On July 11, 2019 EORTC biostatisticians reported that it will present a number of abstracts at the 40th Annual Conference of the International Society for Clinical Biostatistics (ISCB 40) which will take place from 14 to 18 July 2019 in Leuven, Belgium (Press release, EORTC, JUL 11, 2019, View Source [SID1234537476]).

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Oral presentations
Setting standards in patient-reported outcomes analysis for cancer randomized controlled trials: a SISAQOL initiative update

Lien Dorme and the SISAQOL team

Date: 15 July 2019 – 4:42-5:00PM

Location: Auditory BMW 6

There are no standards on how to analyse Patient Related Outcomes (PRO) data in cancer randomised clinical trials (RCTs). The Setting International Standards in Analyzing Patient-Reported Outcomes and Quality of Life Endpoints Data (SISAQOL) Consortium has identified critical issues in PRO analyses in cancer RCTs and has developed standardized research objectives and analysis methods to address these issues. The analysis is presented here.

Prediction models for liver transplantation – comparisons between Cox models and machine learning techniques

George Kantidakis for his Master’s thesis work with the team of Marta Fiocco

Date: 16 July 2019 – 11:54AM-12:12PM

Location: Auditory BMW 5

Currently, Machine Learning (ML) is being discussed extensively. Questions on whether it has greater potential than Cox models when it comes to complex data have been posed. Criticism to ML is related to unsuitable performance measures and lack of interpretability, which is important for the clinicians to take decisions. In this presentation, ML techniques such as random forests and neural networks are applied to large data of 62294 patients and more than 600 variables from the United States. 106 prognostic factors are selected – 52 regarding donor and 54 regarding recipient characteristics – to predict survival of patients since liver transplantation.

A new measure to report the treatment effect in clinical trials involving competing risks

Eva Cantagallo and the BENEFIT team

Date: 17 July 2019 – 3:48-4:06PM

Location: Auditory BMW 6

Generalized pairwise comparisons (GPC) is a recent approach to describe the treatment effect in two-group clinical trials, using the net benefit as a measure of overall treatment effect. This method allows the use of a threshold of clinically relevant difference between the two groups and the simultaneous analysis of prioritized outcomes. In this presentation, the BENEFIT team expand GPC methods to a competing risks setting and provide a new measure of the treatment effect, while offering the advantages of classical GPC.

Poster
Validation of imaging biomarkers for treatment response in multicenter cancer trials conducted by EORTC

Bart Jacobs and the EORTC Imaging Group statisticians
Date: 16 July 2019 – 12:30-13:30PM

Location: Entrance Hall O&N1 + O&N2

Within QuIC-ConCePT, an EU funded initiative to qualify and validate imaging biomarkers for cancer response, two concurrent multi-centre clinical trials were performed. EORTC 1217 (NCT02273271) studied SUV measured with 3’-deoxy-3’-[18F]fluorothymidine-PET and ADC measured with diffusion weighted imaging-MRI in patients with early stage non-small cell lung cancer. EORTC 1423 (NCT02355353) focused on ADC in colorectal cancer patients with resectable liver metastases. Both trials hypothesized that early changes in these biomarkers (14 days post start of neo-adjuvant chemotherapy) could be predictive for pathological response at time of surgery. This potential relation could fasten decisions in early endpoints and would provide a cost-effective tool for early phase clinical trials benefiting both patients and investigators.