Bevacizumab (Bev) with or without erlotinib as maintenance therapy, following induction first-line chemotherapy plus Bev, in patients (pts) with metastatic colorectal cancer (mCRC): Efficacy and safety results of the International GERCOR DREAM phase III trial.

Authors

null

Christophe Tournigand

Hôpital Saint-Antoine, Paris, France

Christophe Tournigand , Benoit Samson , Werner Scheithauer , Gérard Lledo , Frédéric Viret , Thierry Andre , 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 , Benoist Chibaudel , Aimery De Gramont

Organizations

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, Pitie-Salpetriere Hospital, Paris, France, Centre Catherine de Sienne, Nantes, France, CHU 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 Sante De Laval, Laval, QC, Canada, Hôpital Tenon, Paris, France, CICM/Charles LeMoyne Hospital, Longueuil, QC, Canada, Institut Mutualiste Montsouris, Paris, France, GERCOR, Paris, France, Centre Georges François Leclerc, Dijon, France, Hospital Saint Antoine, Paris, France

Research Funding

Other
Background: Therapy targeting VEGF or EGFR demonstrated clinical activity in combination with chemotherapy (CT) in mCRC but monoclonal antibodies cannot be associated. The DREAM trial compares a maintenance therapy (MT) with bev +/- EGFR tyrosine kinase inhibitor erlotinib (E) after a first-line Bev-based induction therapy (IT) in pts with mCRC. Methods: Pts with previously untreated and unresectable mCRC were eligible. After a Bev-based IT with FOLFOX or XELOX or FOLFIRI, pts without disease progression were randomized to MT between Bev alone (Bev 7.5 mg/kg q3w; arm A) or Bev+E (B 7.5 mg/kg q3w, E 150 mg/day continuously; arm B). Pts were treated until progression or unacceptable toxicity. The primary endpoint was PFS on MT. Results: The study enrolled 700 pts from 01/2007 to 11/2011 in 3 countries (France, Canada, Austria). 446 (63.7%) pts were randomized for MT (arm A, N=224; arm B, N=222). Among the 446 randomized pts, IT regimen was FOLFOX-Bev in 265 pts (59.4%), XELOX-Bev in 135 pts (30.3%), and FOLFIRI-Bev in 46 pts (10.3%). Baseline characteristics of randomized pts were (arm A/B): ECOG PS 0, 60% in both arms; normal LDH level 47%/49%; normal alkaline phosphatase level 48%/50%; synchronous metastasis 83%/82%. The median no of MT cycles was 6 in both arms. With a median follow-up of 31.0 months, 327 PFS events were observed. Median MT-PFS were 4.6 m in arm A vs 5.8 m in arm B (HR 0.73 [95%CI: 0.59-0.91], P=.005). Median PFS from inclusion were 9.2 m vs 10.2 m. During MT, in arm A vs arm B, grade 3-4 diarrhea (<1% vs 9%) and grade 3 skin toxicity (0% vs 19%) were the main differences in toxicity. Severe adverse events from randomization related to B or E were 6 in arm A and 7 in arm B. Overall survival is not mature. Conclusions: The addition of erlotinib to bevacizumab after induction therapy significantly improves the duration of maintenance PFS, following induction with first-line chemotherapy plus bevacizumab, in patients with unresectable metastatic colorectal cancer.

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Abstract Details

Meeting

2012 ASCO Annual Meeting

Session Type

Oral Abstract Session

Session Title

Gastrointestinal (Colorectal) Cancer

Track

Gastrointestinal Cancer—Colorectal and Anal

Sub Track

Colorectal Cancer

Clinical Trial Registration Number

NCT00265824

Citation

J Clin Oncol 30, 2012 (suppl; abstr LBA3500^)

Abstract #

LBA3500^

Abstract Disclosures