Response evaluation criteria in solid tumours (RECIST) is widely used to assess tumour response but is limited by not considering disease site or radiological heterogeneity (RH).
To determine whether RH or disease site has prognostic significance in patients with metastatic clear-cell renal cell carcinoma (ccRCC).
A retrospective analysis was conducted of a second-line phase II study in patients with metastatic ccRCC (NCT00942877), evaluating 138 patients with 458 baseline lesions.
The phase II trial assessed vascular endothelial growth factor-targeted therapy±Src inhibition.
RH at week 8 was assessed within individual patients with two or more lesions to predict overall survival (OS) using Kaplan-Meier method and Cox regression model. We defined a high heterogeneous response as occurring when one or more lesion underwent a ≥10% reduction and one or more lesion underwent a ≥10% increase in size. Disease progression was defined by RECIST 1.1 criteria.
In patients with a complete/partial response or stable disease by RECIST 1.1 and two or more lesions at week 8, those with a high heterogeneous response had a shorter OS compared to those with a homogeneous response (hazard ratio [HR] 2.01; 95% confidence interval [CI]: 1.39-2.92; p<0.001). Response by disease site at week 8 did not affect OS. At disease progression, one or more new lesion was associated with worse survival compared with >20% increase in sum of target lesion diameters only (HR 2.12; 95% CI: 1.43-3.14; p<0.001). Limitations include retrospective study design.
RH and the development of new lesions may predict survival in metastatic ccRCC. Further prospective studies are required.
We looked at individual metastases in patients with kidney cancer and showed that a variable response to treatment and the appearance of new metastases may be associated with worse survival. Further studies are required to confirm these findings.
European urology focus. 2019 Feb 06 [Epub ahead of print]
Peter E Hall, Scott T C Shepherd, Janet Brown, James Larkin, Robert Jones, Christy Ralph, Robert Hawkins, Simon Chowdhury, Ekaterini Boleti, Amit Bahl, Kate Fife, Andrew Webb, Simon J Crabb, Thomas Geldart, Robert Hill, Joanna Dunlop, Duncan McLaren, Charlotte Ackerman, Akhila Wimalasingham, Luis Beltran, Paul Nathan, Thomas Powles
Barts Cancer Institute, CRUK Experimental Cancer Medicine Centre, London, UK., Department of Oncology, Royal Free NHS Foundation Trust, London, UK; Department of Medical Oncology, Royal Marsden Hospital, London, UK., Department of Medical Oncology, Leeds Teaching Hospitals NHS Trust, Leeds, UK; Academic Unit of Clinical Oncology, Department of Oncology and Metabolism, University of Sheffield, Sheffield, UK., Department of Medical Oncology, Royal Marsden Hospital, London, UK., Beatson Cancer Centre, University of Glasgow, Glasgow, Scotland, UK., Department of Medical Oncology, Leeds Teaching Hospitals NHS Trust, Leeds, UK., Department of Medical Oncology, Christie Hospital, Manchester, UK., Department of Oncology, Guys and St Thomas' NHS Foundation Trust, London, UK., Department of Oncology, Royal Free NHS Foundation Trust, London, UK., Department of Oncology, University Hospital Bristol NHS Foundation trust, Bristol, UK., Department of Oncology, Cambridge University Hospitals, Cambridge, UK., Department of Oncology, Brighton and Sussex University Hospital Trust, Brighton, UK., Cancer Sciences Unit, University of Southampton, Southampton, UK., Department of Oncology, Royal Bournemouth Hospital, Bournemouth, UK., Scottish Clinical Trials Research Unit (SCTRU), NHS National Services Scotland, Edinburgh, UK., Edinburgh Cancer Centre, Western General Hospital, Edinburgh, UK., Department of Oncology, Mount Vernon Cancer Centre, Northwood, UK., Barts Cancer Institute, CRUK Experimental Cancer Medicine Centre, London, UK; Department of Oncology, Royal Free NHS Foundation Trust, London, UK. Electronic address: .