Tumour Response (RECIST)
This section will describe how to map, load and check Tumour Response (RECIST) data in REACT, ADMIN UI.
The Tumour Response view allows a user to investigate tumour response for the study drug
This view contains sensitive clinical endpoint data therefore permissions to view this data is controlled
As described in the ‘Granting Access’ – Controlling views in VA HUB section, Oncology package permissions need to be granted to enable a user to see the Tumour Response view and access the plots
A reminder that this data is also required to be mapped and loaded and a user granted permissions to the data for the PK-Response Exploration plot to be displayed in the Dosing and Exposure view
Up to three tabs are available on the tumour response view:
Waterfall Plot
The plot presents each individual patient’s response to a particular drug based on a parameter, such as tumour burden.
It is displayed as one bar per dosed subject which has post-baseline assessments of Target Lesions (TLs)
The height of the bar represents percentage change in sum of diameters of TLs
The colour of the bar represents the best overall response for each subject
The plot is organised to show the study population from worst response to best response (left -> right)
The dashed lines +20% and -30% represent thresholds for stable disease
2. Target Lesion Diameters over Time
Target Lesions (TL) diameters over time plot is a line plot displaying one line per dosed subject who has post-baseline assessments of TLs
The plot shows one data point per assessment (baseline and each post-baseline assessments displayed on the plot
Data points on the lines represent percentage change in sum of diameters of Target Lesions or absolute value of the sum (depends on selected Y-axis option)
The X-axis represents days since first dose
Colour of the line represents the overall visit response
The plot is based on RECIST 1.1. rules
3. Prior Therapy vs. Time on Compound
Horizontal bar plot showing the comparison of the 'time on compound' with the 'previous lines of therapy' for each subject
The X-axis shows the time since first treatment in weeks
The "categories" on the y-axis are Subject ID
Bars on the x-axis in the negative direction shows the time in weeks of the most recent previous line of therapy
Bars in the negative direction of the x-axis begin and end at the correct point – they do not start at zero, this is useful representation as it shows the time between the previous therapy and the time on current compound
For more information about the different tabs and the data they represent refer to section 5.11 in the VA HUB Guide
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