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 Anti-Cancer Agents & Biologic Therapy
Colon Cancer
Rectal Cancer
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.