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Accessible transcript 2: The FOCUS4 trial: Foundations for fighting COVID19

Contents

This document provides a fully accessible transcript for the video: FOCUS4: Foundations for fighting COVID-19

Text on screen: FOCUS4 – A flagship precision medicine cancer trial

Tim Maughan:

I'm Tim Maughan, Professor of Clinical Oncology at University of Oxford. I'm the Chief Investigator, one of two Chief Investigators of the FOCUS4 trial programme. FOCUS4 aims to test new therapies for molecular subgroups within colorectal cancer. But patients with metastatic colorectal cancer, that the prognosis has not changed very greatly for many patients in this disease.

Tim Maughan:

And back in 2011, we had a certain amount of information about molecular subgroups and we wanted to test new therapies in a comprehensive way that allowed every patient access to a trial. So we integrated this into this larger adaptive platform within which we were testing novel therapies and different subgroups. We selected the maintenance setting after first line therapy because we'd previously shown in other trials that it was okay to give patients a break from chemotherapy after four months treatment.

Tim Maughan:

So at the end of four months treatment, if they had stable or responding disease, standard of care was for those patients to have a break from treatment. And we were testing whether novel therapies could improve the disease control in that period, following first line therapy to lengthen the time before they needed more treatment. And that was the test bed in which we operated for FOCUS4. Between January 2014 and October 2020 1,434 patients were registered from 88 UK hospitals. Three molecularly targeted sub trials were activated assessing Mesa D8931, and aspirin and Adavosertib. And we also evaluated Capecitabine montherapy in the non-stratified group.

 

Text on screen: The MAMS design enabled the trial to adapt as the science evolved

Tim Maughan:

Our first molecular cohort showed a comprehensive negative result. We were able to close it after only 32 patients had been accrued to FOCUS4-D that was published back in 2017. And you'll see in many platform designs, that actually a number of negative results come out. And that's important because we're showing that things don't work as well as the things that do work.

Tim Maughan:

Secondly, we had good evidence that aspirin might be useful in another molecular cohort, but when we set this up, we found that because aspirin is so widely available and so widely trusted, patients were not happy to be randomised to receive aspirin or a placebo. So that trial only recruited six patients and it was stopped because of feasibility. Then we went on with a third study of molecular study FOCUS4-C, which is completed, and that is now been analysed and is been submitted for publication this year. And because of the pandemic we closed the whole trial during 2020 and have analysed the final results. So the trial is now completed and we will be reporting the results of three molecular comparisons and one non-stratified in comparison FOCUS4-N.

Text on screen: NIHR National Institute for Health Research. For more information visit: www.nihr.ac.uk