114656-132

Maintenance therapy with bevacizumab with or without erlotinib in metastatic colorectal cancer (mCRC) according to KRAS: Results of the GERCOR DREAM phase III trial.

Subcategory: 
Category: 
Gastrointestinal (Colorectal) Cancer
Session Type and Session Title: 
Poster Discussion Session, Gastrointestinal (Colorectal) Cancer
Abstract Number: 
3515
Citation: 
J Clin Oncol 31, 2013 (suppl; abstr 3515)
Author(s): 
Christophe Tournigand, Benoist Chibaudel, Benoit Samson, Werner Scheithauer, Gérard Lledo, Frederic Viret, Thierry André, Jean François Ramée, Nicole Tubiana-Mathieu, Jérôme Dauba, Olivier Dupuis, Yves Rinaldi, May Mabro, Nathalie Aucoin, Ahmed Khalil, Jean Latreille, Christophe Louvet, David Brusquant, Franck Bonnetain, Aimery de Gramont, GERCOR; Hopital Henri Mondor, UPEC, Creteil, France; Hôpital Saint-Antoine, Paris, France; Hopital Charles-LeMoyne, Quebec, QC, Canada; Medical University of Vienna, Vienna, Austria; Hôpital Privé Jean Mermoz, Lyon, France; Institut Paoli Calmettes, Marseille, France; Hôpital Saint Antoine, Paris, France; Centre Catherine de Sienne, Nantes, France; Centre Hospitalier Universitaire de Limoges, Limoges, France; Centre Hospitalier Layné, Mont de Marsan, France; Clinique Victor Hugo, Le Mans, France; Hôpital Ambroise Paré, Marseille, France; Hôpital Foch, Suresnes, France; Cite De La Santé De Laval, Laval, QC, Canada; Hôpital Tenon, Paris, France; Hopital Charles LeMoyne, Greenfield Park, QC, Canada; Department of Oncology, Institut Mutualiste Montsouris, Paris, France; GERCOR, Paris, France; Methodology and Quality of Life in Oncology Unit (EA 3181) & Quality of Life and Cancer Clinical Research Plateform, Besancon, France; Hopital Saint Antoine, Paris, France

Abstracts that were granted an exception in accordance with ASCO's Conflict of Interest Policy are designated with a caret symbol (^).

Abstract Disclosures

Abstract: 

Background: The primary analysis of DREAM demonstrated that a maintenance therapy (MT) with bevacizumab (Bev) + EGFR TKI erlotinib (E) significantly improved progression-free survival (PFS) after a 1st-line Bev-based induction therapy (IT) in patients (pts) with unresectable mCRC. Methods: Pts were randomized to MT after an IT with FOLFOX-bev or XELOX-bev or FOLFIRI-bev between Bev alone (Bev 7.5 mg/kg q3w; arm A) or Bev+E (Bev 7.5 mg/kg q3w, E 150 mg/d ; arm B) until PD or unacceptable toxicity. Primary endpoint was PFS on MT. Secondary endpoints included PFS from inclusion, overall survival (OS) and safety. The impact of KRAS tumor status on treatment efficacy was evaluated in an exploratory analysis. Results: 700 pts were registered and 452 pts were randomized (228 in arm A, 224 in arm B). KRAS status was available for 413/452 (91%) pts. The median duration of MT was 3.6 m. Results for MT are presented below (Table). In the registered population, median OS was 24.9m (22.5 – 27.3). Conclusions: Maintenance treatment with bev + erlotinib increases PFS over maintenance with bev alone in pts with mCRC but does not prolong OS. Further follow-up will determine the impact of 2nd or 3rd line anti-EGFR Mabs in this study. Contrasting with anti-EGFR Mabs, KRAS tumor status is not mandatory to select pts with mCRC for treatment with erlotinib. Clinical trial information: NCT00265824.

GERCOR DREAM study: KRAS analysis.
Endpoints, months (95% CI) Arm A Arm B HR (95% CI) P value
Maintenance population (MP)
(n = 452)
n = 228 n = 224
Median maintenance PFS 4.8 (4.1 - 5.7) 5.9 (4.5 - 6.4) 0.76 (0.61-0.94) 0.010
Median PFS 9.3 (8.7 – 10.1) 10.2 (9.5 – 11.5) 0.76 (0.61 - 0.94) 0.009
Median OS 27.9 (24.1 – 31.1) 28.5 (25.1 – 33.9) 0.89 (0.70-1.12) 0.312
MP - WT KRAS n = 111 n = 129
Median maintenance PFS 5.9 (4.0 – 6.5) 6.0 (4.5 – 7.8) 0.86 (0.64-0.1.16) 0.135
Median PFS 9.7 (8.7 – 11.0) 10.9 (9.8 – 12.6) 0.83 (0.61 - 1.11) 0.197
Median OS 31.5 (27.5 – 38.0) 31.8 (26.6 – 37.8) 0.92 (0.66 – 1.30) 0.644
MP - Mut KRAS (n = 173) n = 95 n = 78
Median maintenance PFS 4.4 (3.9 – 5.3) 4.7 (3.6 – 7.1) 0.77 (0.54 – 1.08) 0.124
Median PFS 9.9 (8.6 – 10.8) 9.8 (8.4 – 12.2) 0.80 (0.57 – 1.13) 0.212
Median OS 26.9 (22.4 – 33.2) 26.3 (21.0 – 34.4) 1.06 (0.72 - 1.55) 0.767