517P - FOLFOXIRI plus bevacizumab (bev) as first-line treatment of RAS wild-type (wt) metastatic colorectal cancer (mCRC) patients (pts)

Date 29 September 2014
Event ESMO 2014
Session Poster Display session
Topics Anti-Cancer Agents & Biologic Therapy
Colon Cancer
Rectal Cancer
Presenter Carlotta Antoniotti
Citation Annals of Oncology (2014) 25 (suppl_4): iv167-iv209. 10.1093/annonc/mdu333
Authors C. Antoniotti1, C. Cremolini2, F. Loupakis3, S. Lonardi4, C. Boni5, C. Carlomagno6, L. Salvatore3, G. Masi7, F. Negri8, C. Barone9, F. Zoratto10, V. Ricci11, A. Bonetti12, F. D'Argenio13, S. Leo14, S. Chiara15, E. Dell'Aquila16, G. Fontanini17, L. Boni18, A. Falcone1
  • 1Azienda Ospedaliero Univesitaria S.chiara, U.O. Oncologia Medica 2 Universitaria, 56127 - Pisa/IT
  • 2U.o. Oncologia Medica 2 Universitaria, Azienda Ospedaliero Univesitaria S.Chiara, IT-56100 - Pisa/IT
  • 3U.o. Oncologia Medica 2 Universitaria, Azienda Ospedaliero Universitaria S.Chiara, 56100 - Pisa/IT
  • 4Medical Oncology Unit 1, Istituto Oncologico Veneto -IRCSS, 35128 - Padua/IT
  • 5Oncology Dept., Arcispedale S. Maria NuovaDivisione di Oncologia, IT-42100 - Reggio Emilia/IT
  • 6Department Of Clinical Medicine And Surgery, Federico II University of Naples, 80131 - Naples/IT
  • 7Oncologia Medica Universitaria, Azienda Ospedaliero-Universitaria Pisana, 56100 - Pisa/IT
  • 8Oncologia Medica, Azienda Ospedaliera di Parma, IT-43100 - Parma/IT
  • 9Oncologia Medica, Università Cattolica del Sacro Cuore, 00168 - Roma/IT
  • 10Oncologia Medica, Santa Maria Goretti Hospital, Latina;, 04100 - Latina/IT
  • 11Oncologia Medica, IRCCS San Raffaele, 22000 - Milano/IT
  • 12Dept. Oncology, Ospedale di Legnago, IT-37045 - Legnago/IT
  • 13Oncologia Medica, Presidio Ospedaliero - Piombino, 56100 - Piombino/IT
  • 14Medical Oncology Unit, Ospedale Vito Fazzi, 73100 - Lecce/IT
  • 15Oncologia Medica, IRCSS Azienda Ospedaliera Universitaria San Martino-IST, Genova/IT
  • 16Uoc Oncologia Medica, Università Campus Biomedico Roma, 00128 - Roma/IT
  • 17Pathology, Azienda Ospedaliera Universitaria Pisana, Pisa/IT
  • 18Centro Coordinamento Sperimentazioni Cliniche, ITT-AOU Careggi, 50134 - firenze/IT

Abstract

Aim

Phase III TRIBE trial demonstrated that FOLFOXIRI plus bev provides a significant advantage in PFS, response rate and OS as compared to FOLFIRI plus bev. No interaction between RAS mutational status and treatment effect was reported. The aim of the present analysis is to describe the clinical outcome of RAS wt pts treated with the triplet plus bev.

Methods

Patients not bearing KRAS or NRAS codon 12, 13 and 61 mutations were defined as RAS wt. Best response according to RECIST, early response and deepness of response (DoR) were analysed. Patients achieving a >20% reduction in the sum of longest diameters of RECIST target lesions at week 8 compared to baseline were defined as early responders. A further analysis was performed in the RAS and BRAF wt subgroup.

Results

Seventy-eight RAS wt patients received first-line FOLFOXIRI plus bev. BRAF mutation was detected in 14 (18%) RAS wt patients. Fifty-one (65%) out of 78 pts achieved RECIST response and 21 (27%) reported a disease stabilization for an overall disease control rate of 92%. Early response was reported in 44 (63%) out of 70 evaluable pts. The median DoR was 43.5% (range 100%/-38.2%). Twenty-three patients (29%) underwent a secondary resection with curative intent (R0/R1/R2) and a R0 resection was performed in 14 patients (18%). Median PFS and OS were 12.8 and 36.0 months, respectively. Out of 64 RAS and BRAF wt pts, RECIST response rate was 69% and median PFS and OS were 13.3 and 41.7 months, respectively.

Conclusions

RAS wt pts treated with the triplet plus bev in the TRIBE trial achieved notable results in terms of RECIST response, PFS and OS. Though acknowledging limitations of cross-trial comparisons, these results compare favourably with those reported in phase III trials with first-line doublets plus an anti-EGFR monoclonal antibody, in particular for PFS.

Disclosure

A. Falcone: Consultant, honoraria and research funding for Roche, Merck and Amgen. Consultant and honoraria fro Sanofi-Aventis, Bayer and Celgene.All other authors have declared no conflicts of interest.