REAL LIFE OUTCOMES IN 1ST LINE NON-SQUAMOUS NON-SMALL CELL LUNG CANCER (NSCLC)- A PILOT STUDY IN FRANCE AND GERMANY ANALYSING BEVACIZUMAB-BASED VERSUS NON-BEVACIZUMAB-BASED TREATMENTS
Author(s)
Bischoff HG1, Chouaid C2, Vergnenegre A3, Heigener DF4, Taylor-Stokes G5, Roughley A5, Walzer S61Thoraxklinik Heidelberg GmbH, Hedelberg, Germany, 2Hôpital Saint Antoine, Paris cedex 12 , France, 3SIME, Limoges, France, 4Krankenhaus Grosshansdorf, Grossha
BACKGROUND Bevacizumab has been used in NSCLC in Europe since its regulatory approval in 2007. Bevacizumab has demonstrated significantly improved survival in randomized phase III trials. The real life outcomes have so far, however, been assessed only in the US with evidence from routine clinical practice not previously available in Europe. OBJECTIVES: To investigate Time to Progression (TTP) in two pilot countries and thus assess the feasibility of such studies in a wider European setting. The primary comparison was bevacizumab-based therapy versus non-bevacizumab-based therapy in first-line non-squamous NSCLC. METHODS: Data were drawn from the Adelphi NSCLC Disease Specific Programme, a large cross-sectional study of consecutively presenting patients in France and Germany in 2010. Physicians provided retrospective information regarding disease status and treatment patterns. TTP was defined as time from start of treatment to physician-reported disease progression or two weeks before the start of second-line therapy. A log rank test was applied to test for differences between the two comparison groups. Cox Proportional Hazard Models were fitted to the data. Sensitivity analyses were run to analyse if age was a prognostic factor for treatment benefit between the two groups. RESULTS: A total of 895 non-squamous patients were included in the analyses, of whom 421 had experienced disease progression. The median time to progression for bevacizumab-treated patients was 8.5 months compared with 6 months in the comparison group (p<0.001). The Hazard ratio relating to the treatment effect (bevacizumab-based versus non-bevacizumab based) was 0.65 (95% CI 0.52 to 0.81). The differences in TTP remain significant between the two first-line therapy groups even after controlling for age. CONCLUSIONS: The feasibility of using real life oncology studies in Europe to demonstrate extended TTP for bevacizumab-based versus non-bevacizumab therapy was shown and was consistent with findings of two phase III trials and real life outcomes from a US study.
Conference/Value in Health Info
2011-05, ISPOR 2011, Baltimore, MD, USA
Value in Health, Vol. 14, No. 3 (May 2011)
Code
PCN8
Topic
Clinical Outcomes
Topic Subcategory
Comparative Effectiveness or Efficacy
Disease
Oncology