer with meticulous quality control of the data, approriate statistical testing, and reduction of selection and confirmation bias.

Materials/Methods: All men diagnosed with NCCN High or Very-High Risk prostate cancer seen between the years 2000 and 2017 were identified by professional registrars and disease-specific cancer encoding specialists from our professionally curated and funded institutional outcomes database that gathers data both prospectively and retrospectively on all subjects. 100 percent of subjects had complete clinical T, N and M stage encoding, known PSA values, known biopsy Gleason scores, and known use of ADT and ADT duration. The study was designed to maximize the data "Reliability Score" proposed by Roach and would score a possible 22 of 24 points on that evidence quality scale. Comorbidity was assessed and adjusted for by NCI comorbidity criteria. Biochemical failure, systemic-therapy free survival (SFS), metastasis free survival (MFS), prostate cancer specific mortality (PCSM), and overall survival (OS) were compared for surgical and radiation therapy cohorts. Outcomes were compared using univariate and multivariate Cox models, and cohorts were also propensity-matched on T-stage, PSA, Gleason, comorbidity and age. Statistical sensitivity testing using various statistical models were performed to ensure a statistical test would not be "cherry-picked" to give a desired result. All of the data in each subject was reviewed by at least 2 professional prostate cancer outcomes experts, and an attending physician expert specializing in prostate cancer to ensure the accuracy and fidelity of the baseline data.

Results: there were 430 evaluable surgical subjects and 219 evaluable radiation therapy subjects. The median follow up was 5 years. On Univariate Cox, Multivariate Cox adjusted for T stage, Gleason, PSA, age and comorbidity, or Propensity Matched cohorts, there was no clinically or statistically significant differences in SFS, MFS, PCSM, or OS between radiation therapy and surgery as a whole. However, EBRT+ Brachy + ADT was superior to EBRT + ADT with regard to SFS and MFS (Hazard Ratio Range 0.24 to 0.30 depending on test or propensity match, p<0.06 for all tests), but not PCSM and OS, regardless of statistical test used. There was a large clinical benefit seen in performing salvage radiation for pN+ subjects with regard to SFS and MFS, but not OS and PCSM.

Conclusion: Using the Roach Reliabilty scale the current study scores 22 of 24 possible points for data evidence reliability. The highest score achieved by an observation study previously was 13 points. In a meticulously quality controlled analysis, with appropriate statistical test application, there were no significant differences in meaningful oncologic outcomes (SFS, MFS, PCSM, and OS) between subjects receiving surgcial or radiation care-standard therapies.

Author Disclosure: J.D. Tward: Advisory Board; Myriad. Board Member; University of Utah IRB. R. Petragallo: None. T. Farr: None. D.C. Shrieve: None.

Jonathan Tward, MD, PhD

University of Utah

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