Enabling smart environment for monitoring cancer patients therapy through OncoSmart

Aim: Treatment-related health symptoms strongly compromise the success of therapy and the quality of life of cancer patients. Patient smart monitoring through wearable devices and the management of electronic patient-reported outcomes (ePROs) prevent missing symptomatic toxicities. This study describes a preliminary clinical trial adopting OncoSmart Software as a Medical Device in the Health Continuum Cancer Care Pathways, realized by Riatlas srl.Methods: The preliminary study enrolled eight mCRC (metastatic colorectal cancer) patients under active medical treatment between June 2019 and January 2020. OncoSmart provides a mobile app integrated with a smartwatch. The mobile app alerts patients to fill ePROs and integrates the smartwatch to collect vital parameters (blood pressure, heart rate, oxygen saturation, respiratory rate, pedometer, sleeping, etc.). On the physician side, OncoSmart provides an interactive dashboard for monitoring the patient’s therapy and treatment-related health symptoms.Results: Despite the low number of enrolled patients, the trial revealed interesting results about OncoSmart’s adoption, measured in compliance and concordance. Compliance is the participation of patients in self-reports, which was about 77%. Overall concordance between ePRO and symptoms detected by physicians at clinical visits was 80%. The remaining 20% included 15% of cases where ePROs included symptoms missed during the visit and 5% of cases where physicians reported toxicities not recorded by patients. Regarding the symptoms that led to treatment modifications and/or suspension, the concordance between PROs and the physician’s evaluation during the visit was 100%.Conclusion: New medical treatments aim at improving patients’ survival and quality of life; using solutions such as OncoSmart increases patient empowerment and engagement. The preliminary results of OncoSmart suggest pursuing further assessment of the impact of a PRO solution in routine clinical practice

Clinical Practice Use of Liquid Biopsy to Identify RAS/BRAF Mutations in Patients with Metastatic Colorectal Cancer (mCRC): A Single Institution Experience

Tumor heterogeneity represents a possible cause of error in detecting predictive genetic alterations on tumor tissue and can be overcome by testing alterations in circulating tumor DNA (ctDNA) using liquid biopsy. We assessed 72 consecutive patients with a diagnosis of metastatic colorectal cancer (mCRC) using Idylla™ Biocartis, a fully automated platform that evaluates the most frequent mutations of KRAS, NRAS and BRAF genes. We correlated the results of liquid biopsy and standard tissue-based next generation sequencing (NGS) analyses to patient clinical features. The overall agreement was 81.94%. Concordance was 85.71% and 96.15% in treatment-naïve patients and in the patient subgroup with liver metastases, respectively. In liver metastases positive, treatment-naïve patients, sensitivity, specificity and positive predictive value (PPV) were 92.31%, 100% and 100%, respectively. Circulating mutational fraction (CMF) was significantly higher in patients with liver metastases and high carcinoembryonic antigen (CEA) levels. In a subgroup of patients pre-treated with anti-Epidermal Growth Factor Receptor (EGFR) agents, emerging KRAS mutations were evidenced in 33% of cases. Testing RAS/BRAF mutations on plasma using the Idylla™ Biocartis platform is feasible and reliable in mCRC patients in clinical practice