- Email: [email protected]
P058 Relationship between tumour burden in the transrectal biopsy and positive margins in radical prostatectomy
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all our patients with a single brachytherapy procedure and delivered a nominal dose of 18 Gy given in 3 fractions over 24 hours. (Group 1) All these patients needed to be hospitalized overnight. Since April, 2011, every HDR brachytherapy case was treated as daysurgery on an outpatient basis with a single fraction of 13 Gy. (Group 2) We are using the GammaMed Plus unit with BrachyVision software for dosimetry planning and treatment delivery. All patients in both groups received external beam therapy after the HDR procedure and a total dose of 45 to 50 Gy over a period of 5 weeks was delivered using contemporary technique. Hormone therapy was given for a minimum of 6 months starting about 2 to 3 months prior to HDR brachytherapy. Results: The median follow-up of our Group 1 patients was 60 months and the follow-up of our Group 2 patients remains too short for analysis. Thus far all our 25 Group 2 patients are doing well without apparent treatment failure or complications. There were a total of 405 patients in Group 1 and the outcome was favorable considering all had intermediate or high risk disease. Biochemical control was achieved in 340 patients (84%) Seventeen (17) patients died from metastatic or recurrent disease, and 65 other patients died from unrelated causes without evidence of prostate cancer. At present, 15 patients are alive with metastatic disease and 23 patients demonstrated biochemical failure without clinical evidence of local or distant disease. The most significant treatment related complication was urethral stricture which occurred in 23 patients (6%). However, only 3 patients ended up requiring urinary diversion. Conclusions: HDR Brachytherapy is effective in the treatment of clinically localized intermediate or high risk prostate cancer. Single dose HDR is appealing because of patient convenience and hospital savings. Most significantly it eliminates the risk of inter-fraction displacement of brachytherapy catheters. The results are encouraging, but further follow-up will be necessary. P057 PROSPER: A phase 3 study of enzalutamide in non-metastatic (M0) castration-resistant prostate cancer (CRPC) patients A. Heidenreich 1 , C. Sternberg 2 , K. Fizazi 3 , F. Saad 4 , N.D. Shore 5 , M. Hirmand 6 , F. Perabo 7 , Z. Khondker 6 , K. Modelska 6 , M. Hussain 8 . 1 University Hospital Aachen, Dept. of Urology, Aachen, Germany; 2 San Camillo and Forlanini Hospitals, Dept. of Oncology, Rome, Italy; 3 Institut Gustave Roussy, Dept. of Urology, Villejuif, France; 4 University of Montreal, Dept. of Urology, Montreal, Canada; 5 Carolina Urologic Research Center, -, Myrtle Beach, United States of America; 6 Medivation Inc, -, San Francisco, United States of America; 7 Astellas Pharma Global, -, Northbrook, United States of America; 8 University of Michigan, Dept. of Oncology, Ann Arbor, United States of America Introduction & Objectives: Prostate cancer growth is dependent on androgen receptor (AR) signaling. There is no standard of care for patients with M0 CRPC and most patients will eventually develop metastatic disease despite ongoing androgen deprivation therapy (ADT). In a recent study, patients with a PSA >8 ng/mL or PSA doubling time of <10 months had a median time to bone metastasis of only 2 years (Smith et al. Lancet 2012; 379: 39–46). Enzalutamide is an oral AR inhibitor that targets multiple steps in the AR signaling pathway. In two large Phase 3 studies (Scher et al. N Engl J Med. 2012; 367: 1187–1197, Beer et al. N Engl J Med. 2014 epub ahead of print) enzalutamide was shown to prolong overall survival and radiographic progression-free survival in patients with metastatic CRPC. The objective of the PROSPER trial is to evaluate the efficacy and safety of enzalutamide in M0 CRPC patients. Material & Methods: PROSPER is a randomized, double-blind, placebo-controlled, Phase 3 study (NCT02003924) initiated in December 2013, and involving more than 200 sites in the United States, Canada, Europe, South America and the Asia Pacific region. Eligibility criteria include: asymptomatic M0 CRPC; PSA doubling time ≤10 months; screening PSA ≥2 ng/mL; and adequate hematologic, hep-
atic, and renal function. Approximately 1560 patients will have continued ADT and will be randomized 2:1 to enzalutamide 160 mg/day or placebo. Patients will be stratified by PSA doubling time (<6 vs 6–10 months) and baseline use of bone-targeting agent (yes vs no). The primary endpoint is metastasis-free survival based on central independent review of whole-body radionuclide bone scans for bone disease assessment and CT or MRI scans for soft tissue disease assessment. Imaging will be undertaken at screening and every 16 weeks post randomization until radiographic progression. The study has 90% power to detect a target hazard ratio of 0.75 based on a 2-sided logrank test at an overall significance level of 0.05. Secondary endpoints include: overall survival; time to pain progression; time to opiate use for prostate cancer pain; time to first use of cytotoxic chemotherapy; time to first use of new antineoplastic therapy; time to PSA progression; PSA response; and quality of life as assessed by FACT-P, EQ-5D5L and QLQ-PR25. P058 Relationship between tumour burden in the transrectal biopsy and positive margins in radical prostatectomy B.Y. Padilla Fernandez 1 , Á.J. Virseda Rodríguez 2 , L.S. Valverde Martínez 2 , B.J. Pereira 3 , H. Coelho 4 , M. Montesino Semper 5 , C. Müller Arteaga 6 , J.L. Álvarez-Ossorio Fernández 7 , F. Migliorini 8 , M.T. Santos Antunes 9 , A. Lorenzo Gómez 9 , M.B. García Cenador 9 , P. Antúnez Plaza 10 , M.F. Lorenzo Gómez 9 , IBSAL (Salamanca Institute for Biomedical Research). 1 University Hospital of The Canary Islands, Dept. of Urology, San Cristóbal De La Laguna, Spain; 2 University Hospital of Salamanca, Dept. of Urology, Salamanca, Spain; 3 University Hospital of Pêro Da Covilhã, Dept. of Urology, Covilhã, Portugal; 4 Centro Hospitalar E Universitário De Coimbra, Dept. of Urology, Coimbra, Portugal; 5 University Hospital “Virgen Del Camino”, Dept. of Urology, Pamplona, Spain; 6 University Hospital of Ourense, Dept. of Urology, Ourense, Spain; 7 University Hospital “Puerta Del Mar”, Dept. of Urology, Cádiz, Spain; 8 Azienda Ospedaliera Universitaria Integrata, Dept. of Urology, Verona, Italy; 9 University of Salamanca, Dept. of Surgery, Salamanca, Spain; 10 University Hospital of Salamanca, Dept. of Pathology, Salamanca, Spain Introduction & Objectives: Prostate cancer’s treatment is becoming increasingly complex, with several treatment options which have a similar oncologic efficacy but different secondary effects. PSA, Gleason score and clinical TNM are the tools to define local-confined cancer with surgical indication. We performed a multicentric study which analyzed the relationship between the tumor burden considering the proportion of affection in the biopsy cores and the presence of positive margins in the surgical specimen. Material & Methods: Retrospective, multicentric study of a sample of 265 patients who underwent RP between March-2009 and March-2013 in seven hospitals (2 level-four hospitals and 5 tertiaryhospitals). Variables: Age, PSA, TNM and Gleason score before (preQ) and after surgery (postQ), prostate’s volume, number of positive biopsy cores and proportion of affection, affected surgical margins, type of prostatectomy [laparoscopic (LP), open retropubic (OP), robot-assisted (RobP)]. Results: Average age 63.19 years (45–72). Level four hospitals: RobP 12.5%, OP 45%, LP 42.5%. Tertiary hospitals: OP 63.82%, LP 37.17%. PSA preQ 8.73 ng/ml (SD 4.23). Volume 41.02cc (SD 18.48). Positive biopsy cores 33.20% (SD22.59). Gleason: preQ 6.40 (SD 0.69), postQ 6.72 (SD 0.71), p=0.0034. PSA postQ 0.061 ng/ml (SD 0.139). Positive correlation was found between the percentage of positive biopsy cores and the Gleason preQ and postQ. Affected surgical margins: 27%. There were found more positive biopsy cores in specimens with affected margins, without significant differences (p=0.3966). There was no difference in the Gleason preQ when comparing specimens with positive and negative margins (p=0.2197). PSA preQ was greater in positive margins (10.06 ng/ml SD 5.00) than in negative (8.05 ng/ml SD 2.63) (p=0.0246).
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Conclusions: Positive correlation was found between the tumour burden considering the proportion of affection in the biopsy cores and the Gleason preQ and postQ. There were 27% of affected surgical margins in the whole sample. When affected margins were found, there were more positive biopsy cores, but the difference was not significant. Further wider studies may clarify the clinical importance and the prognostic significance of the tumour burden considering the proportion of affection in the biopsy cores. P059 Efficacy and safety of cabazitaxel plus prednisolone chemotherapy for metastatic castration-resistant prostatic carcinoma: Data on Korean patients obtained by the cabazitaxel compassionate use program J.L. Lee 1 , S.H. Park 2 , S-J. Koh 3 , S.H. Lee 4 , Y.J. Kim 5 , Y.J. Choi 6 , J. Lee 7 , H.Y. Lim 2 . 1 Asan Medical Center, University of Ulsan College of Medicine, Dept. of Oncology, Seoul, South Korea; 2 Samsung Medical Center, Sungkyunkwan University School of Medicine, Dept. of Hematology-Oncology, Seoul, South Korea; 3 Ulsan University Hospital, University of Ulsan College of Meidicine, Dept. of Hematology-Oncology, Ulsan, South Korea; 4 Seoul National University Hospital, Dept. of Internal Medicine, Seoul, South Korea; 5 Seoul National University Bundang Hospital, Dept. of Hematology and Medical Oncology, Seongnam, South Korea; 6 Korea University Anam Hospital, Dept. of Hematology and Oncology, Seoul, South Korea; 7 Sanofi-Aventis Korea, Medical Department, Seoul, South Korea Introduction & Objectives: To report the efficacy and safety of using cabazitaxel plus prednisolone chemotherapy to treat Korean patients with metastatic castration-resistant prostate cancer (mCRPC) following docetaxel therapy. Material & Methods: This cohort study enrolled 26 mCRPC patients. Treatment consisted of 25 mg/m2 cabazitaxel that was intravenously administered every 3 weeks, in addition to twice-daily 5 mg prednisolone. Results: The median patient age was 67 years (range = 53–82), median ECOG performance status was 1 (range = 0–2), Gleason score was ≥8 in 25 patients (96%), and median serum PSA was 95.3 ng/mL (IQR = 9.1–297.7). A total of 180 treatment cycles were administered, and a median of 5 cycles were administered per patient (range = 1–23). A PSA response was observed in 32% of evaluable patients. Tumor response was evaluated in 8 patients, and 3 and 4 patients achieved partial response and stable disease, respectively. Over a median follow-up duration of 23.4 months (95% CI = 11.1–35.6), median time to treatment failure was 4.2 months (95% CI = 1.8–6.6) and median time to progression was 8.5 months (95% CI = 3.0–13.1). Median overall survival was 16.5 months (95% CI = 12.1–20.9). Grade 3 or worse febrile neutropenia developed in 8 patients (31%) and neutropenic infection in 4 patients (15%). Conclusions: Cabazitaxel plus prednisolone chemotherapy can be used to treat Korean mCRPC patients. Prophylactic growth factor support should be considered for patients at high risk of neutropenic fever or infection.
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Aachen, Germany; 7 University of Copenhagen, Rigshospitalet, Copenhagen, Denmark; 8 UZ Brussel, Dept. of Urology, Brussels, Belgium; 9 Univerzita Karlova V Praze, Dept. of Urology, Prague, Czech Republic; 10 Astellas Pharma, Dept. of Global Development, Leiden, The Netherlands; 11 Astellas Pharma, Dept. of Global Development, Northbrook, United States of America; 12 Medivation, Inc, San Francisco, United States of America; 13 Cliniques Universitaires Saint-Luc, Dept. of Urology, Brussels, Belgium Introduction & Objectives: The efficacy and safety of enzalutamide monotherapy was assessed in men with any-stage hormone-naive prostate cancer eligible for androgen-deprivation therapy (ADT). The primary endpoint of prostate specific antigen (PSA) response rate (≥80% PSA decrease between baseline and week 25) was 92.5% (Tombal B et al, Lancet Oncol 2014). The median (range) maximum PSA decline from baseline to week 25 was −99.6% (−100 to −86.5). 1-year extended follow-up data are presented. Material & Methods: In an open-label, single-arm, Phase 2 study (NCT01302041), men ≥18 years of age with histologically confirmed prostate cancer requiring ADT, with non-castrate testosterone (≥8 nmol/L), PSA ≥2 ng/mL at screening, and a life expectancy ≥12 months, received 160 mg enzalutamide once daily until disease progression or unacceptable toxicity occurred. Other endpoints included changes in hormone levels, metabolic parameters, bone mineral density (BMD), safety and quality of life (QoL). Results: 67 men were enrolled. Median (range) age was 73 years (48 to 86); 38.8% had metastases; 35.8% and 23.9% had undergone prior prostatectomy and radiotherapy, respectively. 54 men completed the 1-year treatment visit. The PSA response rate (≥80% PSA decrease from baseline) in men completing 1-year’s treatment was 100% (54 out of 54) and 53 men (98.1%) had a PSA decrease ≥90% from baseline. The median (range) maximum decline in PSA was −100% (−100 to −86.5) from baseline to 1 year. Luteinising hormone and testosterone were increased from baseline by 215.2% and 101.7%, respectively. Mean changes from baseline for fasting metabolic variables were: +5.0% total cholesterol, +8.9% triglycerides, ±3.5% HbA1c and +19.7% insulin resistance. Total body BMD was maintained (−0.3% from baseline). The most frequently reported treatment-emergent adverse events (AEs) were gynaecomastia (47.8%) and fatigue (38.8%). Seven non-drug-related serious AEs were reported. QoL scores at 1 year demonstrate maintenance of global health status and a decrease in sexual activity and sexual functioning. Conclusions: Extended follow-up of hormone-naive patients demonstrated sustained PSA reductions up to 1 year of enzalutamide monotherapy. Endocrine changes, metabolic changes and AEs were consistent with potent androgen receptor-inhibition, and similar to results reported at 25 weeks. Results beyond 1 year may also be available for presentation. P061 Cancer in urology – is there an App for that? A systematic review
P060 Enzalutamide monotherapy in patients with hormone-naive prostate cancer: 1-year extended follow-up of a Phase 2 study
N. Azevedo 1 , E. Carrasquinho 2 , E. Cardoso De Oliveira 2 , V. Cavadas 3 , L. Osório 3 , A. Fraga 3 , M.J. Roobol 4 , M. Castelo-Branco 1 . 1 University of Beira Interior, Dept. of Health Sciences, Covilhã, Portugal; 2 Espírito Santo Hospital – Évora, Dept. of Urology, Évora, Portugal; 3 Porto Hospital Centre, Dept. of Urology, Porto, Portugal; 4 Erasmus University Rotterdam, Erasmus Medical Centre, Rotterdam, The Netherlands
M. Borre 1 , M.R. Smith 2 , P. Rathenborg 3 , P. Werbrouck 4 , H. Van Poppel 5 , A. Heidenreich 6 , P. Iversen 7 , J. Braeckman 8 , J. Heracek 9 , E. Baskin-Bey 10 , T. Ouatas 10 , F. Perabo 11 , D. Phung 10 , B. Baron 10 , M. Hirmand 12 , B. Tombal 13 . 1 Aarhus University Hospital, Dept. of Urology, Aarhus, Denmark; 2 Massachusetts General Hospital, Cancer Center, Boston, United States of America; 3 Herlev University Hospital, Dept. of Urology, Herlev, Denmark; 4 AZ Groeninge Kortrijk, Dept. of Urology, Kortrijk, Belgium; 5 UZ Leuven, Dept. of Urology, Leuven, Belgium; 6 RWTH University Aachen, Klinik und Poliklinik für Urologie,
Introduction & Objectives: Currently smartphones are almost ubiquitous in our society and represent a popular method of accessing information. Mobile apps are increasingly playing a role in healthcare, with over 100,000 medical apps available on Apple’s App and Google’s Play Store. This comprehensive research reviews and compares urological cancer-specific apps in these platforms. Material & Methods: The researchers conducted a systematic search, between May and June 2014, on Apple’s App and Google’s Play Store, for urology-related and cancer-specific apps in English. Apps related
A B S T R A C T S / E U R O P E A N U R O L O G Y S U P P L E M E N T S 13 (2014) 103—194
all our patients with a single brachytherapy procedure and delivered a nominal dose of 18 Gy given in 3 fractions over 24 hours. (Group 1) All these patients needed to be hospitalized overnight. Since April, 2011, every HDR brachytherapy case was treated as daysurgery on an outpatient basis with a single fraction of 13 Gy. (Group 2) We are using the GammaMed Plus unit with BrachyVision software for dosimetry planning and treatment delivery. All patients in both groups received external beam therapy after the HDR procedure and a total dose of 45 to 50 Gy over a period of 5 weeks was delivered using contemporary technique. Hormone therapy was given for a minimum of 6 months starting about 2 to 3 months prior to HDR brachytherapy. Results: The median follow-up of our Group 1 patients was 60 months and the follow-up of our Group 2 patients remains too short for analysis. Thus far all our 25 Group 2 patients are doing well without apparent treatment failure or complications. There were a total of 405 patients in Group 1 and the outcome was favorable considering all had intermediate or high risk disease. Biochemical control was achieved in 340 patients (84%) Seventeen (17) patients died from metastatic or recurrent disease, and 65 other patients died from unrelated causes without evidence of prostate cancer. At present, 15 patients are alive with metastatic disease and 23 patients demonstrated biochemical failure without clinical evidence of local or distant disease. The most significant treatment related complication was urethral stricture which occurred in 23 patients (6%). However, only 3 patients ended up requiring urinary diversion. Conclusions: HDR Brachytherapy is effective in the treatment of clinically localized intermediate or high risk prostate cancer. Single dose HDR is appealing because of patient convenience and hospital savings. Most significantly it eliminates the risk of inter-fraction displacement of brachytherapy catheters. The results are encouraging, but further follow-up will be necessary. P057 PROSPER: A phase 3 study of enzalutamide in non-metastatic (M0) castration-resistant prostate cancer (CRPC) patients A. Heidenreich 1 , C. Sternberg 2 , K. Fizazi 3 , F. Saad 4 , N.D. Shore 5 , M. Hirmand 6 , F. Perabo 7 , Z. Khondker 6 , K. Modelska 6 , M. Hussain 8 . 1 University Hospital Aachen, Dept. of Urology, Aachen, Germany; 2 San Camillo and Forlanini Hospitals, Dept. of Oncology, Rome, Italy; 3 Institut Gustave Roussy, Dept. of Urology, Villejuif, France; 4 University of Montreal, Dept. of Urology, Montreal, Canada; 5 Carolina Urologic Research Center, -, Myrtle Beach, United States of America; 6 Medivation Inc, -, San Francisco, United States of America; 7 Astellas Pharma Global, -, Northbrook, United States of America; 8 University of Michigan, Dept. of Oncology, Ann Arbor, United States of America Introduction & Objectives: Prostate cancer growth is dependent on androgen receptor (AR) signaling. There is no standard of care for patients with M0 CRPC and most patients will eventually develop metastatic disease despite ongoing androgen deprivation therapy (ADT). In a recent study, patients with a PSA >8 ng/mL or PSA doubling time of <10 months had a median time to bone metastasis of only 2 years (Smith et al. Lancet 2012; 379: 39–46). Enzalutamide is an oral AR inhibitor that targets multiple steps in the AR signaling pathway. In two large Phase 3 studies (Scher et al. N Engl J Med. 2012; 367: 1187–1197, Beer et al. N Engl J Med. 2014 epub ahead of print) enzalutamide was shown to prolong overall survival and radiographic progression-free survival in patients with metastatic CRPC. The objective of the PROSPER trial is to evaluate the efficacy and safety of enzalutamide in M0 CRPC patients. Material & Methods: PROSPER is a randomized, double-blind, placebo-controlled, Phase 3 study (NCT02003924) initiated in December 2013, and involving more than 200 sites in the United States, Canada, Europe, South America and the Asia Pacific region. Eligibility criteria include: asymptomatic M0 CRPC; PSA doubling time ≤10 months; screening PSA ≥2 ng/mL; and adequate hematologic, hep-
atic, and renal function. Approximately 1560 patients will have continued ADT and will be randomized 2:1 to enzalutamide 160 mg/day or placebo. Patients will be stratified by PSA doubling time (<6 vs 6–10 months) and baseline use of bone-targeting agent (yes vs no). The primary endpoint is metastasis-free survival based on central independent review of whole-body radionuclide bone scans for bone disease assessment and CT or MRI scans for soft tissue disease assessment. Imaging will be undertaken at screening and every 16 weeks post randomization until radiographic progression. The study has 90% power to detect a target hazard ratio of 0.75 based on a 2-sided logrank test at an overall significance level of 0.05. Secondary endpoints include: overall survival; time to pain progression; time to opiate use for prostate cancer pain; time to first use of cytotoxic chemotherapy; time to first use of new antineoplastic therapy; time to PSA progression; PSA response; and quality of life as assessed by FACT-P, EQ-5D5L and QLQ-PR25. P058 Relationship between tumour burden in the transrectal biopsy and positive margins in radical prostatectomy B.Y. Padilla Fernandez 1 , Á.J. Virseda Rodríguez 2 , L.S. Valverde Martínez 2 , B.J. Pereira 3 , H. Coelho 4 , M. Montesino Semper 5 , C. Müller Arteaga 6 , J.L. Álvarez-Ossorio Fernández 7 , F. Migliorini 8 , M.T. Santos Antunes 9 , A. Lorenzo Gómez 9 , M.B. García Cenador 9 , P. Antúnez Plaza 10 , M.F. Lorenzo Gómez 9 , IBSAL (Salamanca Institute for Biomedical Research). 1 University Hospital of The Canary Islands, Dept. of Urology, San Cristóbal De La Laguna, Spain; 2 University Hospital of Salamanca, Dept. of Urology, Salamanca, Spain; 3 University Hospital of Pêro Da Covilhã, Dept. of Urology, Covilhã, Portugal; 4 Centro Hospitalar E Universitário De Coimbra, Dept. of Urology, Coimbra, Portugal; 5 University Hospital “Virgen Del Camino”, Dept. of Urology, Pamplona, Spain; 6 University Hospital of Ourense, Dept. of Urology, Ourense, Spain; 7 University Hospital “Puerta Del Mar”, Dept. of Urology, Cádiz, Spain; 8 Azienda Ospedaliera Universitaria Integrata, Dept. of Urology, Verona, Italy; 9 University of Salamanca, Dept. of Surgery, Salamanca, Spain; 10 University Hospital of Salamanca, Dept. of Pathology, Salamanca, Spain Introduction & Objectives: Prostate cancer’s treatment is becoming increasingly complex, with several treatment options which have a similar oncologic efficacy but different secondary effects. PSA, Gleason score and clinical TNM are the tools to define local-confined cancer with surgical indication. We performed a multicentric study which analyzed the relationship between the tumor burden considering the proportion of affection in the biopsy cores and the presence of positive margins in the surgical specimen. Material & Methods: Retrospective, multicentric study of a sample of 265 patients who underwent RP between March-2009 and March-2013 in seven hospitals (2 level-four hospitals and 5 tertiaryhospitals). Variables: Age, PSA, TNM and Gleason score before (preQ) and after surgery (postQ), prostate’s volume, number of positive biopsy cores and proportion of affection, affected surgical margins, type of prostatectomy [laparoscopic (LP), open retropubic (OP), robot-assisted (RobP)]. Results: Average age 63.19 years (45–72). Level four hospitals: RobP 12.5%, OP 45%, LP 42.5%. Tertiary hospitals: OP 63.82%, LP 37.17%. PSA preQ 8.73 ng/ml (SD 4.23). Volume 41.02cc (SD 18.48). Positive biopsy cores 33.20% (SD22.59). Gleason: preQ 6.40 (SD 0.69), postQ 6.72 (SD 0.71), p=0.0034. PSA postQ 0.061 ng/ml (SD 0.139). Positive correlation was found between the percentage of positive biopsy cores and the Gleason preQ and postQ. Affected surgical margins: 27%. There were found more positive biopsy cores in specimens with affected margins, without significant differences (p=0.3966). There was no difference in the Gleason preQ when comparing specimens with positive and negative margins (p=0.2197). PSA preQ was greater in positive margins (10.06 ng/ml SD 5.00) than in negative (8.05 ng/ml SD 2.63) (p=0.0246).
A B S T R A C T S / E U R O P E A N U R O L O G Y S U P P L E M E N T S 13 (2014) 103—194
Conclusions: Positive correlation was found between the tumour burden considering the proportion of affection in the biopsy cores and the Gleason preQ and postQ. There were 27% of affected surgical margins in the whole sample. When affected margins were found, there were more positive biopsy cores, but the difference was not significant. Further wider studies may clarify the clinical importance and the prognostic significance of the tumour burden considering the proportion of affection in the biopsy cores. P059 Efficacy and safety of cabazitaxel plus prednisolone chemotherapy for metastatic castration-resistant prostatic carcinoma: Data on Korean patients obtained by the cabazitaxel compassionate use program J.L. Lee 1 , S.H. Park 2 , S-J. Koh 3 , S.H. Lee 4 , Y.J. Kim 5 , Y.J. Choi 6 , J. Lee 7 , H.Y. Lim 2 . 1 Asan Medical Center, University of Ulsan College of Medicine, Dept. of Oncology, Seoul, South Korea; 2 Samsung Medical Center, Sungkyunkwan University School of Medicine, Dept. of Hematology-Oncology, Seoul, South Korea; 3 Ulsan University Hospital, University of Ulsan College of Meidicine, Dept. of Hematology-Oncology, Ulsan, South Korea; 4 Seoul National University Hospital, Dept. of Internal Medicine, Seoul, South Korea; 5 Seoul National University Bundang Hospital, Dept. of Hematology and Medical Oncology, Seongnam, South Korea; 6 Korea University Anam Hospital, Dept. of Hematology and Oncology, Seoul, South Korea; 7 Sanofi-Aventis Korea, Medical Department, Seoul, South Korea Introduction & Objectives: To report the efficacy and safety of using cabazitaxel plus prednisolone chemotherapy to treat Korean patients with metastatic castration-resistant prostate cancer (mCRPC) following docetaxel therapy. Material & Methods: This cohort study enrolled 26 mCRPC patients. Treatment consisted of 25 mg/m2 cabazitaxel that was intravenously administered every 3 weeks, in addition to twice-daily 5 mg prednisolone. Results: The median patient age was 67 years (range = 53–82), median ECOG performance status was 1 (range = 0–2), Gleason score was ≥8 in 25 patients (96%), and median serum PSA was 95.3 ng/mL (IQR = 9.1–297.7). A total of 180 treatment cycles were administered, and a median of 5 cycles were administered per patient (range = 1–23). A PSA response was observed in 32% of evaluable patients. Tumor response was evaluated in 8 patients, and 3 and 4 patients achieved partial response and stable disease, respectively. Over a median follow-up duration of 23.4 months (95% CI = 11.1–35.6), median time to treatment failure was 4.2 months (95% CI = 1.8–6.6) and median time to progression was 8.5 months (95% CI = 3.0–13.1). Median overall survival was 16.5 months (95% CI = 12.1–20.9). Grade 3 or worse febrile neutropenia developed in 8 patients (31%) and neutropenic infection in 4 patients (15%). Conclusions: Cabazitaxel plus prednisolone chemotherapy can be used to treat Korean mCRPC patients. Prophylactic growth factor support should be considered for patients at high risk of neutropenic fever or infection.
131
Aachen, Germany; 7 University of Copenhagen, Rigshospitalet, Copenhagen, Denmark; 8 UZ Brussel, Dept. of Urology, Brussels, Belgium; 9 Univerzita Karlova V Praze, Dept. of Urology, Prague, Czech Republic; 10 Astellas Pharma, Dept. of Global Development, Leiden, The Netherlands; 11 Astellas Pharma, Dept. of Global Development, Northbrook, United States of America; 12 Medivation, Inc, San Francisco, United States of America; 13 Cliniques Universitaires Saint-Luc, Dept. of Urology, Brussels, Belgium Introduction & Objectives: The efficacy and safety of enzalutamide monotherapy was assessed in men with any-stage hormone-naive prostate cancer eligible for androgen-deprivation therapy (ADT). The primary endpoint of prostate specific antigen (PSA) response rate (≥80% PSA decrease between baseline and week 25) was 92.5% (Tombal B et al, Lancet Oncol 2014). The median (range) maximum PSA decline from baseline to week 25 was −99.6% (−100 to −86.5). 1-year extended follow-up data are presented. Material & Methods: In an open-label, single-arm, Phase 2 study (NCT01302041), men ≥18 years of age with histologically confirmed prostate cancer requiring ADT, with non-castrate testosterone (≥8 nmol/L), PSA ≥2 ng/mL at screening, and a life expectancy ≥12 months, received 160 mg enzalutamide once daily until disease progression or unacceptable toxicity occurred. Other endpoints included changes in hormone levels, metabolic parameters, bone mineral density (BMD), safety and quality of life (QoL). Results: 67 men were enrolled. Median (range) age was 73 years (48 to 86); 38.8% had metastases; 35.8% and 23.9% had undergone prior prostatectomy and radiotherapy, respectively. 54 men completed the 1-year treatment visit. The PSA response rate (≥80% PSA decrease from baseline) in men completing 1-year’s treatment was 100% (54 out of 54) and 53 men (98.1%) had a PSA decrease ≥90% from baseline. The median (range) maximum decline in PSA was −100% (−100 to −86.5) from baseline to 1 year. Luteinising hormone and testosterone were increased from baseline by 215.2% and 101.7%, respectively. Mean changes from baseline for fasting metabolic variables were: +5.0% total cholesterol, +8.9% triglycerides, ±3.5% HbA1c and +19.7% insulin resistance. Total body BMD was maintained (−0.3% from baseline). The most frequently reported treatment-emergent adverse events (AEs) were gynaecomastia (47.8%) and fatigue (38.8%). Seven non-drug-related serious AEs were reported. QoL scores at 1 year demonstrate maintenance of global health status and a decrease in sexual activity and sexual functioning. Conclusions: Extended follow-up of hormone-naive patients demonstrated sustained PSA reductions up to 1 year of enzalutamide monotherapy. Endocrine changes, metabolic changes and AEs were consistent with potent androgen receptor-inhibition, and similar to results reported at 25 weeks. Results beyond 1 year may also be available for presentation. P061 Cancer in urology – is there an App for that? A systematic review
P060 Enzalutamide monotherapy in patients with hormone-naive prostate cancer: 1-year extended follow-up of a Phase 2 study
N. Azevedo 1 , E. Carrasquinho 2 , E. Cardoso De Oliveira 2 , V. Cavadas 3 , L. Osório 3 , A. Fraga 3 , M.J. Roobol 4 , M. Castelo-Branco 1 . 1 University of Beira Interior, Dept. of Health Sciences, Covilhã, Portugal; 2 Espírito Santo Hospital – Évora, Dept. of Urology, Évora, Portugal; 3 Porto Hospital Centre, Dept. of Urology, Porto, Portugal; 4 Erasmus University Rotterdam, Erasmus Medical Centre, Rotterdam, The Netherlands
M. Borre 1 , M.R. Smith 2 , P. Rathenborg 3 , P. Werbrouck 4 , H. Van Poppel 5 , A. Heidenreich 6 , P. Iversen 7 , J. Braeckman 8 , J. Heracek 9 , E. Baskin-Bey 10 , T. Ouatas 10 , F. Perabo 11 , D. Phung 10 , B. Baron 10 , M. Hirmand 12 , B. Tombal 13 . 1 Aarhus University Hospital, Dept. of Urology, Aarhus, Denmark; 2 Massachusetts General Hospital, Cancer Center, Boston, United States of America; 3 Herlev University Hospital, Dept. of Urology, Herlev, Denmark; 4 AZ Groeninge Kortrijk, Dept. of Urology, Kortrijk, Belgium; 5 UZ Leuven, Dept. of Urology, Leuven, Belgium; 6 RWTH University Aachen, Klinik und Poliklinik für Urologie,
Introduction & Objectives: Currently smartphones are almost ubiquitous in our society and represent a popular method of accessing information. Mobile apps are increasingly playing a role in healthcare, with over 100,000 medical apps available on Apple’s App and Google’s Play Store. This comprehensive research reviews and compares urological cancer-specific apps in these platforms. Material & Methods: The researchers conducted a systematic search, between May and June 2014, on Apple’s App and Google’s Play Store, for urology-related and cancer-specific apps in English. Apps related