Paclitaxel-Carboplatin Alone or with Bevacizumab for Non-Small-Cell Lung Cancer

doi:10.1056/NEJMoa061884

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

Paclitaxel–Carboplatin Alone or with Bevacizumab for Non–Small-Cell Lung Cancer

Alan Sandler, M.D., Robert Gray, Ph.D., Michael C. Perry, M.D., Julie Brahmer, M.D., Joan H. Schiller, M.D., Afshin Dowlati, M.D., Rogerio Lilenbaum, M.D., and David H. Johnson, M.D.

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ABSTRACT

Background Bevacizumab, a monoclonal antibody against vascularendothelial growth factor, has been shown to benefit patientswith a variety of cancers.

Methods Between July 2001 and April 2004, the Eastern CooperativeOncology Group (ECOG) conducted a randomized study in which878 patients with recurrent or advanced non–small-celllung cancer (stage IIIB or IV) were assigned to chemotherapywith paclitaxel and carboplatin alone (444) or paclitaxel andcarboplatin plus bevacizumab (434). Chemotherapy was administeredevery 3 weeks for six cycles, and bevacizumab was administeredevery 3 weeks until disease progression was evident or toxiceffects were intolerable. Patients with squamous-cell tumors,brain metastases, clinically significant hemoptysis, or inadequateorgan 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 assignedto chemotherapy plus bevacizumab, as compared with 10.3 monthsin the chemotherapy-alone group (hazard ratio for death, 0.79;P=0.003). The median progression-free survival in the two groupswas 6.2 and 4.5 months, respectively (hazard ratio for diseaseprogression, 0.66; P<0.001), with corresponding responserates of 35% and 15% (P<0.001). Rates of clinically significantbleeding were 4.4% and 0.7%, respectively (P<0.001). Therewere 15 treatment-related deaths in the chemotherapy-plus-bevacizumabgroup, including 5 from pulmonary hemorrhage.

Conclusions The addition of bevacizumab to paclitaxel plus carboplatinin the treatment of selected patients with non–small-celllung cancer has a significant survival benefit with the riskof 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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