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Bevacizumab plus capecitabine effective in older patients with metastatic colorectal cancer
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Bevacizumab plus capecitabine was safe and effective in patients aged 70 years and older with metastatic colorectal cancer, according to study results.
The elderly have been poorly represented in studies of metastatic colorectal cancer. For this reason, researchers set out to assess and compare the safety and efficacy of bevacizumab (Avastin, Genentech) plus capecitabine (Xeloda, Hoffmann-La Roche) vs. capecitabine alone.
The analysis included 280 patients aged 70 years and older with previously untreated, unresectable, metastatic colorectal cancer who were deemed unsuitable for irinotecan-based or oxaliplatin-based treatments.
Researchers randomly assigned 140 patients to twice-daily 1,000 mg/m2 oral capecitabine alone on days 1-14. The other 140 patients received the same capecitabine dose in combination with 7.5 mg/kg IV bevacizumab on day 1. Treatment was administered every 3 weeks until disease progression, unacceptable side effects or withdrawal of consent to participate. PFS served as the primary outcome measure.
Patients assigned to the combination regimen demonstrated significantly longer median PFS than those assigned to capecitabine alone (9.1 months vs. 5.1 months; HR=0.53; P<.0001).
Researchers reported five treatment-related deaths in the combination group and four patients assigned to capecitabine alone. Grade ≥3 treatment-associated adverse events occurred in 40% of patients in the combination group vs. 22% of those assigned capecitabine alone. Hemorrhage was the most common adverse event in the combination arm.
“Our data suggest that bevacizumab plus capecitabine represents an additional therapeutic option in elderly patients with metastatic colorectal cancer, particularly in those who are unsuitable for upfront oxaliplatin-based or irinotecan-based combination regimens,” the researchers wrote.
Disclosure: The researchers report research funding and honoraria from, employment relationships with and stock ownership in Hoffmann-La Roche.
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