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Thomas Wagner,1,2 Jakob Lauritsen,1 Mikkel Bandak,1 Linda Aagaard Rasmussen,3 Johannes Bakker,4 Hanna Birkbak Hovaldt,4 Heidi Larsson,4 Ib Jarle Christensen,1 Birgitte Grønkær Toft,2 Mads Agerbæk,5 Lars Dysager,6 Michael Kreiberg,1 Josephine Julie Rosenvilde,1 Birte Engvad,7 Daniel M Berney,8 Gedske Daugaard1 1Department of Oncology, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark; 2Department of Pathology, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark; 3Research Unit for General Practice, Aarhus, Denmark; 4The Danish Clinical Quality Program – National Clinical Registries (RKKP), Aarhus, Odense and Copenhagen, Denmark; 5Department of Oncology, Aarhus University Hospital, Aarhus, Denmark; 6Department of Oncology, Odense University Hospital, Odense, Denmark; 7Department of Pathology, Odense University Hospital, Odense, Denmark; 8Centre for Cancer Biomarkers and Biotherapeutics, Barts Cancer Institute, Queen Mary University of London, London, UKCorrespondence: Thomas Wagner, Department of Oncology, Copenhagen University Hospital, Rigshospitalet, Blegdamsvej 9, Copenhagen, 2100, Denmark, Tel +45 35459682, Email thomas.wagner.nielsen@regionh.dkPurpose: The Danish Testicular Cancer (DaTeCa) database aims to monitor and improve quality of care for testicular cancer patients. Relapse data registered in the DaTeCa database rely on manual registration. Currently, some safeguarding against missing registrations is attempted by a non-validated register-based algorithm. However, this algorithm is inaccurate and entails time-consuming medical record reviews. We aimed (1) to validate relapse data as registered in the DaTeCa database, and (2) to develop and validate an improved register-based algorithm identifying patients diagnosed with relapse of clinical stage I testicular cancer.Patients and Methods: Patients registered in the DaTeCa database with clinical stage I testicular cancer from 2013 to 2018 were included. Medical record information on relapse data served as a gold standard. A pre-specified algorithm to identify relapse was tested and optimized on a random sample of 250 patients. Indicators of relapse were obtained from pathology codes in the Danish National Pathology Register and from diagnosis and procedure codes in the Danish National Patient Register. We applied the final algorithm to the remaining study population to validate its performance.Results: Of the 1377 included patients, 284 patients relapsed according to the gold standard during a median follow-up time of 5.9 years. The completeness of relapse data registered in the DaTeCa database was 97.2% (95% confidence interval (CI): 95.2– 99.1). The algorithm achieved a sensitivity of 99.6% (95% CI: 98.7– 100), a specificity of 98.9% (95% CI: 98.2– 99.6), and a positive predictive value of 95.9% (95% CI: 93.4– 98.4) in the validation cohort (n = 1127, 233 relapses).Conclusion: The registration of relapse data in the DaTeCa database is accurate, confirming the database as a reliable source for ongoing clinical quality assessments. Applying the provided algorithm to the DaTeCa database will optimize the accuracy of relapse data further, decrease time-consuming medical record review and contribute to important future clinical research.Keywords: testicular cancer, relapse, algorithm, validation, registries

Signe Sørup,1 Bianka Darvalics,1 Azza Ahmed Khalil,2 Marianne Nordsmark,2 Mette Hæe,2 Frede Donskov,3 Mads Agerbæk,2 Leo Russo,4 Dina Oksen,5 Emmanuelle Boutmy,5 Patrice Verpillat,5 Deirdre Cronin-Fenton1 1Department of Clinical Epidemiology, Department of Clinical Medicine, Aarhus University & Aarhus University Hospital, Aarhus, Denmark; 2Department of Oncology, Aarhus University Hospital, Aarhus, Denmark; 3Department of Clinical Medicine, Aarhus University, Aarhus, Denmark; 4Worldwide Medical and Safety, Pfizer, Collegeville, PA, USA; 5Global Epidemiology, Merck Healthcare KGaA, Darmstadt, GermanyCorrespondence: Signe SørupDepartment of Clinical Epidemiology, Aarhus University & Aarhus University Hospital, Olof Palmes Allé 43-45, DK-8200 Aarhus N, DenmarkTel +45 871 68398Email SigneSorup@clin.au.dkPurpose: Few studies have described real-world treatment patterns and survival before the widespread use of immune checkpoint inhibitors (ICIs). We aimed to describe anti-cancer treatment including the use of programmed cell death-1 and ligand-1 (PD-1/PD-L1) ICIs and overall survival (OS) in advanced cancer patients as a benchmarking real-world standard before widespread use of ICIs.Patients and Methods: Using nationwide Danish medical registries, we assembled cohorts of Danish patients with advanced non-small cell lung cancer (NSCLC) (n=12,283), urothelial carcinoma (n=2504), epithelial ovarian cancer (n=1466), gastric adenocarcinoma (n=1457), and renal cell carcinoma (RCC) (n=1261) diagnosed between 1/1/2013 and 31/12/2017. We describe anti-cancer treatment and OS using proportions, medians, and Kaplan–Meier methods.Results: Between 9% (ovarian cancer) and 25% (gastric adenocarcinoma) of patients did not receive anti-cancer treatment. The remaining patients received surgery, radiation therapy, and/or medical therapy. Chemotherapy was the most frequent medical therapy in all cohorts except for RCC (tyrosine kinase inhibitors). PD-L1/PD-1 ICIs were used in 7– 8% of the NSCLC and RCC cohorts—mainly as second or higher line treatments. OS was longest in patients starting treatment with surgery (eg 25.6 months [95%-confidence interval (CI)=21.9– 29.4] for NSCLC and 21.4 months [95%-CI=19.8– 23.5] for urothelial carcinoma) and shortest for radiation therapy (eg 3.9 months [95%-CI=3.6– 4.2] for NSCLC and 12.6 months [95%-CI=9.2– 17.5] for urothelial carcinoma). NSCLC patients starting with medical therapy had OS between these limits. Median OS for NSCLC patients starting treatment with PD-L1/PD-1 ICIs was 21.4 months (95%-CI=13.9-not estimable).Conclusion: Most patients with advanced NSCLC, urothelial carcinoma, epithelial ovarian cancer, gastric adenocarcinoma and RCC had poor OS in an era where only a minority received PD-L1/PD-1 ICIs. This information on treatment patterns and survival is important as a benchmarking real-world standard before widespread use of ICIs.Keywords: cancer, treatment, survival, immunotherapy, programmed cell death-1 immune checkpoint inhibitors, programmed cell death-ligand-1 immune checkpoint inhibitors

Gedske Daugaard,1 Maria Gry Gundgaard Kier,1 Mikkel Bandak,1 Mette Saksø Mortensen,1 Heidi Larsson,2 Mette Søgaard,2 Birgitte Groenkaer Toft,3 Birte Engvad,4 Mads Agerbæk,5 Niels Vilstrup Holm,6 Jakob Lauritsen1 1Department of Oncology 5073, Copenhagen University Hospital, Rigshospitalet, Copenhagen, 2Department of Clinical Epidemiology, Aarhus University Hospital, Aarhus, 3Department of Pathology, Copenhagen University Hospital, Rigshospitalet, Copenhagen, 4Department of Pathology, Odense University Hospital, Odense, 5Department of Oncology, Aarhus University Hospital, Aarhus, 6Department of Oncology, Odense University Hospital, Odense, Denmark Aim: The nationwide Danish Testicular Cancer database consists of a retrospective research database (DaTeCa database) and a prospective clinical database (Danish Multidisciplinary Cancer Group [DMCG] DaTeCa database). The aim is to improve the quality of care for patients with testicular cancer (TC) in Denmark, that is, by identifying risk factors for relapse, toxicity related to treatment, and focusing on late effects. Study population: All Danish male patients with a histologically verified germ cell cancer diagnosis in the Danish Pathology Registry are included in the DaTeCa databases. Data collection has been performed from 1984 to 2007 and from 2013 onward, respectively. Main variables and descriptive data: The retrospective DaTeCa database contains detailed information with more than 300 variables related to histology, stage, treatment, relapses, pathology, tumor markers, kidney function, lung function, etc. A questionnaire related to late effects has been conducted, which includes questions regarding social relationships, life situation, general health status, family background, diseases, symptoms, use of medication, marital status, psychosocial issues, fertility, and sexuality. TC survivors alive on October 2014 were invited to fill in this questionnaire including 160 validated questions. Collection of questionnaires is still ongoing. A biobank including blood/sputum samples for future genetic analyses has been established. Both samples related to DaTeCa and DMCG DaTeCa database are included. The prospective DMCG DaTeCa database includes variables regarding histology, stage, prognostic group, and treatment. Conclusion: The DMCG DaTeCa database has existed since 2013 and is a young clinical database. It is necessary to extend the data collection in the prospective database in order to answer quality-related questions. Data from the retrospective database will be added to the prospective data. This will result in a large and very comprehensive database for future studies on TC patients. Keywords: testis cancer, clinical indicators, database research, DaTeCa, DMCG DaTeCa database, hypogonadism

Studies on the lipoprotein level of an identical group of middle-aged Danish men for 6 weeks after consuming a new milk product fermented with bacteria obtained from the intestinal flora of the people in Abkhasia show a 10% reduction in LDL-cholesterol with no changes in the placebo group. The new milk contained a strain of enterococcus faecium and 2 strains of streptococcus termophilus. The placebo product was chemically fermented.

Vinflunine is to date the only registered agent for second-line treatment of metastatic urothelial cell carcinoma (UCC) in Europe. However, the effect is modest. Pemetrexed has demonstrated some single-agent activity in this disease entity. In order to improve treatment possibilities for UCC patients, a phase I trial (VINTREX) was undertaken to assess the safety of vinflunine and pemetrexed in metastatic UCC patients. A dose escalation design was planned to determine the dose-limiting toxicity (DLT) and maximum tolerated dose (MTD) of a vinflunine/pemetrexed combination. Pemetrexed was added to vinflunine dosed at 280 mg/m2 on day 1 of a 21-day cycle. Three levels of pemetrexed were planned starting at 400 mg/m2. Four patients were enrolled with a mean age of 66 years and with a mean number of prior GC-cycles of 6,8. Two DLT’s were observed at the lowest dose-level in cohort 1. One patient experienced grade 4 thrombocytopenia and a second demonstrated hepatobiliary toxicity grade 3 with an increase in alanine aminotransaminase. Most common grade 3 and 4 adverse events were anemia, thrombocytopenia and neutropenia. Three out of four patients received 3 cycles of pemetrexed and vinflunine, all had progressive disease. Based on these observations and due to protocol design, the study was interrupted at dose level 1 for safety reasons. The combined therapy of vinflunine (Javlor®, Pierre Fabre Pharma) and pemetrexed (Alimta®, Eli Lilly) is poorly tolerated in metastatic UCC patients. The combination cannot be recommended for further investigations in metastatic UCC. [ABSTRACT FROM AUTHOR]

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Copyright of Proges en Urologie is the property of Elsevier B.V. and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)