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Title: Clinical Calculator for Early Mortality in Metastatic Colorectal Cancer: An Analysis of Patients From 28 Clinical Trials in the Aide et Recherche en Cancérologie Digestive Database.
Austin Authors: Renfro, Lindsay A;Goldberg, Richard M;Grothey, Axel;Sobrero, Alberto;Adams, Richard A;Seymour, Matthew T;Heinemann, Volker;Schmoll, Hans-Joachim;Douillard, Jean-Yves;Hurwitz, Herbert;Fuchs, Charles S;Diaz-Rubio, Eduardo;Porschen, Rainer;Tournigand, Christophe;Chibaudel, Benoist;Hoff, Paulo M;Kabbinavar, Fairooz F;Falcone, Alfredo;Tebbutt, Niall C ;Punt, Cornelis J A;Hecht, J Randolph;Souglakos, John;Bokemeyer, Carsten;Van Cutsem, Eric;Saltz, Leonard;de Gramont, Aimery;Sargent, Daniel J
Affiliation: Memorial Sloan Kettering Cancer Center, New York, NY, USA
University of Crete, Heraklion, Greece
University Hospital Leuven, Leuven, Belgium
Duke University Medical Center, Durham, NC, USA
Dana-Farber Cancer Institute, Boston, MA, USA
Hospital Clínico San Carlos, Universidad Complutense, Instituto de Investigación Sanitaria del Hospital Clínico San Carlos, Madrid, Spain
Hospital Sírio-Libanês and University of São Paulo, São Paulo, Brazi
David Geffen School of Medicine at University of California at Los Angeles, Los Angeles, CA, USA
Austin Health, Heidelberg, Victoria, Australia
Mayo Clinic, Rochester, MN, USA
The Ohio State University, Columbus, OH, USA
Ospedale San Martino, Genoa, Italy
University Hospital of Pisa, Pisa, Italy
Cardiff University, Cardiff, United Kingdom
St James's Hospital and University of Leeds, Leeds, United Kingdom
University of Munich, Munich, Germany
University Clinic Halle (Saale), Halle, Germany
Klinikum Bremen-Ost Klinik für Innere Medizin, Bremen, Germany
University Hospital, Hamburg-Eppendorf, Germany
Centre René Gauducheau, Nantes, France
University of Paris Est Creteil, France
Assistance Hopitaux Publique de Paris Henri-Mondor Hospital, Créteil, France
Franco-British Institute, Levallois-Perret, France
University of Amsterdam, Amsterdam, the Netherlands
Issue Date: 10-Jun-2017 2017-04-17
Publication information: Journal of Clinical Oncology 2017; 35(17): 1929-1937
Abstract: Purpose Factors contributing to early mortality after initiation of treatment of metastatic colorectal cancer are poorly understood. Materials and Methods Data from 22,654 patients enrolled in 28 randomized phase III trials contained in the ARCAD (Aide et Recherche en Cancérologie Digestive) database were pooled. Multivariable logistic regression models for 30-, 60-, and 90-day mortality were constructed, including clinically and statistically significant patient and disease factors and interaction terms. A calculator (nomogram) for 90-day mortality was developed and validated internally using bootstrapping methods and externally using a 10% random holdout sample from each trial. The impact of early progression on the likelihood of survival to 90 days was examined with time-dependent Cox proportional hazards models. Results Mortality rates were 1.4% at 30 days, 3.4% at 60 days, and 5.5% at 90 days. Among baseline factors, advanced age, lower body mass index, poorer performance status, increased number of metastatic sites, BRAF mutant status, and several laboratory parameters were associated with increased likelihood of early mortality. A multivariable model for 90-day mortality showed strong internal discrimination (C-index, 0.77) and good calibration across risk groups as well as accurate predictions in the external validation set, both overall and within patient subgroups. Conclusion A validated clinical nomogram has been developed to quantify the risk of early death for individual patients during initial treatment of metastatic colorectal cancer. This tool may be used for patient eligibility assessment or risk stratification in future clinical trials and to identify patients requiring more or less aggressive therapy and additional supportive measures during and after treatment.
DOI: 10.1200/JCO.2016.71.5771
PubMed URL: 28414610
Type: Journal Article
Appears in Collections:Journal articles

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