P-254 - A multicentre, non-interventional, post-authorization study to observe in daily clinical practice the treatment duration of patients treated with be...

Date 04 July 2015
Event WorldGI 2015
Session Posters
Topics Anticancer agents
Colon and Rectal Cancer
Biological Therapy
Presenter J.-C. Goeminne
Citation Annals of Oncology (2015) 26 (suppl_4): 1-100. 10.1093/annonc/mdv233
Authors J.-. Goeminne1, J.-. Vandenbulcke2, A. Bols3, L. Marcelis4, J. Arts5, B. Naessens6, M. De Man7, D. Frijns8, J. Decaestecker9
  • 1Clinique Sainte Elisabeth Namur, Namur/BE
  • 2CHWapi Tournai, Tournai/BE
  • 3AZ Sint Jan Brugge, Brugge/BE
  • 4CHIREC sites Clinique du Parc Léopold, Brussels/BE
  • 5AZ St.?Lucas Brugge, Assebroek/BE
  • 6AZ Nikolaas, Sint-Niklaas/BE
  • 7UZ Gent, Gent/BE
  • 8Roche NV/SA Belgium, Brussels/BE
  • 9Heilig Hart Ziekenhuis Roeselare, Roeselare/BE



Bevacizumab, an antibody that binds circulating VEGF-A, increases the activity of cytotoxic regimen for first-line treatment of mCRC. FOLFIRI, FOLFOX and XELOX are active 1line regimen for mCRC. This real life study aims to complement the knowledge on bevacizumab use in current practice in Belgium.


This was a multi-centre, non-interventional, post-authorization study in patients with first line chemotherapy for mCRC, for whom the physician decided to prescribe bevacizumab. Dosing and treatment were at the discretion of the Investigator and in accordance with Belgian labelling. Twenty Belgian centres were involved in the study to collect data of 200 patients. The primary objective was to observe in daily clinical practice the treatment duration of bevacizumab in first line mCRC. Secondary objectives were to determine the PFS of bevacizumab treatment and to identify the reasons for stopping the bevacizumab treatment.


From January 2010 until July 2011 a total of 201 patients were enrolled in the study, 199 patients received bevacizumab. 58.3% of the patients were men, mean age was 66.3 years. Baseline ECOG performance status of 0, 1 or ≥2 was observed in 43.9% (79/180), 46.7% (84/180) and 9.4% (17/180) of patients respectively. 152 (76.4%) patients received FOLFIRI chemotherapy and 39 patients (19.6%) FOLFOX or XELOX chemotherapy. Overall, the median Kaplan-Meier estimate for treatment duration was 5.95 months (95% CI 5.09-6.80), estimated treatment duration for patients treated with FOLFIRI 6.01 months (95% CI 5.09-6.93), estimated treatment duration for patients treated with FOLFOX/XELOX 4.14 months (95% CI 2.10-6.14). Metastases in the liver were associated with a higher probability of shorter treatment duration. The median Kaplan-Meier estimate for PFS was 11.53 months (95% CI 9.86-13.73), estimated PFS for the FOLFIRI treated patients 12.8 months (95% CI 9.72-14.42), estimated PFS for the FOLFOX/XELOX treated patients 8.54 months (95% CI 6.21-20.73). Reasons for ending the bevacizumab treatment were progressive disease 46.3%, physician decision 20.1%, metastasectomy 6.5%, unacceptable toxicity 6.0%, death 5.0%. No new safety alerts were observed. The toxicity profile confirmed what was known with bevacizumab.


The observed treatment duration and PFS are in line and even tend to be higher compared to recently published studies like CALGB-80405 and FIRE-3. The most likely reason for stopping bevacizumab treatment was progressive disease.

Table: P-254