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- Andreas Charalambous (Limassol, Cyprus)
How virtual reality can facilitate the navigation of patients through active treatment: Findings from a crossover control trial
- Androniki Ioannou (Limassol, Cyprus)
Results of eSMART project, a European Multicenter randomized controlled trial, using real time remote symptom monitoring of patients with cancer receiving chemotherapy
- Roma Maguire (Glasgow, United Kingdom)
Development of an ePRO based model of care for patients treated with immune-checkpoint inhibitors
- André M. Lopes (Lausanne, Switzerland)
CN1 - Remote monitoring by Nurses Navigators (NNs): From experimentation to optimisation of routine practices
- Adeline Duflot Boukobza (Villejuif, Cedex, France)
Abstract
Background
CAPRI is a randomised phase III trial comparing digital and NNs intervention versus usual care in patients (pt) treated with oral anticancer agents (OAA) at Gustave Roussy cancer Center. Results showed that CAPRI intervention improved Relative Dose Intensity, patient experience, grade 3 toxicities and optimised hospitalisation . The aim of this longitudinal analysis is to describe NNs activity data in order to understand how NNs monitoring could be optimised for implementation and sustainability.
Methods
NNs conduct regular phone monitoring, evaluate alert’s level based on algorithms (designed according to NCI-CTCAE) and determine actions to implement mainly: providing advice to patients, referral to the General Practitionner or oncologist, organise an hospitalisation. A coding grid was developed to analyse the interventions of the NNs in order to identify the actions performed and to assess their autonomy in the encountered situations. All interventions (regular follow-ups and patient requests) were included in the evaluation. Two distinct periods (P1 : 11/2016 – 04/2018 and P2 : 05/2018 – 10/2019) were defined to study the evolution of the 6 NNs activities.
Results
A total of 3942 interventions were extracted concerning 272 patients (pt) and 3445 could be analysed. One action was decided by NNs at least in 2062 (59.9%) of these interventions (1345 of which were regular follow-ups, and 717 upon pt requests). 77.4% (n=1595) of the interventions have been processed by the NNs without referral to the oncologist (77.4% for P1 and 79.4% P2). The reasons to refer to the oncologist were: presence of new symptoms/toxicity (82%), follow-up of OAA cessation/resumption of treatment for surgery or treatment, biological tests for resumption of treatment (12,5%), other reasons (5.5%).
Conclusions
NN’s autonomy increases over time, which suggests a learning curve. However, several NNs have practiced and improved a rigorous procedure leading to these results. All of this algorithms make the practices more secured and maximize the NNs decision- making autonomy. The implementation of a new protocol allowing a wider perimeter of action of NNs would allow to limit the solicitations of oncologists.
Clinical trial identification
NCT02828462.
Legal entity responsible for the study
Gustave Roussy.
Funding
Astrazeneca, Novartis, Fondation Philanthropia, ARS Ile de France, Agence Nationale de la Recherche.
Disclosure
F. Scotté: Financial Interests, Personal and Institutional, Invited Speaker: MSD; Financial Interests, Personal and Institutional, Invited Speaker: Roche; Financial Interests, Personal and Institutional, Invited Speaker: Pfizer; Financial Interests, Personal and Institutional, Invited Speaker: BMS; Financial Interests, Personal and Institutional, Invited Speaker: Pierre Fabre Oncology ; Financial Interests, Personal and Institutional, Invited Speaker: Biogaran Mylan; Financial Interests, Personal and Institutional, Invited Speaker: Mundi Pharma; Financial Interests, Personal and Institutional, Invited Speaker: Amgen; Financial Interests, Personal and Institutional, Invited Speaker: Leo Pharma. O. Mir: Financial Interests, Personal, Advisory Board: Bayer; Financial Interests, Personal, Advisory Board: Blueprint Medicines; Financial Interests, Personal, Invited Speaker: BMS; Financial Interests, Personal, Invited Speaker: Eli-Lily; Financial Interests, Personal, Invited Speaker: Ipsen; Financial Interests, Personal, Advisory Board: MSD; Financial Interests, Personal, Advisory Board: Pfizer; Financial Interests, Personal, Invited Speaker: Roche; Financial Interests, Personal, Invited Speaker: Servier; Financial Interests, Institutional, Principal Investigator: Bayer; Financial Interests, Institutional, Principal Investigator: Blueprint Medicines; Financial Interests, Institutional, Principal Investigator: Eli Lily; Financial Interests, Institutional, Principal Investigator: Epizyme. All other authors have declared no conflicts of interest.
CN2 - ROPRO – Real-World Data Prognostic Score: A novel tool to assess patients' performance status
- Jayesh Desai (Melbourne, VIC, Australia)
Abstract
Background
The assessment of our patients' performance status (PS) to predict survival has always been important for toxicity monitoring, treatment selection and clinical trial eligibility. Some existing tools to determine PS may not be suitable for decision-making due to their reliance on subjective assessment, leading to limited reliability and restricted predictive value in patients with better PS.
Methods
By mining the data of more than 120,000 cancer patients from Flatiron Health, we derived the Real-World Data Prognostic Score (ROPRO) for overall survival in cancer patients [1]. ROPRO comprises 27 independently associated, routinely collected clinical parameters such as lactate dehydrogenase, albumin or neutrophil/lymphocyte ratio. ROPRO is a pan-cancer score derived from 17 cancer cohorts and has been shown to be applicable across multiple other tumor types. We have validated ROPRO in over 20 independent clinical studies, demonstrating that ROPRO outperforms other prognostic scores across cancer types and treatment modalities.
Results
We present new data regarding two applications of the ROPRO in clinical development. First, we are using baseline ROPRO for patient selection. ROPRO is a strong predictor of short-term survival [3-months ROC-AUC=82.5] and thus provides quantitative and un-biased decision support to investigators to determine 12-week life expectancy. In this context, ROPRO outperforms standard scores such as Royal Marsden Hospital Score [3-months ROC-AUC=59.3] and ECOG [3-months ROC-AUC=70.4]. Second, we are presenting new data on delta ROPRO analysis over time which may help clinicians detect treatment benefits or progression early.
Conclusions
There is an unmet need for improved and data-driven decision making for clinical development and clinical practise. We believe ROPRO may address that need by being more objective and discriminatory. We show that by using a large amount of Real-World Data (RWD) of oncology patients in combination with artificial intelligence methods, innovative tools aiding clinical decision making, can be developed. A wider adoption will help validating ROPRO further as a quantitative tool to assess patients performance status, an aspect particularly relevant for cancer immunotherapy.
Legal entity responsible for the study
Roche Diagnostics GmbH.
Funding
F. Hoffmann-La Roche Ltd.
Disclosure
J. Desai: Financial Interests, Personal, Advisory Role: Eisai; Financial Interests, Personal, Advisory Role: BeiGene; Financial Interests, Personal, Advisory Role: Pierre Fabre; Financial Interests, Personal, Advisory Role: Bayer; Financial Interests, Institutional, Advisory Role: Amgen; Financial Interests, Institutional, Research Grant: Roche; Financial Interests, Institutional, Research Grant: GlaxoSmithKline; Financial Interests, Institutional, Research Grant: Novartis; Financial Interests, Institutional, Research Grant: Bionomics; Financial Interests, Institutional, Research Grant: BeiGene; Financial Interests, Institutional, Research Grant: Lilly; Financial Interests, Institutional, Research Grant: Bristol Myers Squibb; Financial Interests, Institutional, Research Grant: AstraZeneca/MedImmune. A. Bauer-Mehren: Financial Interests, Personal, Stocks/Shares: Roche. All other authors have declared no conflicts of interest.
Q&A and live discussion
- Andreas Charalambous (Limassol, Cyprus)