Carlson, Rachel E.

106 Background: Some patients with lymph node metastases experience prolonged survival following radical prostatectomy. The purpose of this study was to determine the outcome of patients with clinically suspicious lymph nodes on preoperative imaging who underwent radical prostatectomy and lymphadenectomy. Methods: Patients with lymph node metastases diagnosed during radical prostatectomy from 1988-2003 were reviewed. Patients with preoperative CT or MRI images were included in the study. Radiology reports were reviewed to determine if patients had clinically suspicious lymphadenopathy (cN+). For all analyses, patients with cN+ were compared to those with clinically negative nodes (cN−). Results: Preoperative imaging was available in 202 men with lymph node metastasis at the time of prostatectomy. Of these 17% (34/202) were cN+. None had pre-operative lymph node biopsy and none had abandoned prostatectomy. At a median follow-up of 11.1 years, PSA recurrence occurred in 50% (17/34) and 49% (82/186), local recurrence in 18% (6/34) and 13% (22/186) and systemic progression in 32% (11/34) and 24% (40/186) of patients with cN+ and cN-, respectively. On multivariate analysis, cN+ was not associated with increased risk of death (HR 1.66, p=0.1). Conclusions: cN+ patients undergoing surgical therapy for prostate cancer may experience similar outcomes to cN− patients. The presence of clinically suspicious lymph nodes on preoperative imaging should not be an absolute contraindication for surgical therapy. No significant financial relationships to disclose.

175 Background: The efficient delivery of adjuvant and salvage therapy after radical prostatectomy in patients with prostate cancer is hampered by a lack of biomarkers to assess the risk of clinically significant recurrence and progression. Methods: Mayo Clinic Radical Prostatectomy Registry (RP) patient specimens were selected from a case-control cohort with 14 years median follow-up for training and initial validation of an expression biomarker genomic classifier (GC). An independent, blinded case-cohort study of high-risk RP subjects was used to validate GC, comparing the performance of GC to a multivariate logistic regression clinical model (CM) and GC combined with clinical variables (genomic-clinical classifier, GCC) for predicting clinical recurrence (defined as positive bone or CT scan within 5 years after biochemical recurrence). The concordance index (c-index) and Cox model were used to evaluate discrimination and estimate the risk of clinical recurrence. Results: In the training subset (n=359), both GC and GCC had a c-index of 0.90 whereas CM had a c-index of 0.76. In the internal validation set (n=186), GC and GCC had a c-index of 0.76 and 0.75, while CM had a c-index of 0.69. In an independent high-risk study (n=219), GC and GCC had a c-index of 0.77 and 0.76, while CM had a c-index of 0.68. In subset analysis of Gleason score 7 patients within the high-risk group, GC and GCC showed improved discrimination with c-index of 0.78 and 0.76, respectively compared to 0.70 for CM. In the high-risk group, the risk of recurrence by GC model score quartiles at 5 years after RP was estimated at 1%, 5%, 5% and 18%. Conclusions: The GC model shows improved performance over CM in the prediction of clinical recurrence in a high-risk cohort and in subset analysis of Gleason score 7 patients. The addition of clinical variables to the GC model did not significantly contribute to classifier performance in patients with high-risk features. We are further testing the performance of the GC and GCC models and their usefulness in guiding decision-making (e.g., for the adjuvant therapy setting) in additional studies of prostate cancer clinical risk groups.

BackgroundTo evaluate the impact of adjuvant hormonal therapy after radical prostatectomy on overall survival in high‐risk prostate cancer patients, stratified by comorbidity status.MethodsWe identified 1247 patients who underwent radical prostatectomy from 1988 to 2004 for high‐risk prostate cancer, as defined by National Comprehensive Cancer Network classification. Comorbidity status was stratified by Charlson Comorbidity Index as 0, 1 or >2, as well as by the presence or absence of cardiovascular disease. Overall survival was estimated by the Kaplan–Meier method, and compared within each comorbidity category/adjuvant hormonal therapy strata with the log–rank test.ResultsMedian patient age was 65 years, and the median postoperative follow up was 11.2 years. In total, 419 patients (34%) received adjuvant hormonal therapy. The distribution of Charlson Comorbidity Index was 0, 1 and ≥2 in 861 (69%), 244 (20%) and 142 (11%) patients, respectively. The 10‐year overall survival for patients who received adjuvant hormonal therapy versus those who did not was 75% versus 82% (P = 0.54) for patients with Charlson Comorbidity Index = 0, 72% versus 76% (P = 0.83) with Charlson Comorbidity Index = 1, and 70% versus 68% (P = 0.33) with Charlson Comorbidity Index ≥2. Meanwhile, 155 (12%) patients had cardiovascular disease, and the 10‐year overall survival for patients with cardiovascular disease who received adjuvant hormonal therapy was 72%, compared with 76% without adjuvant hormonal therapy (P = 0.97). On multivariate analysis, receipt of adjuvant hormonal therapy was not associated with non‐prostate cancer mortality (P = 0.24).ConclusionsAdjuvant hormonal therapy after radical prostatectomy for high‐risk prostate cancer does not increase non‐prostate cancer mortality, even among patients with multiple comorbidities. Additional studies are warranted to determine optimal multimodal treatment approach for high‐risk patients.