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Related Experiment Videos

Measuring response in solid tumors: unidimensional versus bidimensional measurement.

K James1, E Eisenhauer, M Christian

  • 1National Cancer Institute of Canada Clinical Trials Group, Queen's University, Kingston, ON. jamesk@ncic.ctg.queensu.ca

Journal of the National Cancer Institute
|March 24, 1999
PubMed
Summary

A new unidimensional measurement for tumor shrinkage is proposed as a simpler alternative to the standard bidimensional method. This approach may be sufficient for assessing solid tumor changes in clinical trials.

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Area of Science:

  • Oncology
  • Clinical Trial Design
  • Biostatistics

Background:

  • Tumor shrinkage is a key endpoint in evaluating new cytotoxic agents.
  • The World Health Organization (WHO) uses a 50% decrease in the sum of bidimensional products for partial response.
  • A simpler unidimensional criterion based on maximum tumor diameter has been proposed.

Purpose of the Study:

  • To compare the standard WHO bidimensional criteria with a new unidimensional criterion for assessing tumor response.
  • To determine if the unidimensional criterion yields similar patient response rates as the bidimensional method.
  • To evaluate the utility of unidimensional measurements in assessing solid tumor changes.

Main Methods:

  • Reanalyzed data from 569 cancer patients across eight studies.

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  • Applied both standard bidimensional and proposed unidimensional response criteria separately.
  • Compared results using the kappa statistic and examined confirmatory measurements and tumor shapes.
  • Assessed a unidimensional progression criterion against the standard bidimensional definition in 128 patients.
  • Main Results:

    • Good agreement was observed between the unidimensional and bidimensional criteria for overall response.
    • The kappa statistic for concordance was 0.95, indicating high agreement.
    • The unidimensional criterion for disease progression also showed good concordance with the standard definition.

    Conclusions:

    • One-dimensional measurement of maximum tumor diameter may be sufficient for assessing changes in solid tumors.
    • The proposed unidimensional criterion offers a potentially simpler and equally effective method for tumor response assessment.
    • This simplification could streamline the evaluation of cytotoxic agents in clinical settings.