Journal of Clinical Oncology, 2007 ASCO Annual Meeting Proceedings (Post-Meeting Edition).
Vol 25, No 18S (June 20 Supplement), 2007: 4526
© 2007 American Society of Clinical Oncology

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Abstract

Cetuximab plus weekly oxaliplatin/5FU/FA (FUFOX) in 1^st line metastatic gastric cancer. Final results from a multicenter phase II study of the AIO upper GI study group

Technische Universität München, Munich, Germany; Onkologische Schwerpunktpraxis Eppendorf, Hamburg, Germany; Universitätsklinikum Carl Gustav Carus, Dresden, Germany; Krankenhaus St. Vinzenz, Zams, Austria; Onkologische Schwerpunktpraxis Ravensburg, Weingarten, Germany; Klinikum der Universität, Regensburg, Germany

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Background: Cetuximab and oxaliplatin-5FU/FA are active in first-line metastatic colorectal cancer. Here we report on the final results from a trial assessing the efficacy of this combination in advanced gastric cancer. Methods: Pts received cetuximab 400mg/m² at first infusion followed by weekly 250mg/m² combined with the FUFOX regimen (oxaliplatin 50mg/m² plus 5FU 2,000mg/m² plus DL-folinic acid 200mg/m² d1,8,15,22 qd36). The primary endpoint was response according to RECIST. Toxicity was reported according to NCI.CTC v3.0. Results: From 4/05 until 03/06 we included 52 pts at 7 study centers: 13 women and 39 men; median age 63 years (38–80). ECOG-PS 0/1/2 in 19/25/8 patients. Median number of involved organ sites 3 (1–5), 46% liver and 31% peritoneal involvement. EGFR was detectable by immunohistochemistry (IHC) in 59.5%. 5 pts (9.6%) died within 60 days after study inclusion, two deaths were treatment-related (1 hypersensitivity reaction, 1 septic diarrhea). One patient withdrew consent during the first infusion cycle and is therefore excluded from the following analyses. Reported grade 3/4 adverse events in 51 evaluable pts were: leukopenia 2.0%, febrile neutropenia 5.9%, thrombocytopenia 2.0%, nausea 5.9%, diarrhea 33.3%, fatigue 9.8%, sensory neuropathy 3.9%, hand-foot-syndrome 5.9%, skin-reactions 23.5%. Response is evaluable in 46 patients showing an overall response rate of 65.2% [CI 95%: 49.8; 78.6] including 4 complete and 26 partial responses. Eighteen (39.1%) responses have been confirmed. The reponse rate according to the EGFR-status is 76.5% in undetectable and 54.2% in detectable tumors. Intention-to-treat analysis reveals a time to progression (TTP) of 7.6 months [CI 95% 5.0; 10.1] and an overall survival (OS) of 9.5 months [CI 95%: 7.9; 11.1]. Conclusions: Cetuximab plus FUFOX is highly active in metastatic gastric cancer, irrespective of the EGFR detection by IHC.

No significant financial relationships to disclose.

Abstract presentation from the 2007 ASCO Annual Meeting