Introduction: Biologics were approved for the treatment of advanced colorectal cancer (CRC) based on favorable benefit-risk-assessments from randomized controlled trials (RCTs), but evidence on their use in the real-world setting is scarce. Based on descriptive analyses we therefore aimed to assess characteristics and survival of CRC patients treated with biologics using large healthcare databases from three European countries (Netherlands, Italy, Germany).Methods: We included CRC patients treated with a biologic in 2010 or 2014 and characterized them regarding age, sex, comorbidities, and absolute survival.Results: Among 4,758 patients, the mean age ranged from 64.8 to 66.8 years, the majority was male, and comorbidities used as exclusion criteria in RCTs were coded in up to 30% of these patients. The proportion of bevacizumab users decreased between 2010 (72–93%) and 2014 (63–85%). In 2014, the absolute 12-month survival in new users was 64% (95% CI 51–77%), 56% (30–80%), and 61% (58–63%) in the Dutch, Italian, and German database, respectively, varying by age and comorbidity.Conclusions: Our study suggests that in the real-world setting, CRC patients treated with biologics are older and less selected regarding comorbidities compared to patients in RCTs, potentially explaining the relatively low 12-month survival we found. Treatment decisions in the real-world setting may require careful evaluation given that the risk-benefit ratio may vary depending on age and co-existing conditions.

Background Incidence rates of advanced cancer stages are important, e.g., for monitoring cancer screening programs. However, information from cancer registries on tumor stage is often incomplete. Exemplified by colorectal cancer (CRC), we explored the potential of German claims data to estimate incidence rates of advanced cancer stages. Methods We used claims data of the German Pharmacoepidemiological Research Database (GePaRD; information on > 20 million persons) to identify incident patients with advanced CRC based on ICD-10 codes for CRC and secondary malignant neoplasms. We calculated annual age-standardized incidence rates (ASIRs) of advanced CRC per 100,000 for the years 2008–2015 stratified by the presence of affected lymph nodes only (C77) vs. distant metastases (C78-C79) and compared them to ASIRs determined using data (2008–2014) from the German Centre for Cancer Registry Data (ZfKD). Results In GePaRD, the ASIRs of advanced CRC per 100,000 in 2014 were 21.5 among men and 14.9 among women. Compared to ZfKD data the ASIR in GePaRD was 2.58 lower in men and 0.27 higher in women (per 100,000) in 2014. Stratification by presence of distant metastases showed divergent patterns: the ASIRs regarding distant metastases were ~ 50% (women) and ~ 30% (men) higher, and the ASIRs regarding affected lymph nodes only were ~ 40% lower in GePaRD as compared to ZfKD. Conclusion While ASIRs of advanced CRCs overall agreed well between claims and cancer registry data in 2014, the analyses stratified by presence of distant metastases showed differences. Cancer registries might underestimate ASIRs of CRCs with distant metastases. Electronic supplementary material The online version of this article (10.1186/s12874-019-0784-y) contains supplementary material, which is available to authorized users.

Aims: Premarketing clinical trials are typically conducted under controlled conditions and in selected study populations, so real-world information on the utilization of new cancer drugs is limited. We aimed to explore the potential of German claims data in this regard, exemplified by the ALK inhibitor crizotinib, used in non-small-cell lung cancer therapy. Materials & methods: We identified patients treated with crizotinib in the German Pharmacoepidemiological Research Database (2004–2017; 20% of the German population) and assessed patient characteristics, treatment and survival. Results: We identified 348 crizotinib-treated patients (56% female; 25% first-line users). After 2 years, overall survival was 48%, with higher survival in men than in women (58 vs 40%). Overall, 76% of patients discontinued crizotinib treatment. Of those, 41% received another ALK inhibitor afterward. Conclusion: The results underline the potential of German claims data for real-world monitoring of oncological drug utilization.

Die Autoren danken den Krankenversicherungen, die für diese Studie Daten zur Verfügung gestellt haben. Dies waren die AOK Bremen/Bremerhaven, die DAK-Gesundheit, die hkk und Die Techniker (TK).