Proof-of-concept study evaluating a new tool for standardizing radiological assessment of tumor response to treatment in routine clinical practice.

person Charles Mastier Centre Leon Berard, Lyon, France info_outline Charles Mastier, Christelle De La Fouchardiere, Pierre-Etienne Heudel, Jerome Fayette, Matthieu Sarabi, Nathan Banaste, Marion Barma, Elodie mercier-Bischoff, Medhi Brahmi, Philippe Alexandre Cassier, Gwenaelle Garin, David Pérol, Frank Pilleul, Jean-Yves Blay

Authors person Charles Mastier Centre Leon Berard, Lyon, France info_outline Charles Mastier, Christelle De La Fouchardiere, Pierre-Etienne Heudel, Jerome Fayette, Matthieu Sarabi, Nathan Banaste, Marion Barma, Elodie mercier-Bischoff, Medhi Brahmi, Philippe Alexandre Cassier, Gwenaelle Garin, David Pérol, Frank Pilleul, Jean-Yves Blay Organizations Centre Leon Berard, Lyon, France, Leon Berard Cancer Centre, Lyon, France, Centre Léon Bérard, Lyon, France, Centre Léon Bérard, Medical Oncology, Lyon, France, Centre Léon Berard, Lyon, France, Centre Léon-Bérard, Lyon, France Abstract Disclosures Research Funding Pharmaceutical/Biotech Company Background: Internationally recognised criteria to evaluate tumour response, such as Response Evaluation Criteria In Solid Tumors (RECIST) and iRECIST (for immunotherapeutics) are not widely used in clinical practice. The main reason is that communications amongst health professionals are insufficiently standardised. To this purpose, ON’COHUB (MIRIO in France), a newly developed tool, automatically streamlines interactions between oncologists and radiologists to optimise and facilitate response evaluation according to the standard criteria. This study aims to identify the benefits in terms of user satisfaction and to provide preliminary data for the standardisation of the tool. Methods: Five oncologists, 3 radiologists, 1 clinical research associate and 1 clinical project officer used ON’COHUB to assess patients’ tumour responses according to RECIST, in an anti-cancer center, over five months. An oncologist compared patients’ regular radiology reports (n = 110) and ON’COHUB’s reports (n = 106), using the following report quality indicators: information on the patient’s context, target and non-target lesions , baseline, NADIR, and overall evaluation. Then a questionnaire on the user’s satisfaction was administered. Two-tailed chi-square tests were performed to compare patients’ regular radiology reports and ON’COHUB’s reports. Results: ON’COHUB was reported to significantly improve the following quality indicators compared to regular reports: presence of the treatment (99% vs 42%; p < 0,001), follow-up criteria (98% vs 5%; p < 0,001); target lesion and location (100% vs 75%; p < 0,001), size of target lesions (99% vs 67%; p < 0,001), value and date of the baseline (100% vs 0% and 4%, respectively; p < 0,001 for both), value of the baseline lesion by lesion (99% vs 4%; p < 0,001), value and date of the Nadir (97% vs 0%; p < 0,001), global response according to RECIST (100% vs 17%; p < 0,001), value of target lesions response (80% vs 20%; p < 0,001), referential for RECIST calculation (98% vs 2% p < 0,001).Finally, 9 out of the 10 users declared that they would use ON’COHUB on a daily basis. Conclusions: These preliminary data suggest that ON’COHUB may have a positive impact on the quality of the treatment response evaluation in clinical trials and in routine use. These results will be confirmed with the deployment of the interoperability with IT hospital System.