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
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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. / Renfro, Lindsay A; Goldberg, Richard M; Grothey, Axel; Sobrero, Alberto; Adams, Richard; 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; ARCAD Clinical Trials Program.
in: J CLIN ONCOL, Jahrgang 35, Nr. 17, 10.06.2017, S. 1929-1937.Publikationen: SCORING: Beitrag in Fachzeitschrift/Zeitung › SCORING: Zeitschriftenaufsatz › Forschung › Begutachtung
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TY - JOUR
T1 - 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
AU - Renfro, Lindsay A
AU - Goldberg, Richard M
AU - Grothey, Axel
AU - Sobrero, Alberto
AU - Adams, Richard
AU - Seymour, Matthew T
AU - Heinemann, Volker
AU - Schmoll, Hans-Joachim
AU - Douillard, Jean-Yves
AU - Hurwitz, Herbert
AU - Fuchs, Charles S
AU - Diaz-Rubio, Eduardo
AU - Porschen, Rainer
AU - Tournigand, Christophe
AU - Chibaudel, Benoist
AU - Hoff, Paulo M
AU - Kabbinavar, Fairooz F
AU - Falcone, Alfredo
AU - Tebbutt, Niall C
AU - Punt, Cornelis J A
AU - Hecht, J Randolph
AU - Souglakos, John
AU - Bokemeyer, Carsten
AU - Van Cutsem, Eric
AU - Saltz, Leonard
AU - de Gramont, Aimery
AU - Sargent, Daniel J
AU - ARCAD Clinical Trials Program
PY - 2017/6/10
Y1 - 2017/6/10
N2 - 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.
AB - 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.
KW - Aged
KW - Clinical Trials, Phase III as Topic
KW - Colorectal Neoplasms
KW - Disease Progression
KW - Female
KW - Humans
KW - Logistic Models
KW - Male
KW - Middle Aged
KW - Multivariate Analysis
KW - Nomograms
KW - Randomized Controlled Trials as Topic
KW - Reproducibility of Results
KW - Journal Article
U2 - 10.1200/JCO.2016.71.5771
DO - 10.1200/JCO.2016.71.5771
M3 - SCORING: Journal article
C2 - 28414610
VL - 35
SP - 1929
EP - 1937
JO - J CLIN ONCOL
JF - J CLIN ONCOL
SN - 0732-183X
IS - 17
ER -