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BMC Cancer. 2012; 12: 271.
Published online Jun 29, 2012. doi:  10.1186/1471-2407-12-271
PMCID: PMC3466131
XELIRI-bevacizumab versus FOLFIRI-bevacizumab as first-line treatment in patients with metastatic colorectal cancer: a Hellenic Cooperative Oncology Group phase III trial with collateral biomarker analysis
Dimitrios Pectasides,corresponding author1 George Papaxoinis,1 Konstantine T Kalogeras,2,3 Anastasia G Eleftheraki,4 Ioannis Xanthakis,2 Thomas Makatsoris,5 Epaminondas Samantas,6 Ioannis Varthalitis,7 Pavlos Papakostas,8 Nikitas Nikitas,9 Christos N Papandreou,10 George Pentheroudakis,11 Eleni Timotheadou,2 Angelos Koutras,5 Joseph Sgouros,6 Dimitrios Bafaloukos,12 George Klouvas,13 Theofanis Economopoulos,14 Konstantinos N Syrigos,15 and George Fountzilas2
1Oncology Section, Second Department of Internal Medicine, “Hippokration” Hospital, University of Athens School of Medicine, Athens, Greece
2Department of Medical Oncology, Papageorgiou Hospital, Aristotle University of Thessaloniki School of Medicine, Thessaloniki, Greece
3Translational Research Section, Hellenic Cooperative Oncology Group, Data Office, Athens, Greece
4Section of Biostatistics, Hellenic Cooperative Oncology Group, Data Office, Athens, Greece
5Division of Oncology, Department of Medicine, University Hospital of Patras, Rion, Greece
6Third Department of Medical Oncology, Agii Anargiri Cancer Hospital, Athens, Greece
7Oncology Department, General Hospital of Chania, Creta, Greece
8Department of Medical Oncology, Hippokration Hospital, Athens, Greece
9Department of Clinical Therapeutics, Alexandra Hospital, University of Athens School of Medicine, Athens, Greece
10Department of Internal Medicine, Oncology Section, Larissa University Hospital, Larissa, Greece
11Department of Medical Oncology, Ioannina University Hospital, Ioannina, Greece
12First Department of Medical Oncology, Metropolitan Hospital, Athens, Greece
13Second Department of Medical Oncology, Metropolitan Hospital, Athens, Greece
14Second Department of Internal Medicine, Propaedeutic, Oncology Section, Attikon University Hospital, Athens, Greece
15Oncology Unit, Third Department of Medicine, Athens Medical School, Sotiria General Hospital, Athens, Greece
corresponding authorCorresponding author.
Dimitrios Pectasides: pectasid/at/otenet.gr; George Papaxoinis: georgexoinis/at/gmail.com; Konstantine T Kalogeras: k_kalogeras/at/hecog.ondsl.gr; Anastasia G Eleftheraki: a_eleftheraki/at/hecog.ondsl.gr; Ioannis Xanthakis: efipsarouli/at/yahoo.gr; Thomas Makatsoris: maktom/at/yahoo.com; Epaminondas Samantas: epsam/at/otenet.gr; Ioannis Varthalitis: oncol/at/chaniahospital.gr; Pavlos Papakostas: oncologydepart/at/hippocratio.gr; Nikitas Nikitas: nnikit/at/med.uoa.gr; Christos N Papandreou: cpapandr/at/otenet.gr; George Pentheroudakis: gpenther/at/otenet.gr; Eleni Timotheadou: nellitim/at/hotmail.com; Angelos Koutras: angkoutr/at/otenet.gr; Joseph Sgouros: josephsgouros/at/yahoo.co.uk; Dimitrios Bafaloukos: dimmp/at/otenet.gr; George Klouvas: gklouvas/at/otenet.gr; Theofanis Economopoulos: economopoulosth/at/ath.forthnet.gr; Konstantinos N Syrigos: knsyrigos/at/usa.net; George Fountzilas: fountzil/at/auth.gr
Received September 4, 2011; Accepted May 16, 2012.
Abstract
Background
The aim was to compare two standard chemotherapy regimens combined with bevacizumab as first-line treatment in patients with metastatic colorectal cancer.
Methods
Patients previously untreated for metastatic disease were randomized in: group A (irinotecan, capecitabine, bevacizumab, every 3 weeks; XELIRI-bevacizumab) and group B (irinotecan, leucovorin, fluorouracil, bevacizumab, every 2 weeks; FOLFIRI-bevacizumab). Primary endpoint was progression-free survival (PFS). Plasma concentrations of nitric oxide, osteopontin, TGF-β1 and VEGF-A were measured at baseline and during treatment.
Results
Among 285 eligible patients, 143 were randomized to group A and 142 to group B. Fifty-five patients (38.5%) in group A and 57 (40.1%) in group B responded (p = 0.81). After a median follow-up of 42 months, median PFS was 10.2 and 10.8 months (p = 0.74), while median OS was 20.0 and 25.3 months (p = 0.099), for groups A and B, respectively. Most frequent grade 3–4 toxicities (group A vs group B) were neutropenia (13% vs 22%, p = 0.053) and diarrhea (19% vs 11%, p = 0.082). Baseline plasma osteopontin concentrations demonstrated prognostic significance for both PFS and OS.
Conclusions
This trial did not show significant differences in efficacy between the groups. However, the toxicity profile was different. Baseline plasma osteopontin concentrations demonstrated independent prognostic significance. (Registration number: ACTRN12610000270011)
Keywords: Angiogenic markers, Bevacizumab, Capecitabine, Chemotherapy, Colorectal cancer, Irinotecan
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