Bevacizumab plus capecitabine versus capecitabine alone in elderly patients with previously untreated metastatic colorectal cancer (AVEX): An open-label, randomised phase 3 trial

David Cunningham, I. Láng, Eugenio Marcuello, Vito Lorusso, Janja Ocvirk, Dong Bok Shin, Derek Jonker, Stuart Osborne, Niko Andre, Daniel Waterkamp, Mark P. Saunders

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299 Citations (Scopus)

Abstract

Background: Elderly patients are often under-represented in clinical trials of metastatic colorectal cancer. We aimed to assess the efficacy and safety of bevacizumab plus capecitabine compared with capecitabine alone in elderly patients with metastatic colorectal cancer. Methods: For this open-label, randomised phase 3 trial, patients aged 70 years and older with previously untreated, unresectable, metastatic colorectal cancer, who were not deemed to be candidates for oxaliplatin-based or irinotecan-based chemotherapy regimens, were randomly assigned in a 1:1 ratio via an interactive voice-response system, stratified by performance status and geographical region. Treatment consisted of capecitabine (1000 mg/m2 orally twice a day on days 1-14) alone or with bevacizumab (7·5 mg/kg intravenously on day 1), given every 3 weeks until disease progression, unacceptable toxic effects, or withdrawal of consent. Efficacy analyses were based on the intention-to-treat population. The primary endpoint was progression-free survival. The trial is registered with ClinicalTrials.gov, number NCT00484939. Findings: From July 9, 2007, to Dec 14, 2010, 280 patients with a median age of 76 years (range 70-87) were recruited from 40 sites across ten countries. Patients were randomly assigned to receive either bevacizumab plus capecitabine (n=140) or capecitabine only (n=140). Progression-free survival was significantly longer with bevacizumab and capecitabine than with capecitabine alone (median 9·1 months [95% CI 7·3-11·4] vs 5·1 months [4·2-6·3]; hazard ratio 0·53 [0·41-0·69]; p

Original languageEnglish
Pages (from-to)1077-1085
Number of pages9
JournalThe Lancet Oncology
Volume14
Issue number11
DOIs
Publication statusPublished - Oct 2013

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Colorectal Neoplasms
oxaliplatin
irinotecan
Disease-Free Survival
Poisons
Bevacizumab
Capecitabine
Disease Progression
Clinical Trials
Safety
Drug Therapy
Population

ASJC Scopus subject areas

  • Oncology

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Bevacizumab plus capecitabine versus capecitabine alone in elderly patients with previously untreated metastatic colorectal cancer (AVEX) : An open-label, randomised phase 3 trial. / Cunningham, David; Láng, I.; Marcuello, Eugenio; Lorusso, Vito; Ocvirk, Janja; Shin, Dong Bok; Jonker, Derek; Osborne, Stuart; Andre, Niko; Waterkamp, Daniel; Saunders, Mark P.

In: The Lancet Oncology, Vol. 14, No. 11, 10.2013, p. 1077-1085.

Research output: Contribution to journalArticle

Cunningham, David ; Láng, I. ; Marcuello, Eugenio ; Lorusso, Vito ; Ocvirk, Janja ; Shin, Dong Bok ; Jonker, Derek ; Osborne, Stuart ; Andre, Niko ; Waterkamp, Daniel ; Saunders, Mark P. / Bevacizumab plus capecitabine versus capecitabine alone in elderly patients with previously untreated metastatic colorectal cancer (AVEX) : An open-label, randomised phase 3 trial. In: The Lancet Oncology. 2013 ; Vol. 14, No. 11. pp. 1077-1085.
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AU - Marcuello, Eugenio

AU - Lorusso, Vito

AU - Ocvirk, Janja

AU - Shin, Dong Bok

AU - Jonker, Derek

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AU - Andre, Niko

AU - Waterkamp, Daniel

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