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UP-02.077 Is Radical Cystectomy a Treatment Option for Very High-risk T4-Prostate Cancer?
UNMODERATED POSTER SESSIONS
castration was observed in 69% of treatment compliant men receiving 1000mg, and 91% of men receiving 1500mg of GTx-758. Baseline osteocalcin was reduced by 21.37% and 17.53% in men treated with 1000mg and 1500 mg GTx758, respectively. Similarly, bone specific alkaline phosphatase was reduced by 6% and 19%, respectively. Conclusions: In preclinical models GTx758, an oral selective ER␣ agonist, has demonstrated favorable effects on hot flashes and on body composition in castrated animals. In a Phase II study, GTx758 showed the ability to lower testosterone to castrate levels and reduce bone turnover markers. By exerting a favorable effect on bone GTx-758 differs from currently available ADT.
UP-02.077 Is Radical Cystectomy a Treatment Option for Very High-risk T4-Prostate Cancer? Spahn M1, Gontero P2, Kneitz B1, Bader P4, van Poppel H3, Joniau S3, Frohneberg D4 1 University Hospital Würzburg, Germany, 2University Hospital Turin, Italy, 3University Hospital Leuven, Belgium, 4Community Hospital Karslruhe, Germany Introduction and Objectives: Prostate cancer (PCa) pts with cT4-tumor are at high risk for disease progression and cancer-related death. Surgery is gradually becoming accepted as a first step in a multimodality treatment in selected pts, although controversy remains regarding this approach. RP is often unable to achieve complete tumor removal and positive resection margins may have a deleterious effect on the outcome. The outcomes of radical cystectomy in 27 men with T4prostate cancer are presented. Materials and Methods: We retrospectively analysed our institutional PCa databases and included all men with cT4-PCa, and negative bone scan who underwent radical cystectomy (RC) ⫹ extended lymphadenectomy. Adj. or salvage radiotherapy (RT) or hormonal therapy (HT) were administered according to institutional protocols. Pts were followed up at regular time intervals with PSA testing. Imaging studies were performed at the time of biochemical failure or at symptoms. Kaplan-Meier analysis and Cox regression analysis were used for the outcome analysis. Results: Between 1/1991 and 11/2007, 27 men with cT4 N0-1 M0 PCa underwent
S286
UP-02.077, Table 1.
Freedom from biochemical progression (PSA ⬎0.2 ng/ml) Freedom from clincal recurrence Cancer specific survival Overall survival
RC at two institutions. Mean PSA was 10.5 (0.1-349) ng/ml (SD ⫹/⫺77.6). Mean age was 65 years (SD ⫹/⫺7). pTNM showed no understaging, all patients had pT4 disease. Positive surgical margins were present in half of the pts (14 out of 27). Lymph node involvement was present in 17 pts (62.9%). Median pathological Gleason score was 8 (range 5-10). In two pts neoadjuvant HT was administered. Adjuvant RT and HT were administered in 7.4% and 77.7%, while salvage RT and HT were given in 7.4% and 11.1% of pts respectively. Mean follow up was 43 months (SD ⫹/⫺41). Cox multivariate regression analysis confirmed only seminal vesicle invasion to be an independent predictors of freedom of clinical NED (p⫽ 0.008; 95% CI: 1.51-15.3), CSS (p⫽0.003; 95% CI: 2.13-45.7) and OS (p⫽0.018; 95%CI: 1.66-244.7). None of the patients required hospital admission due to local tumor recurrence. Conclusions: Men with cT4-PCa have a significant risk of biochemical and clinical recurrence after radical cystectomy. However, local tumor control is excelent and CSS was 32% at 10-years. Radical cystectomy therefore might be a treatment option in men with symptomatic T4-PCa to prevent local symptoms and should be further evaluated in new multimodal treatment concepts.
UP-02.078 What Can We Tell Patients Newly Diagnosed with Gleason 8 or 9 Disease? A UK-Population Study Yamamoto H1, Ooi J1, Challacombe B1, Cahill D1, Chandra A2, Popert R1 1 Dept of Urology; 2Dept of Histopathology, Guy’s Hospital, London, UK Introduction and Objective: Gleason score of 8 to 10 is an independent predictor of high progression risk in prostate cancer, and a cause for concern and distress in the newly diagnosed cancer patient. Prognostic information we provide to patients relies on extrapolation of trials conducted in populations with different demographics and health services. The
5-year projected survival (%) 25.7
10-year projected survival (%) 12.8
22.6 35.7 34.3
22.6 35.7 34.3
objective is to evaluate the intermediate term oncological outcomes of a series of patients with Gleason patterns 8, 9 and 10 in a UK population. Materials and Methods: There were 206 patients diagnosed with Gleason score 8-10 between 2004 and 2010 who were included (mean age 68⫾8yrs, follow-up 33⫾19months). We recorded: biopsy Gleason score, PSA, primary treatment modality, bone scan, MRI stage, and salvage treatment. Results: Proportion of tumour grades were: Gleason 8 (27%), 9 (69%), 10 (4%). There were 21% who were metastatic at diagnosis, which was not influenced by Gleason score (p⬎0.05). For treatment, patients received radical prostatectomy (RP) (21%), hormones with radiotherapy (HRT) (25%), and hormone therapy only (37%). These cohorts differed significantly in PSA and age. Overall 5-year survival stratified by Gleason score favoured Gleason 8 (87%) as compared to Gleason 9 (43%). A 48-month overall survival stratified by treatment was highest in RP (100%), followed by HRT (92%) (p⫽0.4), although biochemical progression-free survival was higher in HRT (97%) in contrast to RP (51%) (p⫽0.0004), and 40% of RP patients required further treatment. Conclusion: We determined the oncological outcomes of patients with high Gleason score in UK patients. RP and HRT are associated with good overall survival rates, although RP is associated with higher rates of biochemical failure.
UP-02.079 Prognostic Significance of the Quantification of Circulating Tumor Cells in Patients with Metastatic Hormone-Sensitive Prostate Cancer Celada G1, Resel L2, San José L2, Galante I2, Vidaurreta M3, Maestro M3, Díaz-Rubio E4, Silmi A2, Olivier C1 1 Dept. of Urology. Hospital Universitario De La Princesa, Dept. of 2Urology, 3 Clinical Analysis, 4Clinical Oncology, Hospital Universitario Clínico San Carlos, Madrid, Spain Introduction and Objectives: Analysis
UROLOGY 78 (Supplement 3A), September 2011
castration was observed in 69% of treatment compliant men receiving 1000mg, and 91% of men receiving 1500mg of GTx-758. Baseline osteocalcin was reduced by 21.37% and 17.53% in men treated with 1000mg and 1500 mg GTx758, respectively. Similarly, bone specific alkaline phosphatase was reduced by 6% and 19%, respectively. Conclusions: In preclinical models GTx758, an oral selective ER␣ agonist, has demonstrated favorable effects on hot flashes and on body composition in castrated animals. In a Phase II study, GTx758 showed the ability to lower testosterone to castrate levels and reduce bone turnover markers. By exerting a favorable effect on bone GTx-758 differs from currently available ADT.
UP-02.077 Is Radical Cystectomy a Treatment Option for Very High-risk T4-Prostate Cancer? Spahn M1, Gontero P2, Kneitz B1, Bader P4, van Poppel H3, Joniau S3, Frohneberg D4 1 University Hospital Würzburg, Germany, 2University Hospital Turin, Italy, 3University Hospital Leuven, Belgium, 4Community Hospital Karslruhe, Germany Introduction and Objectives: Prostate cancer (PCa) pts with cT4-tumor are at high risk for disease progression and cancer-related death. Surgery is gradually becoming accepted as a first step in a multimodality treatment in selected pts, although controversy remains regarding this approach. RP is often unable to achieve complete tumor removal and positive resection margins may have a deleterious effect on the outcome. The outcomes of radical cystectomy in 27 men with T4prostate cancer are presented. Materials and Methods: We retrospectively analysed our institutional PCa databases and included all men with cT4-PCa, and negative bone scan who underwent radical cystectomy (RC) ⫹ extended lymphadenectomy. Adj. or salvage radiotherapy (RT) or hormonal therapy (HT) were administered according to institutional protocols. Pts were followed up at regular time intervals with PSA testing. Imaging studies were performed at the time of biochemical failure or at symptoms. Kaplan-Meier analysis and Cox regression analysis were used for the outcome analysis. Results: Between 1/1991 and 11/2007, 27 men with cT4 N0-1 M0 PCa underwent
S286
UP-02.077, Table 1.
Freedom from biochemical progression (PSA ⬎0.2 ng/ml) Freedom from clincal recurrence Cancer specific survival Overall survival
RC at two institutions. Mean PSA was 10.5 (0.1-349) ng/ml (SD ⫹/⫺77.6). Mean age was 65 years (SD ⫹/⫺7). pTNM showed no understaging, all patients had pT4 disease. Positive surgical margins were present in half of the pts (14 out of 27). Lymph node involvement was present in 17 pts (62.9%). Median pathological Gleason score was 8 (range 5-10). In two pts neoadjuvant HT was administered. Adjuvant RT and HT were administered in 7.4% and 77.7%, while salvage RT and HT were given in 7.4% and 11.1% of pts respectively. Mean follow up was 43 months (SD ⫹/⫺41). Cox multivariate regression analysis confirmed only seminal vesicle invasion to be an independent predictors of freedom of clinical NED (p⫽ 0.008; 95% CI: 1.51-15.3), CSS (p⫽0.003; 95% CI: 2.13-45.7) and OS (p⫽0.018; 95%CI: 1.66-244.7). None of the patients required hospital admission due to local tumor recurrence. Conclusions: Men with cT4-PCa have a significant risk of biochemical and clinical recurrence after radical cystectomy. However, local tumor control is excelent and CSS was 32% at 10-years. Radical cystectomy therefore might be a treatment option in men with symptomatic T4-PCa to prevent local symptoms and should be further evaluated in new multimodal treatment concepts.
UP-02.078 What Can We Tell Patients Newly Diagnosed with Gleason 8 or 9 Disease? A UK-Population Study Yamamoto H1, Ooi J1, Challacombe B1, Cahill D1, Chandra A2, Popert R1 1 Dept of Urology; 2Dept of Histopathology, Guy’s Hospital, London, UK Introduction and Objective: Gleason score of 8 to 10 is an independent predictor of high progression risk in prostate cancer, and a cause for concern and distress in the newly diagnosed cancer patient. Prognostic information we provide to patients relies on extrapolation of trials conducted in populations with different demographics and health services. The
5-year projected survival (%) 25.7
10-year projected survival (%) 12.8
22.6 35.7 34.3
22.6 35.7 34.3
objective is to evaluate the intermediate term oncological outcomes of a series of patients with Gleason patterns 8, 9 and 10 in a UK population. Materials and Methods: There were 206 patients diagnosed with Gleason score 8-10 between 2004 and 2010 who were included (mean age 68⫾8yrs, follow-up 33⫾19months). We recorded: biopsy Gleason score, PSA, primary treatment modality, bone scan, MRI stage, and salvage treatment. Results: Proportion of tumour grades were: Gleason 8 (27%), 9 (69%), 10 (4%). There were 21% who were metastatic at diagnosis, which was not influenced by Gleason score (p⬎0.05). For treatment, patients received radical prostatectomy (RP) (21%), hormones with radiotherapy (HRT) (25%), and hormone therapy only (37%). These cohorts differed significantly in PSA and age. Overall 5-year survival stratified by Gleason score favoured Gleason 8 (87%) as compared to Gleason 9 (43%). A 48-month overall survival stratified by treatment was highest in RP (100%), followed by HRT (92%) (p⫽0.4), although biochemical progression-free survival was higher in HRT (97%) in contrast to RP (51%) (p⫽0.0004), and 40% of RP patients required further treatment. Conclusion: We determined the oncological outcomes of patients with high Gleason score in UK patients. RP and HRT are associated with good overall survival rates, although RP is associated with higher rates of biochemical failure.
UP-02.079 Prognostic Significance of the Quantification of Circulating Tumor Cells in Patients with Metastatic Hormone-Sensitive Prostate Cancer Celada G1, Resel L2, San José L2, Galante I2, Vidaurreta M3, Maestro M3, Díaz-Rubio E4, Silmi A2, Olivier C1 1 Dept. of Urology. Hospital Universitario De La Princesa, Dept. of 2Urology, 3 Clinical Analysis, 4Clinical Oncology, Hospital Universitario Clínico San Carlos, Madrid, Spain Introduction and Objectives: Analysis
UROLOGY 78 (Supplement 3A), September 2011