Cediranib plus FOLFOX/XELOX versus placebo plus FOLFOX/XELOX in patients with previously untreated metastatic colorectal cancer: a randomized, double-blind, Phase III study (HORIZON II)

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Cediranib plus FOLFOX/XELOX versus placebo plus
FOLFOX/XELOX in patients with previously
untreated metastatic colorectal cancer a
randomized, double-blind, Phase III study
(HORIZON II)

• Authors Hoff et al
• Reviewed by Scott Berry
• Date posted Nov 8 2010

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Study Design
N 880 2 1 Randomization Primary Outcome PFS
and OS
FOLFOX/CapeOx Placebo
R
FOLFOX/CapeOx Cediranib 20 mg
1st Line Met CRC
Cediranib is an oral VEGF Tyrosine Kinase
Inhibitor
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RESULTS
FOLFOX/CapeOx FOLFOX/CapeOx Cediranib p-value
Response Rate () 50 51 P0.90
PFS/TTP (median, mos) 8.2 8.6 P0.01
OS (median, mos) 18.9 19.7 P0.57
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Gr 3/4 TOXICITY
Adverse events resulted in reduced chemotherapy
delivery
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STUDY COMMENTARY

• The addition of cediranib to FOLFOX/CapeOX
  produced a statistically but not clinically
  significant improvement in PFS and no improvement
  in OS
• In addition cediranib produced toxicity that
  resulted in reduced chemotherapy delivery