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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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R. S. Herbst and A. Sandler
Bevacizumab and Erlotinib: A Promising New Approach to the Treatment of Advanced NSCLC
Oncologist, November 1, 2008; 13(11): 1166 - 1176.
[Abstract] [Full Text] [PDF]

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 Eur Heart JHome page
D. Pereg and M. Lishner
Bevacizumab treatment for cancer patients with cardiovascular disease: a double edged sword?
Eur. Heart J., October 1, 2008; 29(19): 2325 - 2326.
[Abstract] [Full Text] [PDF]

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 JCOHome page
S. A. Cannistra
Challenges and Pitfalls of Combining Targeted Agents in Phase I Studies
J. Clin. Oncol., August 1, 2008; 26(22): 3665 - 3667.
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 Neuro OncolHome page
C. P. Carden, J. M.G. Larkin, and M. A. Rosenthal
What is the risk of intracranial bleeding during anti-VEGF therapy?
Neuro Oncology, August 1, 2008; 10(4): 624 - 630.
[Abstract] [Full Text] [PDF]

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 JCOHome page
R. Leff and M. Andrews
Predicting Success in Phase III Studies From Phase II Results: A New Paradigm Is Needed
J. Clin. Oncol., July 20, 2008; 26(21): 3653 - 3654.
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 JCOHome page
G. V. Scagliotti, P. Parikh, J. von Pawel, B. Biesma, J. Vansteenkiste, C. Manegold, P. Serwatowski, U. Gatzemeier, R. Digumarti, M. Zukin, et al.
Phase III Study Comparing Cisplatin Plus Gemcitabine With Cisplatin Plus Pemetrexed in Chemotherapy-Naive Patients With Advanced-Stage Non-Small-Cell Lung Cancer
J. Clin. Oncol., July 20, 2008; 26(21): 3543 - 3551.
[Abstract] [Full Text] [PDF]

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 ChestHome page
W. H. Geerts, D. Bergqvist, G. F. Pineo, J. A. Heit, C. M. Samama, M. R. Lassen, and C. W. Colwell
Prevention of Venous Thromboembolism: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (8th Edition)
Chest, June 1, 2008; 133(6_suppl): 381S - 453S.
[Abstract] [Full Text] [PDF]

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 Am. J. Respir. Crit. Care Med.Home page
S. Dubey and C. A. Powell
Update in Lung Cancer 2007
Am. J. Respir. Crit. Care Med., May 1, 2008; 177(9): 941 - 946.
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P. S. Hodkinson, A. MacKinnon, and T. Sethi
Targeting Growth Factors in Lung Cancer
Chest, May 1, 2008; 133(5): 1209 - 1216.
[Abstract] [Full Text] [PDF]

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 JCOHome page
L. B. Saltz, S. Clarke, E. Diaz-Rubio, W. Scheithauer, A. Figer, R. Wong, S. Koski, M. Lichinitser, T.-S. Yang, F. Rivera, et al.
Bevacizumab in Combination With Oxaliplatin-Based Chemotherapy As First-Line Therapy in Metastatic Colorectal Cancer: A Randomized Phase III Study
J. Clin. Oncol., April 20, 2008; 26(12): 2013 - 2019.
[Abstract] [Full Text] [PDF]

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 JCOHome page
S. A. Laurie, I. Gauthier, A. Arnold, F. A. Shepherd, P. M. Ellis, E. Chen, G. Goss, J. Powers, W. Walsh, D. Tu, et al.
Phase I and Pharmacokinetic Study of Daily Oral AZD2171, an Inhibitor of Vascular Endothelial Growth Factor Tyrosine Kinases, in Combination With Carboplatin and Paclitaxel in Patients With Advanced Non-Small-Cell Lung Cancer: The National Cancer Institute of Canada Clinical Trials Group
J. Clin. Oncol., April 10, 2008; 26(11): 1871 - 1878.
[Abstract] [Full Text] [PDF]

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 JCOHome page
A. Dowlati and P. Fu
Is Response Rate Relevant to the Phase II Trial Design of Targeted Agents?
J. Clin. Oncol., March 10, 2008; 26(8): 1204 - 1205.
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 Ann OncolHome page
B. D. Badgwell, E. R. Camp, B. Feig, R. A. Wolff, C. Eng, L. M. Ellis, and J. N. Cormier
Management of bevacizumab-associated bowel perforation: a case series and review of the literature
Ann. Onc., March 1, 2008; 19(3): 577 - 582.
[Abstract] [Full Text] [PDF]

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 Clin. Cancer Res.Home page
C. Salvador, B. Li, R. Hansen, D. E. Cramer, M. Kong, and J. Yan
Yeast-Derived {beta}-Glucan Augments the Therapeutic Efficacy Mediated by Anti-Vascular Endothelial Growth Factor Monoclonal Antibody in Human Carcinoma Xenograft Models
Clin. Cancer Res., February 15, 2008; 14(4): 1239 - 1247.
[Abstract] [Full Text] [PDF]

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 JCOHome page
M. A. Socinski, S. Novello, J. R. Brahmer, R. Rosell, J. M. Sanchez, C. P. Belani, R. Govindan, J. N. Atkins, H. H. Gillenwater, C. Pallares, et al.
Multicenter, Phase II Trial of Sunitinib in Previously Treated, Advanced Non-Small-Cell Lung Cancer
J. Clin. Oncol., February 1, 2008; 26(4): 650 - 656.
[Abstract] [Full Text] [PDF]

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 ChestHome page
B. Vahid and P. E. Marik
Pulmonary Complications of Novel Antineoplastic Agents for Solid Tumors*
Chest, February 1, 2008; 133(2): 528 - 538.
[Abstract] [Full Text] [PDF]

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 JCOHome page
G. H. Lyman, A. A. Khorana, A. Falanga, D. Clarke-Pearson, C. Flowers, M. Jahanzeb, A. Kakkar, N. M. Kuderer, M. N. Levine, H. Liebman, et al.
American Society of Clinical Oncology Guideline: Recommendations for Venous Thromboembolism Prophylaxis and Treatment in Patients With Cancer
J. Clin. Oncol., December 1, 2007; 25(34): 5490 - 5505.
[Abstract] [Full Text] [PDF]

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S. de Bouard, P. Herlin, J. G. Christensen, E. Lemoisson, P. Gauduchon, E. Raymond, and J.-S. Guillamo
Antiangiogenic and anti-invasive effects of sunitinib on experimental human glioblastoma
Neuro Oncology, October 1, 2007; 9(4): 412 - 423.
[Abstract] [Full Text] [PDF]

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 Clin. Cancer Res.Home page
Q. Li, S. Yano, H. Ogino, W. Wang, H. Uehara, Y. Nishioka, and S. Sone
The Therapeutic Efficacy of Anti Vascular Endothelial Growth Factor Antibody, Bevacizumab, and Pemetrexed against Orthotopically Implanted Human Pleural Mesothelioma Cells in Severe Combined Immunodeficient Mice
Clin. Cancer Res., October 1, 2007; 13(19): 5918 - 5925.
[Abstract] [Full Text] [PDF]

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S. Ekman, M. Bergqvist, C.-H. Heldin, and J. Lennartsson
Activation of Growth Factor Receptors in Esophageal Cancer Implications for Therapy
Oncologist, October 1, 2007; 12(10): 1165 - 1177.
[Abstract] [Full Text] [PDF]

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C. Gridelli, P. Maione, A. Rossi, and F. De Marinis
The Role of Bevacizumab in the Treatment of Non-Small Cell Lung Cancer: Current Indications and Future Developments
Oncologist, October 1, 2007; 12(10): 1183 - 1193.
[Abstract] [Full Text] [PDF]

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 JCOHome page
J. V. Heymach, B. E. Johnson, D. Prager, E. Csada, J. Roubec, M. Pesek, I. Spasova, C. P. Belani, I. Bodrogi, S. Gadgeel, et al.
Randomized, Placebo-Controlled Phase II Study of Vandetanib Plus Docetaxel in Previously Treated Non Small-Cell Lung Cancer
J. Clin. Oncol., September 20, 2007; 25(27): 4270 - 4277.
[Abstract] [Full Text] [PDF]

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 JCOHome page
I. E. Haines
A Positive Step Forward, but More Needed to Maximize Cost Benefits of New-Generation Cancer Therapies
J. Clin. Oncol., September 1, 2007; 25(25): e31 - e32.
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 ChestHome page
M. A. Socinski, R. Crowell, T. E. Hensing, C. J. Langer, R. Lilenbaum, A. B. Sandler, and D. Morris
Treatment of Non-small Cell Lung Cancer, Stage IV: ACCP Evidence-Based Clinical Practice Guidelines (2nd Edition)
Chest, September 1, 2007; 132(3_suppl): 277S - 289S.
[Abstract] [Full Text] [PDF]

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 JNCI J Natl Cancer InstHome page
F. A. Scappaticci, J. R. Skillings, S. N. Holden, H.-P. Gerber, K. Miller, F. Kabbinavar, E. Bergsland, J. Ngai, E. Holmgren, J. Wang, et al.
Arterial Thromboembolic Events in Patients with Metastatic Carcinoma Treated with Chemotherapy and Bevacizumab
J Natl Cancer Inst, August 15, 2007; 99(16): 1232 - 1239.
[Abstract] [Full Text] [PDF]

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 Clin. Cancer Res.Home page
A. Sandler
Bevacizumab in Non Small Cell Lung Cancer
Clin. Cancer Res., August 1, 2007; 13(15): 4613s - 4616s.
[Abstract] [Full Text] [PDF]

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 Clin. Cancer Res.Home page
E. O. Hanrahan and J. V. Heymach
Vascular Endothelial Growth Factor Receptor Tyrosine Kinase Inhibitors Vandetanib (ZD6474) and AZD2171 in Lung Cancer
Clin. Cancer Res., August 1, 2007; 13(15): 4617s - 4622s.
[Abstract] [Full Text] [PDF]

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 Clin. Cancer Res.Home page
G. J. Riely and V. A. Miller
Vascular Endothelial Growth Factor Trap in Non Small Cell Lung Cancer
Clin. Cancer Res., August 1, 2007; 13(15): 4623s - 4627s.
[Abstract] [Full Text] [PDF]


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