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.

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 / Cascinu, Stefano; Rosati, Gerardo; Bilancia, Domenico; Nasti, Guglielmo; Iaffaioli, Rosario Vincenzo; Lonardi, Sara; Zagonel, Vittorina; Zaniboni, Alberto; Marchetti, Paolo; Romiti, Adriana; Leone, Francesco; Aglietta, Massimo; Giordano, Monica; Corsi, Domenico C.; Ferraú, Francesco; Labianca, Roberto; Mosconi, Stefania; Ronzoni, Monica; Gianni, Luca; Rulli, Eliana; Poli, Davide; Galli, Francesca; Torri, Valter; De Simone, Irene; Galli, Fabio; Pasini, Felice; Rangoni, Giovanni; Venezia, Raffaele; Sozzi, Pietro; Nuzzo, Antonio; Berardi, Rossana; Frontini, Luciano; Rota, Silvia; Cozzi, Lorena; Rosati, Gerardo; Bilancia, Domenico; Nasti, Guglielmo; Iaffaioli, Rosario Vincenzo; Lonardi, Sara; Zagonel, Vittorina; Zaniboni, Alberto; Marchetti, Paolo; Leone, Francesco; Giordano, Monica; Corsi, Domenico C.; Ferraú, Francesco; Labianca, Roberto; Scartozzi, Mario; Galli, Francesca. - In: EUROPEAN JOURNAL OF CANCER. - ISSN 0959-8049. - 83:(2017), pp. 106-115. [10.1016/j.ejca.2017.06.029]

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

Cascinu, Stefano;Leone, Francesco;Aglietta, Massimo;Rota, Silvia;Leone, Francesco;Scartozzi, Mario;
2017

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.
2017
83
106
115
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 / Cascinu, Stefano; Rosati, Gerardo; Bilancia, Domenico; Nasti, Guglielmo; Iaffaioli, Rosario Vincenzo; Lonardi, Sara; Zagonel, Vittorina; Zaniboni, Alberto; Marchetti, Paolo; Romiti, Adriana; Leone, Francesco; Aglietta, Massimo; Giordano, Monica; Corsi, Domenico C.; Ferraú, Francesco; Labianca, Roberto; Mosconi, Stefania; Ronzoni, Monica; Gianni, Luca; Rulli, Eliana; Poli, Davide; Galli, Francesca; Torri, Valter; De Simone, Irene; Galli, Fabio; Pasini, Felice; Rangoni, Giovanni; Venezia, Raffaele; Sozzi, Pietro; Nuzzo, Antonio; Berardi, Rossana; Frontini, Luciano; Rota, Silvia; Cozzi, Lorena; Rosati, Gerardo; Bilancia, Domenico; Nasti, Guglielmo; Iaffaioli, Rosario Vincenzo; Lonardi, Sara; Zagonel, Vittorina; Zaniboni, Alberto; Marchetti, Paolo; Leone, Francesco; Giordano, Monica; Corsi, Domenico C.; Ferraú, Francesco; Labianca, Roberto; Scartozzi, Mario; Galli, Francesca. - In: EUROPEAN JOURNAL OF CANCER. - ISSN 0959-8049. - 83:(2017), pp. 106-115. [10.1016/j.ejca.2017.06.029]
Cascinu, Stefano; Rosati, Gerardo; Bilancia, Domenico; Nasti, Guglielmo; Iaffaioli, Rosario Vincenzo; Lonardi, Sara; Zagonel, Vittorina; Zaniboni, Alb...espandi
File in questo prodotto:
File Dimensione Formato  
1-s2.0-S095980491731095X-main (1).pdf

Accesso riservato

Tipologia: Versione pubblicata dall'editore
Dimensione 994.52 kB
Formato Adobe PDF
994.52 kB Adobe PDF   Visualizza/Apri   Richiedi una copia
Pubblicazioni consigliate

Licenza Creative Commons
I metadati presenti in IRIS UNIMORE sono rilasciati con licenza Creative Commons CC0 1.0 Universal, mentre i file delle pubblicazioni sono rilasciati con licenza Attribuzione 4.0 Internazionale (CC BY 4.0), salvo diversa indicazione.
In caso di violazione di copyright, contattare Supporto Iris

Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11380/1157137
Citazioni
  • ???jsp.display-item.citation.pmc??? 14
  • Scopus 25
  • ???jsp.display-item.citation.isi??? 24
social impact