Radiological imaging markers predicting clinical outcome in patients with metastatic colorectal carcinoma treated with regorafenib: Post hoc analysis of the CORRECT phase III trial (RadioCORRECT study)

Riccardo Ricotta, Antonella Verrioli, Silvia Ghezzi, Luca Porcu, A. Grothey, Alfredo Falcone, Eric Van Cutsem, Guillem Argilés, Antoine Adenis, Marc Ychou, Carlo Barone, Olivier Bouché, Marc Peeters, Yves Humblet, Laurent Mineur, Alberto F. Sobrero, Joleen M. Hubbard, Chiara Cremolini, Hans Prenen, Josep TaberneroHajer Jarraya, Thibault Mazard, Sophie Deguelte-Lardiere, Konstantinos Papadimitriou, Marc Van Den Eynde, Alessandro Pastorino, Daniela Redaelli, Katia Bencardino, Chiara Funaioli, Alessio Amatu, Giulia Carlo-Stella, Valter Torri, Andrea Sartore-Bianchi, Angelo Vanzulli, Salvatore Siena

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17 Scopus citations

Abstract

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.

Original languageEnglish (US)
Article numbere000111
JournalESMO Open
Volume1
Issue number6
DOIs
StatePublished - Dec 2016

Keywords

  • Cavitation
  • Metastatic Colorectal Cancer
  • Radiological Predictive Factors
  • Regorafenib

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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    Ricotta, R., Verrioli, A., Ghezzi, S., Porcu, L., Grothey, A., Falcone, A., Van Cutsem, E., Argilés, G., Adenis, A., Ychou, M., Barone, C., Bouché, O., Peeters, M., Humblet, Y., Mineur, L., Sobrero, A. F., Hubbard, J. M., Cremolini, C., Prenen, H., ... Siena, S. (2016). Radiological imaging markers predicting clinical outcome in patients with metastatic colorectal carcinoma treated with regorafenib: Post hoc analysis of the CORRECT phase III trial (RadioCORRECT study). ESMO Open, 1(6), [e000111]. https://doi.org/10.1136/esmoopen-2016-000111