Safety and effectiveness of bevacizumab-containing treatment for non-small-cell lung cancer: Final results of the ARIES observational cohort study

Thomas J. Lynch, David R. Spigel, Julie Brahmer, Neal Fischbach, Jennifer Garst, Mohammad Jahanzeb, Priya Kumar, Regina M. Vidaver, Antoinette J. Wozniak, Susan Fish, E. Dawn Flick, Larry Leon, Sebastien J. Hazard, Michael P. Kosty

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Abstract

INTRODUCTION: Bevacizumab, a recombinant humanized monoclonal antibody against vascular endothelial growth factor, was approved by the US Food and Drug Administration for the treatment of advanced non-small-cell lung cancer (NSCLC) in combination with carboplatin and paclitaxel. ARIES (Avastin Regimens: Investigation of Effectiveness and Safety), a prospective observational cohort study, evaluated outcomes in a large, community-based population of patients with first-line NSCLC. METHODS: From 2006 to 2009, ARIES enrolled patients with locally advanced or metastatic NSCLC who were eligible for bevacizumab, excluding those with predominantly squamous histology. Patients were required to provide informed consent and to have initiated bevacizumab with chemotherapy within 4 months before enrollment. There were no protocol-defined treatments or assessments. The dosing of bevacizumab and chemotherapy, and the choice of chemotherapy regimen, was at the discretion of the treating physician. RESULTS: ARIES enrolled 1967 patients with first-line NSCLC. At study closure, median follow-up was 12.5 months (range, 0.2-65.5). Median age was 65 years (range, 31-93), and 252 patients (12.8%) identified as never smokers. Median progression-free survival was 6.6 months (95% confidence interval, 6.3-6.9), and median overall survival was 13.0 months (95% confidence interval, 12.2-13.8) with first-line bevacizumab plus chemotherapy. Incidences of bevacizumab-associated adverse events (19.7% overall) were consistent with those in randomized controlled trials of bevacizumab in NSCLC. CONCLUSION: Results from ARIES demonstrate similar outcomes to randomized controlled trials of bevacizumab when added to standard chemotherapy in a real-world patient population with advanced NSCLC.

Original languageEnglish
Pages (from-to)1332-1339
Number of pages8
JournalJournal of Thoracic Oncology
Volume9
Issue number9
DOIs
StatePublished - Jan 1 2014

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Non-Small Cell Lung Carcinoma
Observational Studies
Cohort Studies
Safety
Drug Therapy
Therapeutics
Bevacizumab
Randomized Controlled Trials
Confidence Intervals
Antibodies, Monoclonal, Humanized
Carboplatin
United States Food and Drug Administration
Patient Safety
Clinical Protocols
Paclitaxel
Informed Consent
Vascular Endothelial Growth Factor A
Population
Disease-Free Survival
Histology

Keywords

  • Bevacizumab
  • Chemotherapy
  • Non-small-cell lung cancer

ASJC Scopus subject areas

  • Oncology
  • Pulmonary and Respiratory Medicine

Cite this

Safety and effectiveness of bevacizumab-containing treatment for non-small-cell lung cancer : Final results of the ARIES observational cohort study. / Lynch, Thomas J.; Spigel, David R.; Brahmer, Julie; Fischbach, Neal; Garst, Jennifer; Jahanzeb, Mohammad; Kumar, Priya; Vidaver, Regina M.; Wozniak, Antoinette J.; Fish, Susan; Flick, E. Dawn; Leon, Larry; Hazard, Sebastien J.; Kosty, Michael P.

In: Journal of Thoracic Oncology, Vol. 9, No. 9, 01.01.2014, p. 1332-1339.

Research output: Contribution to journalArticle

Lynch, TJ, Spigel, DR, Brahmer, J, Fischbach, N, Garst, J, Jahanzeb, M, Kumar, P, Vidaver, RM, Wozniak, AJ, Fish, S, Flick, ED, Leon, L, Hazard, SJ & Kosty, MP 2014, 'Safety and effectiveness of bevacizumab-containing treatment for non-small-cell lung cancer: Final results of the ARIES observational cohort study', Journal of Thoracic Oncology, vol. 9, no. 9, pp. 1332-1339. https://doi.org/10.1097/JTO.0000000000000257
Lynch, Thomas J. ; Spigel, David R. ; Brahmer, Julie ; Fischbach, Neal ; Garst, Jennifer ; Jahanzeb, Mohammad ; Kumar, Priya ; Vidaver, Regina M. ; Wozniak, Antoinette J. ; Fish, Susan ; Flick, E. Dawn ; Leon, Larry ; Hazard, Sebastien J. ; Kosty, Michael P. / Safety and effectiveness of bevacizumab-containing treatment for non-small-cell lung cancer : Final results of the ARIES observational cohort study. In: Journal of Thoracic Oncology. 2014 ; Vol. 9, No. 9. pp. 1332-1339.
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abstract = "INTRODUCTION: Bevacizumab, a recombinant humanized monoclonal antibody against vascular endothelial growth factor, was approved by the US Food and Drug Administration for the treatment of advanced non-small-cell lung cancer (NSCLC) in combination with carboplatin and paclitaxel. ARIES (Avastin Regimens: Investigation of Effectiveness and Safety), a prospective observational cohort study, evaluated outcomes in a large, community-based population of patients with first-line NSCLC. METHODS: From 2006 to 2009, ARIES enrolled patients with locally advanced or metastatic NSCLC who were eligible for bevacizumab, excluding those with predominantly squamous histology. Patients were required to provide informed consent and to have initiated bevacizumab with chemotherapy within 4 months before enrollment. There were no protocol-defined treatments or assessments. The dosing of bevacizumab and chemotherapy, and the choice of chemotherapy regimen, was at the discretion of the treating physician. RESULTS: ARIES enrolled 1967 patients with first-line NSCLC. At study closure, median follow-up was 12.5 months (range, 0.2-65.5). Median age was 65 years (range, 31-93), and 252 patients (12.8{\%}) identified as never smokers. Median progression-free survival was 6.6 months (95{\%} confidence interval, 6.3-6.9), and median overall survival was 13.0 months (95{\%} confidence interval, 12.2-13.8) with first-line bevacizumab plus chemotherapy. Incidences of bevacizumab-associated adverse events (19.7{\%} overall) were consistent with those in randomized controlled trials of bevacizumab in NSCLC. CONCLUSION: Results from ARIES demonstrate similar outcomes to randomized controlled trials of bevacizumab when added to standard chemotherapy in a real-world patient population with advanced NSCLC.",
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AU - Fischbach, Neal

AU - Garst, Jennifer

AU - Jahanzeb, Mohammad

AU - Kumar, Priya

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AU - Leon, Larry

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