Challenges and solutions to system-wide use of precision oncology as the standard of care paradigm.

The personalised oncology paradigm remains challenging to deliver despite technological advances in genomics-based identification of actionable variants combined with the increasing focus of drug development on these specific targets. To ensure we continue to build concerted momentum to improve outcomes across all cancer types, financial, technological and operational barriers need to be addressed. For example, complete integration and certification of the 'molecular tumour board' into 'standard of care' ensures a unified clinical decision pathway that both counteracts fragmentation and is the cornerstone of evidence-based delivery inside and outside of a research setting. Generally, integrated delivery has been restricted to specific (common) cancer types either within major cancer centres or small regional networks. Here, we focus on solutions in real-world integration of genomics, pathology, surgery, oncological treatments, data from clinical source systems and analysis of whole-body imaging as digital data that can facilitate cost-effectiveness analysis, clinical trial recruitment, and outcome assessment. This urgent imperative for cancer also extends across the early diagnosis and adjuvant treatment interventions, individualised cancer vaccines, immune cell therapies, personalised synthetic lethal therapeutics and cancer screening and prevention. Oncology care systems worldwide require proactive step-changes in solutions that include inter-operative digital working that can solve patient centred challenges to ensure inclusive, quality, sustainable, fair and cost-effective adoption and efficient delivery. Here we highlight workforce, technical, clinical, regulatory and economic challenges that prevent the implementation of precision oncology at scale, and offer a systematic roadmap of integrated solutions for standard of care based on minimal essential digital tools. These include unified decision support tools, quality control, data flows within an ethical and legal data framework, training and certification, monitoring and feedback. Bridging the technical, operational, regulatory and economic gaps demands the joint actions from public and industry stakeholders across national and global boundaries.

Adherence to guidelines-recommended diagnostic testing was associated with overall survival in patients with diffuse large B-cell lymphoma after rituximab-based treatment: an observational cohort study.

PURPOSE: This study assessed the impact of adherence to guidelines-recommended diagnostic testing on treatment selection and overall survival (OS) in patients with diffuse large B-cell lymphoma (DLBCL) initiated on rituximab-based first line of treatment (1-LOT). METHODS: This retrospective cohort study used a nationwide electronic health record-derived de-identified database, including diagnostic testing information on immunohistochemistry (IHC), fluorescence in situ hybridization (FISH) and karyotype analysis that were abstracted from pathology reports or clinical visit notes, where available. The study included patients above 18 years old who were diagnosed with DLBCL between January 2011 and December 2019 and initiated on rituximab-based 1-LOT. Patients were classified into 'non-adherence,' 'partial-adherence' and 'complete-adherence' groups according to the evidence/documentation of a confirmed known result for IHC and molecular profiling tests (FISH and karyotyping) on a selection of the markers prior to the initiation of 1-LOT. Logistic regression was used to evaluate associations of adherence to diagnostic testing with 1-LOT between R-CHOP and other rituximab-based regimens. Median OS after the start of rituximab-based 1-LOT was calculated using the Kaplan-Meier method. Multivariable-adjusted Cox proportional hazards regression was used to assess the risk of all-cause death after initiation of 1-LOT by the degrees of adherence to guidelines-recommended diagnostic testing. RESULTS: In total, 3730 patients with DLBCL who initiated on rituximab-based 1-LOT were included. No association was found between adherence to guidelines-recommended diagnostic testing and treatment selection of 1-LOT for R-CHOP versus other rituximab-based regimens. Patients with a higher degree of adherence to guidelines-recommended diagnostic testing survived longer (median OS at 5.1, 6.9 and 7.1 years for 'non-adherence,' 'partial-adherence' and 'complete-adherence' groups, respectively [log-rank p < 0.001]) and had a decreased mortality risk (multivariable-adjusted hazard ratio with 95% confidence intervals at 0.83 [0.70-0.99] for 'partial-adherence' and 0.77 [0.64-0.91] for 'complete-adherence' groups, respectively). CONCLUSION: Patients' adherence to guidelines-recommended diagnostic testing were associated with better survival benefit, reinforcing the need for adoption of diagnostic testing guidelines in routine clinical care.

Development and validation of ACTE-MTB: A tool to systematically assess the maturity of molecular tumor boards.

Molecular tumor boards (MTBs) require specialized activities to leverage genomic data for therapeutic decision-making. Currently, there are no defined standards for implementing, executing, and tracking the impact of MTBs. This study describes the development and validation of ACTE-MTB, a tool to evaluate the maturity of an organization's MTB to identify specific areas that would benefit from process improvements and standardization. The ACTE-MTB maturity assessment tool is composed of 3 elements: 1) The ACTE-MTB maturity model; 2) a 59-question survey on MTB processes and challenges; and 3) a 5-level MTB maturity scoring algorithm. This tool was developed to measure MTB maturity in the categories of Access, Consultation, Technology, and Evidence (ACTE) and was tested on 20 MTBs spanning the United States, Europe, and Asia-Pacific regions. Validity testing revealed that the average maturity score was 3.3 out of 5 (+/- 0.1; range 2.0-4.3) with MTBs in academic institutions showing significantly higher overall maturity levels than in non-academic institutions (3.7 +/- 0.2 vs. 3.1 +/- 0.2; P = .018). While maturity scores for academic institutions were higher for Consultation, Technology, and Evidence domains, the maturity score for the Access domain did not significantly differ between the two groups, highlighting a disconnect between MTB operations and the downstream impact on ability to access testing and/or therapies. To our knowledge, ACTE-MTB is the first tool of its kind to enable structured, maturity assessment of MTBs in a universally-applicable manner. In the process of establishing construct validity of this tool, opportunities for further investigation and improvements were identified that address the key functional areas of MTBs that would likely benefit from standardization and best practice recommendations. We believe a unified approach to assessment of MTB maturity will help to identify areas for improvement at both the organizational and system level.

Digital Tumor Board Solutions Have Significant Impact on Case Preparation.

PURPOSE: Multidisciplinary tumor boards (TBs) are the gold standard for decision-making in cancer care. Variability in preparation, conduction, and impact is widely reported. The benefit of digital technologies to support TBs is unknown. This study evaluated the impact of the NAVIFY Tumor Board solution (NTB) on TB preparation time across multiple user groups in 4 cancer categories: breast, GI, head and neck (ie, ear, nose, and throat, or ENT), and hematopathology. METHODS: This prospective study evaluated TB preparation time in multiple phases pre- and post-NTB implementation at an academic health care center. TB preparation times were recorded for multiple weeks using a digital time tracker. RESULTS: Preparation times for 59 breast, 61 GI, 36 ENT, and 71 hematopathology cancer TBs comparing a pre-NTB phase to 3 phases of NTB implementation were evaluated between February 2018 and July 2019. NTB resulted in significant reductions in overall preparation time (30%) across 3 TBs pre-NTB compared with the final post-NTB implementation phase. In the breast TB, NTB reduced overall preparation time by 28%, with a 76% decrease in standard deviation (SD). In the GI TB, a 23% reduction in average preparation time was observed for all users, with a 48% decrease in SD. In the ENT TB, a 33% reduction in average preparation time was observed for all users, with a 73% decrease in SD. The hematopathology TB, which was the cocreation partner and initial adopter of the solution, showed variable results. CONCLUSION: This study showed a significant impact of a digital solution on time preparation for TBs across multiple users and different TBs, reflecting the generalizability of the NTB. Adoption of such a solution could improve the efficiency of TBs and have a direct economic impact on hospitals.

A clinician's perspective on co-developing and co-implementing a digital tumor board solution.

Healthcare has entered the information age. This will deliver huge opportunities for healthcare providers to deliver more individualized treatments for patients, and as such improve outcomes. Nowhere is the prospect greater than in cancer care. Healthcare providers now need to manage the challenge of how to best capture, interpret and exploit insights from real-world clinical data. A significant aspect of cancer care is the challenge of preparing and conducting tumor boards. Currently, data are distributed across multiple systems and cannot be easily aggregated or integrated. In recognition that no suitable solution existed, the University of Missouri School of Medicine, in partnership with Roche, have co-developed and co-implemented a digital tumor board solution. This article describes the development process and the enablers and barriers for adoption from a clinician's perspective. In addition, it reflects on some of the key factors for success and some of the future opportunities.