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Previous Volume 355:2542-2550 December 14, 2006 Number 24 Next

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ABSTRACT

Background Bevacizumab, a monoclonal antibody against vascular endothelial growth factor, has been shown to benefit patients with a variety of cancers.

Methods Between July 2001 and April 2004, the Eastern Cooperative Oncology Group (ECOG) conducted a randomized study in which 878 patients with recurrent or advanced non–small-cell lung cancer (stage IIIB or IV) were assigned to chemotherapy with paclitaxel and carboplatin alone (444) or paclitaxel and carboplatin plus bevacizumab (434). Chemotherapy was administered every 3 weeks for six cycles, and bevacizumab was administered every 3 weeks until disease progression was evident or toxic effects were intolerable. Patients with squamous-cell tumors, brain metastases, clinically significant hemoptysis, or inadequate organ function or performance status (ECOG performance status, >1) were excluded. The primary end point was overall survival.

Results The median survival was 12.3 months in the group assigned to chemotherapy plus bevacizumab, as compared with 10.3 months in the chemotherapy-alone group (hazard ratio for death, 0.79; P=0.003). The median progression-free survival in the two groups was 6.2 and 4.5 months, respectively (hazard ratio for disease progression, 0.66; P<0.001), with corresponding response rates of 35% and 15% (P<0.001). Rates of clinically significant bleeding were 4.4% and 0.7%, respectively (P<0.001). There were 15 treatment-related deaths in the chemotherapy-plus-bevacizumab group, including 5 from pulmonary hemorrhage.

Conclusions The addition of bevacizumab to paclitaxel plus carboplatin in the treatment of selected patients with non–small-cell lung cancer has a significant survival benefit with the risk of increased treatment-related deaths. (ClinicalTrials.gov number, NCT00021060 [ClinicalTrials.gov] .)

Source Information

From Vanderbilt University, Nashville (A.S., D.H.J.); the Dana–Farber Cancer Institute, Boston (R.G.); the Ellis Fischel Cancer Center, University of Missouri, Columbia (M.C.P.); Johns Hopkins University, Baltimore (J.B.); the University of Wisconsin, Madison (J.H.S.); University Hospitals of Cleveland, Cleveland (A.D.); and Mount Sinai Hospital, Miami (R.L.).

Address reprint requests to Dr. Sandler at the Vanderbilt–Ingram Cancer Center, 2220 Pierce Ave., Nashville, TN 37232, or at alan.sandler{at}vanderbilt.edu.

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