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Andrea Casadei-Gardini,1 Emanuela Scarpi,2 Paola Ulivi,3 Maria Angela Palladino,4 Caterina Accettura,5 Ilaria Bernardini,6 Andrea Spallanzani,7 Fabio Gelsomino,7 Jody Corbelli,8 Giorgia Marisi,8 Silvia Ruscelli,1 Martina Valgiusti,1 Giovanni Luca Frassineti,1 Alessandro Passardi11Department of Medical Oncology, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy; 2Unit of Biostatistics and Clinical Trials, IRST IRCCS, Meldola, Italy; 3Biosciences Laboratory, IRST IRCCS, Meldola, Italy; 4Medical Oncology Department, Piacenza Hospital, Piacenza, Italy; 5Medical Oncology Unit, Vito Fazzi Hospital, Lecce, Italy; 6Medical Oncology Unit, Ramazzini Hospital, Carpi, Italy; 7Department of Oncology and Hematology, Division of Oncology, University Hospital Modena, Modena, Italy; 8Oncolgy Unit, Degli Infermi Hospital, Faenza, ItalyAim: The aim of this study was to investigate the role of a new inflammatory index (Colon Inflammatory Index [CII]) as a predictor of prognosis and treatment efficacy in patients with metastatic colorectal cancer (mCRC) enrolled in the prospective multicenter randomized ITACa (Italian Trial in Advanced Colorectal Cancer) trial to receive first-line chemotherapy (CT)+ bevacizumab or CT alone.Patients and methods: Between November 14, 2007 and March 6, 2012, 276 patients diagnosed with CRC were available for baseline neutrophil-to-lymphocyte ratio (NLR) and lactate dehydrogenase (LDH). We divided the population into three groups on basis of the CII index.Results: At baseline in all populations, median PFS and OS was predictive of clinical outcome (p

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.