Benefits of ziv-aflibercept plus FOLFIRI observed across subgroups of patients with pretreated metastatic colorectal cancer
The benefits of ziv-aflibercept plus FOLFIRI chemotherapy in patients with metastatic colorectal cancer previously treated with oxaliplatin were maintained across specified patient subgroups, according to study results.
Prior research showed the addition of ziv-aflibercept (Zaltrap, Sanofi-Aventis) to FOLFIRI is associated with significantly improved survival in patients with metastatic colorectal cancer who were previously treated with an oxaliplatin-based regimen.
The current analysis assessed outcomes in subgroups of patients to examine treatment consistency.
Researchers randomly assigned patients to FOLFIRI plus ziv-aflibercept or placebo every 2 weeks until disease progression or unacceptable toxicity. The investigators analyzed efficacy and safety with regard to demographics and baseline characteristics. They also stratified results based on prior treatment with bevacizumab (Avastin, Genentech) and ECOG performance status.
Among patients previously treated with bevacizumab, median OS was 12.5 months in the ziv-aflibercept group and 11.7 months in the placebo group. Among patients who had not undergone prior bevacizumab treatment, median OS was 13.9 months in the ziv-aflibercept group and 12.4 months in the placebo group. Researchers observed no heterogeneity across subgroups (P=.5668).
The beneficial effect on OS (P=.0899) and PFS (P=.0076) observed with ziv-aflibercept was greater among those with liver metastases only compared with those with no liver metastases/liver metastases with other organ involvement.
Disclosure: The study was funded by Sanofi-Aventis and Regeneron Pharmaceuticals.