BACKGROUND
End points for assessing drug activity in brain tumors are determined by measuring the change in tumor size by magnetic resonance imaging (MRI) relative to a pretreatment or best-response scan. Traditionally, two-dimensional (2D) tumor measurements have been used, but one-dimensional (1D) measurements have recently been proposed as an alternative. Because software to estimate three-dimensional (3D) tumor volume from digitized MRI images is available, we compared all three methods of tumor measurement for childhood brain tumors and clinical outcome.
METHODS
Tumor size from 130 MRI scans from 32 patients (32 baseline and 98 follow-up scans, for a total of 130 scans; median, three scans per patient; range, two to 18 scans) was measured by each method. Tumor-response category (partial response, minor response, stable disease, or progressive disease) was determined from the percentage change in tumor size between the baseline or best-response scan and follow-up scans. Time to clinical progression was independently determined by chart review. All statistical tests were two-sided.
RESULTS
Concordances between 1D and 2D, 1D and 3D, and 2D and 3D were 83% (95% confidence interval [CI] = 67% to 99%), 61% (95% CI = 47% to 75%), and 66% (95% CI = 52% to 80%), respectively, on follow-up scans. Concordances for 1D and 3D and for 2D and 3D were statistically significantly lower than the concordance for 1D and 2D (P< .001 and P = .003, respectively). Concordance among 1D, 2D, and 3D methods in detecting partial response was high; there was less concordance in classifying tumors in the minor response and progressive-disease categories. Median times to progression measured by the 1D, 2D, and 3D methods were 154, 105, and 112 days, respectively, compared with 114 days based on neurologic symptoms and signs (P = .09 for overall comparison).
CONCLUSIONS
Detection of partial responses was not influenced by the measurement method, but estimating time to disease progression may be method dependent for childhood brain tumors.
[1]
M. van Glabbeke,et al.
New guidelines to evaluate the response to treatment in solid tumors
,
2000,
Journal of the National Cancer Institute.
[2]
P. Lavin,et al.
Studies in variation associated with the measurement of solid tumors
,
1980,
Cancer.
[3]
E. Gehan,et al.
Will there be resistance to the RECIST (Response Evaluation Criteria in Solid Tumors)?
,
2000,
Journal of the National Cancer Institute.
[4]
M. Christian,et al.
Measuring response in solid tumors: unidimensional versus bidimensional measurement.
,
1999,
Journal of the National Cancer Institute.
[5]
L. J. Wei,et al.
Regression analysis of multivariate incomplete failure time data by modeling marginal distributions
,
1989
.
[6]
A. Agresti,et al.
Categorical Data Analysis
,
1991,
International Encyclopedia of Statistical Science.
[7]
Robert Tibshirani,et al.
An Introduction to the Bootstrap
,
1994
.