Combination therapy with Avastin® (bevacizumab) and Xeloda® (capecitabine) may be an optimal first-line treatment for treatment-naïve older patients with metastatic colorectal cancer, according to the results of a study presented at the 2013 Gastrointestinal Cancers Symposium in San Francisco.
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. Although the majority of patients diagnosed with metastatic colorectal cancer are elderly, they are underrepresented in clinical trials.
The AVEX trial was a phase III open-label trial designed to evaluate the safety and efficacy of first-line treatment with Avastin and Xeloda in a population of 280 treatment-naive patients ages 70 and older with metastatic colorectal cancer across 10 countries. The trial is the first phase III study to prospectively evaluate the use of a biologic therapy in an older population with metastatic colorectal cancer. Patients were randomized to receive Xeloda plus Avastin or Xeloda alone.
The results indicated that combination therapy with Xeloda and Avastin improved the overall response rate—19.3 percent compared with 10 percent for those who received Avastin alone. Median overall survival was 20.7 months in the combination group, compared to 16.8 months in the group that received monotherapy. What’s more—combination therapy was associated with significantly prolonged progression-free survival, significantly improved overall response rate, and a trend toward overall survival. The disease control rate was superior in the combination group—74.3 percent compared with 57.0 percent in the monotherapy group.
The rates of adverse events were similar between the two groups—95.5 percent for combination therapy versus 95.6 percent for monotherapy. Grade 3 or 4 adverse events were more common in the combination therapy group; however, grade 5 adverse events were more common in the monotherapy group.
The researchers concluded that combination therapy with Xeloda and Avastin was well-tolerated and effective in elderly, treatment-naïve patients with metastatic colorectal cancer—and significantly prolonged progression-free survival.
Cunningham D, Lang I, Lorusso V, et al. Bevacizumab (bev) in combination with capecitabine (cape) for the first-line treatment of elderly patients with metastatic colorectal cancer (mCRC): Results of a randomized international phase III trial (AVEX). Journal of Clinical Oncology. 2012; 30(suppl 34): Abstract 337.
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