© 1999 by Oxford University Press
Journal of the National Cancer Institute, Vol. 91, No. 6, 523-528,
March 17, 1999
© 1999 Oxford University Press
ARTICLES |
Measuring Response in Solid Tumors: Unidimensional Versus Bidimensional Measurement
Affiliations of authors: K. James, E. Eisenhauer, A. Muldal, National Cancer Institute of Canada Clinical Trials Group, Queen's University, Kingston, ON, Canada; M. Christian, Cancer Therapy Evaluation Program, National Cancer Institute (NCI), Bethesda, MD; M. Terenziani, Division of Medical Oncology, NCI, Milan, Italy; D. Vena, The Emmes Corporation, Rockville, MD; P. Therasse, European Organization for Research and Treatment of Cancer, Data Center, Brussels, Belgium.
Correspondence to: Keith James, M.A., M.B., F.R.C.R., National Cancer Institute of Canada Clinical Trials Group, Queen's University, 82-84 Barrie St., Kingston, ON K7L 3N6, Canada (e-mail: jamesk{at}ncic.ctg.queensu.ca).
BACKGROUND: Tumor shrinkage is a common end point used in screening new cytotoxic
agents. The standard World Health Organization criterion for partial response is a 50% or
more decrease in the sum of the products of two measurements (the maximum diameter of a
tumor and the largest diameter perpendicular to this maximum diameter) of individual tumors.
However, theoretically, the simple sum of the maximum diameters of individual tumors is more
linearly related to cell kill than is the sum of the bidimensional products. It has been
hypothesized that the calculation of bidimensional products is unnecessary, and a 30%
decrease in the sum of maximum diameters of individual tumors (assuming spherical shape and
equivalence to a 50% reduction in the sum of the bidimensional products) was proposed as
a new criterion. We have applied the standard response and the new response criteria to the same
data to determine whether the same number of responses in the same patients would result.
METHODS: Data from 569 patients included in eight studies of a variety of cancers were
reanalyzed. The two response criteria were separately applied, and the results were compared
using the 
statistic. The importance of confirmatory measurements and the frequency of
nonspherical tumors were also examined. In addition, for a subset of 128 patients, a
unidimensional criterion for disease progression (30% increase in the sum of maximum
diameters) was applied and compared with the standard definition of a 25% increase in the
sum of the bidimensional products. RESULTS: Agreement between the unidimensional and
bidimensional criteria was generally found to be good. The statistic for concordance for
overall response was 0.95. CONCLUSION: We conclude that one dimensional measurement of
tumor maximum diameter may be sufficient to assess change in solid tumors.
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