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Thus, evaluation of methods that can be applied to assess response at earlier time points during treatment is important.
Secondary objectives were to assess response at primary and metastatic sites by CT and FDG-PET imaging.
This study did show that FDG-PET could successfully assess response at 2 weeks, however, data from all tyrosine kinase inhibitors were combined and analysis of patients only receiving sunitinib was not reported.
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Assessing response at a fixed time after treatment was more powerful than assessing the best observed response.
Changes in these three markers at 2, 4 and 6 months showed a highly significant correlation with UICC assessed response at 6 months.
Marker changes at 2 and 4 months showed a highly significant correlation with the UICC assessed response at 3 and 6 months (P < 0.001); sensitivity 100%, specificity 87%; positive predictive value 85%; negative predictive value 100%.
Using a cut-off of 33 U ml-1 changes in EMCA at 2, 4 and 6 months showed a highly significant correlation (P < 0.001) with UICC assessed response at 6 months; selectivity 70%, sensitivity 80%, specificity 91%, positive predictive value 84%; negative predictive value 89% at 2 months.
The recruitment methods meant that information was not available to assess response bias at baseline.
Furthermore, PET offers opportunities to measure functional aspects of the tumour microenvironment, predict response to treatment and assess response early rather than at the traditional time point on completion of therapy.
From these data, a number of mathematical models were used to assess responses arriving at a conclusion that "An important advantage of this approach is that all relevant data can be used in the derivation as opposed to a NOAEL for the critical effect.
The primary aim of the study was to evaluate the recruitment strategies for and the feasibility of collecting PROMs data in LTCs by assessing response rates at two points of data collection.
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