The addition of Zaltrap® (ziv-aflibercept) to the FOLFIRI chemotherapy regimen improved overall survival in patients with metastatic colorectal cancer who were previously treated with Eloxatin® (oxaliplatin), according to the results of a phase III study published in the Journal of Clinical Oncology.
Colorectal cancer remains the second leading cause of cancer-related death in the United States. Metastatic colorectal cancer refers to cancer that has spread from the colon to distant sites in the body.
Targeted therapies are anticancer drugs that interfere with specific pathways involved in cancer cell growth or survival. Zaltrap is a type of targeted therapy called an angiogenesis inhibitor. It works by inhibiting the blood supply to tumors. Zaltrap is approved for use in metastatic cancer that is resistant to or that has progressed after a chemotherapy regimen containing oxaliplatin.
Researchers conducted a phase III randomized study that included 1,226 patients with metastatic colorectal cancer. Patients were randomly assigned to receive Zaltrap or placebo every two weeks in combination with FOLFIRI. Treatment continued until disease progression or until side effects became unacceptable. The primary endpoint of the study was overall survival.
The results indicated that the addition of Zaltrap to FOLFIRI significantly improved overall survival compared to placebo. The median survival time among patients treated with Zaltrap was 13.5 months compared to 12.06 months in the placebo group. Zaltrap also improved progression-free survival, with median PFS times of 6.9 months versus 4.67 months. The response rate was 19.8 percent among patients treated with Zaltrap plus FOLFIRI compared with 11.1 percent in patients treated with placebo plus FOLFIRI.
The researchers concluded that Zaltrap in combination with FOLFIRI provides a statistically significant survival benefit over FOLFIRI and placebo in patients with metastatic colorectal cancer previously treated with Eloxatin.
Van Cutsem E, Tabernero J, Lakomy R, et al. Addition of aflibercept to fluorouracil, leucovorin, and irinotecan improves survival in a phase III randomized trial in patients with metastatic colorectal cancer previously treated with an oxaliplatin-based regimen. Journal of Clinical Oncology. 2012; 30(28): 3499-3506.