The evolving value assessment of cancer therapies: Results from a modified Delphi study.

The move toward early detection and treatment of cancer presents challenges for value assessment using traditional endpoints. Current cancer management rarely considers the full economic and societal benefits of therapies. Our study used a modified Delphi process to develop principles for defining and assessing value of cancer therapies that aligns with the current trajectory of oncology research and reflects broader notions of value. 24 experts participated in consensus-building activities across 5 months (16 took part in structured interactions, including a survey, plenary sessions, interviews, and off-line discussions, while 8 participated in interviews). Discussion focused on: 1) which oncology-relevant endpoints should be used for assessing treatments for early-stage cancer and access decisions for early-stage treatments, and 2) the importance of additional value components and how these can be integrated in value assessments. The expert group reached consensus on 4 principles in relation to the first area (consider oncology-relevant endpoints other than overall survival; build evidence for endpoints that provide earlier indication of efficacy; develop evidence for the next generation of predictive measures; use managed entry agreements supported by ongoing evidence collection to address decision-maker evidence needs) and 3 principles in relation to the second (routinely use patient reported outcomes in value assessments; assess broad economic impact of new medicines; consider other value aspects of relevance to patients and society).

Influence of Artificial Intelligence on the Adenoma Detection Rate throughout the Day.

BACKGROUND: Artificial intelligence systems recently demonstrated an increase in polyp and adenoma detection rate. Over the daytime, the adenoma detection rate decreases as tiredness leads to a lack of attention. It is not clear if a polyp detection system with artificial intelligence leads to constant adenoma detection over the day. METHODS: We performed a database analysis of screening and surveillance colonoscopies with and without the use of AI. In both groups, patients were investigated with the same endoscopy equipment and by the same endoscopists. Only patients with good bowel preparation (BBPS >6) were included. We correlated the daytime, the investigational time, day of the week, and the adenoma and polyp detection. RESULTS: A total of 303 colonoscopies were analyzed. 163 endoscopies in the AI+ group and 140 procedures in the AI- group were included. In both groups, the total adenoma detection rate was equal (AI+ 0.39 vs. AI- 0.43). The adenoma detection rate throughout the day had a significant decreasing trend in the group without the use of AI (p = 0.015), whereas this trend was not present in the investigations that have been performed with AI (p = 0.65). The duration of investigation did not show a significant difference between the groups (8.9 min in both groups). No relevant effect was noticed in adenoma detection between single days of the working week with or without the use of AI. CONCLUSION: AI helps overcome the decay in adenoma detection over the daytime. This may be attributed to a constant awareness caused by the use of the AI system.

[Further Development and Interoperability in Oncological Care Structures, Quality Control and Research]. / Weiterentwicklung und Vernetzung der onkologischen Versorgungsstrukturen, der Qualitätssicherung und der Forschung.

How can we improve the interoperability of medical guidelines and the implementation and measurement of outcomes in medical health care for cancer patients as well as for care providers? This is the aim of the working group "Quality and Cross-linking". The following publication gives an overview of the targets reached in the development of guidelines together with quality indicators and documentation in cancer registries.

Can a Polyp Detection and Characterization System Predict Complete Resection?

INTRODUCTION: Artificial Intelligence (AI) is one of the most evolving fields in endoscopy. We aimed to test if a system for polyp detection and polyp characterization can be used to predict complete endoscopic resection of colon adenomas. METHODS: We used the CAD-Eye AI system (Fujifilm Europe) in consecutive patients who received polypectomy using a cold snare. After resection, the submucosal space was flushed with water using an irrigation pump. Images were obtained using the CAD Eye system, and the characterization of the system was noted and afterward compared to histology of the removed specimen. RESULTS: In total, 17 polypectomies were observed, and in no case the AI was able to give information about resection status. First, the resection plane itself was classified as being adenomatous in all cases, while, second, all adenomas were resected completely, thus harboring no potential for overlying misinterpretations in the images. CONCLUSION: An AI system trained to characterize polyps in healthy surrounding colorectal mucosa cannot predict the state of resection after removal of the adenoma. This is explained by the training and programming. Endoscopists using AI from now on should learn about the basics of AI and the pitfalls in interpreting results from AI.

Research driving innovation: what are key factors for successful integration of translational science into oncology care concepts? 5th European Roundtable Meeting (ERTM) May 4th, 2018, Berlin, Germany.

PURPOSE: To identify key factors for successful integration of translational science into cancer care. RESULTS: Organisation of the health care system matters to optimally bridge between public and private cancer research, cancer registries and routine care. Currently, there are deficits on various levels of connectivity. These hamper rapid and optimal transfer of innovation. CONCLUSION: To overcome the deficits, strategies of data sharing and infrastructures allowing fast-track implementation of translational research findings into routine care need to be developed.

Impact of radiation, systemic therapy and treatment sequencing on survival of patients with melanoma brain metastases.

BACKGROUND: Combining stereotactic radiosurgery (SRS) and active systemic therapies (STs) achieved favourable survival outcomes in patients with melanoma brain metastases (MBMs) in retrospective analyses. However, several aspects of this treatment strategy remain poorly understood. We report on the overall survival (OS) of patients with MBM treated with a combination of radiotherapy (RT) and ST as well as the impact of the v-Raf murine sarcoma viral oncogene homolog B (BRAF)-V600 mutation (BRAFmut) status, types of RT and ST and their sequence. PATIENTS AND METHODS: Data of 208 patients treated with SRS or whole brain radiation therapy (WBRT) and either immunotherapy (IT) or targeted therapy (TT) within a 6-week interval to RT were analysed retrospectively. OS was calculated from RT to death or last follow-up. Univariate and multivariate Cox proportional hazard analyses were performed to determine prognostic features associated with OS. RESULTS: The median follow-up was 7.3 months. 139 patients received IT, 67 received TT and 2 received IT and TT within 6 weeks to RT (WBRT 45%; SRS 55%). One-year Kaplan-Meier OS rates were 69%, 65%, 33% and 18% (P < .001) for SRS with IT, SRS with TT, WBRT with IT and WBRT with TT, respectively. Patients with a BRAFmut receiving IT combined with RT experienced higher OS rates (88%, 65%, 50% and 18%). TT following RT or started before and continued thereafter was associated with improved median OS compared with TT solely before RT (12.2 [95% confidence interval {CI} 9.3-15.1]; 9.8 [95% CI 6.9-12.6] versus 5.1 [95% CI 2.7-7.5]; P = .03). CONCLUSION: SRS and IT achieved the highest OS rates. A BRAFmut appears to be a favourable prognostic factor for OS. For the combination of RT and TT, the sequence appears to be crucial. Combinations of WBRT and ST achieved unprecedentedly high OS rates and warrant further studies.

Carbo-Iron as improvement of the nanoiron technology: From laboratory design to the field test.

In a first pilot-scale field test the use of Carbo-Iron® was successfully demonstrated. Carbo-Iron was developed with the goal to overcome significant shortcomings of nanoscale zero-valent iron (NZVI) for in-situ groundwater remediation. The composite material of colloidal activated carbon and embedded nanoiron structures has been tested for the remediation of a tetrachloroethene (PCE) contaminated field site in Lower Saxony, Germany. The results of the two-step field test confirmed the properties intended by its design and the particle performance achieved in the laboratory experiments. The material showed transport lengths of several metres in the field and fast PCE decomposition with no vinyl chloride formation. Extended longevity of the PCE decrease in the treated area and evidence for microbiological participation were found. Carbo-Iron is now under study in the framework of the EU-project NanoREM where its performance is being further optimized at various scales from laboratory via large-scale tank to field testing. Targeted property adjustment was successful for Carbo-Iron performance in both directions: plume treatment and source attack.

Application of nanoscale zero valent iron (NZVI) for groundwater remediation in Europe.

PURPOSE: Nanoscale zero valent iron (NZVI) is emerging as a new option for the treatment of contaminated soil and groundwater targeting mainly chlorinated organic contaminants (e.g., solvents, pesticides) and inorganic anions or metals. The purpose of this article is to give a short overview of the practical experience with NZVI applications in Europe and to present a comparison to the situation in the USA. Furthermore, the reasons for the difference in technology use are discussed. METHOD: The results in this article are based on an extensive literature review and structured discussions in an expert workshop with experts from Europe and the USA. The evaluation of the experiences was based on a SWOT (strength, weakness, opportunity, threat) analysis. RESULT: There are significant differences in the extent and type of technology used between NZVI applications in Europe and the USA. In Europe, only three full-scale remediations with NZVI have been carried out so far, while NZVI is an established treatment method in the USA. Bimetallic particles and emulsified NZVI, which are extensively used in the USA, have not yet been applied in Europe. Economic constraints and the precautionary attitude in Europe raise questions regarding whether NZVI is a cost-effective method for aquifer remediation. Challenges to the commercialization of NZVI include mainly non-technical aspects such as the possibility of a public backlash, the fact that the technology is largely unknown to consultants, governments and site owners as well as the lack of long-term experiences. CONCLUSION: Despite these concerns, the results of the current field applications with respect to contaminant reduction are promising, and no major adverse impacts on the environment have been reported so far. It is thus expected that these trials will contribute to promoting the technology in Europe.

[Funding and sponsorship of clinical trials in oncology]. / Finanzierung und Förderung von klinischen Studien in der Onkologie.

The lack of clinical trials represents a bottleneck in the future of the German health care system. Although central organizations as the G-BA (Federal Joint Committee), the IQWiG (Institute for Quality and Efficiency in Health Care) or the INEK (Institute for Hospital Reimbursement), which were established during the last years as central boards for the decision process in health care, use the results of high-quality trials as basis of their decisions, the off-label use as an implicit way of clinical trial promotion by German sickness funds to reduce the cost of care in this special setting has at the same time been combatted in recent years.Thereby, an important basis for the development of oncological therapies through clinical studies was abolished and completely impeded. Also, the underlying conditions of investigator-initiated clinical trials caused more effort because of new legislation. The trend of prioritization in the German health care system based on short resources and the use of study-based evidence for decision-making must lead to the establishment of a new and effective financing and funding of clinical trials. Sickness funds must also be involved in this funding. G-BA and IQWiG, who are castigators of the quality and sponsoring of investigator-initiated clinical trials, must in conclusion postulate basic conditions for successful financing and funding of clinical trials in consideration of their duties and responsibilities.