Gary Chien

The Continuum of Prostate Cancer Care: An Integrated Population Based Model of Health Care Delivery

Introduction: We present a comprehensive model for population based prostate cancer management that is scalable, and has improved quality and outcomes. Methods: Kaiser Permanente Southern California is an integrated health care system that provides comprehensive care for 3.7 million members. Beginning in 2003 we put programs into place to improve the spectrum of care related to prostate cancer. These programs addressed screening, shared decision making for treatment after diagnosis, and care improvement for men with localized and advanced disease. These were implemented with traditional quality improvement techniques and outcomes were evaluated in collaboration with research groups embedded in the organization. Results: Prostate cancer screening in men 75 years old or older decreased 50% from 30% to 15%. The Safety Net program identified nearly 1,200 men with prostate cancer who had not been seen for followup from 2006 to 2010. There was a reduction in blood loss in surgical procedures that obviated the need for transfusion while maintaining a low positive margin rate. Hormonal therapy was changed to a dosing approach that was based on circulating testosterone levels, preventing some of the side effects of this therapy. Coupled with a systems approach to osteoporosis prevention, this approach resulted in a dramatic reduction in fracture rates in this high risk population. Conclusions: These data demonstrate that a systems approach to a population based prostate cancer program can lead to efficient and reliable care that can be successfully disseminated through an integrated health plan.

361 QUALITY OF LIFE OUTCOMES IN MEN UNDERGOING TREATMENT OF LOCALIZED PROSTATE CANCER: INITIAL RESULTS FROM THE KAISER PERMANENTE SOUTHERN CALIFORNIA REGION

INTRODUCTION AND OBJECTIVES: Risk-stratification based on preoperative data cannot reliably predict organ-confined disease. This is of particular relevance for selecting patients for nerve-sparing (NS) radical prostatectomy (RP). We assessed the impact of our intraoperative neurovascular structure adjacent frozen section examination (NeuroSAFE) guided nerve-sparing approach on the frequency of nerve-sparing and surgical margin rates in D’Amico low-, intermediate-, and high-risk patients, applying a novel score (SAFE-R), combining surgical margin status (SM) and extend of NS. METHODS: From January 2002 to January 2011, 9,674 consecutive RPs were performed at our center. Of these, 4,518 (47%) were conducted with NeuroSAFE. Proportions of NS, SM-status were assessed. Subsequently, a score for oncological safe NS (SAFE-R) was developed. SAFE-R was categorized as 3 (for negative SM and bilateral NS), 2 (for negative SM and unilateral NS), 1 (for negative SM without NS) and 0 (for patients with positive SM), respectively. The impact of NeuroSAFE on SAFE-R was analyzed by chi-square test and confirmed with a multinominal logistic regression, controlling for preoperative risk-factors. All analyses were stratified for patients of lowintermediateor high-risk according to the D’Amico classification. RESULTS: D’Amico high-, intermediateand low-risk profile was found in 1,319 (13.6%), 4,245 (43.9%) and 4,110 (42.5%) of all patients respectively. Within the low-risk group, a SAFE-R-0 (positive SM) was significantly less prevalent and SAFE-R scores of 2 or 3 (unior bilateral NS and negative SM) were more prevalent in patients undergoing neuroSAFE, compared to non-neuroSAFE patients (10.5 vs. 13.2%, and 88.1 vs. 85.7%, respectively, p 0.001). Similarly, in intermediate and high-risk patients, neuroSAFE resulted in lower proportions of SAFE-R score 0 (15.9 vs. 19.9% and 27.6 vs. 33.6%) and higher proportions of SAFE-R score 3 (53.7 vs. 44.1% and 32.4 vs. 17.3%, respectively, all p 0.001). Linkage between the neuroSAFE approach and SAFE-R was confirmed after multinominal logistic adjustment for preoperative risk factors. CONCLUSIONS: SAFE-R represents a novel score to assess and report on oncological safe nerve-sparing in RP. Frozen section navigated nerve-sparing (NeuroSAFE) is associated with enhanced SAFE-R-scores without compromising oncological safety, even in highrisk patients.

1786 TIME TO ONCOLOGIC PROFICIENCY IN ROBOTIC RADICAL PROSTATECTOMY: SUCCESSFULLY REDUCING THE LEARNING CURVE IN A MULTI-SURGEON PROGRAM

INTRODUCTION AND OBJECTIVES: In the last 5 years Robotic–assisted Radical Prostatectomy (RALP) has rapidly become the primary form of surgical treatment for radical prostatectomy (RP). Multiple studies have documented a significant learning curve for RALP, even for experienced open or laparoscopic surgeons. Our objective was to develop a multi-surgeon robotic surgery program that would allow all surgeons learning RALP to achieve proficiency (as measured by surgical margin status), without compromising “cancer control” during the learning curve. METHODS: The robotic surgery program for Southern California Kaiser Permanente started August, 2008. The program began with 10 surgeons, all with prior experience in laparoscopic RP ( 50 cases). In addition, three of the surgeons had completed an accredited fellowship in robotic surgery, and had prior experience in performing RALP. These surgeons served as preceptors for the other surgeons. Surgery was undertaken in a step-wise fashion, with all surgeons completing 10 cases with the preceptor. Subsequently, each RALP that was performed was done so with one of the original 10 surgeons serving as primary assistant. Since the inception of the program, 8 additional surgeons have been trained. We prospectively collected pathologic data, using margin status as a surrogate endpoint for cancer control. RESULTS: As of October, 2010, 1232 RALPs have been performed. Mean patient age is 59.3. Mean pre-operative PSA level is 7.2 (0.6–41). Mean Gleason’s score was 6.3 (5–10). All prostate specimens were reviewed by the same 3 pathologists at one institution. 962 (78%) patients were pathologic stage pT2 and 270 (22%) of patients were pT3. The mean number of cases performed per surgeon is 79 (4–147). Surgical margin status was evaluated for the first 1200 cases by quartile (1st 300 cases, 2nd 300, 3rd 300 and 4th 300) and is as follows: For pT2: 24%, 14%, 13% and 11%; for pT3: 51%, 43, 21 and 25%, respectively per quartile. Total Major complication rate (Clavien grade 3 and 4): 1.3%. CONCLUSIONS: While it is premature for us to use biochemical recurrence to evaluate surgical proficiency, surgical margin status remains a primary surrogate endpoint to assess surgical technique and to provide feedback to surgeons along the “learning curve.” We have demonstrated that an acceptable positive surgical margin status for RALP, as well as a low complication rate, can be achieved within a relatively short period of time, using a standardized preceptorship program. We are currently using this same format to train surgeons for additional robotic procedures.

80 OSTEOPOROSIS MANAGEMENT PROGRAM DECREASES THE INCIDENCE OF HIP FRACTURES IN PATIENTS WITH PROSTATE CANCER ON ANDROGEN SUPPRESSION

INTRODUCTION AND OBJECTIVES: Androgen suppression as a treatment for prostate cancer can cause osteoporosis, which can result in hip fractures. Kaiser Permanente Southern California (KPSC) has pioneered an osteoporosis disease management program, Healthy Bones Program (HBP), which has shown to reduce hip fracture rates in the osteoporotic population. However, it is currently unknown if patients who are on androgen suppression due to prostate cancer would also experience a lower rate of hip fracture if enrolled in HBP. METHODS: Since 2002, the Healthy Bones Program has been implemented at all KPSC hospitals for any patient who has the risk of developing osteoporosis. HBP patients undergo a dual x-ray absorptiometry scan (DEXA), and are started on oral Vitamin D/calcium and/or bisphosphonate therapy based on their initial T score. Using the KPSC Cancer Registry, we performed a retrospective review of 2,182 patients who were diagnosed with prostate cancer between January 2003 and December 2007 and are on leuprolide androgen suppression up to September 2008. Patients who were in the HBP were identified by the presence of DEXA scans, whereas patients who were not followed by the protocol did not have DEXA scans. Exclusion criteria included: patients who had less than 6 months of health plan membership, were younger than 50 years of age, had a DEXA scan performed greater than 3 months prior to the first leuprolide dose, had less than 6 months of follow up, had a previous hip fracture, and patients who had only one dose of leuprolide. The number of hip fractures was recorded. RESULTS: A final group of 1,482 patients was identified. There were 1,025 patients in the HBP cohort, and 457 patients in the nonHBP group. The mean age was older in the HBP group, 74 vs. 71 years, respectively (p 0.01). The mean total number of leuprolide dosages given was also higher for the HBP group, 6.3 vs. 4.8, respectively (p 0.01). The racial breakdown was similar between the two groups (p 0.5). The incidence rate of hip fractures per 1,000 person years was lower for the HBP group, 4.44 vs. 11.96, respectively. For patients who sustained hip fractures, median time from first leuprolide dose to hip fracture was longer for the HBP group, 834 days to 390 days, respectively. CONCLUSIONS: Hip fracture incidence rates are reduced by nearly one third when castrated prostate cancer patients are enrolled in the HBP. Due to the high healthcare costs, morbidity and mortality of hip fractures, this finding may have a significant implication in the management of this population of patients on androgen suppression for prostate cancer.