P-0180 - Bevacizumab in combination with irinotecanand capecitabine as first-line treatment for mCRC - efficacy and safety

Date 28 June 2014
Event World GI 2014
Session Poster Session
Topics Anti-Cancer Agents & Biologic Therapy
Colon Cancer
Rectal Cancer
Presenter Sasa Jungic
Citation Annals of Oncology (2014) 25 (suppl_2): ii14-ii104. 10.1093/annonc/mdu165
Authors S. Jungic1, G. Kecman Malcic2, I. Rakita3, D. Jovanovic4, R. Gajanin5, Z. Maric6, B. Tubic7, Z. Gojkovic8
  • 1Clinical Center Banja Luka, Banja Luka/RS
  • 2Clinic of Oncology, Clinical Center Banja Luka, Banja Luka/RS
  • 3UKC Banja Luka, Banja Luka/RS
  • 4Institue of Oncology Vojvodina, Novi Sad/RS
  • 5Clinic of Pathology, Banja Luka/RS
  • 6Clinic of Surgery, Banja Luka/RS
  • 7Agency for Medicines and Medical Devices, Banja Luka/RS
  • 8UKC, Banja Luka/RS



The safety and efficacy of first-line XIA (capecitabine in combination with irinotecan plus bevacizumab) have been evaluated in patients with metastatic colorectal cancer (mCRC). Capecitabine is a non-cytotoxic fluoropyrimidine carbamate which functions as an orally administered is very selective and important. Bevacizumab binds to vascular endothelial growth factor (VEGF), the key driver of vasculogenesis and angiogenesis. Neutralising the biological activity of VEGF regresses the vascularisation of tumours, normalises remaining tumour vasculature, and inhibits the formation of new tumour vasculature, thereby inhibiting tumour growth. Irinotecan is a semi-synthetic derivative of camptothecin. In this study we analyzed the efficacy and toxicity of a combination capecitabine/irinotecan/bevacizumab in first line for patients with mCRC. It was evaluated the overall response rate (ORR), other objectives were progression-free survival (PFS), overall survival (OS) and toxicity of the combination capecitabine/irinotecan/bevacizumab in first line for patients with advanced or metastatic CRC.


Patients diagnosed with initially unresectable chemotherapy-naïve mCRC were eligible. Main enrolment criteria were: adult patients 18 years and older; Eastern Cooperative Oncology Group (ECOG) performance status ≤2; adequate bone marrow function (neutrophil count ≥ 1.5 × 109, the platelet count ≥100 × 109, haemoglobin ≥9 g/dl); serum creatinine <1.25 mg/dl; alanine aminotransferase or aspartate aminotransferase or alkaline phosphatase < 3 times the upper limit of normal and keratin ≤1.5 times the upper limit of normal. Previous adjuvant chemotherapy must have been finished at least 6 months before enrolment in the study. Patients received capecitabine (1000 mg/m2 per os from 2nd to 7th days every cycle), irinotecan (175 mg/m2 every 2 weeks), plus bevacizumab (5 mg/kg i.v. every 2 weeks). Appropriate dose interruptions/reductions were implemented in the event of specific toxicities, depending on their nature and intensity. The next course of treatment only began when the neutrophil count was >1.5 × 109, the platelet count was >100 × 109, and any other treatment-related toxicities were less than or equal to grade 1.


The study was conducted as a prospective study, which analyzed 35 patients both sexes. Median age was 50,8 years (range 27–69). Overall response rate (ORR) was: 71.4%, partial response (PR): 28.6%, progressive disease: 28.6% and stable disease (SD): 42.8%. PFS of patients analyzed was 11.3 months (95% CL: 9.1 to 12.9). OS of patients analyzed was 25,2 months (95% CL: 17.4 to 28.4 months). There were 117 adverse events reported in 24 patients. Most frequent adverse events were alopecia 51.4%, nausea and vomiting 37.1%, haemorrhage 37.1%, hand-foot syndrome 25.7%, diarrhoea 22.8%, abdominal pain 20.0%, proteinuria 20.0%, and hypertension 17.1%. No treatment-related deaths were reported.


The results of this trial support the use of bevacizumab plus capecitabine and irinotecan as first-line treatment for patients with mCRC. Our analyses show that the combination of BEV with the XELIRI regimen is feasible with manageable toxicity, and that is associated with a promising efficacy in terms of PFS, ORR and OS in previously untreated mCRC.