648 - Efficacy and safety of bevacizumab combined with chemotherapy in daily practice in 765 French patients with mCRC: the concert cohort at a maximum of...

Date 28 September 2012
Event ESMO Congress 2012
Session Publication Only
Topics Anticancer agents
Colon and Rectal Cancer
Therapy
Biological Therapy
Presenter Jaafar Bennouna
Authors J. Bennouna1, M. Ducreux2, B. Asselain3, J. Phelip4, T. André5, H. Senellart6, B. Commenges7
  • 1Oncology/ Pneumology, Institut de Cancerologie de l’Ouest-site René Gauducheau, 44805 - Saint Herblain/FR
  • 2Oncologie Digestive, Institut Gustave Roussy, Villejuif/FR
  • 3Biostatitique, Institut Curie, Paris/FR
  • 4Gastro-entérologie Et Hépatologie, CHU de Saint Etienne, Saint Etienne/FR
  • 5Department Of Medical Oncology, Hôpital Pitié Salpêtrière, Paris/FR
  • 6Medical Oncology, Centre R. Gauducheau, Nantes/FR
  • 7Etudes Pharmaco-epidémiologiques, Laboratoires Roche, Boulogne-Billancourt/FR

Abstract

Background

CONCERT is a prospective, non-interventional study assessing the first use of bevacizumab (Bv) combined with standard chemotherapy (CT) -all lines, in daily practice in mCRC patients (pts) included in 2008/2009. We present results at 24 months including overall survival (OS). Results at 12 months were presented earlier (Poster # 249 - WCGIC 2011).

Method

Pts with mCRC initiating Bv + CT, doses and schedules at investigator's discretion, were followed at 3, 6, 9, 12, 18, 24 and 36 months. Pts characteristics, safety and efficacy of Bv + CT were assessed. Targeted adverse effects (AEs) and serious/unexpected AEs were collected.

Results

On a total of 725 evaluable pts with mCRC, initiating Bv + CT, 435 (60%) were men, median age 66 years (min–max: 25-88), ECOG score 0-1 (90%). After a maximum of 24 months of follow-up per patient, median progression-free survival (primary endpoint) was 10.4 months [9.6;11.7], 8.6 [7.1;9.5] and 6.3 [5.6;8.9] in 1st, 2nd and 3rd line or more, respectively. Median OS was 25.4 [21.2;-], 19.0 [15.4; 22.3] and 14.3 [11.6; 20.4] in 1st, 2nd and 3rd line or more, respectively. In 1st line, progression-free survival was 10.4 [9.3; 11.7] with irinotecan-based CT and 11.8 months [9.9;15.2] with oxaliplatin-based CT. Bv median treatment duration was 7,5 months. AEs were reported in 56.2%, 68.1% and 51.7% of pts in 1st, 2nd and 3rd line or more. Grade 3/4 AEs were reported in 10.4% of pts overall. Main grade 3/4 targeted AEs were neutropenia (3.0%), venous thromboembolic events (1.8%) and hypertension (1.3%) and 6.8% of pts were newly treated for hypertension at M3. Most AEs occurred during the first 12 months. Deaths were reported in 39.9% of pts, 51.4% and 56.9% in 1st, 2nd and 3rd line or more, respectively mainly for disease progression (87.8%). During follow-up, 33.8% of pts had at least one surgery, mainly of the liver (40.7% of all surgeries).

Conclusions

Efficacy and safety outcomes after 24 months of follow-up in mCRC pts treated confirm the appropriate use of bevacizumab in daily practice in France as they are consistent with published reports of international non-interventional studies and registry (BRiTE, Tree, Beat).

Disclosure

J. Bennouna: Honoraries : Roche, Amgen, Sanofi-Aventis.

M. Ducreux: Consultant : Roche, Merck Serono Honoraries : Roche, Merck Serono, Amgen, Bayer, Fresenus, Pfizer, Sanofi Clinical research project: Pfizer, Chugai, Merck Serono.

T. André: Consultant : Roche Honoraries : Amgen, Merck, Sanofi.

H. Senellart: Honoraries : Roche.

B. Commenges: Employment : Roche.

All other authors have declared no conflicts of interest.