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Clinical Trial
. 2012 Jun 29:12:271.
doi: 10.1186/1471-2407-12-271.

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  1 , George Papaxoinis, Konstantine T Kalogeras, Anastasia G Eleftheraki, Ioannis Xanthakis, Thomas Makatsoris, Epaminondas Samantas, Ioannis Varthalitis, Pavlos Papakostas, Nikitas Nikitas, Christos N Papandreou, George Pentheroudakis, Eleni Timotheadou, Angelos Koutras, Joseph Sgouros, Dimitrios Bafaloukos, George Klouvas, Theofanis Economopoulos, Konstantinos N Syrigos, George Fountzilas
Affiliations
Clinical Trial

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 et al. BMC Cancer. .

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).

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Figures

Figure 1
Figure 1
Consort diagram: Among 285 eligible patients 143 were randomized in group A (XELIRI-Bev) and 142 in group B (FOLFIRI-Bev). In group A 88 (61%) and in group B 89 (63%) of the patients completed treatment. Reasons of discontinuation were death, non-fatal toxicity, disease progression and doctor’s or patient’s decision. Discontinuation rates did not differ between the two groups (p = 0.80).
Figure 2
Figure 2
Kaplan-Meier curves for survival (left) and PFS (right) according to treatment allocation.
Figure 3
Figure 3
High baseline plasma OPN concentrations (above the median) were significantly associated with shorter OS and PFS.
See this image and copyright information in PMC

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