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1 Hospices Civils de Lyon, Centre Hospitalier Lyon Sud, 2 Université Claude Bernard EA 643, Lyon, 3 Centre Régional de Lutte Contre le Cancer Léon Bérard, Lyon, 4 Clinique Saint Jean, Lyon, 5 Hospices Civils de Lyon, Hôpital Edouard Herriot, 6 Hospices Civils de Lyon, Hôpital de la Croix Rousse, 7 Clinique Pasteur de Valence, 8 Centre Hospitalier de Roanne, 9 Centre Hospitalier de Valence, 10 Centre Hospitalier Général Lucien Hussel, Vienne, 11 Centre Hospitalier de Privas, 12 Centre Hospitalier de Bourgoin, 13 Centre Hospitalier de Villefranche, Gleizé, 14 Clinique Pasteur de Saint Priest, 15 Hospices Civils de Lyon, Département d'Information Médicale and 16 Aventis, France
Correspondence: Véronique Trillet-Lenoir, Hospices Civils de Lyon, Department of Medical Oncology, Centre Hospitalier Lyon Sud, 69495 Pierre Bénite, France
Evaluation of tumour size modifications in response to treatment is a critical issue in the management of advanced malignancies. In 1981, the World Health Organization (WHO) established guidelines for tumour response assessment. These WHO1981 criteria were recently simplified in a revised version, named RECIST (Response Evaluation Criteria in Solid Tumours), which uses unidimensional instead of bidimensional measurements, a reduced number of measured lesions, withdrawal of the progression criteria based on isolated increase of a single lesion, and different shrinkage threshold for definitions of tumour response and progression. In order to validate these new guidelines, we have compared results obtained with both classifications in a prospective series of 91 patients receiving chemotherapy for metastatic colorectal cancer. Data from iterative tomographic measurements were fully recorded and reviewed by an expert panel. The overall response and progression rates according to the WHO1981 criteria were 19% and 58%, respectively. Using RECIST criteria, 16 patients were reclassified in a more favourable subgroup, the overall response rate being 28% and the progression rate 45% (non-weighted kappa concordance test 0.72). When isolated increase of a single measurable lesion is not taken into account for progression with the WHO1981 criteria, only 7 patients were reclassified and the kappa test was satisfying, i.e.
0.75, for the whole population as well as for each of the responding and progressive subgroups. Since it provides concordant results with a simplified method, the use of RECIST criteria is recommended for evaluation of treatment efficacy in clinical trials and routine practice.
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