- Email: [email protected]
MP14-13 COST-EFFECTIVENESS ANALYSIS OF ADJUVANT VERSUS SALVAGE RADIOTHERAPY AFTER RADICAL PROSTATECTOMY FOR HIGH-RISK DISEASE
THE JOURNAL OF UROLOGYâ
e148
Vol. 195, No. 4S, Supplement, Friday, May 6, 2016
difference was observed between early SRT and ART groups (p¼0.28). Men with low to intermediate CAPRA-S scores and low Decipher risk have a low rate of metastatic events regardless of treatment selection. In contrast, men with high CAPRA-S and Decipher scores benefit from ART, however the cumulative incidence of metastasis remains high. CONCLUSIONS: The decision as to the timing and need for additional local therapy following RP is nuanced and requires providers and patients to balance risks of morbidity with improved oncologic outcomes. This analysis provides the most robust and accurate quantification of risk for these patients. Post-RP treatment can be safely avoided for men who are low risk by clinical-genomic risk, whereas those at high risk should strongly favor enrollment in clinical trials. Source of Funding: GenomeDx Biosciences, Inc.
MP14-13 COST-EFFECTIVENESS ANALYSIS OF ADJUVANT VERSUS SALVAGE RADIOTHERAPY AFTER RADICAL PROSTATECTOMY FOR HIGH-RISK DISEASE Source of Funding: none
MP14-12 EFFICACY OF EARLY AND DELAYED RADIATION IN A PROSTATECTOMY COHORT ADJUSTED FOR GENOMIC AND CLINICAL RISK Ashley Ross*, Baltimore, MD; Robert Den, Philadelphia, PA; Kasra Yousefi, Vancouver, Canada; Bruce Trock, Baltimore, MD; Elai Davicioni, Vancouver, Canada; Jeffrey Tosoian, Baltimore, MD; Darby Thompson, Burnaby, Canada; Voleak Choeurng, Zaid Haddad, Vancouver, Canada; Phuoc Tran, Baltimore, MD; Edouard Trabulsi, Leonard Gomella, Costas Lallas, Philadelphia, PA; Firas Abdollah, Detroit, MI; Felix Feng, Ann Arbor, MI; Adam Dicker, Philadelphia, PA; Stephen Freedland, Los Angeles, CA; Jeffrey Karnes, Rochester, MN; Edward Schaeffer, Baltimore, MD INTRODUCTION AND OBJECTIVES: In 3 published randomized clinical trials, adjuvant radiation therapy (ART) for prostate cancer (PCa) resulted in improved progression free survival. However, the impact on metastases and overall survival is unclear. To date, there have been no published prospective trials examining the impact of salvage radiation therapy (SRT) in this disease state. Hence, we conducted a retrospective, nonrandomized comparative study of adjuvant, salvage, or no radiation following radical prostatectomy (RP) for men with pT3 disease or positive margins (adverse pathologic features, APF). METHODS: 422 PCa patients treated at four institutions with RP and having APF were analyzed with a primary end point of clinical metastasis. Men undergoing ART (n¼111), early SRT (n¼70) and delayed SRT (n¼83) were defined by having prostate specific antigen (PSA) levels of <0.2, 0.2 to 0.5, and 0.5 ng/mL, respectively, prior to initiation of radiation therapy (RT). Remaining 157 patients who did not receive additional therapy (RT or hormonal) prior to metastatic onset formed the no RT group. Clinical-genomic risk was assessed by CAPRA-S and Decipher. Cox univariable (UVA) and multivariable (MVA) proportional hazards models were used to evaluate the impact of treatment on outcome. RESULTS: During study follow-up, 37 patients developed metastasis with a median follow-up of 8 years. Both CAPRA-S and Decipher had independent predictive value on MVA for metastatic outcome (both p<0.05). On MVA adjusting for clinical and genomic risk, delayed SRT and no RT had a hazard ratio (HR) of 4.31 (95% confidence interval [CI], 1.20-15.47) and 5.42 (95% CI, 1.59-18.44) for metastasis compared to ART as the reference group. No significance
Ellen Daily*, Chicago, IL; Sangtae Park, Evanston, IL INTRODUCTION AND OBJECTIVES: There is continued debate on adjuvant radiotherapy (ART) compared to observation plus salvage radiotherapy (SRT) after radical prostatectomy (RP) in men with adverse pathology (seminal vesicle invasion, positive surgical margins, extraprostatic extension). While three randomized clinical trials (SWOG 8794, EORTC 22911 and ARO 96-02) have consistently demonstrated improved PSA-free survival with ART, metastases and overall survival rates are inconsistent. Furthermore, if ART were given to all high risk post-RP patients, those who would have never had PSA recurrence would be overtreated with its attendant costs and impact on post-RP bowel, urinary and sexual function. Thus, this cost-effectiveness analysis was conducted to integrate overall survival, need for adjuvant therapies, quality of life, and healthcare costs in comparing ART versus SRT in these patients. METHODS: A Markov model was created using TreeAge (Williamstown, MA), to compare ART versus SRT for a hypothetical cohort of 65-year-old men with adverse RP pathology. PSA survival, radiotherapy success, progression to androgen deprivation and castrate resistance requiring chemotherapy, overall survival, and treatment-related toxicities were obtained from the published literature. Quality of life utilities were collected using a time tradeoff survey of prostate cancer specialists and 2015 Medicare healthcare costs were used. RESULTS: Our model showed that in men with adverse pathology after RP, PSA surveillance with SRT as needed results in more quality-adjusted life years (QALYs) than ART (4.38 versus 3.67, respectively). ART is also the more expensive strategy, with an incremental cost of $17,206 over SRT across the lifetime of the patient for an incremental cost-effectiveness ratio of $24,233 per QALY. One-way and two-way sensitivity analyses varying patient age, radiation costs, urinary/bowel/sexual QOL, and utility values confirmed the robustness of our model, and SRT remained the more cost-effective strategy. CONCLUSIONS: In men with adverse pathological features after RP, our study suggests that the strategy of PSA surveillance plus selective SRT is less costly, and provides more QALYs than universal ART. Future randomized trials should aim to gather more detailed quality of life data on radiotherapy after RP, and future cost-effectiveness analyses should integrate private and public healthcare costs in order to refine the appropriateness of ART and SRT in high-risk prostate cancer patients. Source of Funding: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Grant #5T35DK062719-28
e148
Vol. 195, No. 4S, Supplement, Friday, May 6, 2016
difference was observed between early SRT and ART groups (p¼0.28). Men with low to intermediate CAPRA-S scores and low Decipher risk have a low rate of metastatic events regardless of treatment selection. In contrast, men with high CAPRA-S and Decipher scores benefit from ART, however the cumulative incidence of metastasis remains high. CONCLUSIONS: The decision as to the timing and need for additional local therapy following RP is nuanced and requires providers and patients to balance risks of morbidity with improved oncologic outcomes. This analysis provides the most robust and accurate quantification of risk for these patients. Post-RP treatment can be safely avoided for men who are low risk by clinical-genomic risk, whereas those at high risk should strongly favor enrollment in clinical trials. Source of Funding: GenomeDx Biosciences, Inc.
MP14-13 COST-EFFECTIVENESS ANALYSIS OF ADJUVANT VERSUS SALVAGE RADIOTHERAPY AFTER RADICAL PROSTATECTOMY FOR HIGH-RISK DISEASE Source of Funding: none
MP14-12 EFFICACY OF EARLY AND DELAYED RADIATION IN A PROSTATECTOMY COHORT ADJUSTED FOR GENOMIC AND CLINICAL RISK Ashley Ross*, Baltimore, MD; Robert Den, Philadelphia, PA; Kasra Yousefi, Vancouver, Canada; Bruce Trock, Baltimore, MD; Elai Davicioni, Vancouver, Canada; Jeffrey Tosoian, Baltimore, MD; Darby Thompson, Burnaby, Canada; Voleak Choeurng, Zaid Haddad, Vancouver, Canada; Phuoc Tran, Baltimore, MD; Edouard Trabulsi, Leonard Gomella, Costas Lallas, Philadelphia, PA; Firas Abdollah, Detroit, MI; Felix Feng, Ann Arbor, MI; Adam Dicker, Philadelphia, PA; Stephen Freedland, Los Angeles, CA; Jeffrey Karnes, Rochester, MN; Edward Schaeffer, Baltimore, MD INTRODUCTION AND OBJECTIVES: In 3 published randomized clinical trials, adjuvant radiation therapy (ART) for prostate cancer (PCa) resulted in improved progression free survival. However, the impact on metastases and overall survival is unclear. To date, there have been no published prospective trials examining the impact of salvage radiation therapy (SRT) in this disease state. Hence, we conducted a retrospective, nonrandomized comparative study of adjuvant, salvage, or no radiation following radical prostatectomy (RP) for men with pT3 disease or positive margins (adverse pathologic features, APF). METHODS: 422 PCa patients treated at four institutions with RP and having APF were analyzed with a primary end point of clinical metastasis. Men undergoing ART (n¼111), early SRT (n¼70) and delayed SRT (n¼83) were defined by having prostate specific antigen (PSA) levels of <0.2, 0.2 to 0.5, and 0.5 ng/mL, respectively, prior to initiation of radiation therapy (RT). Remaining 157 patients who did not receive additional therapy (RT or hormonal) prior to metastatic onset formed the no RT group. Clinical-genomic risk was assessed by CAPRA-S and Decipher. Cox univariable (UVA) and multivariable (MVA) proportional hazards models were used to evaluate the impact of treatment on outcome. RESULTS: During study follow-up, 37 patients developed metastasis with a median follow-up of 8 years. Both CAPRA-S and Decipher had independent predictive value on MVA for metastatic outcome (both p<0.05). On MVA adjusting for clinical and genomic risk, delayed SRT and no RT had a hazard ratio (HR) of 4.31 (95% confidence interval [CI], 1.20-15.47) and 5.42 (95% CI, 1.59-18.44) for metastasis compared to ART as the reference group. No significance
Ellen Daily*, Chicago, IL; Sangtae Park, Evanston, IL INTRODUCTION AND OBJECTIVES: There is continued debate on adjuvant radiotherapy (ART) compared to observation plus salvage radiotherapy (SRT) after radical prostatectomy (RP) in men with adverse pathology (seminal vesicle invasion, positive surgical margins, extraprostatic extension). While three randomized clinical trials (SWOG 8794, EORTC 22911 and ARO 96-02) have consistently demonstrated improved PSA-free survival with ART, metastases and overall survival rates are inconsistent. Furthermore, if ART were given to all high risk post-RP patients, those who would have never had PSA recurrence would be overtreated with its attendant costs and impact on post-RP bowel, urinary and sexual function. Thus, this cost-effectiveness analysis was conducted to integrate overall survival, need for adjuvant therapies, quality of life, and healthcare costs in comparing ART versus SRT in these patients. METHODS: A Markov model was created using TreeAge (Williamstown, MA), to compare ART versus SRT for a hypothetical cohort of 65-year-old men with adverse RP pathology. PSA survival, radiotherapy success, progression to androgen deprivation and castrate resistance requiring chemotherapy, overall survival, and treatment-related toxicities were obtained from the published literature. Quality of life utilities were collected using a time tradeoff survey of prostate cancer specialists and 2015 Medicare healthcare costs were used. RESULTS: Our model showed that in men with adverse pathology after RP, PSA surveillance with SRT as needed results in more quality-adjusted life years (QALYs) than ART (4.38 versus 3.67, respectively). ART is also the more expensive strategy, with an incremental cost of $17,206 over SRT across the lifetime of the patient for an incremental cost-effectiveness ratio of $24,233 per QALY. One-way and two-way sensitivity analyses varying patient age, radiation costs, urinary/bowel/sexual QOL, and utility values confirmed the robustness of our model, and SRT remained the more cost-effective strategy. CONCLUSIONS: In men with adverse pathological features after RP, our study suggests that the strategy of PSA surveillance plus selective SRT is less costly, and provides more QALYs than universal ART. Future randomized trials should aim to gather more detailed quality of life data on radiotherapy after RP, and future cost-effectiveness analyses should integrate private and public healthcare costs in order to refine the appropriateness of ART and SRT in high-risk prostate cancer patients. Source of Funding: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Grant #5T35DK062719-28