Paclitaxel-carboplatin alone or with bevacizumab for non-small-cell lung cancer

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

Research output: Contribution to journalArticle

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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.)

Original languageEnglish (US)
Pages (from-to)2542-2550
Number of pages9
JournalNew England Journal of Medicine
Volume355
Issue number24
DOIs
StatePublished - Dec 14 2006

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Carboplatin
Paclitaxel
Non-Small Cell Lung Carcinoma
Drug Therapy
Survival
Disease Progression
Hemorrhage
Hemoptysis
Poisons
Brain Neoplasms
Vascular Endothelial Growth Factor A
Disease-Free Survival
Bevacizumab
Therapeutics
Epithelial Cells
Monoclonal Antibodies
Neoplasm Metastasis
Lung
Neoplasms

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Sandler, A., Gray, R., Perry, M. C., Brahmer, J., Schiller, J. H., Dowlati, A., ... Johnson, D. H. (2006). Paclitaxel-carboplatin alone or with bevacizumab for non-small-cell lung cancer. New England Journal of Medicine, 355(24), 2542-2550. https://doi.org/10.1056/NEJMoa061884

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.

In: New England Journal of Medicine, Vol. 355, No. 24, 14.12.2006, p. 2542-2550.

Research output: Contribution to journalArticle

Sandler, A, Gray, R, Perry, MC, Brahmer, J, Schiller, JH, Dowlati, A, Lilenbaum, R & Johnson, DH 2006, 'Paclitaxel-carboplatin alone or with bevacizumab for non-small-cell lung cancer', New England Journal of Medicine, vol. 355, no. 24, pp. 2542-2550. https://doi.org/10.1056/NEJMoa061884
Sandler A, Gray R, Perry MC, Brahmer J, Schiller JH, Dowlati A et al. Paclitaxel-carboplatin alone or with bevacizumab for non-small-cell lung cancer. New England Journal of Medicine. 2006 Dec 14;355(24):2542-2550. https://doi.org/10.1056/NEJMoa061884
Sandler, Alan ; Gray, Robert ; Perry, Michael C. ; Brahmer, Julie ; Schiller, Joan H. ; Dowlati, Afshin ; Lilenbaum, Rogerio ; Johnson, David H. / Paclitaxel-carboplatin alone or with bevacizumab for non-small-cell lung cancer. In: New England Journal of Medicine. 2006 ; Vol. 355, No. 24. pp. 2542-2550.
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AU - Sandler, Alan

AU - Gray, Robert

AU - Perry, Michael C.

AU - Brahmer, Julie

AU - Schiller, Joan H.

AU - Dowlati, Afshin

AU - Lilenbaum, Rogerio

AU - Johnson, David H.

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N2 - 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.)

AB - 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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