First-line non-squamous non-small cell lung cancer (NSCLC)
Avastin, in combination with carboplatin and paclitaxel, is indicated for the first‑line treatment of patients with unresectable, locally advanced, recurrent or metastatic non–squamous non–small cell lung cancer.
nsNSCLC=non-squamous non-small cell lung cancer; PC=paclitaxel + carboplatin; OS=overall survival; HR=hazard ratio; CI=confidence interval.
The Warnings and Precautions for Avastin include gastrointestinal perforation and fistulae, surgery and wound healing complications, hemorrhage, arterial thromboembolic events, venous thromboembolic events, hypertension, posterior reversible encephalopathy syndrome, renal injury and proteinuria, infusion-related reactions, embryo-fetal toxicity, ovarian failure, and congestive heart failure.
Study E4599 was the first prospective Phase III randomized clinical trial of an FDA-approved biologic in first-line advanced non-squamous NSCLC to demonstrate statistically significant improvement in OS (>12 months), its primary endpoint, in an intent-to-treat population.[1,8]
The intent-to-treat population included all patients randomized before start of treatment. The results of Study E4599 included both progressors and non-progressors.[8]
In nsNSCLC, approval of Avastin is only in first line and as treatment to progression or unacceptable toxicity[1]
Adapted with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Non-Small Cell Lung Cancer V.5.2019. © 2019 National Comprehensive Cancer Network, Inc. The National Comprehensive Cancer Network makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application in any way. All rights reserved. The NCCN Guidelines® and illustrations herein may not be reproduced in any form for any purpose without the express written permission of NCCN. To view the most recent and complete version of the NCCN Guidelines, go online to NCCN.org. The NCCN Guidelines are a work in progress that may be refined as often as new significant data becomes available.[9]
*Chemotherapy given for up to 6 cycles.[1,8]
†PS 0-1 non-squamous NSCLC and no recent history of hemoptysis. Bevacizumab should not be given as a single agent unless as maintenance if initially used with chemotherapy. Any regimen with a high risk of thrombocytopenia and the potential risk of bleeding should be used with caution in combination with bevacizumab.[9]
Patients studied in ECOG Study E4599 included: |
---|
|
ECOG=Eastern Cooperative Oncology Group.
One patient in the Avastin plus PC arm was missing in the evaluation of histologies.
The intent-to-treat population included all patients randomized before start of treatment. The results of Study E4599 included both progressors and non-progressors. Baseline demographics and patient characteristics were evaluated for the intent-to-treat population. Histology information was not available for 1 patient in the Avastin + PC arm.[3,8,11]
The WARNINGS AND PRECAUTIONS section of the Avastin full Prescribing Information states: |
---|
In clinical studies in NSCLC where patients with CNS metastases who completed radiation and surgery more than 4 weeks prior to the start of Avastin were evaluated with serial CNS imaging, symptomatic grade 2 CNS hemorrhage was documented in 1 of 83 Avastin-treated patients (rate 1.2%; 95% CI, 0.06%–5.93%). [1] |
CNS=central nervous system.
Avastin Prescribing Information. Genentech, Inc. 2022.
Avastin Prescribing Information. Genentech, Inc. 2022.
Hurwitz H, Fehrenbacher L, Novotny W, et al. N Engl J Med. 2004;350:2335-2342. PMID: 15175435
Hurwitz H, Fehrenbacher L, Novotny W, et al. N Engl J Med. 2004;350:2335-2342. PMID: 15175435
Data on file. Genentech, Inc.
Data on file. Genentech, Inc.
Bennouna J, Sastre J, Arnold D, et al. Lancet Oncol. 2013;14:29-37.
Bennouna J, Sastre J, Arnold D, et al. Lancet Oncol. 2013;14:29-37.
Österlund P, Alonso-Orduña V, Schlichting C, et al. Poster presented at: European Society for Medical Oncology Meeting; September 28-October 2, 2012; Vienna, Austria.
Österlund P, Alonso-Orduña V, Schlichting C, et al. Poster presented at: European Society for Medical Oncology Meeting; September 28-October 2, 2012; Vienna, Austria.
Giantonio BJ, Catalano PJ, Meropol NJ, et al. J Clin Oncol. 2007;25:1539-1544. PMID: 17442997
Giantonio BJ, Catalano PJ, Meropol NJ, et al. J Clin Oncol. 2007;25:1539-1544. PMID: 17442997
Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Colon Cancer V.2.2019. © National Comprehensive Cancer Network, Inc. 2019. All rights reserved. Accessed July 24, 2019. To view the most recent and complete version of the guideline, go online to NCCN.org.
Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Colon Cancer V.2.2019. © National Comprehensive Cancer Network, Inc. 2019. All rights reserved. Accessed July 24, 2019. To view the most recent and complete version of the guideline, go online to NCCN.org.
Sandler A, Gray R, Perry MC, et al. N Engl J Med. 2006;355:2542-2550. PMID: 17167137
Sandler A, Gray R, Perry MC, et al. N Engl J Med. 2006;355:2542-2550. PMID: 17167137
Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Non-Small Cell Lung Cancer V.5.2019. © National Comprehensive Cancer Network, Inc. 2019. All rights reserved. Accessed July 24, 2019. To view the most recent and complete version of the guideline, go online to NCCN.org.
Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Non-Small Cell Lung Cancer V.5.2019. © National Comprehensive Cancer Network, Inc. 2019. All rights reserved. Accessed July 24, 2019. To view the most recent and complete version of the guideline, go online to NCCN.org.
Sandler AB, Schiller JH, Gray R, et al. J Clin Oncol. 2009;27:1405-1412.
Sandler AB, Schiller JH, Gray R, et al. J Clin Oncol. 2009;27:1405-1412.
Cohen MH, Gootenberg J, Keegan P, Pazdur R. Oncologist. 2007;12:713-718.
Cohen MH, Gootenberg J, Keegan P, Pazdur R. Oncologist. 2007;12:713-718.
Sandler A, Leon L, Fages S, et al. Poster presented at: World Conference on Lung Cancer; July 3-7, 2011; Amsterdam, The Netherlands.
Sandler A, Leon L, Fages S, et al. Poster presented at: World Conference on Lung Cancer; July 3-7, 2011; Amsterdam, The Netherlands.
Escudier B, Bellmunt J, Negrier S, et al. Slides presented at: Annual Meeting of the American Society of Clinical Oncology; May 29-June 2, 2009; Orlando, FL.
Escudier B, Bellmunt J, Negrier S, et al. Slides presented at: Annual Meeting of the American Society of Clinical Oncology; May 29-June 2, 2009; Orlando, FL.
Escudier B, Pluzanska A, Koralewski P, et al. Lancet. 2007;370:2103-2111. PMID: 18156031
Escudier B, Pluzanska A, Koralewski P, et al. Lancet. 2007;370:2103-2111. PMID: 18156031
Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Kidney Cancer V.1.2020. © National Comprehensive Cancer Network, Inc. 2019. All rights reserved. Accessed July 24, 2019. To view the most recent and complete version of the guideline, go online to NCCN.org.
Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Kidney Cancer V.1.2020. © National Comprehensive Cancer Network, Inc. 2019. All rights reserved. Accessed July 24, 2019. To view the most recent and complete version of the guideline, go online to NCCN.org.
Tewari KS, Sill MW, Long HJ III, et al. N Engl J Med. 2014;370:734-743 [supplementary appendix appears online].
Tewari KS, Sill MW, Long HJ III, et al. N Engl J Med. 2014;370:734-743 [supplementary appendix appears online].
Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Cervical Cancer V.4.2019. © National Comprehensive Cancer Network, Inc. 2019. All rights reserved. Accessed July 25, 2019. To view the most recent and complete version of the guideline, go online to NCCN.org.
Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Cervical Cancer V.4.2019. © National Comprehensive Cancer Network, Inc. 2019. All rights reserved. Accessed July 25, 2019. To view the most recent and complete version of the guideline, go online to NCCN.org.
Rich JT, Neely JG, Paniello RC, et al. Otolaryngol Head Neck Surg. 2010;143:331-336.
Rich JT, Neely JG, Paniello RC, et al. Otolaryngol Head Neck Surg. 2010;143:331-336.
Burger RA, Brady MF, Bookman MA, et al. N Engl J Med. 2011;365:2473-2483.
Burger RA, Brady MF, Bookman MA, et al. N Engl J Med. 2011;365:2473-2483.
Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Ovarian Cancer V.1.2019. © National Comprehensive Cancer Network, Inc. 2019. All rights reserved. Accessed July 24, 2019. To view the most recent and complete version of the guideline, go online to NCCN.org.
Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Ovarian Cancer V.1.2019. © National Comprehensive Cancer Network, Inc. 2019. All rights reserved. Accessed July 24, 2019. To view the most recent and complete version of the guideline, go online to NCCN.org.
Aghajanian C, Blank S, Goff B, et al. J Clin Oncol. 2012;30(17):2039-2045.
Aghajanian C, Blank S, Goff B, et al. J Clin Oncol. 2012;30(17):2039-2045.
Aghajanian C, Goff B, Nycum LR, et al. Gynecol Oncol. 2015;139(1):10-16.
Aghajanian C, Goff B, Nycum LR, et al. Gynecol Oncol. 2015;139(1):10-16.
Coleman RL, Brady MF, Herzog TJ, et al. Lancet Oncol. 2013;18(6):779-791.
Coleman RL, Brady MF, Herzog TJ, et al. Lancet Oncol. 2013;18(6):779-791.
Pujade-Lauraine E, Hilpert F, Weber B, et al. J Clin Oncol. 2014;32(13):1302-1308.
Pujade-Lauraine E, Hilpert F, Weber B, et al. J Clin Oncol. 2014;32(13):1302-1308.
Bevacizumab and lomustine for recurrent GBM. ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01290939. Updated February 21, 2018. Accessed July 24, 2019.
Bevacizumab and lomustine for recurrent GBM. ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01290939. Updated February 21, 2018. Accessed July 24, 2019.
Friedman HS, Prados MD, Wen PY, et al. J Clin Oncol. 2009;27:4733-4740.
Friedman HS, Prados MD, Wen PY, et al. J Clin Oncol. 2009;27:4733-4740.
Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Central Nervous System Cancers V.1.2019. © National Comprehensive Cancer Network, Inc. 2019. All rights reserved. Accessed July 24, 2019. To view the most recent and complete version of the guideline, go online to NCCN.org.
Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Central Nervous System Cancers V.1.2019. © National Comprehensive Cancer Network, Inc. 2019. All rights reserved. Accessed July 24, 2019. To view the most recent and complete version of the guideline, go online to NCCN.org.
Hicklin DJ, Ellis LM. J Clin Oncol. 2005;23:1011-1027.
Hicklin DJ, Ellis LM. J Clin Oncol. 2005;23:1011-1027.
Bergers G, Benjamin LE. Nat Rev Cancer. 2003;3:401-410.
Bergers G, Benjamin LE. Nat Rev Cancer. 2003;3:401-410.
Folkman J. In: DeVita VT Jr, Hellman S, Rosenberg SA, eds. Cancer: Principles & Practice of Oncology. Vol 2. 7th ed. Philadelphia, PA: Lippincott Williams & Wilkins; 2005:2865-2882.
Folkman J. In: DeVita VT Jr, Hellman S, Rosenberg SA, eds. Cancer: Principles & Practice of Oncology. Vol 2. 7th ed. Philadelphia, PA: Lippincott Williams & Wilkins; 2005:2865-2882.
Hanrahan V, Currie MJ, Gunningham SP, et al. J Pathol. 2003;200:183-194.
Hanrahan V, Currie MJ, Gunningham SP, et al. J Pathol. 2003;200:183-194.
Rini BI, Small EJ. J Clin Oncol. 2005;23:1028-1043.
Rini BI, Small EJ. J Clin Oncol. 2005;23:1028-1043.
Presta LG, Chen H, O’Connor SJ, et al. Cancer Res. 1997;57:4593-4599.
Presta LG, Chen H, O’Connor SJ, et al. Cancer Res. 1997;57:4593-4599.
Ferrara N. Endocr Rev. 2004;25:581-611.
Ferrara N. Endocr Rev. 2004;25:581-611.
Ferrara N, Hillan KJ, Gerber HP, et al. Nat Rev Drug Discov. 2004;3:391-400.
Ferrara N, Hillan KJ, Gerber HP, et al. Nat Rev Drug Discov. 2004;3:391-400.
O’Connor JPB, Carano RAD, Clamp AR, et al. Clin Cancer Res. 2009;15:6674-6682.
O’Connor JPB, Carano RAD, Clamp AR, et al. Clin Cancer Res. 2009;15:6674-6682.
Tobelem G. Targ Oncol. 2007;2:153-164.
Tobelem G. Targ Oncol. 2007;2:153-164.
Yuan F, Chen Y, Dellian M, et al. Proc Natl Acad Sci U S A. 1996;93:14765-14770.
Yuan F, Chen Y, Dellian M, et al. Proc Natl Acad Sci U S A. 1996;93:14765-14770.
Willett CG, Boucher Y, di Tomaso E, et al. Nat Med. 2004;10:145-147.
Willett CG, Boucher Y, di Tomaso E, et al. Nat Med. 2004;10:145-147.
Lee CG, Heijn M, di Tomaso E, et al. Cancer Res. 2000;60:5565-5570.
Lee CG, Heijn M, di Tomaso E, et al. Cancer Res. 2000;60:5565-5570.
Gerber HP, Ferrara N. Cancer Res. 2005;65:671-680.
Gerber HP, Ferrara N. Cancer Res. 2005;65:671-680.
Yanagisawa M, Yorozu K, Kurasawa M, et al. Anti-Cancer Drugs. 2010;21:687-694.
Yanagisawa M, Yorozu K, Kurasawa M, et al. Anti-Cancer Drugs. 2010;21:687-694.
Borgström P, Hillan KJ, Sriramarao P, et al. Cancer Res. 1996;56:4032-4039.
Borgström P, Hillan KJ, Sriramarao P, et al. Cancer Res. 1996;56:4032-4039.
Borgström P, Bourdon MA, Hillan KJ, et al. Prostate. 1998;35:1-10.
Borgström P, Bourdon MA, Hillan KJ, et al. Prostate. 1998;35:1-10.
Bagri A, Berry L, Gunter B, et al. Clin Cancer Res. 2010;16:3887-3900 [and supplemental appendix].
Bagri A, Berry L, Gunter B, et al. Clin Cancer Res. 2010;16:3887-3900 [and supplemental appendix].
Warren RS, Yuan H, Matli MR, et al. J Clin Invest. 1995;95:1789-1797.
Warren RS, Yuan H, Matli MR, et al. J Clin Invest. 1995;95:1789-1797.
Mabuchi S, Terai Y, Morishige K, et al. Clin Cancer Res. 2008;14:7781-7789.
Mabuchi S, Terai Y, Morishige K, et al. Clin Cancer Res. 2008;14:7781-7789.
Nagy JA, Dvorak AM, Dvorak HF. Annu Rev Pathol. 2007;2:251-275.
Nagy JA, Dvorak AM, Dvorak HF. Annu Rev Pathol. 2007;2:251-275.
Galizia G, Lieto E, Ferraraccio F, et al. Clin Cancer Res. 2004;10:3490-3499.
Galizia G, Lieto E, Ferraraccio F, et al. Clin Cancer Res. 2004;10:3490-3499.
Vosseler S, Mirancea N, Bohlen P, et al. Cancer Res. 2005;65:1294-1305.
Vosseler S, Mirancea N, Bohlen P, et al. Cancer Res. 2005;65:1294-1305.
MMIT Analysis.
MMIT Analysis.
IQVIA Plantrak Corticosteroid Data.
IQVIA Plantrak Corticosteroid Data.
HLI lives database.
HLI lives database.
The information contained in this section of the site is intended for U.S. healthcare professionals only. Click "OK" if you are a healthcare professional.
The link you have selected will take you away from this site to one that is not owned or controlled by Genentech, Inc. Genentech, Inc. makes no representation as to the accuracy of the information contained on sites we do not own or control. Genentech does not recommend and does not endorse the content on any third-party websites. Your use of third-party websites is at your own risk and subject to the terms and conditions of use for such sites.