The ITACa trial was designed to define the role of cetuximab (Cet) and bevacizumab (Bev) in combination with standard chemotherapy (CT, FOLFIRI or FOLFOX4) as first- and second-line treatment in metastatic colorectal cancer. All patients with WT KRAS tumors who had been enrolled in the first-line trial were randomized onto two independent second-line trials: CT or CT + Cet (study 2A) and CT + Bev or CT + Bev + Cet (study 2B). Patients with mutated KRAS were not eligible for randomization and were treated with CT alone (study 2A) or CT + Bev (study 2B). The primary endpoint was progression-free survival (PFS). 48 and 56 KRAS WT patients were randomized while 31 and 40 KRAS mutated patients were treated without randomization. Study 2A: median PFS was 3.4 (95%CI 2.3-4.6) and 6.2 (95%CI 4.3-7.8) months for the CT and CT + Cet arms, respectively, with a hazard ratio (HR) = 0.64 (95%CI 0.35-1.16, p = 0.144). Study 2B: median PFS was 7.7 (95%CI 4.1-10.1) and 4.9 (95%CI 3.2-7.0) months for CT + Bev and CT + Cet + Bev arms, respectively, with a HR = 1.31 (95%CI 0.76-2.26, p = 0.330). Notwithstanding limitations due to the small sample size, among patients with WT KRAS the addition of Cet to second-line CT increased PFS, whereas the addition of Cet to CT + Bev was associated with worse PFS.

Impact of second-line cetuximab-containing therapy in patients with KRAS wild-type metastatic colorectal cancer: Results from the ITACa randomized clinical trial / Passardi, Alessandro; Scarpi, Emanuela; Gelsomino, Fabio; Palladino, Maria Angela; Casadei Gardini, Andrea; Turci, Daniele; Chiuri, Vincenzo Emanuele; Mucciarini, Claudia; Tassinari, Davide; Ragazzini, Angela; Frassineti, Giovanni Luca; Valgiusti, Martina; Ulivi, Paola; Amadori, Dino. - In: SCIENTIFIC REPORTS. - ISSN 2045-2322. - 7:1(2017), pp. 1-8. [10.1038/s41598-017-11048-9]

Impact of second-line cetuximab-containing therapy in patients with KRAS wild-type metastatic colorectal cancer: Results from the ITACa randomized clinical trial

Gelsomino, Fabio;Casadei Gardini, Andrea;CHIURI, Vincenzo Emanuele;Mucciarini, Claudia;
2017

Abstract

The ITACa trial was designed to define the role of cetuximab (Cet) and bevacizumab (Bev) in combination with standard chemotherapy (CT, FOLFIRI or FOLFOX4) as first- and second-line treatment in metastatic colorectal cancer. All patients with WT KRAS tumors who had been enrolled in the first-line trial were randomized onto two independent second-line trials: CT or CT + Cet (study 2A) and CT + Bev or CT + Bev + Cet (study 2B). Patients with mutated KRAS were not eligible for randomization and were treated with CT alone (study 2A) or CT + Bev (study 2B). The primary endpoint was progression-free survival (PFS). 48 and 56 KRAS WT patients were randomized while 31 and 40 KRAS mutated patients were treated without randomization. Study 2A: median PFS was 3.4 (95%CI 2.3-4.6) and 6.2 (95%CI 4.3-7.8) months for the CT and CT + Cet arms, respectively, with a hazard ratio (HR) = 0.64 (95%CI 0.35-1.16, p = 0.144). Study 2B: median PFS was 7.7 (95%CI 4.1-10.1) and 4.9 (95%CI 3.2-7.0) months for CT + Bev and CT + Cet + Bev arms, respectively, with a HR = 1.31 (95%CI 0.76-2.26, p = 0.330). Notwithstanding limitations due to the small sample size, among patients with WT KRAS the addition of Cet to second-line CT increased PFS, whereas the addition of Cet to CT + Bev was associated with worse PFS.
2017
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Impact of second-line cetuximab-containing therapy in patients with KRAS wild-type metastatic colorectal cancer: Results from the ITACa randomized clinical trial / Passardi, Alessandro; Scarpi, Emanuela; Gelsomino, Fabio; Palladino, Maria Angela; Casadei Gardini, Andrea; Turci, Daniele; Chiuri, Vincenzo Emanuele; Mucciarini, Claudia; Tassinari, Davide; Ragazzini, Angela; Frassineti, Giovanni Luca; Valgiusti, Martina; Ulivi, Paola; Amadori, Dino. - In: SCIENTIFIC REPORTS. - ISSN 2045-2322. - 7:1(2017), pp. 1-8. [10.1038/s41598-017-11048-9]
Passardi, Alessandro; Scarpi, Emanuela; Gelsomino, Fabio; Palladino, Maria Angela; Casadei Gardini, Andrea; Turci, Daniele; Chiuri, Vincenzo Emanuele;...espandi
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11380/1177513
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