Induction treatment in first-line with chemotherapy + bevacizumab (bev) in metastatic colorectal cancer: Results from the gercor-DREAM phase III study.

Authors

null

Christophe Tournigand

Hopital Henri Mondor

Christophe Tournigand , Werner Scheithauer , Benoit Samson , 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

Hopital Henri Mondor, Medical University of Vienna, Hopital Charles-LeMoyne, Hôpital Privé Jean Mermoz, Institut Paoli-Calmettes, Hôpital Saint-Antoine, Centre Catherine de Sienne, CHU de Limoges, Centre Hospitalier Layné, Clinique Victor Hugo, Hôpital Ambroise Paré, Hôpital Foch, Cite De La Sante De Laval, Hôpital Tenon, Hopital Charles LeMoyne, Department of Oncology, Institut Mutualiste Montso, GERCOR, CHU, Hopital Saint Antoine

Research Funding

Pharmaceutical/Biotech Company

Background: the DREAM study compares a maintenance therapy with bevacizumab (bev) alone or with the erlotinib after a bev-based induction therapy with FOLFOX, or biweekly XELOX or FOLFIRI. Efficacy of the induction treatment is reported here. Methods: Patients (pts) with previously untreated metastatic colorectal cancer received one of the following regimen (investigator’s choice): mFOLFOX7-bev, biweekly mXELOX-bev or FOLFIRI-bev. Oxaliplatin was administered no more than 6 cycles. In the 1st cohort, pts received 3 months (m) of FOLFOX-bev or mXELOX-bev before randomization. In the 2nd cohort, pts received 3m of FOLFOX-bev or mXELOX-bev then 3 m of fluoropyrimidine-bev, or 6 m of FOLFIRI-bev before randomization. Pts with disease control were then randomized between bev alone or with erlotinib until progression. Results: FOLFOX-bev was administered in 424 pts, mXELOX-bev in 203 pts and FOLFIRI-bev in 67 pts. Pts characteristics for the whole population are: median age 63 yrs (26-80), male/female 59.8%/40.2%, synchronous mets/metachronous 82.6%/17.4%, PS 0/1/2 58%/39%/3%, LDH>UNL 53%, platelets >400000/mm3 27%. Patients received a median nb of 6 cycles of oxaliplatin for FOLFOX-bev and mXELOX-bev, and a median nb of 12 cycles of irinotecan with FOLFIRI-bev. Response rates are respectively 48%, 50% and 63%. Median PFS are respectively 8.61m, 8.97m and 9m. Severe toxicity profiles (grade 3-4) appear to be different according to the schedule : more neutropenia and diarrhea with FOLFIRI-bev, HFS and diarrhea with mXELOX-bev and neuropathy with FOLFOX-bev. Conclusions: Modified biweekly XELOX-bev provides similar efficacy results with FOLFOX-bev, and FOLFIRI-bev as induction therapy in first-line. Clinical trial information: NCT00265824.

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Abstract Details

Meeting

2013 Gastrointestinal Cancers Symposium

Session Type

Poster Session

Session Title

General Poster Session C: Cancers of the Colon and Rectum

Track

Cancers of the Colon, Rectum, and Anus

Sub Track

Multidisciplinary Treatment

Clinical Trial Registration Number

NCT00265824

Citation

J Clin Oncol 31, 2013 (suppl 4; abstr457)

DOI

10.1200/jco.2013.31.4_suppl.457

Abstract #

457

Poster Bd #

C13

Abstract Disclosures