TY - JOUR
T1 - Radiological imaging markers predicting clinical outcome in patients with metastatic colorectal carcinoma treated with regorafenib
T2 - Post hoc analysis of the CORRECT phase III trial (RadioCORRECT study)
AU - Ricotta, Riccardo
AU - Verrioli, Antonella
AU - Ghezzi, Silvia
AU - Porcu, Luca
AU - Grothey, A.
AU - Falcone, Alfredo
AU - Van Cutsem, Eric
AU - Argilés, Guillem
AU - Adenis, Antoine
AU - Ychou, Marc
AU - Barone, Carlo
AU - Bouché, Olivier
AU - Peeters, Marc
AU - Humblet, Yves
AU - Mineur, Laurent
AU - Sobrero, Alberto F.
AU - Hubbard, Joleen M.
AU - Cremolini, Chiara
AU - Prenen, Hans
AU - Tabernero, Josep
AU - Jarraya, Hajer
AU - Mazard, Thibault
AU - Deguelte-Lardiere, Sophie
AU - Papadimitriou, Konstantinos
AU - Van Den Eynde, Marc
AU - Pastorino, Alessandro
AU - Redaelli, Daniela
AU - Bencardino, Katia
AU - Funaioli, Chiara
AU - Amatu, Alessio
AU - Carlo-Stella, Giulia
AU - Torri, Valter
AU - Sartore-Bianchi, Andrea
AU - Vanzulli, Angelo
AU - Siena, Salvatore
N1 - Publisher Copyright:
© European Society for Medical Oncology (unless otherwise stated in the text of the article) [year]. All rights reserved.
PY - 2016/12
Y1 - 2016/12
N2 - Objective To identify imaging markers predicting clinical outcomes to regorafenib in metastatic colorectal carcinoma (mCRC). Methods The RadioCORRECT study is a post hoc analysis of a cohort of patients with mCRC treated within the phase III placebo-controlled CORRECT trial of regorafenib. Baseline and week 8 contrast-enhanced CT were used to assess response by RECIST 1.1, changes in the sum of target lesion diameters (ΔSTL), lung metastases cavitation and liver metastases density. Primary and secondary objectives were to develop ex novo univariable and multivariable models to predict overall survival (OS) and progression-free survival (PFS), respectively. Results 202 patients were enrolled, 134 (66.3%) treated with regorafenib and 68 (33.7%) with placebo. In the univariate analysis, PFS predictors were lung metastases cavitation at baseline (HR 0.50, 95% CI 0.27 to 0.92, p=0.03) and at week 8 (HR 0.58, 95% CI 0.36 to 0.93, p=0.02). Baseline cavitation (HR 0.23, 95% CI 0.08 to 0.66, p=0.007), RECIST 1.1 (HR 0.23, 95% CI 0.14 to 0.4, p <0.0001) and ΔSTL (HR 1.16, 95% CI 1.06 to 1.27, p=0.002) predicted OS. We found an increase of 9% of diameter as the best threshold for discriminating OS (HR 2.64, 95% CI 1.61 to 4.34, p <0.001). In the multivariate analysis, baseline and week 8 cavitation remained significant PFS predictors. Baseline cavitation, RECIST 1.1 and ΔSTL remained predictors of OS in exploratory multivariable models. Assessment of liver metastases density did not predict clinical outcome. Conclusions RECIST 1.1 and ΔSTL predict favourable outcome to regorafenib. In contrast to liver metastases density that failed to be a predictor, lung metastases cavitation represents a novel radiological marker of favourable outcome that deserves consideration.
AB - Objective To identify imaging markers predicting clinical outcomes to regorafenib in metastatic colorectal carcinoma (mCRC). Methods The RadioCORRECT study is a post hoc analysis of a cohort of patients with mCRC treated within the phase III placebo-controlled CORRECT trial of regorafenib. Baseline and week 8 contrast-enhanced CT were used to assess response by RECIST 1.1, changes in the sum of target lesion diameters (ΔSTL), lung metastases cavitation and liver metastases density. Primary and secondary objectives were to develop ex novo univariable and multivariable models to predict overall survival (OS) and progression-free survival (PFS), respectively. Results 202 patients were enrolled, 134 (66.3%) treated with regorafenib and 68 (33.7%) with placebo. In the univariate analysis, PFS predictors were lung metastases cavitation at baseline (HR 0.50, 95% CI 0.27 to 0.92, p=0.03) and at week 8 (HR 0.58, 95% CI 0.36 to 0.93, p=0.02). Baseline cavitation (HR 0.23, 95% CI 0.08 to 0.66, p=0.007), RECIST 1.1 (HR 0.23, 95% CI 0.14 to 0.4, p <0.0001) and ΔSTL (HR 1.16, 95% CI 1.06 to 1.27, p=0.002) predicted OS. We found an increase of 9% of diameter as the best threshold for discriminating OS (HR 2.64, 95% CI 1.61 to 4.34, p <0.001). In the multivariate analysis, baseline and week 8 cavitation remained significant PFS predictors. Baseline cavitation, RECIST 1.1 and ΔSTL remained predictors of OS in exploratory multivariable models. Assessment of liver metastases density did not predict clinical outcome. Conclusions RECIST 1.1 and ΔSTL predict favourable outcome to regorafenib. In contrast to liver metastases density that failed to be a predictor, lung metastases cavitation represents a novel radiological marker of favourable outcome that deserves consideration.
KW - Cavitation
KW - Metastatic Colorectal Cancer
KW - Radiological Predictive Factors
KW - Regorafenib
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U2 - 10.1136/esmoopen-2016-000111
DO - 10.1136/esmoopen-2016-000111
M3 - Article
AN - SCOPUS:85025099646
SN - 2059-7029
VL - 1
JO - ESMO Open
JF - ESMO Open
IS - 6
M1 - e000111
ER -