Validating the PredicTR treatment response classifier for oropharyngeal cancer
Acronym:
Predictr2
Background
Oropharyngeal cancer (OPC) - throat cancer - is one of the mostly rapidly rising cancers in the West, with ~115,000 new cases per year; this is due mainly to increased human papillomavirus (HPV)-related incidence. Standard treatment for OPC involves chemoradiotherapy (CRT). Adding surgery may improve outcomes for those patients most at risk of recurrence, but may also result in increased complications and poorer function - including swallowing/eating and speech - as well as increased cost.
Currently, there are no markers to guide treatment selection, therefore the decision whether or not to operate is made according to clinician and patient preference.
We have developed a 'biomarker classifier' that can predict which OPC patients will receive most benefit from additional surgery, and so could guide treatment decision-making. This 'biomarker classifier' comprises four factors: (i) detection of HPV DNA within tumour cells, (ii) the presence (or absence) of a subset of immune cells called lymphocytes within the tumour microenvironment, (iii) the expression of a protein called survivin, which helps to protect cells from programmed cell death, and (iv) p16, a protein whose expression within tumour cells is linked to HPV infection.
The classifier categorises patients into 'low-risk' or 'high-risk' subgroups, using an algorithm (formula) to interpret results from the combined analysis of these four factors. Low-risk patients do not benefit from additional surgery and so can be treated with CRT alone. High-risk patients demonstrate ~20% improvement in overall survival if surgery is added to CRT.
Status
Not open to recruitment. Working with our collaborators we will complete clinical validation of our biomarker classifier and make the preparations necessary for converting it into a standardised assay which can be adopted into clinical practice.
Download the Predictr2 Protocol
Lead Centre
University of Birmingham
Project Manager
Dr Rachel Spruce
Translational Team Leader
InHANSE
University of Birmingham
R.Spruce@bham.ac.uk
