Abstract
Purpose
Progressive disease (PD) per Response Evaluation Criteria in Solid Tumours (RECIST)
1.1 is defined as growth of measurable target lesions, presence of new lesions or
unequivocal progression of non-target disease. In this manuscript we explored whether
a more refined categorisation of tumour response and/or these components of progression,
varying over time, can improve prediction of overall survival (OS) in the RECIST database.
Methods
Data were randomly selected from 13 randomised clinical trials (3758 patients with
breast, lung or colorectal cancer). A maximum of five target lesions contributed to
the sum of longest diameters. At each measurement time we determined: best target
response as best % improvement from baseline; tumour growth of target lesions as worst
% change and worst rate of increase (mm/week) from nadir; presence of new lesions
and occurrence of non-target PD. OS was analysed by tumour type using Cox regression,
adjusting for baseline sum and including these parameters as time-dependent covariates.
Results
36% of patients had new lesions, 28% non-target PD and 49% experienced target lesion
growth (median strongest growth 1.5 mm/week). Regardless of tumour type, presence of new lesions (hazard ratio (HR) ranging
1.5–2.3) and non-target PD (HR 1.5–2.0) were strongly associated with worse OS. The
explanatory value of tumour growth for OS was low compared to the other components.
Conclusion
Modelling target lesion tumour growth did not show a marked improvement in OS prediction
over and above the other components. These analyses enable a better understanding
of the role of each component in PD evaluation. Work is ongoing to incorporate this
information into an updated version of RECIST with enhanced prediction of subsequent
survival.
Keywords
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Article info
Publication history
Published online: April 10, 2014
Accepted:
March 11,
2014
Received in revised form:
March 7,
2014
Received:
December 30,
2013
Identification
Copyright
© 2014 Elsevier Ltd. Published by Elsevier Inc. All rights reserved.
ScienceDirect
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- Non-target progression – The fine line between objectivity and subjectivityEuropean Journal of CancerVol. 50Issue 18
- PreviewWe have read with great interest the article by Litière et al. ‘The components of progression as explanatory variables for overall survival in the Response Evaluation Criteria in Solid Tumours 1.1 database’ published recently in the European Journal of Cancer [1]. We were intrigued by the sub-categorisation of progressive disease into (i) progression of targeted lesions; (ii) occurrence of a new lesion and (iii) non-targeted progressive disease and the potential implications of these on clinical practice and research.
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