Towards volumetric thresholds in RECIST 1.1: Therapeutic response assessment in hepatic metastases
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To empirically determine thresholds for volumetric assessment of response and progress of liver metastases in line with the unidimensional RECIST thresholds.
Patients with metastatic colorectal cancer initially enrolled in a multicentre clinical phase-III trial were included. In all CT scans, the longest axial diameters and volumes of hepatic lesions were determined semi-automatically. The sum of diameters and volumes of 1, ≤2 and ≤5 metastases were compared to all previous examinations. Volumetric thresholds corresponding to RECIST 1.1 thresholds were predicted with loess-regression. In sensitivity analysis, the concordances of proposed thresholds, weight-maximizing thresholds and thresholds from loess-regression were compared. Classification concordance for measurements of ≤2 metastases was further analyzed.
For measurements of ≤2 metastases, 348 patients with 629 metastases were included, resulting in 4,773 value pairs. Regression analysis yielded volumetric thresholds of -65.3% for a diameter change of -30%, and +64.6% for a diameter change of +20%. When comparing measurements of unidimensional RECIST assessment with volumetric measurements, there was a concordance of significant progress (≥+20% and ≥+65%) in 88.3% and of significant response (≤-30% and ≤-65%) in 85.0%.
In patients with hepatic metastases, volumetric thresholds of +65% and -65% were yielded corresponding to RECIST thresholds of +20% and -30%.
• Volumes and diameters of liver metastases from colorectal cancer were determined.
• Volumetric thresholds of +65%/-65% corresponding to RECIST 1.1 are proposed.
• Comparing both measurements, concordance was 88.3% (significant progress) and 85.0% (significant response).
KeywordsTomography, X-Ray computed Liver Neoplasm metastasis Image interpretation, computer-assisted Response evaluation criteria in solid tumors
Abbreviations and acronyms
Epidermal growth factor receptor
FOLFIRI plus cetuximab versus FOLFIRI plus bevacizumab as irst-line treatment for patients with metastatic colorectal cancer
Folinic acid, fluorouracil and irinotecan
Vascular endothelial growth factor
The authors would like to thank Merck KGaA Darmstadt, Germany, for providing financial support to perform the current study.
This study has received funding by Merck KGaA Darmstadt, Germany.
Compliance with ethical standards
The scientific guarantor of this publication is Melvin D’Anastasi.
Conflict of interest
The authors of this manuscript declare relationships with the following companies: Merck KGaA Darmstadt, Germany.
Julian Walter Holch served on advisory board for Roche, has received honoraria from Roche and travel support from Novartis
Honoraria: Merck, Amgen, Roche, BMS, MSD, Servier, Sirtex
Travel Support: Amgen, Merck, Roche, Bayer, BMS
Research Grant: Merck, Amgen, Roche
Honoraria for talks and advisory board role from: AMGEN, Bayer, Lilly, Merck KgaA, Roche, Sanofi, Takeda
Honoraria (myself): Merck, Amgen, Roche, Sanofi, SIRTEX, Servier Consulting or Advisory Board (myself): Merck, Amgen, Roche, Sanofi, SIRTEX, BMS; MSD, Novartis, Boehringer Ingelheim, Servier Research funding (my institution): Merck, Amgen, Roche, Sanofi, Pfizer, Boehringer Ingelheim, Sirtex, Bayer Travel accommodation expenses (myself): Merck, Roche, Amgen, SIRTEX, Bayer
Founder Smart Reporting GmbH
Statistics and biometry
One of the authors has significant statistical expertise.
Written informed consent was waived by the Institutional Review Board.
Institutional Review Board approval was obtained.
Study subjects or cohorts overlap
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