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

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Sandler, Alan, Gray, Robert, Perry, Michael C., Brahmer, Julie, Schiller, Joan H., Dowlati, Afshin, Lilenbaum, Rogerio, Johnson, David H.·2006·New England Journal of Medicine

DOI 10.1056/nejmoa061884

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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.)

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Authors: Sandler, A., Gray, R., Perry, M. C., Brahmer, J., Schiller, J. H., Dowlati, A., Lilenbaum, R., & Johnson, D. H.
Affiliations: Vanderbilt University (US)
Dana-Farber Cancer Institute (US)
University of Missouri (US)
Johns Hopkins University (US)
University of Wisconsin–Madison (US)
University Hospitals of Cleveland (US)
ORCID: Sandler, Alan
Gray, Robert
Brahmer, Julie
Schiller, Joan H.
Dowlati, Afshin
Johnson, David H.
Venue: New England Journal of Medicine
Publisher: Massachusetts Medical Society
Published: 2006-12-14
Volume: 355
Issue: 24
Pages: 2542-2550
ISSN: 0028-4793 (ISSN-L)
1533-4406
DOI: 10.1056/nejmoa061884
OpenAlex: W2145835533
Cited by: 5,761
References: 24
Citations by year: 2026: 49 · 2025: 71 · 2024: 112 · 2023: 135 · 2022: 177 · 2021: 183 · 2020: 180 · 2019: 227 · 2018: 257 · 2017: 278 · 2016: 321 · 2015: 389 · 2014: 400 · 2013: 461 · 2012: 513
FWCI: 299.17
Type: journal article
Language: en
Open access: bronze
doi.org
Locations: New England Journal of Medicine (publishedVersion)
PubMed (publishedVersion)
Funders: National Cancer Institute (U10CA066636, CA-23318, CA49957, U10CA016116, CA66636, U10CA012046, U10CA014548, CA-16116, CA14548, U10CA031946, CA21076, U10CA049957, U10CA021076, U10CA023318, U10CA021115, CA 21115, CA-31946, CA12046)
Topics: Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Lung Cancer Treatments and Mutations
Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Lung Cancer Diagnosis and Treatment
Health Sciences › Medicine › Oncology › Lung Cancer Research Studies
Keywords: non-small cell lung cancer, bevacizumab, paclitaxel, carboplatin, combination chemotherapy, vascular endothelial growth factor inhibition, overall survival, progression-free survival, pulmonary hemorrhage
MeSH terms: Bevacizumab, Aged, Antibodies, Monoclonal, Antineoplastic Combined Chemotherapy Protocols, Carcinoma, Non-Small-Cell Lung, Female, Humans, Lung Neoplasms, Male, Middle Aged, Carboplatin, Paclitaxel, Disease-Free Survival, Angiogenesis Inhibitors, Vascular Endothelial Growth Factor A, Kaplan-Meier Estimate, Antibodies, Monoclonal, Humanized

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

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