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Cited by 1,505

The DOI matches its Crossref record; 6 of the 6 references it cites were found in a registry or an index.

Phase III Trial of Cisplatin Plus Gemcitabine With Either Placebo or Bevacizumab As First-Line Therapy for Nonsquamous Non–Small-Cell Lung Cancer: AVAiL

Reck, Martin, von Pawel, Joachim, Zatloukal, Petr, Ramlau, Rodryg, Gorbounova, Vera, Hirsh, Vera, Leighl, Natasha, Mezger, Jörg, Archer, Venice, Moore, Nicola, Manegold, Christian·2009·Journal of Clinical Oncology

Abstract

Purpose: Bevacizumab, a monoclonal antibody targeting vascular endothelial growth factor, improves survival when combined with carboplatin/paclitaxel for advanced nonsquamous non–small-cell lung cancer (NSCLC). This randomized phase III trial investigated the efficacy and safety of cisplatin/gemcitabine (CG) plus bevacizumab in this setting. Patients and Methods: Patients were randomly assigned to receive cisplatin 80 mg/m 2 and gemcitabine 1,250 mg/m 2 for up to six cycles plus low-dose bevacizumab (7.5 mg/kg), high-dose bevacizumab (15 mg/kg), or placebo every 3 weeks until disease progression. The trial was not powered to compare the two doses directly. The primary end point was amended from overall survival (OS) to progression-free survival (PFS). Between February 2005 and August 2006, 1,043 patients were randomly assigned (placebo, n = 347; low dose, n = 345; high dose, n = 351). Results: PFS was significantly prolonged; the hazard ratios for PFS were 0.75 (median PFS, 6.7 v 6.1 months for placebo; P = .003) in the low-dose group and 0.82 (median PFS, 6.5 v 6.1 months for placebo; P = .03) in the high-dose group compared with placebo. Objective response rates were 20.1%, 34.1%, and 30.4% for placebo, low-dose bevacizumab, and high-dose bevacizumab plus CG, respectively. Duration of follow-up was not sufficient for OS analysis. Incidence of grade 3 or greater adverse events was similar across arms. Grade ≥ 3 pulmonary hemorrhage rates were ≤ 1.5% for all arms despite 9% of patients receiving therapeutic anticoagulation. Conclusion: Combining bevacizumab (7.5 or 15 mg/kg) with CG significantly improved PFS and objective response rate. Bevacizumab plus platinum-based chemotherapy offers clinical benefit for bevacizumab-eligible patients with advanced NSCLC.

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Metadata

Authors
Reck, M., von Pawel, J., Zatloukal, P., Ramlau, R., Gorbounova, V., Hirsh, V., Leighl, N., Mezger, J., Archer, V., Moore, N., & Manegold, C.
Venue
Journal of Clinical Oncology
Published
2009-03-10
Volume
27
Issue
8
Pages
1227-1234
ISSN
  • 0732-183X (ISSN-L)
  • 1527-7755
OpenAlex
W2144660856
Cited by
1,505
References
6
FWCI
148.39
Type
journal article
Language
en
Open access
closed

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CoChat. (2026). Citation check: Phase III Trial of Cisplatin Plus Gemcitabine With Either Placebo or Bevacizumab As First-Line Therapy for Nonsquamous Non–Small-Cell Lung Cancer: AVAiL. https://app.cochat.ai/papers/10.1200/jco.2007.14.5466
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Reck, M., von Pawel, J., Zatloukal, P., Ramlau, R., Gorbounova, V., Hirsh, V., Leighl, N., Mezger, J., Archer, V., Moore, N., & Manegold, C. (2009). Phase III Trial of Cisplatin Plus Gemcitabine With Either Placebo or Bevacizumab As First-Line Therapy for Nonsquamous Non–Small-Cell Lung Cancer: AVAiL. Journal of Clinical Oncology. https://doi.org/10.1200/jco.2007.14.5466

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