Thursday, July 22, 2010 (Last Updated: 07/23/2010)
THURSDAY, July 22 (HealthDay News) -- Bevacizumab used in combination with standard chemotherapy for advanced non-squamous non-small-cell lung cancer (NSCLC) has a generally manageable safety profile, according to an open-label, single group, phase 4 study published online July 21 in The Lancet: Oncology.
Lucio Crinò, M.D., of the Hospital Santa Maria della Misericordia in Perugia, Italy, and colleagues evaluated 2,212 patients with untreated locally advanced, metastatic, or recurrent non-squamous NSCLC recruited between August 2006 and June 2008. Patients received bevacizumab (7.5 or 15 mg/kg every three weeks) plus standard chemotherapy for up to six cycles, and then single-agent bevacizumab until their disease progressed.
The researchers found that the incidence of clinically significant (grade ≥3) adverse events was low, with thromboembolism occurring in 8 percent of patients, hypertension in 6 percent, bleeding in 4 percent, proteinuria in 3 percent, and pulmonary hemorrhage in 1 percent. Pulmonary embolism (1 percent of patients), as well as epistaxis, neutropenia, febrile neutropenia, and deep vein thrombosis (1 percent) were the most common grade ≥3 serious adverse events the researchers believed to be linked to bevacizumab treatment. Bevacizumab was permanently stopped after 8 percent of bleeding events and 4 percent of hypertension events, and temporarily interrupted after 2 percent of bleeding events and 7 percent of hypertension events.
"Our results confirm the manageable safety profile of first-line bevacizumab in combination with various standard chemotherapy regimens for treatment of advanced non-squamous NSCLC," the authors write.
The study was funded by F. Hoffmann-La Roche Ltd. Several authors disclosed financial ties to F. Hoffmann-La Roche and other pharmaceutical companies.
Hematology & Oncology
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