Search

Objective: To investigate non‐inferiority of intermittent docetaxel compared to continuous docetaxel in patients with metastatic castration‐resistant prostate cancer (mCRPC). Patient and Methods: The investigator initiated randomised phase III study included 187 chemotherapy‐naïve patients with mCRPC who were allocated to two treatment arms: intermittent docetaxel and continuous docetaxel. Docetaxel was applied in both arms as weekly (35 mg/m2) or 3‐weekly (75 mg/m2). The primary endpoint was 1‐year survival, which was tested for non‐inferiority (margin δ = 0.125). The secondary endpoints were: overall survival (OS), progression‐free survival (PFS), median time to treatment failure (TTF), and toxicity. Results: Of 156 eligible patients, 78 were allocated to each arm. The intermittent treatment met the non‐inferiority criteria for 1‐year survival (two‐sided 95% confidence interval, −0.12, 18, P = 0.022), but not for OS, according to the result of a post hoc analysis. The differences between the study arms in PFS and TTF were not significant. The median (range) treatment holiday in the intermittent arm was 110 (13–486) days, or 38% of the overall treatment duration. Safety profiles of both study arms were comparable. The main limitation of this study was that the planned number of patients could not be recruited. Conclusion: Intermittent docetaxel chemotherapy was non‐inferior to continuous therapy for 1‐year survival; non‐inferiority in regard to OS was not reached. [ABSTRACT FROM AUTHOR]

The German Society of Uro-Oncologists ("Deutsche Uro-Onkologen e.V.", d-uo) provides a national registry for urothelial cancer (UroNat) and a national registry for prostate cancer (ProNAT). These registries aim to evaluate the standard of care for urothelial cancer of the bladder and the upper urinary tract as well as prostate cancer by office-based urologists, oncologists and outpatient hospital departments in Germany. This includes, but is not limited to, adherence to guidelines during the treatment of patients with urothelial cancer and prostate cancer. The registries aim to capture and analyse scientifically how patients with these two most frequent urological tumours are treated and how quality assurance is implemented to improve the quality of their outpatient treatment in Germany. Both registries may share basic patient data supplied by the non-interventional, prospective, multicentre VERSUS registry by d-uo, which has been ongoing since 2018 and today includes more than 15,000 patients with different urological malignancies. In the UroNAT and ProNAT registries, additional items and parameters are included to allow for more detailed analyses of outcomes of outpatient treatments in Germany, which have so far been unavailable from the German Cancer Registry. By documenting the current treatment landscape of urothelial and prostate cancer in the outpatient setting, the registries intend to identify potential improvements of patient care and to initiate their implementation into clinical practice. These non-interventional prospective registries only document daily routine diagnostics, clinical courses and procedures., Competing Interests: Manfred Johannsen: Vortrags- und/oder Beratertätigkeit: AstraZeneca, Astellas, Bayer HealthCare, Bristol Myers Squibb, Janssen, Pfizer, medac, Merck Serono, MSD. Jörg Klier: Vortrags- und/oder Beratertätigkeit: Amgen, Astellas, AstraZeneca, Bayer HealthCare, BMS, Eisai, Janssen, Lilly, medac, MSD. Frank König: Vortrags- und/oder Beratertätigkeit: Amgen, Apogepha, Astra Zeneca, Bayer HealthCare, Janssen. Robert Schönfelder: Vortrags- und/oder Beratertätigkeit: Amgen, Apogepha, Astellas, AstraZeneca, Bayer Vital, Bristol Myers Squibb, Hexal, Janssen, medac, MSD, Roche, Takeda. Christian Doehn: Vortrags- und/oder Beratertätigkeit: Apogepha, BMS, Eisai, EUSA Pharm, Ipsen, Merck Serono, MSD, Novartis, Pfizer, Roche. Jörg Schröder und Elke Hempel: keine Interessenkonflikte. Rolf Eichenauer: Vortrags- und/oder Beratertätigkeit: Anwerina, Astellas, AstraZeneca, Bayer HealthCare, Bristol Myers Squibb, Ferring, Ipsen, Janssen-Cilag, medac, MSD, Novartis, Pierre Fabre, Pfizer, Sanofi-Aventis, Takeda, Teva., (Thieme. All rights reserved.)

At the beginning of 2017, the German Society of Uro-Oncologists (d-uo) had the idea of designing a documentation platform that would enable d-uo members to report cancer cases to the cancer registry and transfer data to d-uo's own database - without a double effort. The cancer registry reimburses the first notification of a tumour with €18. As the only provider, d-uo reimburses its members for the documentation effort associated with the additional notification to d-uo with a further €18. In addition to the basic oncological data set, further parameters were defined by d-uo. This data is collected, evaluated and interpreted as part of the VERSUS study. At the end of 2022, 14,834 patients with a newly diagnosed urological tumour were included in the VERSUS study. Almost two thirds of all patients had prostate cancer. About half of all patients with prostate cancer were diagnosed as part of an early detection measure. These patients then also had more favourable tumour stages. Overall, almost every eighth patient already had metastases at the time of initial diagnosis. Data from the VERSUS study are available for 2,167 operations on prostate cancer with tumour category T2 or T3. There were 1,360 operations in patients with a T2 tumour (62.8%) and 807 operations in patients with T3 tumours (37.2%). A positive margin was present in 25.5% of all operated-on patients. In relation to tumour categories T2 and T3, the proportion of a positive resection margin was 14.3% and 44.2%, respectively. The VERSUS study will continue to provide answers to many questions from the uro-oncological field with reference to the "real world" situation in Germany., Competing Interests: Jörg Klier: Vortrags- und/oder Beratertätigkeit: Amgen, Astellas, AstraZeneca, Bayer HealthCare, BMS, Eisai, Janssen, Lilly, medac, MSD. Rolf Eichenauer: Vortrags- und/oder Beratertätigkeit: Anwerina, Astellas, AstraZeneca, Bayer HealthCare, Bristol Myers Squibb, Ferring, Ipsen, Janssen-Cilag, medac, MSD, Novartis, Pierre Fabre, Pfizer, Sanofi-Aventis, Takeda, Teva. Manfred Johannsen: Vortrags- und/oder Beratertätigkeit: AstraZeneca, Astellas, Bayer HealthCare, Bristol Myers Squibb, Janssen, Pfizer, medac, Merck Serono, MSD. Frank König: Vortrags- und/oder Beratertätigkeit: Amgen, Apogepha, Astra Zeneca, Bayer HealthCare, Janssen., (Thieme. All rights reserved.)

The current cancer registry notification, which was introduced in Germany as a mandatory institution in 2015, has its starting point in the National Cancer Plan of 2008. Other milestones include the Federal Cancer Registry Data Act (2009), the Cancer Early Detection and Registry Act (2013), the Uniform Oncological Basic Data Set (2014/2021) with its modules (e.g. the module prostate carcinoma 2017) as well as the Cancer Registry Data Merger Act (2021). At the beginning of 2017, the German Society of Uro-Oncologists (d-uo) had the idea of designing a documentation platform that would enable d-uo members to report to the cancer registry and transfer data to d-uo's own database - without a double effort. The cancer registry reimburses the first notification of a tumour with € 18. As the only provider, d-uo reimburses its members for the documentation effort associated with the additional notification to d-uo with a further € 18. In addition to the basic oncological data set, further parameters were defined by d-uo. This data is collected, evaluated and interpreted as part of the VERSUS study. The realisation that the parameters of the basic data set are limited in their informative value led d-uo to establish the two national registries for urothelial carcinoma (UroNAT) and prostate carcinoma (ProNAT). This underscores d-uo's leading position in uro-oncological healthcare research in Germany., Competing Interests: Christian Doehn: Vortrags- und/oder Beratertätigkeit: Apogepha, BMS, Eisai, EUSA Pharm, Ipsen, Merck Serono, MSD, Novartis, Pfizer, Roche. Manfred Johannsen: Vortrags- und/oder Beratertätigkeit: AstraZeneca, Astellas, Bayer HealthCare, Bristol Myers Squibb, Janssen, Pfizer, medac, Merck Serono, MSD. Rolf Eichenauer: Vortrags- und/oder Beratertätigkeit: Anwerina, Astellas, AstraZeneca, Bayer HealthCare, Bristol Myers Squibb, Ferring, Ipsen, Janssen-Cilag, medac, MSD, Novartis, Pierre Fabre, Pfizer, Sanofi-Aventis, Takeda, Teva. Jörg Klier: Vortrags- und/oder Beratertätigkeit: Amgen, Astellas, AstraZeneca, Bayer HealthCare, BMS, Eisai, Janssen, Lilly, medac, MSD. Frank König: Vortrags- und/oder Beratertätigkeit: Amgen, Apogepha, Astra Zeneca, Bayer HealthCare, Janssen. Jörg Schröder und Elke Hempel: keine Interessenkonflikte. Robert Schönfelder: Vortrags- und/oder Beratertätigkeit: Amgen, Apogepha, Astellas, AstraZeneca, Bayer Vital, Bristol Myers Squibb, Hexal, Janssen, medac, MSD, Roche, Takeda., (Thieme. All rights reserved.)

Introduction: Patients with bone metastasis due to prostate cancer often present allover reduced bone mineral density. Additionally, patients with bone metastatic castration-resistant prostate cancer (mCRPC) have a relevant risk for skeletal-related events (SRE). We herein present real-world data (RWD) regarding osteoprotection in mCRPC patients with bone metastasis treated by German urologists in private practice., Material and Methods: This is a questionnaire-based study including members of d-uo ("Deutsche Uro-Onkologen", German uro-oncologists). All patients with histologically confirmed prostate cancer seen at least once in the surveyed urology practice between July 2019 and June 2020 were included. Questions included start, type and duration of osteoprotection as well as supplementation with calcium and vitamin D., Results: Between July 2019 and June 2020, a total of 3,692 patients with prostate cancer were seen at least once in 15 urology practices. There were 410 mCRPC patients (11.1%) with bone metastasis. Osteoprotection with denosumab or a bisphosphonate to prevent SRE was applied in 274/410 mCRPC patients (66.4%) with bone metastasis. In patients receiving osteoprotection, denosumab was chosen for 67.9% of patients and a bisphosphonate was chosen for 32.1%. Supplementation with calcium and vitamin D was performed in 93.4% of the patients. The median duration of treatment was 25.3 months for denosumab compared with 39.6 months for bisphosphonates., Conclusions: Patients with mCRPC with bone metastasis received osteoprotection in 2/3 of cases. Of these, 2/3 received denosumab and 1/3 received a bisphosphonate. The majority of patients were also treated with calcium and vitamin D. According to guideline recommendations regarding osteoprotection in mCRPC patients with bone metastasis, our RWD data showed some lack of guideline adherence., Competing Interests: Doehn und Klier haben von Amgen Honorare für Vortrags- bzw. Beratertätigkeit erhalten. Schönfelder und König haben von Amgen Honorare für Vortragstätigkeit erhalten., (Thieme. All rights reserved.)

During phase III study ERA-223, patients under combination therapy with radium-223 and abiraterone showed an increased risk of bone fractures and a possible higher risk of death. This observation led to a change in the German therapeutic guidelines in 2018. Radium-223 is now only allowed as a third-line monotherapy (besides ADT) in patients with metastatic castration resistant prostate cancer (mCRPC) with symptomatic bone lesions without known visceral metastases or for patients with mCRPC, for whom no other available systematic therapy is suitable. Since almost no data on practice-related care research on the use of radium-223 exist, we consulted members of d-uo (German Uro-Oncologists) over their therapy algorithms. This study analysed data of patients treated with radium-223 between 2014 and 2019. It could be shown that 50% of mCRPC-patients had received radium-223 in the past as third-line therapy. Half of these were treated in combination with new androgen receptor targeted therapies (ARTA) and no increase in bone fractures was observed. This was most likely due to the additional use of bone protecting agents. Despite the late cancer stage, treatment response was seen in almost half of the patients., Competing Interests: Die Autoren R. Schönfelder, J. Klier, M. Johannsen und F. König erhielten in der Vergangenheit von der Firma BAYER Unterstützungen für Kongressreisen sowie Honorare für die Teilnahme an Advisory Boards und für das Halten von Vorträgen., (Thieme. All rights reserved.)

Introduction: Patients with prostate cancer often present with reduced bone mineral density. We herein present real-world data (RWD) regarding osteoprotection in patients with non-metastatic hormone-sensitive prostate cancer (nmHSPC) receiving androgen deprivation therapy (ADT) treated by German urologists in private practice., Material and Methods: This is a questionnaire-based study including members of d-uo ("Deutsche Uro-Onkologen", German uro-oncologists). Patients with nmHSPC between July 2019 and June 2020 were included. They were asked about start, type and duration of osteoprotection as well as supplementation with calcium and vitamin D., Results: Between July 2019 and June 2020, a total of 3,692 patients with prostate cancer were seen at least once in one of the private practices of 15 urologists (all d-uo members). There were 844 patients (22.9%) with nmHSPC treated with ADT. Osteoprotection using denosumab or a bisphosphonate to prevent skeletal-related events (SRE) was applied in 183/844 patients (21.7%) with nmHSPC. In patients receiving osteoprotection, denosumab was chosen in 73.2% of patients and a bisphosphonate was chosen in 26.8% of patients. Supplementation with calcium and vitamin D was given in 84.7% of patients., Conclusion: Patients with nmHSPC received osteoprotection in 1/5 of patients. Of these, 3/4 received denosumab and 1/4 received a bisphosphonate. The majority of patients were additionally treated with calcium and vitamin D. In our study, osteoprotection in patients with nmHSPC was rather an exception., Competing Interests: Doehn und Klier haben von Amgen Honorare für Vortrags- bzw. Beratertätigkeit erhalten. Schönfelder und König haben von Amgen Honorare für Vortragstätigkeit erhalten., (Thieme. All rights reserved.)