Comparison of RECIST 1.0 and RECIST 1.1 in Patients with Metastatic Cancer: A Pooled Analysis

Abstract

Background:We conducted this pooled analysis to investigate the impact of RECIST 1.1 on the selection of target lesions and classification of tumor response, in comparison with RECIST 1.0.Methods: We searched MEDLINE and EMBASE for articles with terms of RECIST 1.0 or RECIST 1.1. We looked into all abstracts and virtual meeting presentations from the conferences of ASCO and ESMO between 2009 and 2013.Results: There were six articles in the literature comparing the clinical impacts of RECIST 1.0 and RECIST 1.1 in patients with metastatic cancer. A total of 359 patients were recruited from the six trials; 217 with non-small cell lung cancer, 61 with gastric cancer, 58 with colorectal cancer, and 23 with thyroid cancer. The number of target lesions by RECIST 1.1 was significantly lower than that by RECIST 1.0 (P<0.001). Because of new lymph node criteria, fourteen patients (3.1%) had no target lesions when adopting RECIST 1.1. RECIST 1.1 showed high concordance with RECIST 1.0 in the assessment of tumor responses (k = 0.903). Sixteen patients (4.8%) showed disagreement between the two criteria.Conclusion: This pooled study demonstrated that RECIST 1.1 showed a highly concordant response assessment with RECIST 1.0 in patients with metastatic cancer.

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“…With these different treatment options and different clinically approved agents available within each treatment category, it is important to assess treatment response throughout the entire treatment. Currently, treatment response assessment is based on Response Evaluation Criteria in Solid Tumors (RECIST) and the guidelines of the World Health Organization (WHO) . These guidelines help to assess the treatment response based on tumor size changes measured by MRI, which are typically only detected at a relatively late point in time, after 2–3 months and several cycles of treatment.…”

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“…However, a study of different advanced cancers has shown that RECIST 1.1 showed a highly concordant response assessment with RECIST 1.0. 34 Third, due to the lack of correlation between DR with PFS/OS at an individual level, it is not meaningful to test further at trial-level. Fourth, we were not able to provide any information on patients with CR as there were none at weeks 6 and 12.…”

Comparison of tumor response assessment methods in patients with metastatic colorectal cancer after locoregional therapy

“…However, this cohort represents a population seen in everyday practice and also represents a standard cohort in LRT treatment registries. A fourth limitation is that our study was based on RECIST 1.0 and not the newer RECIST 1.1; however, it has been reported that both criteria are concordant . Another limitation was that response assessment was performed prospectively by a single observer, an oncologic surgeon with extensive experience evaluating lesions using defined objective criteria.…”