Abstract
The objectives of this study were to evaluate whether the number of lesions that are
used to measure tumour burden affects response assessment and inter-rater variability.
In order to accomplish this, a simulation study was conducted. Data were generated
from a mixed-effects mixture model. Parameter values to input in the model were obtained
from the analysis of real data. Response assessments based on 10, five, three, two
and one lesion were evaluated. There was little difference between response assessments
based on five lesions and response assessments based on 10 lesions. When fewer than
five lesions were used to assess response, there were notable differences from the
10 lesion-based response assessment. Basing response assessment on a small number
of lesions tends to overestimate response rates and leads to misclassification of
patients’ response status. Therefore, measuring five lesions per patient appears to
sufficiently capture patients’ response to therapy. Measuring fewer than five lesions
results in the loss of information that may adversely affect clinical trial results
as well as patient management.
Keywords
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Article info
Publication history
Published online: December 17, 2008
Accepted:
November 7,
2008
Received:
November 4,
2008
Identification
Copyright
© 2008 Elsevier Ltd. Published by Elsevier Inc. All rights reserved.
