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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

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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, Vol. 35, No. 17, 10.06.2017, p. 1929-1937.

Research output: SCORING: Contribution to journal › SCORING: Journal article › Research › peer-review

Harvard

Renfro, LA, Goldberg, RM, Grothey, A, Sobrero, A, Adams, R, Seymour, MT, Heinemann, V, Schmoll, H-J, Douillard, J-Y, Hurwitz, H, Fuchs, CS, Diaz-Rubio, E, Porschen, R, Tournigand, C, Chibaudel, B, Hoff, PM, Kabbinavar, FF, Falcone, A, Tebbutt, NC, Punt, CJA, Hecht, JR, Souglakos, J, Bokemeyer, C, Van Cutsem, E, Saltz, L, de Gramont, A, Sargent, DJ & ARCAD Clinical Trials Program 2017, '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', J CLIN ONCOL, vol. 35, no. 17, pp. 1929-1937. https://doi.org/10.1200/JCO.2016.71.5771

APA

Renfro, L. A., Goldberg, R. M., Grothey, A., Sobrero, A., Adams, R., Seymour, M. T., Heinemann, V., Schmoll, H-J., Douillard, J-Y., Hurwitz, H., Fuchs, C. S., Diaz-Rubio, E., Porschen, R., Tournigand, C., Chibaudel, B., Hoff, P. M., Kabbinavar, F. F., Falcone, A., Tebbutt, N. C., ... ARCAD Clinical Trials Program (2017). 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. J CLIN ONCOL, 35(17), 1929-1937. https://doi.org/10.1200/JCO.2016.71.5771

Vancouver

Renfro LA, Goldberg RM, Grothey A, Sobrero A, Adams R, Seymour MT et al. 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. J CLIN ONCOL. 2017 Jun 10;35(17):1929-1937. https://doi.org/10.1200/JCO.2016.71.5771

Bibtex

@article{7042dfeca2ce4160b2fb6e6253e2cae1,
title = "Clinical Calculator for Early Mortality in Metastatic Colorectal Cancer: An Analysis of Patients From 28 Clinical Trials in the Aide et Recherche en Canc{\'e}rologie Digestive Database",
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 Canc{\'e}rologie 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.",
keywords = "Aged, Clinical Trials, Phase III as Topic, Colorectal Neoplasms, Disease Progression, Female, Humans, Logistic Models, Male, Middle Aged, Multivariate Analysis, Nomograms, Randomized Controlled Trials as Topic, Reproducibility of Results, Journal Article",
author = "Renfro, {Lindsay A} and Goldberg, {Richard M} and Axel Grothey and Alberto Sobrero and Richard Adams and Seymour, {Matthew T} and Volker Heinemann and Hans-Joachim Schmoll and Jean-Yves Douillard and Herbert Hurwitz and Fuchs, {Charles S} and Eduardo Diaz-Rubio and Rainer Porschen and Christophe Tournigand and Benoist Chibaudel and Hoff, {Paulo M} and Kabbinavar, {Fairooz F} and Alfredo Falcone and Tebbutt, {Niall C} and Punt, {Cornelis J A} and Hecht, {J Randolph} and John Souglakos and Carsten Bokemeyer and {Van Cutsem}, Eric and Leonard Saltz and {de Gramont}, Aimery and Sargent, {Daniel J} and {ARCAD Clinical Trials Program}",
year = "2017",
month = jun,
day = "10",
doi = "10.1200/JCO.2016.71.5771",
language = "English",
volume = "35",
pages = "1929--1937",
journal = "J CLIN ONCOL",
issn = "0732-183X",
publisher = "American Society of Clinical Oncology",
number = "17",

}

RIS

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 -