Evaluation of RECIST in chemotherapy-treated lung cancer: the Pharmacogenoscan Study.

Anne-Claire Toffart,Maurice Perol,Gilbert R Ferretti,Philippe Romand,Patrick Chatellain,Christian Brambilla,Aurélien Vesin,Elisabeth Brambilla,Bénédicte Mastroianni,Jean-François Timsit,Pierre-Jean Souquet,Denis Moro-Sibilot,Sébastien Couraud,Patrick Merle,Nicolas Girard

doi:10.1186/1471-2407-14-989

Abstract

BackgroundResponse Evaluation Criteria in Solid Tumors (RECIST) are widely used to assess the effect of chemotherapy in patients with cancer. We hypothesised that the change in unidimensional tumour size handled as a continuous variable was more reliable than RECIST in predicting overall survival (OS).MethodsThe prospective Pharmacogenoscan study enrolled consecutive patients with non-small-cell lung cancer (NSCLC) at any stage seen between 2005 and 2010 at six hospitals in France, given chemotherapy. After exclusion of patients without RECIST or continuous-scale tumour size data and of those with early death, 464 patients were left for the survival analyses. Cox models were built to assess relationships between RECIST 1.1 categories or change in continuous-scale tumour size and OS. The best model was defined as the model minimising the Akaike Information Criterion (AIC).ResultsOS was 14.2 months (IQR, 7.3-28.9 months). According to RECIST 1.1, 146 (31%) patients had a partial or complete response, 245 (53%) stable disease, and73 (16%) disease progression. RECIST 1.1 predicted better OS than continuous-scale tumour in early (<6 months) predicted survival analyses (p = 0.03) but the accuracy of the two response evaluation methods was similar in late (≥6 months) predicted survival analyses (p = 0.15).ConclusionIn this large observational study, change in continuous-scale tumour size did not perform better than RECIST 1.1 in predicting survival of patients given chemotherapy to treat NSCLC.Trial registrationNCT00222404

Highlights

Response Evaluation Criteria in Solid Tumors (RECIST) are widely used to assess the effect of chemotherapy in patients with cancer
It has been suggested that a patient with 15% tumour shrinkage may have a better survival than a patient with 15% tumour growth, both patients fall in the stable-disease category according to RECIST criteria
Patients and study design The Pharmacogenoscan study is a prospective study conducted in six hospitals in the Rhône-Alpes-Auvergne region of France to identify biological and histological factors associated with outcomes of patients with non-small-cell lung cancer (NSCLC)

Summary

Introduction

Response Evaluation Criteria in Solid Tumors (RECIST) are widely used to assess the effect of chemotherapy in patients with cancer. We hypothesised that the change in unidimensional tumour size handled as a continuous variable was more reliable than RECIST in predicting overall survival (OS). Response Evaluation Criteria in Solid Tumors (RECIST) was developed in 2000 [1] to assess changes in solid tumour size in patients given cancer chemotherapy. RECIST criteria are based on the sum of the maximum diameters of target lesions seen on imaging studies. This value is categorised as follows: complete/partial response (CR/PR), complete disappearance of all targets/greater than 30% decrease; stable disease (SD), change between −30% and +20%; and progressive disease (PD), greater than 20%. Further new lesions cannot be quantified numerically, and are generally classified as PD or ignored

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