TY - JOUR
T1 - XELIRI-bevacizumab versus FOLFIRI-bevacizumab as first-line treatment in patients with metastatic colorectal cancer
T2 - a Hellenic Cooperative Oncology Group phase III trial with collateral biomarker analysis
AU - Pectasides, Dimitrios
AU - Papaxoinis, George
AU - Kalogeras, Konstantine T.
AU - Eleftheraki, Anastasia G.
AU - Xanthakis, Ioannis
AU - Makatsoris, Thomas
AU - Samantas, Epaminondas
AU - Varthalitis, Ioannis
AU - Papakostas, Pavlos
AU - Nikitas, Nikitas
AU - Papandreou, Christos N.
AU - Pentheroudakis, George
AU - Timotheadou, Eleni
AU - Koutras, Angelos
AU - Sgouros, Joseph
AU - Bafaloukos, Dimitrios
AU - Klouvas, George
AU - Economopoulos, Theofanis
AU - Syrigos, Konstantinos N.
AU - Fountzilas, George
PY - 2012/6/29
Y1 - 2012/6/29
N2 - 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).
AB - 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).
KW - Angiogenic markers
KW - Bevacizumab
KW - Capecitabine
KW - Chemotherapy
KW - Colorectal cancer
KW - Irinotecan
UR - http://www.scopus.com/inward/record.url?scp=84862991983&partnerID=8YFLogxK
U2 - 10.1186/1471-2407-12-271
DO - 10.1186/1471-2407-12-271
M3 - Article
C2 - 22748098
AN - SCOPUS:84862991983
SN - 1471-2407
VL - 12
JO - BMC Cancer
JF - BMC Cancer
M1 - 271
ER -