• Open Access

Tumor response to chemotherapy: The validity and reproducibility of RECIST guidelines in NSCLC patients1

Authors


  • 1

    A part of this work was presented at the 36th ASCO Annual Meeting, May 23, 2000.

To whom correspondence should be addressed at Department of Radiology, Kobe University Graduate School of Medicine. E-mail: h-watanabe@kcc.zaq.ne.jp

Abstract

We investigated the validity and inter-criteria reproducibility between RECIST (Response Evaluation Criteria in Solid Tumors) guidelines and WHO (World Health Organization) criteria, considering the decrease in patient numbers resulting from inclusion of the minimum lesion size criterion introduced in RECIST guidelines. RECIST guidelines are based on unidimensional measurement and exclusion of small lesions from measurement. The aims of the study were to examine: (1) the effect of the minimum lesion size criterion, (2) the validity of unidimensional and bidimensional measurements, i.e., their relationship with tumor volume, (3) the inter-criteria reproducibility between current RECIST guidelines and previous WHO criteria. One hundred and twenty patients with non-small cell lung cancer (NSCLC) in clinical trials were evaluated. By applying the minimum lesion size criterion, six cases became ineligible without any influence on precision of tumor volume measurement. In the validity study, actual tumor volume was regarded as the gold standard. Although the unidimensional measurement had a lower correlation with tumor volume value than the bidimensional measurement, both the unidimensional measurement and bidimensional measurement correlated sufficiently well with tumor volume changes and the assessed tumor volume response. In the inter-criteria reproducibility study between RECIST guidelines and WHO criteria, the response rate assessed by RECIST guidelines (19.3%) was almost the same as that assessed by WHO criteria (20.0%). In conclusion, RECIST guidelines are adequate for evaluating tumor response to chemotherapy in terms of both validity in relation to tumor volume and inter-criteria reproducibility with the WHO criteria.

Abbreviations:
WHO

World Health Organization

RECIST

Response Evaluation Criteria in Solid Tumors

NSCLC

non-small cell lung cancer

CDDP

cisplatin

CT

computed tomography

MRI

magnetic resonance imaging

CR

complete response

PR

partial response

SD

stable disease

PD

progressive disease

CI

confidence intervals

Ancillary