Treatment sequence with either irinotecan/cetuximab followed by FOLFOX-4 or the reverse strategy in metastatic colorectal cancer patients progressing after first-line FOLFIRI/bevacizumab: An Italian Group for the Study of Gastrointestinal Cancer phase III, randomised trial comparing two sequences of therapy in colorectal metastatic patients

Stefano Cascinu, Gerardo Rosati, Domenico Bilancia, Guglielmo Nasti, Rosario Vincenzo Iaffaioli, Sara Lonardi, Vittorina Zagonel, Alberto Zaniboni, Paolo Marchetti, Adriana Romiti, Francesco Leone, Massimo Aglietta, Monica Giordano, Domenico C. Corsi, Francesco Ferraú, Roberto Labianca, Stefania Mosconi, Monica Ronzoni, Luca Gianni, Eliana RulliDavide Poli, Francesca Galli, Valter Torri, Irene De Simone, Fabio Galli, Felice Pasini, Giovanni Rangoni, Raffaele Venezia, Pietro Sozzi, Antonio Nuzzo, Rossana Berardi, Luciano Frontini, Silvia Rota, Lorena Cozzi, Stefano Cascinu, Gerardo Rosati, Domenico Bilancia, Guglielmo Nasti, Rosario Vincenzo Iaffaioli, Sara Lonardi, Vittorina Zagonel, Alberto Zaniboni, Paolo Marchetti, Francesco Leone, Monica Giordano, Domenico C. Corsi, Francesco Ferraú, Roberto Labianca, Monica Ronzoni, Mario Scartozzi, Francesca Galli

Research output: Contribution to journalArticle

Abstract

Introduction The optimal treatment strategy for RAS wild type (WT) mCRC is controversial. Our phase III study investigated the effect of introducing earlier (second-line) or later (third-line) cetuximab in patients progressed after FOLFIRI/bevacizumab first-line. Patients and methods mCRC patients progressing after FOLFIRI/bevacizumab first-line were randomised to receive second-line irinotecan/cetuximab followed by third-line FOLFOX-4 (arm A) or the reverse sequence (arm B). Primary end-point was progression-free survival (PFS). Results About 54 and 56 patients were randomised in arm A and in arm B, respectively. After a median follow-up of 37.5 months, 100 PFS events were recorded. Median PFS was 9.9 months in arm A and 11.3 months in arm B (Hazard ratio [HR] 1.04, 95% confidence interval [CI]: 0.69–1.56, p = 0.854), while median overall survival was 12.3 months in arm A and 18.6 months in arm B (HR 0.84, 95% CI: 0.55–1.28; p = 0.411). No overall difference in side-effects were observed between the two treatment arms. Conclusions This trial did not meet the primary end-point (PFS). Like other preclinical and clinical evidences, our study seems to suggest a reduced activity of cetuximab after a first-line bevacizumab-based therapy.

Original languageEnglish
Pages (from-to)106-115
Number of pages10
JournalEuropean Journal of Cancer
Volume83
DOIs
Publication statusPublished - Sep 1 2017

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Keywords

  • Cetuximab
  • K-RAS wild type
  • Metastatic colorectal cancer
  • Treatment sequence
  • Treatment strategy

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

Cite this

Cascinu, S., Rosati, G., Bilancia, D., Nasti, G., Iaffaioli, R. V., Lonardi, S., Zagonel, V., Zaniboni, A., Marchetti, P., Romiti, A., Leone, F., Aglietta, M., Giordano, M., Corsi, D. C., Ferraú, F., Labianca, R., Mosconi, S., Ronzoni, M., Gianni, L., ... Galli, F. (2017). Treatment sequence with either irinotecan/cetuximab followed by FOLFOX-4 or the reverse strategy in metastatic colorectal cancer patients progressing after first-line FOLFIRI/bevacizumab: An Italian Group for the Study of Gastrointestinal Cancer phase III, randomised trial comparing two sequences of therapy in colorectal metastatic patients. European Journal of Cancer, 83, 106-115. https://doi.org/10.1016/j.ejca.2017.06.029