Olaf Schoffer

Gegenwärtig ist die Nutzung der vorhandenen Datenressourcen durch die onkologische Forschung unzureichend. Zu den Gründen gehören heterogene, komplizierte oder fehlende Regularien für die Datenübergabe und Forschungsnutzung bei vielen der vorhandenen Datenressourcen, unklare gesetzliche Rahmenbedingungen und teils datenschutzrechtliche Restriktionen sowie ein teilweise begrenztes Wissen der Forschenden über die vorhandenen Datenressourcen und ebenso der Verantwortlichen für die Daten über aktuelle, relevante onkologische Forschungsfragen. In vielen dieser Bereiche gibt es in jüngerer Zeit Fortschritte – die parallelen Entwicklungen in Deutschland sind jedoch weitgehend unverbunden und nicht prioritär auf die Forschung ausgerichtet. Mit dem Gesetz zur Zusammenführung von Krebsregisterdaten vom 18. August 2021 wurde die jährliche Zusammenführung klinischer Daten aller Landeskrebsregister am Zentrum für Krebsregisterdaten (ZfKD) am Robert Koch-Institut festgelegt – die sogenannte Stufe 1. Mit PLATO 2 wurde nun – gefördert durch das Bundesministerium für Gesundheit (BMG) – das Konzept für Stufe 2 entwickelt, für eine gezielte, anlassbezogene Zusammenführung dieser Daten und weiterer relevanter Datenquellen zur Förderung der klinischen und wissenschaftlichen Auswertung. Die Konzeption von PLATO 2 erfolgte unter anderem durch einen im Gesetz beauftragten Kreis relevanter Akteure: die Arbeitsgemeinschaft Deutscher Tumorzentren (ADT), die Deutsche Krebsgesellschaft (DKG), die Krebsregister (Plattform §65c SGB V), die Stiftung Deutsche Krebshilfe, das Zentrum für Krebsregisterdaten (ZfKD) und Vertretende von Patientenorganisationen. Ziel von PLATO 2 ist es, den Zugang zu versorgungsnahen onkologischen Daten zu erleichtern, deren Nutzung zu verbessern und so evidenzbasierte Versorgung und Forschung deutlich zu stärken. Im Mittelpunkt der Konzepterstellung stand die Untersuchung, welche wissenschaftlichen Fragestellungen bereits heute durch bestehende Datenquellen beantwortet werden können und wo bestehende Defizite die Forschung behindern. Darauf aufbauend wurden praxisnahe Lösungsansätze zur Überwindung dieser Hürden aufgezeigt. Grundlage bilden sieben konkrete Anwendungsfälle, die zentrale Themen der onkologischen Forschung abbilden. Eine bereichsübergreifende Arbeitsgruppe und ein rechtswissenschaftliches Gutachten bewerteten zudem gesetzliche Rahmenbedingungen und mögliche Zugangswege. Diese Publikation basiert auf dem Gesamtkonzept PLATO 2, das am 07.05.2025 dem Bundesministerium für Gesundheit übergeben worden ist, und fasst dessen wesentlichen Inhalte zusammen. Currently, the use of existing data resources in oncology research is insufficient. Reasons for this include heterogeneous, complicated, or missing regulations governing data transfer and research use for many of the existing data resources, unclear legal frameworks and, in some cases, data protection restrictions, as well as limited knowledge among researchers about the available data resources and, similarly, among those responsible for the data regarding current, relevant oncology research questions. Progress has been made in many of these areas in recent times—however, parallel developments in Germany are largely uncoordinated and not primarily focused on research. The Act on the Consolidation of Cancer Registry Data of August 18, 2021, established the annual consolidation of clinical data from all state cancer registries at the Center for Cancer Registry Data (ZfKD) at the Robert Koch Institute—the so-called Phase 1. With PLATO 2, the concept for Phase 2 has now been developed — funded by the Federal Ministry of Health (BMG) —to enable the targeted, event-driven integration of this data and other relevant data sources to support clinical and scientific analysis. The design of PLATO 2 was carried out, among others, by a group of relevant stakeholders mandated by law: the Association of German Cancer Centers (ADT), the German Cancer Society (DKG), the cancer registries (Platform §65c SGB V), German Cancer Aid, the Center for Cancer Registry Data (ZfKD), and representatives of patient organizations. The goal of PLATO 2 is to facilitate access to clinical oncology data, improve its utilization, and thereby significantly strengthen evidence-based care and research. The concept development focused on identifying which scientific questions can already be answered today using existing data sources and where existing gaps hinder research. Building on this, practical solutions for overcoming these hurdles were identified. The framework is based on seven specific use cases that reflect key topics in oncology research. An interdisciplinary working group and a legal expert opinion are also evaluating the legal framework and potential access pathways. This publication is based on the overall concept PLATO 2, which was submitted to the Federal Ministry of Health on May 7, 2025, and summarizes its key contents.

Cervical cancer is the fourth most prevalent malignancy among women worldwide, with more patients treated in specialized centers. The WiZen study examines whether treatment at German Cancer Society-certified centers improves survival. This cohort study uses data from eleven statutory health insurance funds (SHI) and four population-based clinical cancer registries (CCRs) in Germany. The analysis includes 10596 incident cervical cancer cases from the AOK dataset and 3468 patients from the CCR dataset who received initial treatment for cervical cancer (ICD-10-GM code C53) between 2009 and 2017. Survival was compared between patients treated at certified centers and non-certified units, using Kaplan–Meier estimators and multivariable Cox models with adjustment for patient and hospital characteristics. Based on SHI data, the 5-year overall survival rate estimated by the Kaplan–Meier method was 59.1% for patients treated at certified centers, compared to 53.3% for those at non-certified hospitals. According to CCR data, the corresponding survival rates were 61.6% and 53.2%, respectively. In both cases the survival benefit was highly significant (Log rank p < 0.001). Multivariable hazard ratios (HRs) for mortality favored treatment in certified centers, with an HR of 0.839 (SHI data; 95% confidence interval [CI]: 0.757–0.930; p = 0.001) and 0.741 (CCR data; 95% CI: 0.634–0.865; p < 0.001). The findings of this analysis indicate that initial treatment in certified gynecologic cancer centers is associated with a significant survival advantage and should be further promoted as a component of high-quality oncologic care.

Purpose: MISSION4Sax aims to develop and pilot new concepts for cross-sectoral oncological care, data integration and networking between maximum care centres and rural practitioners in medical underserved, enabling access to guideline-based therapy, innovative surgery, and clinical trials. Methods: This pilot project is an exploratory multicentre, prospective longitudinal study. It assesses the feasibility, acceptability, implementation and data-quality aspects of the proposed care model and study infrastructure, rather than to determine the effectiveness or causal impact of the interventions. It implements an interdisciplinary, cross-sectoral care model centred on a regional surgical indication tumour board at the National Center for Tumor Diseases (NCT) Dresden. Evidence-based, standardised patient care pathways are developed and piloted across three regional hospitals and two oncology practices. A database using the infrastructure of the NCT Core Unit “Registry Trial Platform”, targeted training programmes and “Flying Data Nurses” support coordination, data flow and communication. Patient-reported outcomes complement the clinical data. Routinely collected health insurance data will be used exclusively as external reference data for a descriptive comparison with the MISSION4Sax cohort; no individual-level data linkage will be performed. A mixed-methods process evaluation will be performed alongside the project. Expected outcomes: The study will assess feasibility in routine care and explore access to specialised care, waiting times, coordination, pathway adherence, and clinical and patient-reported outcomes. Conclusion: Strengthening cancer care infrastructure, interdisciplinary cooperation, and digital systems may support equitable access to high-value care in rural regions. The proposed tumour board, patient pathways, and trained staff may improve care quality and collaboration across sectors. Trial registration: DRKS00036134 (registration date: 30 June 2025)

Colorectal and pancreatic cancers impose profound physical, psychological, and social challenges on patients, underscoring the need for comprehensive assessments of their impact on health-related quality of life (HRQoL). This study aimed to evaluate HRQoL levels in colorectal and pancreatic cancer patients, including the comparison to the general population and the assessment of sociodemographic as well as disease- and treatment-related predictors. The analyses are based on data from a clinical registry of the NCT/UCC Dresden. Patients were recruited during consultation hours between August 2020 and December 2024. Baseline quality of life data and routine data from the tumor documentation system were used. The final analytical sample comprised n=417 patients in the colorectal study group and n=193 patients in the pancreatic study group. Multivariable linear regression analyses were calculated, with results presented as regression coefficients (b) and 95% confidence intervals (CI). Colorectal and pancreatic cancer patients exhibited significantly lower HRQoL compared to the general population, with large differences in social function and medium differences in role function and global health. Pancreatic cancer patients reported lower HRQoL across most domains compared to colorectal cancer patients. In the colorectal study group, statutory health insurance (b=–14.10, CI=–22.54; –5.66), living in rural counties with some urbanization (b=–5.34, CI=–10.51; –0.17) and recent chemotherapy (b=–9.10, CI=–16.36; –1.85) predicted worse global health. With regard to pancreatic cancers, residence in rural counties with some urbanization (b=–10.26, CI=–18.93; –1.59) was associated with worse global health, whereas longer time since diagnosis (b=0.06, CI=0.01; 0.12) was associated with better global health. Sociodemographic factors were the most consistent predictors of HRQoL in patients with pancreatic and colorectal cancer. These findings suggest social disparities, particularly for patients in rural areas and those with lower socioeconomic status. Efforts to improve access to healthcare, provide psychosocial support, and manage symptom burden are critical to enhancing the quality of life for these patients.

Linking project data and data from routine clinical practice with healthcare-related data is essential for German healthcare research in order to answer complex questions validly and efficiently. Currently, fragmented data sources, heterogeneous legal requirements, and a lack of infrastructure prevent the optimal use and linking of these data. The Network University Medicine (NUM) is therefore developing a dedicated data infrastructure to link primary study data and routine clinical data with external healthcare-related data (e. g., data from statutory and private health insurance companies, data from cancer registries of the federal states, and data from registration offices). The position paper describes the various data worlds, including examples from epidemiological and clinical research that illustrate the added value and challenges of data linkage. In particular, it presents the new structures of the data acceptance and processing center (DAAeD) in the NUM, which is intended to enable quality-assured, data protection-compliant receipt and linkage of data. Standardized application and approval procedures as well as innovative privacy-preserving record linkage procedures are central to this. International experience, including from Scandinavia and the UK, demonstrates the benefits of such infrastructures for research and healthcare. In conclusion, we advocate rapid political and institutional implementation of the recommendations described in order to make health research in Germany competitive in international comparison and to ensure sustainable, patient-centered health care.

Background: Hospital certification programs in Germany aim to improve the quality of cancer care. Previous research indicates that treatment in certified cancer centres leads to better overall and disease-free survival compared to non-certified hospitals for various cancers. Skin cancer, however, has not been investigated in this regard. Objectives: To test the hypothesis that treatment of melanoma in a certified cancer centre is related to survival benefits. Methods: Data from clinical cancer registries in Germany were analysed. The analytical sample included n = 47,924 patients diagnosed with malignant melanoma between 2000 and 2022. Mixed-effects Cox regression models, adjusted for demographic and clinical confounders, were used to assess overall and disease-free survival. Hazard ratios (HR) with 95% confidence intervals (CI) are reported. Results: The proportion of patients treated in certified cancer centres increased over time to > 60 % from 2016 onward. Treatment in certified centres was associated with significant better overall survival (HR = 0.85, 95% CI = 0.82-0.88, p < 0.001). Results were statistically significant for stages I to III. For stage IV, the overall survival difference was not statistically significant, but subgroup analyses revealed a significant effect for cases diagnosed since 2011 (HR = 0.75, 95% CI = 0.61-0.91, p < 0.010). With regard to disease-free survival, multivariable analyses revealed better survival in certified centres (HR = 0.88, 95% CI = 0.85-0.92, p < 0.001). Similar results were observed across all subgroups stratified by stage of disease, except for stage IV. Conclusions: Treatment in certified cancer centres was associated with significant survival benefits for malignant melanoma patients, suggesting that the adherence to evidence-based quality standards improves patient outcomes. The fact that one in three patients has not been treated in certified cancer centres in recent years underscores the importance of expanding access to high-quality care. Graphical Plain Language Summary: How specialized cancer centres improve survival for melanoma patients: This study examined whether treatment in certified cancer centres in Germany improves survival outcomes for patients with malignant melanoma, a type of skin cancer. Using data from nearly 50,000 patients diagnosed between 2000 and 2022, we compared survival rates between those treated in certified cancer centres and non-certified hospitals. Certified centres adhere to strict quality standards designed to enhance cancer care. The proportion of patients treated in certified centres increased significantly over time, from 22% in 2000 to over 60% after 2016. Patients treated in certified centres had better overall survival, with a 16% lower risk of death compared to those treated in non-certified hospitals. This survival benefit was consistent across early stages of melanoma (stages I–III) and cases with unknown stages. For patients with advanced stage IV melanoma, a positive effect of treatment in certified centres was only visible for diagnoses made since 2011. Disease-free survival, which measures the time patients remain cancer-free, was also better in certified centres, showing an 12% lower risk of recurrence or progression. The findings emphasize the critical role of certified cancer centres in improving outcomes for melanoma patients. Expanding access to these centres and ensuring adherence to high-quality treatment protocols could further enhance survival rates and reduce disease recurrence, particularly for patients diagnosed at earlier stages. Key points: Why was the study undertaken?: Existing evidence suggests that treatment in certified centres leads to better survival compared to non-certified hospitals. Using data from clinical cancer registries in Germany, this study aims to evaluate whether these benefits extend to malignant melanoma. What does this study add?: Treatment in certified cancer centres is associated with significant survival benefits for malignant melanoma patients, with effects particularly pronounced for patients diagnosed at earlier stages. What are the implications of this study for disease understanding and/or clinical care?: The findings underscore the importance of expanding access to certified care and ensuring adherence to high-quality treatment protocols in order to ensure equitable care for all patients.

Introduction: Head and neck cancers represent a heterogeneous group of tumor in terms of both, their entity and location. This includes cancers of the lip, oral cavitiy, pharynx (epi-, oro- and hypopharynx), larynx, nasal cavity/ sinus and salivary gland. Additionally, they are associated with functional impairments that place highly specific demands on treating practitioners. Since the introduction of the German National Cancer Plan in 2008, cancer treatment has been aligned with the latest scientific findings through evidence-based guidelines. Meanwhile, treatment courses and outcomes have been systematically recorded by expanding the German cancer registry. In addition, the certification of treatment centers aims to ensure consistently high-quality care. Given the considerable investment of time, personnel, and financial resources required for certification, the question arises whether patients with head and neck cancer benefit from receiving (initial) treatment at a certified center compared to a non-certified facility. Methods: We used patient-specific information from statutory health insurance (SHI) and clinical cancer registry (CCR) data for the period 2009–2017 as well as hospital characteristics from standardized quality reports. We applied multivariable Cox regressions to analyze differences in survival between patients treated in hospitals with and without German Cancer Society (DKG) certification. Results: The sample comprised 52,749 (SHI) and 15,287 (CCR) patients with head and neck cancer who were treated in 872 hospitals (44 DKG-certified, 828 not DKG-certified). 15.5% (SHI) and 25.9% (CCR) of patients were (initially) treated in DKG-certified cancer centers. Cox regression analysis for overall survival showed that patients treated in DKG-certified cancer centers were at significantly lower risk of death (SHI data: HR = 0.94, 95% CI = 0.89–1.00, p = 0.043; CCR data: HR = 0.89, 95% CI = 0.83–0.95, p < 0.001). Notably, the difference was even more pronounced for recurrence-free survival (CCR data: HR = 0.81, 95% CI = 0.72–0.92, p = 0.001). Conclusion: Although achieving certification requires a substantial investment of personnel, time, and financial resources by the treating institution, it is associated with a measurable survival advantage for patients. Therefore, treatment of head and neck cancer patients should preferably be provided at certified head and neck cancer centers.

Background: For the treatment of colorectal cancer, the S3-Guideline of the German Guideline Program in Oncology supports clinical decision-making. Centers certified by the German Cancer Society are required to implement the guideline recommendations as comprehensively as possible. When guidelines provide insufficient or ambiguous evidence, heterogeneity of treatment preferences is likely to emerge across individual centers. The aim of this study is to describe the preferences of the centers’ tumor boards for treatment decisions when clear, evidence-based guideline recommendations are lacking. Methods: To investigate the tumor boards’ preferences for different treatment options, an anonymous online survey was conducted among 314 certified colorectal cancer centers. The survey included seven visceral oncological and nine visceral surgical case vignettes. Centers were asked to discuss the vignettes in the tumor board or, alternatively, delegate them to an appropriate physician representatively speaking for the tumor board. The responses were analyzed descriptively and normalized entropy estimates (NE) were calculated for each vignette. Results: A total of 123 centers (39%) responded to the survey. For oncological cases without clear guideline recommendations, substantial heterogeneity (NE: 0.39–0.71) in treatment preferences was observed. For instance, opinions varied widely for UICC II pT4a colon cancer. In this situation, 28% of centers would prefer fluoropyrimidine monotherapy, 39% oxaliplatin-based combination therapy and 33% no adjuvant chemotherapy at all. Surgical vignettes showed a preference for laparoscopic and robotic approaches, with variations based on tumor location (NE: 0.46–0.67). Importantly, in case of a clear evidence-based guideline recommendation, treatment preferences did not differ considerably between hospital sites. Conclusions: In prototypical case vignettes without evidence-based guideline recommendations, pronounced heterogeneity of treatment preferences between centers was found. Reconstructing these treatment preferences can contribute to enhancing the quality of evidence derived from observational studies. This seems especially important in the context of clinical questions that cannot be assessed in randomized trials; clinical routine data represent an adequate resource for evidence generation in these scenarios. Trial registration: After conducting this study, the main study was registered in the German Clinical Trials Register (DRKS) on October 4, 2024 under study No. DRKS00034650.

Background: To evaluate whether machine learning (ML) methods (Elastic Net (EN), eXtreme Gradient Boosting (XGBoost), Feed Forward Neural Net (FNN)) can improve claims-based inpatient quality measurement by Logistic Regression. Methods: This retrospective cohort study used German claims data from the years 2015-2021. The study population encompassed inpatient cases of acute myocardial infarction ( n = 165,130) and proximal humerus fracture ( n = 34,912), for which quality related outcomes were assessed. The performances of risk adjustment models based on machine learning methods (EN, XGBoost, FNN) were compared to stepwise backwards Logistic Regression by Receiver Operating Characteristics-Area under the Curve (ROC-AUC), Precision Recall-Area under the Curve (PR-AUC), Brier Score (BS). The institution-specific quality was measured by Standardised Mortality Ratios (SMR) which were used to visualise the impact of the tested methods on quality assessment. Results: For most of the outcomes none or only marginal gains were found for the machine learning methods. Highest gain in model performance showed the FNN in comparison to Logistic Regression with a gain in ROC-AUC of 2.4%, in PR-AUC of 4.5%, and slightly in the BS with a loss of 0.007. The FNN was followed by XGBoost with a gain in ROC-AUC of 2.3%, anyhow this improvement was not reflected in a lower BS. Conclusions: None of the machine learning methods tested is generally superior for creating quality indicators. Marginal gain in model performance should not be the main basis for choosing an adequate method; instead, interpretability should be emphasised, especially when dealing with new datasets with little knowledge of important risk factors.