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

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

doi:10.1056/nejmoa061884

Cited by 5,761Lung Cancer Treatments and MutationsLung Cancer Diagnosis and TreatmentLung Cancer Research Studies

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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Three studies using bevacizumab or anti-EGFR monoclonal antibodies given with chemotherapy and continued as monotherapy until progression showed survival benefits, but the specific contribution of the maintenance phase cannot be determined.
“three studies, one employing bevacizumab and the other two using monoclonal antibodies against EGFR (cetuximab or necitumumab) administered concomitantly to chemotherapy and further continued as monotherapy until disease progression, have demonstrated survival benefits, but the specific role of the maintenance phase cannot be appreciated in this context [52,58,84].”
From Metastatic non-small-cell lung cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up (2016) · cites this paper as [58]
In the pre-immunotherapy era, bevacizumab combined with paclitaxel and platinum was a standard first-line regimen for advanced non-squamous NSCLC.
“In the pre‐immunotherapy era, bevacizumab combined with paclitaxel and platinum was a standard first‐line regimen for advanced nsqNSCLC. 18”
From Bevacizumab plus nab‐paclitaxel and platinum as second‐line therapy for driver‐gene‐negative non‐squamous non‐small cell lung cancer after immunochemotherapy: A prospective single‐arm single‐centre study (2026) · cites this paper as [18]

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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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