e810 THE JOURNAL OF UROLOGY� Vol. 191, No. 4S, Supplement, Tuesday, May 20, 2014

MP70-11IMPACT OF PRIOR ENDOCRINE THERAPY ON CLINICAL BENEFITOF ABIRATERONE ACETATE IN PATIENTS WITHCHEMOTHERAPY-NA€IVE METASTATIC CASTRATION-RESISTANTPROSTATE CANCER: RESULTS FROM COU-AA-302

Fred Saad*, Montr�eal, Canada; Thian Kheoh, Margaret K. Yu, LosAngeles, CA; Matthew R. Smith, Boston, MA; Eric J. Small, San Fran-cisco, CA; Peter F. A. Mulders, Nijmegen, Netherlands; Karim Fizazi,Villejuif, France; Dana Rathkopf, New York, NY; St�ephane Oudard,Paris, France; Howard I. Scher, New York, NY; Joaquim Bellmunt,Mary-Ellen Taplin, Boston, MA; Ian D. Davis, Victoria, Australia;Dirk Schrijvers, Antwerp, Belgium; Andrew Protheroe, Oxford, UnitedKingdom; Arturo Molina, Menlo Park, CA; Thomas W. Griffin, LosAngeles, CA; Johann S. de Bono, Sutton, United Kingdom;Charles J. Ryan, San Francisco, CA

INTRODUCTION AND OBJECTIVES: Abiraterone acetate (AA)is a prodrug of abiraterone, a selective androgen biosynthesis inhibitorthat prolongs overall survival (OS) in patients (pts) with metastaticcastration-resistant prostate cancer (mCRPC) and is approved for usein this population. We conducted an exploratory analysis to determinethe impact of prior endocrine therapy on clinical benefit of AA inchemotherapy-na€ive pts with mCRPC in the randomized phase 3 studyCOU-AA-302.

METHODS: 1088 pts receiving mandatory continuous gonad-otropin-releasing hormone [GnRH] agonists if not orchiectomized (96%)were randomized 1:1 to AA (1 g) + prednisone (P) (5 mg BID) or pla-cebo + P. Radiographic progression-free survival (rPFS) and OS wereco-primary end points. rPFS was defined as time to first occurrence ofbone scan progression by Prostate Cancer Working Group 2 criteria,progression by computed tomography/magnetic resonance imaging bymodified Response Evaluation Criteria in Solid Tumors 1.0, or death,whichever came first. We compared the treatment effect of AA on rPFS(investigator review at 55% of OS events) for subgroups above or belowthe median duration of prior endocrine therapy in 2 categories: priorGnRH agonists and androgen receptor (AR) inhibitors. Cox model wasused to obtain the hazard ratio (HR) and associated 95% confidenceinterval (CI) with statistical inference by log rank statistic.

RESULTS: Most pts were exposed to prior GnRH agonists andAR inhibitors (Table). Irrespective of median duration of prior GnRHagonist or AR inhibitor therapy, rPFS was significantly more favorablewith AA + P than placebo + P. Median rPFS was increased in pts withlonger prior exposure to GnRH agonists or AR inhibitors as comparedwithin both AA + P and placebo + P treatment groups.

CONCLUSIONS: Clinical benefit with AA + P vs placebo + Pwas demonstrated by significantly improved rPFS regardless of whetherpts had exposure to prior endocrine therapy above or below the medianduration of 37 and 16 months for GnRH agonists or AR inhibitors,respectively. Additional analyses are warranted to fully assess theimpact of prior GnRH agonist and antiandrogen treatment duration.

Source of Funding: Janssen Research & Development(formerly Ortho Biotech Research & Development, a unit ofCougar Biotechnology)

MP70-12AN INDIRECT TREATMENT COMPARISON AND COST-EFFECTIVENESS ANALYSIS OF ABIRATERONE ACETATE ANDENZALUTAMIDE FOR THE TREATMENT OF METASTATICCASTRATION-RESISTANT PROSTATE CANCER POSTCHEMOTHERAPY

Melissa Thompson*, Burlington, Canada; Tracy Li, Mary Beth Todd,Raritan, NJ; Margaret K. Yu, Thian Kheoh, Los Angeles, CA;Jianming He, Ryan Saadi, Raritan, NJ

INTRODUCTION AND OBJECTIVES: Abiraterone acetate (AA)and enzalutamide (ENZ) are 2 new treatment options for patients withmetastatic castration-resistant prostate cancer (mCRPC) after doce-taxel-based chemotherapy. Presently, there is great interest in under-standing the relative clinical and economic value of these therapies. Theobjective of this study was to determine the comparative effectivenessand cost-effectiveness of AA versus ENZ.

METHODS: The PICO (population, intervention, comparison,and outcomes) construct was used to assess the comparability of thepivotal phase 3 trials COU-AA-301 for AA and AFFIRM for ENZ. Anindirect treatment comparison (ITC) was conducted using the Buchermethod and Bayesian statistics. A survival-based Markov cohort modelwith 3 health states (progression-free, progressed, and death) wasdeveloped to estimate cost-effectiveness over a lifetime horizon. Re-sults from the ITC were used to inform OS transitions within the model.Since the price of ENZ was publicly available only in the United States(US) at the time of the analysis, US drug acquisition costs were used.Average wholesale prices for a 30-day supply of AA and ENZ were$7674 and $8940, respectively. One-way sensitivity analyses wereperformed for all probability, utility, and cost values incorporated intothe model.

RESULTS: The results of the ITC showed no significant dif-ference in overall survival (OS) for AA versus ENZ (hazard ratio ¼ 0.95;95% confidence interval: 0.71-1.26) after accounting for important dif-ferences in comparators and background treatments. In the base caseof the economic analysis, AA was found to provide an annual costsavings of $13,322 per patient versus ENZ, primarily due to higheracquisition costs of ENZ. Quality-adjusted life years gained werecomparable for AA and ENZ. These results were supported by sensi-tivity analyses.

CONCLUSIONS: The results of this ITC showed that AA andENZ have similar efficacy in terms of OS in mCRPC patients postchemotherapy. Despite this similarity, AA is cost-saving compared withENZ in the treatment of this population in the US.

Source of Funding: Janssen

MP70-13IMPACT OF SCREENING AND TREATMENT PATTERN ON RACIALAND ETHNIC DIFFERENCES IN OUTCOMES AMONG ADVANCEDSTAGE PROSTATE CANCER PATIENTS

Sumedha Chhatre, S Bruce Malkowicz, Ravishankar Jayadevappa*,Philadelphia, PA

INTRODUCTION AND OBJECTIVES: We sought to analyzethe race/ethnic differences in health service use, cost and mortality, andassess the mediating effect of prostate cancer screening and treatmenton these differences in fee-for-service Medicare patients with advancedprostate cancer.

METHODS: Retrospective, observational, case-control studyusing SEER-Medicare linked data. Cohort consisted of 15,054 menaged 66 or older and diagnosed with advanced stage prostate cancerbetween 2001 and 2004. The cohort was followed retrospectively up to2009. Cancer free controls from Medicare were used to determine theincremental cost of advanced stage prostate cancer. Racial/ethnicvariation in health service use, cost and mortality were analyzed usingPoisson, GLM log-link, and Cox regression models.

Vol. 191, No. 4S, Supplement, Tuesday, May 20, 2014 THE JOURNAL OF UROLOGY� e811

RESULTS: African Americans were less likely to have receivedprostate cancer screening in the pre-diagnosis year and less likely tohave received any treatment. African Americans had higher outpatientvisits compared to whites in the age group 66-75 (OR¼1.24, CI: 1.22-1.27); and age group 76-85 (OR¼1.18, CI: 1.14 -1.22). In the follow-upphases, African Americans had higher costs (range 28% to 49%). Forage group 66-75, African Americans had higher hazard of all-causemortality (HR¼1.22, CI¼1.09-1.38), and Asians had lower hazard ofall-cause mortality (HR¼0.79, CI¼0.65-0.98). For age group 76-85,African Americans had higher hazard of all-cause mortality (HR¼1.22,CI¼1.05-1.41).

CONCLUSIONS: The pattern of racial/ethnic disparity varies byage group. Higher mortality among African Americans may be associ-ated with disparity in prostate cancer screening and treatment. Thusscreening guidelines such as USPSTF, need to incorporate race/ethnicity and age in developing recommendations.

Source of Funding: Supported in part by National CancerInstitute, National Institute on Aging, National Institutes ofHealth-Grant # 5RO3CA 121338-2 and Grant #R21AG034870-01A1

MP70-14WITHDRAWN

MP70-15LONG TERM OUTCOMES OF SALVAGE LYMPH NODEDISSECTION FOR CLINICALLY RECURRENT PROSTATECANCER: RESULTS OF A SINGLE INSTITUTION SERIES WITH AMINIMUM FOLLOW-UP OF 5 YEARS

Nazareno Suardi*, Ettore Di Trapani, Andrea Salonia, Manuela Tutolo,Dario Di Trapani, Fabio Castiglione, Massimo Freschi, Roberta Lucian�o,Andrea Gallina, Milan, Italy; Pierre I. Karakiewicz, Maxine Sun,Montreal, Canada; Shahrokh F. Shariat, Vienna, Austria;Francesco Montorsi, Alberto Briganti, Milan, Italy

INTRODUCTION AND OBJECTIVES: Management of patientswith clinical recurrence (CR) of prostate cancer after radical prosta-tectomy (RP) is challenging. Despite the absence of randomizedstudies, salvage lymph node dissection (sLND) for patients with lymphnode recurrent disease is gaining attention. However, data on longterm outcomes are still lacking. We tested the outcome of sLND in asingle institution series of patients with a minimum follow-up of5 years.

METHODS: We identified 59 patients affected by biochemicalrecurrence (BCR) after RP associated with a nodal pathologic [11C]choline PET/CT scan. Patients underwent imaging guided sLNDbetween 2002 and 2008 at a single tertiary care center. Biochemicalresponse (BR) was defined as prostate-specific antigen (PSA)<0.2 ng/mlat 40 days after salvage LND. Clinical recurrence (CR) was definedas positive imaging in presence of raising PSA. Kaplan-Meier methodwas used to assess time to CR and cancer specific mortality(CSM) after sLND. Moreover, univariable (UVA) and multivariable(MVA) Cox regression analyses were fitted to assess predictorsof CR.

RESULTS: Mean PSA at sLNDwas 3.95 ng/ml (median 2 ng/ml;IQR: 0.81-5.35). Mean age at sLNDwas 66.6 years (median 66.4 years).[11C]choline PET/CT scan showed nodal uptake in the pelvis in36 patients (61%), in the retroperitoneum in 10 patients (16.9%) andin both in 13 patients (22%). Overall, 59.3% of patients achieved BR.Median follow-up after LND were 75.9 months (IQR: 61.6-98.3). The8-yr BCR-free survival rate in patients with complete BR to surgery was23%. Overall, 8-yr CR-free and cancer-specific survival were 28% and

81%, respectively. At UVA, PSA at sLND (HR:1.12, p<0.001), thepresence of retroperitoneal uptake at [11C]choline PET/CT (HR:2.03,p¼0.05) and the n. of positive spots at [11C]choline PET/CT (HR:1.64,p¼0.01) were associated with higher risk of CR. However, at MVA onlyPSA value at sLND represented an independent predictor of CR, afteradjusting for the number and the site of positive [11C]choline PET/CT.When post-operative variables were considered, at MVA the numberof positive nodes (HR:1.06, p¼0.006) and the presence of completePSA remission after sLND (HR:0.34, p¼0.01) emerged as predictors oflong-term CR.

CONCLUSIONS: Salvage LND may represent a therapeuticoption for patients with BCR after RP and nodal pathologic uptake at[11C]choline PET/CT scan. Biochemical response after surgery can beachieved in a consistent proportion of patients, despite only one third ofpatients showed absence of CR 8 yr after surgery.

Source of Funding: None

MP70-16COMPARISON OF OVERALL SURVIVAL BETWEEN THE LIFEEXPECTANCY AND THE ACTUAL ESTIMATED OUTCOME INPATIENTS WHO RECEIVED PRIMARY ANDROGEN DEPRIVATIONTHERAPY

Nobumichi Tanaka*, Kashihara, Japan; Hinotsu Shiro, Okayama,Japan; Hideyuki Akaza, Tokyo, Japan; Yoshihiko Hirao,Kiyohide Fujimoto, Kashihara, Japan

INTRODUCTION AND OBJECTIVES: To compare overallsurvival between the life expectancy and the actual estimated outcomein patients who received primary androgen deprivation therapy.

METHODS: Out of 19250 patients who received androgendeprivation therapy between 2001 and 2003 in the Japan Study Groupof Prostate Cancer (J-CaP Study Group; http://www.j-cap.net), a total of15265 patients with whole clinical data set including age, PSA value,Gleason score, clinical stage and co-morbidity was enrolled in thisretrospective study. The median age, PSA value at diagnosis, andfollow-up period were 75 years (range: 35-99), 5.0 ng/mL (range: 0.01-30789), and 36 months (range: 1-147), respectively. The clinical TNMclassification was followed by 1997 UICC classification. The proportionof low risk, intermediate risk, high risk, very high risk (cT3a-bN0M0),locally advanced (T4 or N1), and Metastatic (M1), were 11.5%, 12.2%,24.1%, 19.1%, 6.1%, and 26.6%, respectively. The life expectancy wasdefined by using a simple life table of Japanese. Patient whose lifeexpectancy at diagnosis is longer than the follow-up period is defined as,galive,h at last follow-up day. Patient whose life expectancy atsurgery is shorter than the follow-up period is defined as ,gdeath,hwith survival time as same as the life expectancy. The overall survivalwas estimated by Kaplan-Meier method. The difference was tested bylog-rank test.

RESULTS: The estimated 5-year and 10-year overall survivalrate were 77.8%, and 61.5%, respectively. On the other hand, the 5-yearand 10-year life expectancy were 98.4% and 76.1%, respectively. Theactual estimated overall survival was significantly lower than the life ex-pectancy (p<0.001). This trend was observed in all risk groups. Theoverall survival without cancer death was also significantly lower than thelife expectancy not only in all patients but also in each risk group. Therewas no significant difference between the overall survival without cancerdeath and the life expectancy in the elderly patients (80 years orgreater) (p¼0.174).

CONCLUSIONS: The estimated overall survival was signifi-cantly lower than the life expectancy in patients who received primaryandrogen deprivation therapy.