P-283 - Impact of second-line cetuximab-containing therapy in patients with KRAS wild type metastatic colorectal cancer: results from ITACa trial

Date 04 July 2015
Event WorldGI 2015
Session Posters
Topics Anticancer agents
Colon and Rectal Cancer
Translational Research
Basic Principles in the Management and Treatment (of cancer)
Biological therapy
Presenter A. Passardi
Citation Annals of Oncology (2015) 26 (suppl_4): 1-100. 10.1093/annonc/mdv233
Authors A. Passardi1, G.L. Frassineti1, V. Lorusso2, E. Scarpi1, A. Fontana3, L. Cavanna4, S. Ruscelli1, D. Turci5, C. Mucciarini6, D. Tassinari7, A. Ragazzini1, M. Valgiusti1, P. Ulivi1, D. Amadori1
  • 1Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola/IT
  • 2Istituto Tumori “Giovanni Paolo II” I.R.C.C.S. Ospedale Oncologico di Bari, Bari/IT
  • 3Policlinico di Modena, Modena/IT
  • 4Azienda Ospedaliera Civile, Piacenza/IT
  • 5Ravenna Hospital, Ravenna/IT
  • 6Ramazzini Hospital, Carpi/IT
  • 7Infermi Rimini City Hospital, Rimini/IT



The ITACA trial was an academic study on the management strategy for patients with metastatic colorectal cancer, designed to define the role of cetuximab (Cet) and bevacizumab (Bev) in combination with standard chemotherapy (CT, FOLFIRI or FOLFOX4) in first- and second-line treatment. Results from the first-line trial (Arm A: CT + Bev vs Arm B: CT alone) were recently published; the second-line trial results are presented here.


All patients randomized in the first-line trial who fulfilled inclusion criteria were randomized onto two independent second-line trials:

-Study 153 01/2A: Arm A patients with wild type (WT) KRAS were randomized to the other CT regimen or the other CT plus cetuximab. Arm A patients with mutated KRAS were not randomized and treated with the other CT regimen alone.

-Study 153 01/2B: Arm B patients with WT KRAS were randomized to the other CT plus B or the other CT plus B plus cetuximab. Arm B patients with mutated KRAS were not randomized and treated with the other CT plus B.

The primary objective was to determine, separately for each study, whether the addition of Cet to CT or to CT plus Bev, would improve efficacy in terms of PFS. Secondary objectives were to determine the ORR, OS and the safety profile of the treatments administered.


Of the 370 patients recruited in the first-line trial, 48 and 56 KRAS WT patients were randomized onto Study 153 01/2A and 153 01/2B, respectively, while 31 and 40 KRAS mutated patients were treated without randomization in the 2 study groups. Efficacy results are shown in the Table.


Notwithstanding limitations due to the small sample size, our results show that, among patients with WT KRAS, the addition of Cet to second-line CT increased PFS, while the addition of Cet to CT + Bev was associated with worse PFS.

Table: P-283