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Towards volumetric thresholds in RECIST 1.1: Therapeutic response assessment in hepatic metastases

  • Oncology
  • Published:
European Radiology Aims and scope Submit manuscript

Abstract

Objectives

To empirically determine thresholds for volumetric assessment of response and progress of liver metastases in line with the unidimensional RECIST thresholds.

Methods

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.

Results

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%.

Conclusions

In patients with hepatic metastases, volumetric thresholds of +65% and -65% were yielded corresponding to RECIST thresholds of +20% and -30%.

Key Points

• 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).

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Abbreviations

3D:

Three-dimensional

EGFR:

Epidermal growth factor receptor

FIRE-3:

FOLFIRI plus cetuximab versus FOLFIRI plus bevacizumab as irst-line treatment for patients with metastatic colorectal cancer

FOLFIRI:

Folinic acid, fluorouracil and irinotecan

VEGF:

Vascular endothelial growth factor

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Acknowledgements

The authors would like to thank Merck KGaA Darmstadt, Germany, for providing financial support to perform the current study.

Funding

This study has received funding by Merck KGaA Darmstadt, Germany.

Author information

Author notes

  1. Katharina S. Winter and Felix O. Hofmann contributed equally to this work.

Authors and Affiliations

  1. Department of Radiology, University Hospital, LMU Munich, Marchioninistrasse 15, 81377, Munich, Germany

    Katharina S. Winter, Felix O. Hofmann, Nina Hesse, Alena B. Baumann, Jens Ricke, Wieland H. Sommer & Melvin D’Anastasi

  2. Institute of Diagnostic and Interventional Radiology, University Medical Center Rostock, Ernst-Heydemann-Str. 6, Rostock, 18057, Germany

    Kolja M. Thierfelder

  3. Department of Internal Medicine III, Comprehensive Cancer Center Munich, University Hospital Grosshadern, Ludwig-Maximilians-Universität München, Marchioninistrasse 15, Munich, 81377, Germany

    Julian W. Holch, Dominik P. Modest, Sebastian Stintzing & Volker Heinemann

  4. German Cancer Consortium (DKTK), Partner Site Munich and German Cancer Research Centre (DKFZ), Heidelberg, Germany

    Julian W. Holch, Dominik P. Modest, Sebastian Stintzing & Volker Heinemann

  5. Medical Imaging Department, Mater Dei Hospital, Msida, Malta

    Melvin D’Anastasi

Authors
  1. Katharina S. Winter
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  2. Felix O. Hofmann
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  3. Kolja M. Thierfelder
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  4. Julian W. Holch
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  5. Nina Hesse
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  6. Alena B. Baumann
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  7. Dominik P. Modest
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  8. Sebastian Stintzing
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  9. Volker Heinemann
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  10. Jens Ricke
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  11. Wieland H. Sommer
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  12. Melvin D’Anastasi
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Corresponding author

Correspondence to Katharina S. Winter.

Ethics declarations

Guarantor

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.

In addition:

J.W. Holch:

Julian Walter Holch served on advisory board for Roche, has received honoraria from Roche and travel support from Novartis

N. Hesse:

Merck KGaA

A.B. Baumann:

Merck KGaA

D.P. Modest:

Honoraria: Merck, Amgen, Roche, BMS, MSD, Servier, Sirtex

Travel Support: Amgen, Merck, Roche, Bayer, BMS

Research Grant: Merck, Amgen, Roche

S. Stintzing:

Honoraria for talks and advisory board role from: AMGEN, Bayer, Lilly, Merck KgaA, Roche, Sanofi, Takeda

V. Heinemann:

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

W.H. Sommer:

Founder Smart Reporting GmbH

Statistics and biometry

One of the authors has significant statistical expertise.

Informed consent

Written informed consent was waived by the Institutional Review Board.

Ethical approval

Institutional Review Board approval was obtained.

Study subjects or cohorts overlap

Some study subjects or cohorts have been previously reported in:

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Submitted manuscripts

“Prognostic value of radiologically enlarged lymph nodes in patients with metastatic colorectal cancer: subgroup findings of the randomized, open-label FIRE-3/AIO KRK0306 trial” (meanwhile published in European Journal of Radiology)

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• multicentre study

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Winter, K.S., Hofmann, F.O., Thierfelder, K.M. et al. Towards volumetric thresholds in RECIST 1.1: Therapeutic response assessment in hepatic metastases. Eur Radiol 28, 4839–4848 (2018). https://doi.org/10.1007/s00330-018-5424-0

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  • DOI: https://doi.org/10.1007/s00330-018-5424-0

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