THE JOURNAL OF UROLOGY®
Vol. 181, No. 4, Supplement, Sunday, April 26, 2009
541 POTENTIALLY AVOIDED SURGERIES IN MEN WITH LOCALIZED, LOW-RISK PROSTATE CANCER UNDERGOING ACTIVE SURVEILLANCE: A MODEL-BASED ANALYSIS Bin Zhang, Joseph Menzin*, Waltham, MA; David W Lee, Waukesha, WI; Mark Friedman, Jonathan R Korn, Waltham, MA; John Kurhanewicz, San Francisco, CA; Robert Dann, Waukesha, WI INTRODUCTION AND OBJECTIVE: Active surveillance (AS) is emerging as an alternative to immediate treatment for patients with clinically localized, low-risk prostate cancer. Beneﬁts from AS (avoidance of costs and risks of complications and mortality associated with treatment) must be balanced against potential harms (reduced life expectancy from metastatic progression, and worries of living with cancer). This study estimated the number of immediate surgeries avoidable by patients undergoing AS without any sacriﬁce of life expectancy. METHODS: We developed a Markov model comparing patients with clinically localized, low-risk prostate cancer (T 1-2b N0 M0, PSA <=10 ng/mL, Gleason sum <=6) undergoing AS with those receiving immediate surgery. We modeled patients’ annual progression through 4 health states (no clinical progression; clinical progression; metastatic cancer; dead), and surgery prompted by disease progression or patient choice in those with non-metastatic disease. Published literature, SEER*Stat and US life tables provided inputs. We derived the metastatic disease progression rates to equalize life expectancy under the two strategies (AS vs. immediate surgery), and then estimated the corresponding number of surgeries avoided by patients following AS starting at ages 65, 70 or 75. RESULTS: Simulated life expectancies under AS and immediate surgery were equal when annual rates of progression to metastatic cancer for the AS group were 1.6%, 2.1%, and 2.7% at ages 65, 70, and 75, respectively. With equalized life expectancies, the corresponding proportions of patients undergoing AS who would avoid surgery were 54.4%, 61.4%, and 68.6%. When life expectancy is quality-adjusted, 2-3% more patients in each age group could avoid surgery under AS. These results vary by the annual clinical progression rate and by the proportion of patients electing surgery without evidence of clinical progression. Based on the number of incident cases of localized, low-risk prostate cancer among US men aged 65-75, AS could avoid approximately 8,500-9,000 surgeries annually. CONCLUSIONS: Our simulations show that active surveillance has the potential to substantially reduce the number of patients with localized, low-risk prostate cancer who receive immediate surgery. Source of Funding: GE Healthcare
542 DECISION AIDS IMPROVE NEWLY DIAGNOSED PROSTATE CANCER PATIENTS UNDERSTANDING OF THE RATIONALE FOR ACTIVE SURVEILLANCE John D Seigne*, Telisa Stewart, Kate Clay, Stephen Kearing, Shaun Wason, John Heaney, Lebanon, NH INTRODUCTION AND OBJECTIVE: Engaging patients in high quality decision making regarding prostate cancer screening and treatment choice for early stage disease is challenging. Decision aids (DA) have been shown to be an effective tool in improving patient decision making where treatment choice is complex. In the United States it is clear that radical therapy is over utilized and that increasing the appropriate use of active surveillance has the potential for maintaining quality of life for patients with low risk prostate cancer. We examined the ability of an audiovisual Decision Aid to improve the understanding of the rationale for active surveillance in patients with newly diagnosed clinically localized prostate cancer. METHODS: From September 2007 - February 2008, a prospective cohort of 228 patients with newly diagnosed early stage prostate cancer were mailed a cover letter, informational pamphlets, and a video DA which includes facts about prostate cancer, treatment options, and testimony from patients prior to their consultation. Participants then
complete a questionnaire that captures prostate cancer knowledge, clinical and decision making data prior to the counseling visit. RESULTS: Of the 228 patients, 219 received the information package and completed the questionnaire prior to their appointment. 141(64%) patients watched the DA. 90 patients (41%) were newly diagnosed at our center while the remainder were diagnosed and initially counseled elsewhere and were coming for a second opinion. In general the patients’ knowledge about prostate cancer was good with ~90% answering correctly. Watching the DA did improve knowledge to >97% answering correctly (P<0.05). However, baseline understanding of the risk and rationale for active surveillance was low with only 50% of patients who did not watch the DA answering correctly compared to >70% of those watching the DA (P<0.01). A worrisome ﬁnding was that patients, who had been previously counseled elsewhere and did not watch the DA, knowledge of the rationale for active surveillance was no better than those who had never been counseled. CONCLUSIONS: Patients with early stage prostate cancer’s knowledge of the rationale for active surveillance is poor even following an initial consultation with a urologist. The use of an evidence based DA signiﬁcantly improves patients knowledge regarding active surveillance Source of Funding: Foundation for Informed Medical Decision Making
543 SURVEILLANCE AND TREATMENT EXPENDITURES OF STAGE I TESTIS CANCER Hua-yin Yu*, Los Angeles, CA; Rodger A Madison, Santa Monica, CA; Christopher S Saigal, Los Angeles, CA; the Urologic Diseases in America Project INTRODUCTION AND OBJECTIVE: The economic impact of treatment choice for men with stage I testis cancer has primarily been examined via modeling at referral centers. Actual expenditures in the community are unknown. We evaluated expenditures for surveillance, retroperitoneal lymph node dissection (RPLND) and radiation therapy (XRT) in a population of privately insured men. METHODS: Using a claims database, we identiﬁed men who had radical orchiectomy for testis cancer from 2002 to 2007. Stage I men were identiﬁed as having primary RPLND or XRT if they occurred within 4 months of orchiectomy and were not preceded by chemotherapy. Surveillance patients were deﬁned as men without RPLND, XRT, or chemotherapy within 4 months of orchiectomy. We identiﬁed claims related to testis cancer and calculated annual expenditures per patient, including treatment, follow up, and treatment for recurrences. We compared follow up test expenditures to expenditures predicted using National Comprehensive Cancer Network guidelines. RESULTS: 279, 72, and 388 patients had surveillance, RPLND and XRT, respectively, with mean follow up of 30, 30, and 28 mo. Cumulative 5-year expenditures were greatest for RPLND and lowest for XRT. Most expenditures were incurred during year 1. Physician and hospital services comprised the majority of expenditures. Overall expenditures in years 2-5 were highest among men on surveillance. Follow up test expenditures were lower among surveillance patients and higher among RPLND and XRT patients than projected. CONCLUSIONS: Long-term expenditures for stage I testis cancer are lowest after XRT. Expenditures for surveillance are between XRT and RPLND, even though no active treatment occurs at the initiation of this strategy. Follow up testing in these patients do not account for the bulk of expenditures. This suggests that surveillance patients are incurring more expenses related to physician and hospital services, including treatment for recurrences. These data also emphasize that actual expenditures for this disease may vary from projected models due to high rates of non-compliance with follow up protocols.
THE JOURNAL OF UROLOGY®
Vol. 181, No. 4, Supplement, Sunday, April 26, 2009
545 THREE YEAR COST ANALYSIS OF SACRAL NEUROMODULATION, INTRA-DETRUSOR INJECTION OF BOTULINUM TOXIN TYPE A, AND AUGMENTATION CYSTOPLASTY FOR OVERACTIVE BLADDER WITH URINARY URGE INCONTINENCE Jonathan H Watanabe*, Jonathan D Campbell, Seattle, WA; Arliene Ravelo, Irvine, CA; Michael B Chancellor, Royal Oak, MI; Jonathan Kowalski, Irvine, CA; Sean D Sullivan, Seattle, WA
Source of Funding: National Institute of Diabetes and Digestive and Kidney Diseases
544 OUTCOMES OF ELDERLY PATIENTS WITH UROTHELIAL CARCINOMA OF THE BLADDER AND CONSEQUENCES OF GUIDELINE-DISCORDANT TREATMENT Christian Bolenz*, Richard Ho, Geoffrey R Nuss, Nicolas Ortiz, Ganesh V Raj, Arthur I Sagalowsky, Yair Lotan, Dallas, TX INTRODUCTION AND OBJECTIVE: Treatment decisions in elderly patients diagnosed with urothelial carcinoma of the bladder (UCB) may not meet guideline recommendations (GR) due to presumed short lifespan, comorbidities, and psychosocial factors. We describe the management and clinical course of elderly patients following transurethral resection (TUR) of UCB. METHODS: The records of 116 consecutive patients with available data, over 75 yrs. [89 males, 27 females, median age 80 (range 75-94)], treated between 10/1998 and 08/2008 were reviewed. The AUA Treatment Recommendations were used as a reference when evaluating concordance with GR and clinical outcome. Median follow-up was 17.0 (0.3-111.5) months. RESULTS: Based on TUR pathology, 70 patients with nonmuscle-invasive UCB had an indication for conservative treatment [TUR±intravesical therapy(IVT)]. 39 patients had an indication for BCG, 34 (87.2%) of which received at least a BCG induction cycle. 46 patients (39.7%) had an indication for radical cystectomy (RC), including muscleinvasive UCB, recurrent high-grade UCB and BCG failure. Of these, 29 patients (63%) underwent RC (n=24) or radio-chemotherapy (RCHT; n=5) in a curative attempt. The GR concordance rate was 87% and 63% in patients with and without indication for RC, respectively. Patients at higher age (p=0.006), lower Karnofsky performance status (KPS; p=0.008) and higher Charlson comorbidity index (p=0.025) were less likely to be treated following GR. 82 patients (70.7%) were eventually treated conservatively (TUR+/- IVT). Of 35 patients (42.7%) who recurred after IVT, 23 met indication for RC, but only 3 patients underwent RC. Overall, 42 deaths occurred (36.2%). Patients with indication for RC but considered unﬁt for this procedure showed signiﬁcantly reduced OS, however, multivariable analysis revealed KPS as the sole independent predictor for reduced OS (p<0.001). In the subgroup of patients with a clear indication for RC, univariable analysis showed no difference in OS between treatment according to GR or not (p=0.976). Again, KPS at the time of TUR was the only parameter associated with reduced OS in this group (p=0.005). CONCLUSIONS: A vast majority of elderly patients appropriately received intravesical therapy. However, over one third of elderly patients did not undergo RC despite indication for the same. No difference in survival based on treatment with RC or not in this patient group was observed. KPS is a strong predictor for reduced OS and should be considered to optimize patient care. Source of Funding: None
INTRODUCTION AND OBJECTIVE: Three treatment options for oral antimuscarinic refractory patients are Sacral Neuromodulation (SNM), Intra-Detrusor injections of Botulinum Toxin Type A (BoNTA), and Augmentation Cystoplasty (AC). With U.S. OAB related costs estimated at $12.2 billion, decision makers are interested in understanding the cost of treatment options for antimuscarinic refractory patients. The objective was to estimate the average initial treatment costs, ﬁrst year costs, and cumulative costs extending to three years of SNM, BoNTA, and AC in OAB patients. METHODS: SNM billing codes for procedures and surgical center costs were derived from commonly billed codes issued to providers by the SNM manufacturer. Intra-detrusor injection of BoNTA billing codes were based on recommended BoNTA-speciﬁc codes for OAB from a large health plan. AC codes were derived from literature review describing the surgical procedure. Procedure costs were based on the Center for Medicare and Medicaid Services (CMS) National Physician Fee Schedule. BoNTA drug cost was calculated using CMS Average Selling Price. SNM surgical center costs were based on CMS Ambulatory Payment Classiﬁcation schedules. AC surgical center costs were determined from Diagnosis Related Group reimbursement ﬁles. One-way sensitivity analysis was performed to evaluate assumptions and uncertainty of results based on plausible variation in parameter estimates. All costs were reported in 2007 US dollars. RESULTS: Initial treatment costs were $22,226, $1,313, and $10,252 for SNM, Intra-Detrusor Injection of BoNTA, and AC respectively. The ﬁrst-year costs were $23,614, $2,626, and $11,637 respectively. Three years after initiating treatment, the cumulative costs were $26,269, $7,651 , and $14,337 respectively. Sensitivity analysis revealed that SNM persisted as the most costly intervention in all modeled scenarios. The range of three year cumulative costs by intervention for SNM, BoNTA, and AC was $25,384-$27,357, $4,586-$11,476, and $12,315-$16,830 respectively. CONCLUSIONS: All estimates of cost endpoints for SNM were markedly greater than those for BoNTA and AC for OAB patients. These cost estimates, when combined with data on efﬁcacy and safety outcomes, are important components of a robust health care technology assessment of treatment options for patients with OAB with urinary incontinence who fail or cannot tolerate oral antimuscarinic treatment. Source of Funding: University of Washington Post-Doctoral Fellowship sponsored by Allergan
546 PREOPERATIVE EXPENSES FOR PATIENTS UNDERGOING ROBOTIC-ASSISTED LAPAROSCOPIC RADICAL PROSTATECTOMY: ARE COSTS JUSTIFIED? George Dakwar*, Ihor S Sawczuk, Jayant Uberoi, Ravi Munver, Hackensack, NJ INTRODUCTION AND OBJECTIVE: The number of patients with localized prostate cancer that elect for robotic-assisted laparoscopic radical prostatectomy (RLRP) is steadily increasing. We assessed individual and total costs for preoperative staging in patients that underwent RLRP in a major metropolitan area. METHODS: A retrospective review was performed of 249 patients that underwent RLRP over 12 consecutive months at a major referral institution. Preoperative parameters were analyzed, including PSA, biopsy Gleason score, cystoscopy, and radiographic imaging studies. Medicare reimbursement for cystoscopy and the various imaging modalities were used to estimate individual and total costs. The mean radiation dosage was calculated for the imaging modalities.