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Journal of Clinical Oncology, Vol 22, No 11 (June 1), 2004: pp. 2184-2191
© 2004 American Society of Clinical Oncology.
DOI: 10.1200/JCO.2004.11.022
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Randomized Phase II Trial Comparing Bevacizumab Plus Carboplatin and Paclitaxel With Carboplatin and Paclitaxel Alone in Previously Untreated Locally Advanced or Metastatic Non-Small-Cell Lung Cancer

David H. Johnson, Louis Fehrenbacher, William F. Novotny, Roy S. Herbst, John J. Nemunaitis, David M. Jablons, Corey J. Langer, Russell F. DeVore, III, Jacques Gaudreault, Lisa A. Damico, Eric Holmgren, Fairooz Kabbinavar

From the Division of Hematology & Oncology, Vanderbilt University Medical School, Nashville, TN; Department of Thoracic/Head & Neck Medical Oncology, M.D. Anderson Cancer Center, Houston; US Oncology, Sammons Cancer Center, Baylor University Medical Center, Mary Crowley Medical Research Center, Dallas, TX; Kaiser Permanente, Vallejo; Thoracic Oncology Program, University of California San Francisco/Mount Zion Medical Center; Genentech Inc, South San Francisco, CA; and Fox Chase Cancer Center, Philadelphia, PA

Address reprint requests to David H. Johnson MD, Division of Hematology & Oncology, Vanderbilt University Medical School, 777 Preston Research Bldg, Nashville, TN; e-mail: david.johnson{at}vanderbilt.edu

PURPOSE: To investigate the efficacy and safety of bevacizumab plus carboplatin and paclitaxel in patients with advanced or recurrent non-small-cell lung cancer.

PATIENTS AND METHODS: In a phase II trial, 99 patients were randomly assigned to bevacizumab 7.5 (n = 32) or 15 mg/kg (n = 35) plus carboplatin (area under the curve = 6) and paclitaxel (200 mg/m2) every 3 weeks or carboplatin and paclitaxel alone (n = 32). Primary efficacy end points were time to disease progression and best confirmed response rate. On disease progression, patients in the control arm had the option to receive single-agent bevacizumab 15 mg/kg every 3 weeks.

RESULTS: Compared with the control arm, treatment with carboplatin and paclitaxel plus bevacizumab (15 mg/kg) resulted in a higher response rate (31.5% v 18.8%), longer median time to progression (7.4 v 4.2 months) and a modest increase in survival (17.7 v 14.9 months). Of the 19 control patients that crossed over to single-agent bevacizumab, five experienced stable disease, and 1-year survival was 47%. Bleeding was the most prominent adverse event and was manifested in two distinct clinical patterns; minor mucocutaneous hemorrhage and major hemoptysis. Major hemoptysis was associated with squamous cell histology, tumor necrosis and cavitation, and disease location close to major blood vessels.

CONCLUSION: Bevacizumab in combination with carboplatin and paclitaxel improved overall response and time to progression in patients with advanced or recurrent non-small-cell lung cancer. Patients with nonsquamous cell histology appear to be a subpopulation with improved outcome and acceptable safety risks.

Research support provided by Genentech, Inc, South San Francisco, CA.

Authors' disclosures of potential conflicts of interest are found at the end of this article.


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Bevacizumab-Induced Transient Remodeling of the Vasculature in Neuroblastoma Xenografts Results in Improved Delivery and Efficacy of Systemically Administered Chemotherapy
Clin. Cancer Res., July 1, 2007; 13(13): 3942 - 3950.
[Abstract] [Full Text] [PDF]

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 JNCI J Natl Cancer InstHome page
C. G. Azzoli, M. G. Kris, and D. G. Pfister
Cisplatin Versus Carboplatin for Patients With Metastatic Non-Small-Cell Lung Cancer--An Old Rivalry Renewed
J Natl Cancer Inst, June 6, 2007; 99(11): 828 - 829.
[Full Text] [PDF]

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 The OncologistHome page
M. H. Cohen, J. Gootenberg, P. Keegan, and R. Pazdur
FDA Drug Approval Summary: Bevacizumab (Avastin(R)) Plus Carboplatin and Paclitaxel as First-Line Treatment of Advanced/Metastatic Recurrent Nonsquamous Non-Small Cell Lung Cancer
Oncologist, June 1, 2007; 12(6): 713 - 718.
[Abstract] [Full Text] [PDF]

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 Nephrol Dial TransplantHome page
H. Izzedine, I. Brocheriou, G. Deray, and O. Rixe
Thrombotic microangiopathy and anti-VEGF agents
Nephrol. Dial. Transplant., May 1, 2007; 22(5): 1481 - 1482.
[Full Text] [PDF]

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 Clin. Cancer Res.Home page
A. Norden-Zfoni, J. Desai, J. Manola, P. Beaudry, J. Force, R. Maki, J. Folkman, C. Bello, C. Baum, S. E. DePrimo, et al.
Blood-Based Biomarkers of SU11248 Activity and Clinical Outcome in Patients with Metastatic Imatinib-Resistant Gastrointestinal Stromal Tumor
Clin. Cancer Res., May 1, 2007; 13(9): 2643 - 2650.
[Abstract] [Full Text] [PDF]

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 Clin. Cancer Res.Home page
G. Giaccone
The Potential of Antiangiogenic Therapy in Non-Small Cell Lung Cancer
Clin. Cancer Res., April 1, 2007; 13(7): 1961 - 1970.
[Abstract] [Full Text] [PDF]

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 The OncologistHome page
S. Senan and E. F. Smit
Design of Clinical Trials of Radiation Combined with Antiangiogenic Therapy
Oncologist, April 1, 2007; 12(4): 465 - 477.
[Abstract] [Full Text] [PDF]

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 NEJMHome page
M. C. Garassino, L. Hollander, V. Torri, G. R. Oxnard, J.-P. Sculier, A.-P. Meert, M. Paesmans, G. Sonpavde, A. Sandler, R. Gray, et al.
Bevacizumab for Non-Small-Cell Lung Cancer
N. Engl. J. Med., March 29, 2007; 356(13): 1373 - 1375.
[Full Text] [PDF]

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 Mol Cancer ResHome page
J. Tabernero
The Role of VEGF and EGFR Inhibition: Implications for Combining Anti-VEGF and Anti-EGFR Agents
Mol. Cancer Res., March 1, 2007; 5(3): 203 - 220.
[Abstract] [Full Text] [PDF]

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 Am. J. Physiol. Lung Cell. Mol. Physiol.Home page
M. K. Sakurai, S. Lee, D. A. Arsenault, V. Nose, J. M. Wilson, J. V. Heymach, and M. Puder
Vascular endothelial growth factor accelerates compensatory lung growth after unilateral pneumonectomy
Am J Physiol Lung Cell Mol Physiol, March 1, 2007; 292(3): L742 - L747.
[Abstract] [Full Text] [PDF]

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 NEJMHome page
A. Sandler, R. Gray, M. C. Perry, J. Brahmer, J. H. Schiller, A. Dowlati, R. Lilenbaum, and D. H. Johnson
Paclitaxel-Carboplatin Alone or with Bevacizumab for Non-Small-Cell Lung Cancer
N. Engl. J. Med., December 14, 2006; 355(24): 2542 - 2550.
[Abstract] [Full Text] [PDF]

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 Cancer Res.Home page
C. Cao, J. M. Albert, L. Geng, P. S. Ivy, A. Sandler, D. H. Johnson, and B. Lu
Vascular Endothelial Growth Factor Tyrosine Kinase Inhibitor AZD2171 and Fractionated Radiotherapy in Mouse Models of Lung Cancer
Cancer Res., December 1, 2006; 66(23): 11409 - 11415.
[Abstract] [Full Text] [PDF]

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 JCOHome page
M. P. Fanucchi, F. V. Fossella, R. Belt, R. Natale, P. Fidias, D. P. Carbone, R. Govindan, L. E. Raez, F. Robert, M. Ribeiro, et al.
Randomized Phase II Study of Bortezomib Alone and Bortezomib in Combination With Docetaxel in Previously Treated Advanced Non-Small-Cell Lung Cancer
J. Clin. Oncol., November 1, 2006; 24(31): 5025 - 5033.
[Abstract] [Full Text] [PDF]

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 The OncologistHome page
T. A. Traina, L. Norton, K. Drucker, and B. Singh
Nasal Septum Perforation in a Bevacizumab-Treated Patient with Metastatic Breast Cancer
Oncologist, November 1, 2006; 11(10): 1070 - 1071.
[Full Text] [PDF]

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 ChestHome page
J. R. Molina, A. A. Adjei, and J. R. Jett
Advances in Chemotherapy of Non-small Cell Lung Cancer.
Chest, October 1, 2006; 130(4): 1211 - 1219.
[Abstract] [Full Text] [PDF]

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 Clin. Cancer Res.Home page
J. Ruan, E. Hyjek, P. Kermani, P. J. Christos, A. T. Hooper, M. Coleman, B. Hempstead, J. P. Leonard, A. Chadburn, and S. Rafii
Magnitude of Stromal Hemangiogenesis Correlates with Histologic Subtype of Non-Hodgkin's Lymphoma.
Clin. Cancer Res., October 1, 2006; 12(19): 5622 - 5631.
[Abstract] [Full Text] [PDF]

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 Molecular Cancer TherapeuticsHome page
M. Muruganandham, M. Lupu, J. P. Dyke, C. Matei, M. Linn, K. Packman, K. Kolinsky, B. Higgins, and J. A. Koutcher
Preclinical evaluation of tumor microvascular response to a novel antiangiogenic/antitumor agent RO0281501 by dynamic contrast-enhanced MRI at 1.5 T.
Mol. Cancer Ther., August 1, 2006; 5(8): 1950 - 1957.
[Abstract] [Full Text] [PDF]

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 Ann OncolHome page
J. A. Gietema, R. Hoekstra, F. Y. F. L. de Vos, D. R. A. Uges, A. van der Gaast, H. J. M. Groen, W. J. Loos, R. A. Knight, R. A. Carr, R. A. Humerickhouse, et al.
A phase I study assessing the safety and pharmacokinetics of the thrombospondin-1-mimetic angiogenesis inhibitor ABT-510 with gemcitabine and cisplatin in patients with solid tumors
Ann. Onc., August 1, 2006; 17(8): 1320 - 1327.
[Abstract] [Full Text] [PDF]

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 Clin. Cancer Res.Home page
A. Sandler and R. Herbst
Combining targeted agents: blocking the epidermal growth factor and vascular endothelial growth factor pathways.
Clin. Cancer Res., July 15, 2006; 12(14): 4421s - 4425s.
[Abstract] [Full Text] [PDF]

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 The OncologistHome page
A. Morabito, E. De Maio, M. Di Maio, N. Normanno, and F. Perrone
Tyrosine Kinase Inhibitors of Vascular Endothelial Growth Factor Receptors in Clinical Trials: Current Status and Future Directions
Oncologist, July 1, 2006; 11(7): 753 - 764.
[Abstract] [Full Text] [PDF]

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 The OncologistHome page
T. E. Stinchcombe, D. Fried, D. E. Morris, and M. A. Socinski
Combined Modality Therapy for Stage III Non-Small Cell Lung Cancer
Oncologist, July 1, 2006; 11(7): 809 - 823.
[Abstract] [Full Text] [PDF]

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 Cancer Res.Home page
R. Kim, M. Emi, K. Tanabe, and K. Arihiro
Tumor-Driven Evolution of Immunosuppressive Networks during Malignant Progression
Cancer Res., June 1, 2006; 66(11): 5527 - 5536.
[Abstract] [Full Text] [PDF]

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 Clin. Cancer Res.Home page
J. R. Tonra, D. S. Deevi, E. Corcoran, H. Li, S. Wang, F. E. Carrick, and D. J. Hicklin
Synergistic antitumor effects of combined epidermal growth factor receptor and vascular endothelial growth factor receptor-2 targeted therapy.
Clin. Cancer Res., April 1, 2006; 12(7): 2197 - 2207.
[Abstract] [Full Text] [PDF]

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 The OncologistHome page
D. S. Ettinger
Clinical Implications of EGFR Expression in the Development and Progression of Solid Tumors: Focus on Non-Small Cell Lung Cancer.
Oncologist, April 1, 2006; 11(4): 358 - 373.
[Abstract] [Full Text] [PDF]

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 Integr Cancer TherHome page
D. R. Yance Jr and S. M. Sagar
Targeting Angiogenesis With Integrative Cancer Therapies
Integr Cancer Ther, March 1, 2006; 5(1): 9 - 29.
[Abstract] [PDF]

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 Ann OncolHome page
W. Voigt, T. Kegel, G. Maher, K. Jordan, L. Muller, and H.-J. Schmoll
Bevacizumab plus high-dose ifosfamide, etoposide and carboplatin (HD-ICE) as third-line salvage chemotherapy induced an unexpected dramatic response in highly platinum refractory germ-cell cancer
Ann. Onc., March 1, 2006; 17(3): 531 - 533.
[Full Text] [PDF]

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 Ann OncolHome page
I. Dimopoulou, A. Bamias, P. Lyberopoulos, and M. A. Dimopoulos
Pulmonary toxicity from novel antineoplastic agents
Ann. Onc., March 1, 2006; 17(3): 372 - 379.
[Abstract] [Full Text] [PDF]

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 The OncologistHome page
P. Maione, C. Gridelli, T. Troiani, and F. Ciardiello
Combining Targeted Therapies and Drugs with Multiple Targets in the Treatment of NSCLC.
Oncologist, March 1, 2006; 11(3): 274 - 284.
[Abstract] [Full Text] [PDF]

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 Cancer Res.Home page
A. J. Garton, A. P.A. Crew, M. Franklin, A. R. Cooke, G. M. Wynne, L. Castaldo, J. Kahler, S. L. Winski, A. Franks, E. N. Brown, et al.
OSI-930: A Novel Selective Inhibitor of Kit and Kinase Insert Domain Receptor Tyrosine Kinases with Antitumor Activity in Mouse Xenograft Models
Cancer Res., January 15, 2006; 66(2): 1015 - 1024.
[Abstract] [Full Text] [PDF]

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 JCOHome page
S. Faivre, C. Delbaldo, K. Vera, C. Robert, S. Lozahic, N. Lassau, C. Bello, S. Deprimo, N. Brega, G. Massimini, et al.
Safety, Pharmacokinetic, and Antitumor Activity of SU11248, a Novel Oral Multitarget Tyrosine Kinase Inhibitor, in Patients With Cancer
J. Clin. Oncol., January 1, 2006; 24(1): 25 - 35.
[Abstract] [Full Text] [PDF]

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 Ann OncolHome page
A. Kurup, C.-W. Lin, D. J. Murry, L. Dobrolecki, D. Estes, C. T. Yiannoutsos, L. Mariano, C. Sidor, R. Hickey, and N. Hanna
Recombinant human angiostatin (rhAngiostatin) in combination with paclitaxel and carboplatin in patients with advanced non-small-cell lung cancer: a phase II study from Indiana University
Ann. Onc., January 1, 2006; 17(1): 97 - 103.
[Abstract] [Full Text] [PDF]

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 The OncologistHome page
D. Dornbusch, C. Allegra, J. Willey, M. Andrews, R. Leff, J. Epstein, J. Jones, L. Lokey, and M. R. Green
How Do U.S. Medical Oncologists Learn and Apply New Clinical Trials Information from Press Releases in Nonmedical Media? A Case Study Based on ECOG 4599
Oncologist, January 1, 2006; 11(1): 31 - 38.
[Abstract] [Full Text] [PDF]

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 The OncologistHome page
O. Belvedere and F. Grossi
Lung Cancer Highlights from ASCO 2005
Oncologist, January 1, 2006; 11(1): 39 - 50.
[Abstract] [Full Text] [PDF]


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