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Cediranib failed to improve FOLFOX/CAPOX survival outcomes
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The addition of cediranib to chemotherapy did not improve survival in patients with previously untreated metastatic colorectal cancer, according to study results.
Cediranib (AZD2171, Recentin; AstraZeneca) has demonstrated activity against all three VEGF receptors, according to researchers.
The HORIZON II study evaluated infusional fluorouracil, leucovorin, and oxaliplatin/capecitabine and oxaliplatin (FOLFOX/CAPOX) with or without one of two cediranib doses in patients with previously untreated metastatic colorectal cancer (mCRC). All eligible patients received FOLFOX/CAPOX plus cediranib 20 mg or 30 mg per day, or placebo. The ratio was 1:1:1.
Results from HORIZON I, II and III — all of which involved cediranib and a chemotherapy regimen — suggested that the 20-mg dose met predefined criteria for continuation. Consequently, subsequent patients were randomly assigned cediranib 20 mg or placebo in a 2:1 ratio.
PFS and OS served as the two primary endpoints.
The analysis included 502 patients who received 20 mg of the study drug and 358 patients who received placebo.
Patients assigned to cediranib plus FOLFOX/CAPOX had a median PFS of 8.6 months compared with 8.3 months for placebo (HR=0.84; 95% CI, 0.73-0.98). The study drug was associated with prolonged OS (19.7 months vs. 18.9 months; HR=0.94; 95% CI, 0.79-1.12), but the researchers noted that difference was of “no impact.”
The researchers observed no significant differences in secondary endpoints between the two arms. Those endpoints included objective response rate, duration of response and liver resection rate.
Patients assigned to cediranib experienced a reduction in chemotherapy dose intensity of 10%. The study drug also was linked to a manageable adverse event profile.
“Because of the lack of improvement in OS, cediranib plus an oxaliplatin-based regimen cannot be recommended as a treatment for patients with mCRC,” the researchers concluded.
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