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Signe Sørup,1 Bianka Darvalics,1 Jakob Schöllhammer Knudsen,1 Anne Staub Rasmussen,1 Cathrine Fonnesbech Hjorth,1 Søren Viborg Vestergaard,1 Azza Ahmed Khalil,2 Leo Russo,3 Dina Oksen,4 Emmanuelle Boutmy,4 Patrice Verpillat,4 Mikael Rørth,1,5 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; 3Worldwide Medical and Safety, Pfizer, Collegeville, PA, USA; 4Global Epidemiology, Merck Healthcare KGaA, Darmstadt, Germany; 5Department of Oncology, Rigshospitalet, Copenhagen, DenmarkCorrespondence: Signe Sørup, Department of Clinical Epidemiology, Aarhus University Hospital, Olof Palmes Allé 43-45, Aarhus, DK-8200, Denmark, Tel +45 871 68230, Fax +45 87 16 72 15, Email SigneSorup@clin.au.dkPurpose: To develop algorithms to identify number of lines of anti-neoplastic therapy per patient based on the Danish National Patient Registry (DNPR) and identify which algorithm has the highest percentage agreement with a reference standard of documentation in medical records.Patients and Methods: We included 179 patients diagnosed between January 1, 2012, and December 31, 2016, with stage II, III, or IV urothelial cell carcinoma or stage III or IV epithelial ovarian cancer, gastric adenocarcinoma, renal cell carcinoma, or non-small cell lung cancer (NSCLC). We developed two algorithms for number of lines of anti-neoplastic therapy based on dates and treatment codes (eg, “treatment with cisplatin” or “cytostatic treatment”) in the DNPR. First, to denote a change in line of therapy the “Time-based algorithm” used the number of days between consecutive administrations. Second, the “Drug-based algorithm” used information on drug names if available or the number of days between consecutive administrations if no drug names were specified. We calculated the percentage agreement between the algorithms setting the number of allowed days between consecutive administrations from 28 to 50 and the reference standard – information on anti-neoplastic therapy drugs abstracted from medical records and subsequently coded according to lines of anti-neoplastic therapy.Results: For the “Time-based algorithm”, the highest percentage agreement with the reference standard was found when using < 45 days between consecutive administrations (67.6%; 95% CI: 60.1– 73.8%). However, the percentage agreement was higher for the “Drug-based algorithm” using < 45 days between consecutive administrations for registrations where the drug name was unspecified (90.5%; 95% CI: 85.0– 93.7%).Conclusion: The algorithm for number of lines of anti-neoplastic therapy that had the highest percentage agreement with the reference standard (medical records) incorporated both registration of specific drug names and < 45 days between consecutive administrations if the drug name was unspecified in routinely recorded data from DNPR.Keywords: positive predictive value, medical records review, duration of chemotherapy, medical oncologic treatments, Denmark

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