Journal
ACADEMIC RADIOLOGY
Volume 29, Issue 4, Pages 514-522Publisher
ELSEVIER SCIENCE INC
DOI: 10.1016/j.acra.2021.04.015
Keywords
overall survival; progression-free survival; melanoma; treatment response; computed tomography
Funding
- German research foundation (DFG) [OT534/2-1, El1126/2-1]
- junior clinician scientist program of the medical faculty of Tuebingen University [461-0-0]
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This study aims to validate the predictive capacity of early tumor size reduction (TSR) and compare it with RECIST 1.1 criteria in predicting overall survival (OS) and progression-free survival (PFS) in patients with advanced melanoma. The results showed that tumor size reduction by at least 10% can be considered as a biomarker for predicting OS and PFS.
Rationale and Objectives: Early tumor size reduction (TSR) has been explored as a prognostic factor for survival in patients with advanced melanoma in clinical trials. The purpose of this analysis is to validate, in a routine clinical milieu, the predictive capacity of TSR by 10% for overall survival (OS) and progression-free survival (PFS) and to compare its predictive performance with the RECIST 1.1 criteria. Materials and Methods: This retrospective study was approved by the local ethics committee. A total of 152 patients with both CT before immunotherapy initiation and at first response evaluation after immunotherapy initiation were included. Prior to statistical analysis, treatment response was trichotomized as follows: Complete response and/or partial response, stable disease and progressive disease. Furthermore, response was dichotomized regarding TSR (TSR >= 10% and TSR < 10%). Kaplan-Meier survival estimates, Cox regression and Harrel's concordance index (C-index) were computed for prediction of overall survival and progression-free survival. Results: Tumor size reduction by at least 10% significantly differentiated between patients with increased survival from the ones with decreased survival (median OS: TSR >= 10%: 2137 days vs. TSR < 10%: 263 days) (p < 0.001) (median PFS: TSR >= 10%: 590 days vs. TSR < 10%: 11 days) (p < 0.001). RECIST 1.1. criteria had a slightly higher C-index for overall survival reflecting a slight superior predictive capacity (RECIST: 0.69 vs TSR: 0.64) but a similar predictive capacity regarding progression-free survival (both: 0. 63). Conclusion: Early tumor size reduction serves as a simple-to-use metric which can be implemented on the first follow-up CT. Tumor size reduction by at least 10% can be considered an additional biomarker predictive of overall survival and progression-free survival in routine clinical care and not only in the context of clinical trials in patients with advanced melanoma undergoing immunotherapy. Nevertheless, RECIST-based criteria should remain the main tool of treatment response assessment until results of prospective studies validating the TSR method are available.
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