title: 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.
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. (
  
  
  BACKGROUND
  ACTRN12610000270011).
authors: Oncology Section, Second Department of Internal Medicine, Hippokration Hospital, University of Athens School of Medicine, Athens, Greece. pectasid@otenet.gr
authors: Dimitrios
authors: D
authors: Pectasides
authors: George
authors: G
authors: Papaxoinis
authors: Konstantine T
authors: KT
authors: Kalogeras
authors: Anastasia G
authors: AG
authors: Eleftheraki
authors: Ioannis
authors: I
authors: Xanthakis
authors: Thomas
authors: T
authors: Makatsoris
authors: Epaminondas
authors: E
authors: Samantas
authors: Ioannis
authors: I
authors: Varthalitis
authors: Pavlos
authors: P
authors: Papakostas
authors: Nikitas
authors: N
authors: Nikitas
authors: Christos N
authors: CN
authors: Papandreou
authors: George
authors: G
authors: Pentheroudakis
authors: Eleni
authors: E
authors: Timotheadou
authors: Angelos
authors: A
authors: Koutras
authors: Joseph
authors: J
authors: Sgouros
authors: Dimitrios
authors: D
authors: Bafaloukos
authors: George
authors: G
authors: Klouvas
authors: Theofanis
authors: T
authors: Economopoulos
authors: Konstantinos N
authors: KN
authors: Syrigos
authors: George
authors: G
authors: Fountzilas
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D042501:Angiogenic Proteins / Q000097:blood*; D061067:Antibodies, Monoclonal, Humanized / Q000008:administration & dosage; D000970:Antineoplastic Agents / Q000008:administration & dosage; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D000068258:Bevacizumab; D015415:Biomarkers / Q000097:blood; D002166:Camptothecin / Q000008:administration & dosage / Q000031:analogs & derivatives; D000069287:Capecitabine; D015179:Colorectal Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000031:analogs & derivatives; D006801:Humans; D000077146:Irinotecan; D002955:Leucovorin / Q000008:administration & dosage; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis; D009367:Neoplasm Staging; D053495:Osteopontin / Q000097:blood; D016896:Treatment Outcome
chemical_list: D042501:Angiogenic Proteins; D061067:Antibodies, Monoclonal, Humanized; D000970:Antineoplastic Agents; D015415:Biomarkers; D003841:Deoxycytidine; D053495:Osteopontin; D000068258:Bevacizumab; D000069287:Capecitabine; D000077146:Irinotecan; D002955:Leucovorin; D005472:Fluorouracil; D002166:Camptothecin