Implementing Precision Medicine (-omics, liquid biopsies, cancer drugs) to improve cancer management
Precision medicine technologies offer the promise of tailored risk assessment, diagnosis and treatment. However, despite significant investments and breakthroughs in genomics and precision medicine, successful translation into health services for the benefit of patients remains challenging. The CHSR unit has a significant number of projects dealing with the challenges of developing the evidence base required for market approval, reimbursement and clinical implementation of genomics in cancer services.
Genomic sequencing to improve diagnosis of Bone-Marrow Failure
Bone Marrow Failure (BMF) is an extremely complicated condition of either hereditary (IBMFS) or acquired (AA) origin. The underlying cause of BMF cannot be made on standard-of-care investigations, however, it is fundamental for patient management. Inadequate management of BMF can result in serious adverse-events, long-term effects and potentially inappropriate use of healthcare resource Genomic testing potentially will improve diagnosis and direct appropriate clinical management and thus improves clinical outcomes. The Melbourne Genomics BMF Flagship project is offering genomic testing (panel and whole exome sequencing) to patients and collecting data to allow determination of comparative effectiveness of molecular testing with usual care for patient diagnosis and management. This project intends to provide the health economic analysis of genomic testing in BMF aiming at routine implementation and reimbursement. The BMF flagship is managed under the Melbourne Genomics initiative and involves several leading clinical and translational experts.
Utilising CTC Counts to Optimize Systemic Therapy of Metastatic Prostate Cancer (CTC-STOP) (Institute of Cancer Research, UK)
CTC-STOP is a multicentre prospective randomised controlled phase III trial for metastatic castration-resistant prostate cancer patients. This study will determine if serial CTC counts can be used as early markers of progression to direct early discontinuation of docetaxel chemotherapy in patients with mCRPC without adversely impacting overall survival, when compared with standard approaches to guide treatment switch decisions. Patients with metastatic castration-resistant prostate cancer will be randomised 1:1 to either control group (standard of care) or intervention group (CTC-guided treatment). All patients will commence first line chemotherapy with docetaxel three-weekly and will receive a minimum of 3 cycles of treatment before any recommendation to discontinue first-line docetaxel. Chief investigator of the CTC-STOP study is Professor Johann de Bono. The CHSR group is responsible for the health economic analysis of biomarker-based treatment switching.
European funded projects: liquid biopsies and whole-genome sequencing
The CHSR unit is involved in several European studies either as a contract partner or through the University of Twente. The H2020 European Liquid Biopsies Academy (ELBA) project is a research programme and educational curriculum covering the entire value chain of diagnostics development of liquid biopsy approaches. The training includes training on state-of-the-art technologies and tools, health economics and health technology assessment.
Technology Assessment of Next-Generation Sequencing (ZonMw, the Netherlands) is a large network consortium investigating the effectiveness and cost-effectiveness of implementing routine WGS technologies through the Hartwig Medical foundation for non-small cell lung cancer and melanoma. One of the work packages develops a dynamic simulation model to analyse the impact of real-world variation in access and organisation of WGS services on health economic outcomes.
The STIC-trial is a French led (Institut Curie) randomised controlled trial investigating the use of Circulating Tumor Cells to decide about first-line treatment in metastatic Breastcancer. Based on CTC counts (>5 CTC/7,5ml) the intervention arm patients are switched to chemotherapy instead of hormone therapy, while CTC counts are not disclosed to the physician in the intervention arm. We are working with the French team on the health economic modelling of the STIC trial.