Cetuximab plus oxaliplatin/leucovorin/5-fluorouracil in first-line metastatic gastric cancer: a phase II study of the Arbeitsgemeinschaft Internistische Onkologie (AIO)

Lordick, F. and Luber, B. and Lorenzen, S. and Hegewisch-Becker, S. and Folprecht, G. and Woell, E. and Decker, T. and Endlicher, E. and Roethling, N. and Schuster, T. and Keller, G. and Fend, F. and Peschel, C. (2010) Cetuximab plus oxaliplatin/leucovorin/5-fluorouracil in first-line metastatic gastric cancer: a phase II study of the Arbeitsgemeinschaft Internistische Onkologie (AIO). BRITISH JOURNAL OF CANCER, 102 (3). pp. 500-505. ISSN 0007-0920,

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Abstract

BACKGROUND: Cetuximab enhances the efficacy of chemotherapy in several cancer types. This trial assessed the activity of cetuximab and chemotherapy in advanced gastric cancer. METHODS: Patients with previously untreated, metastatic, gastric cancer received cetuximab 400 mg m(-2) at first infusion followed by weekly infusions of 250 mg m(-2) combined with FUFOX (oxaliplatin 50 mg m(-2), 5-FU 2000 mg m(-2), and DL-folinic acid 200 mg m(-2) d1, 8, 15 and 22 qd36). The primary endpoint was tumour response. RESULTS: Overall, 52 patients were enrolled. The most common grade 3/4 toxicities were diarrhoea (33%), and skin toxicity (24%). Efficacy was evaluable in 46 patients who showed a response rate of 65% (CI 95%: 50-79%) including four complete responses. Time to progression (TTP) was 7.6 months (CI 95%: 5.0-10.1 months) and overall survival (OS) was 9.5 months (CI 95%: 7.9-11.1 months). Epidermal growth factor receptor (EGFR) was detectable in 60% of tumours but showed no correlation with treatment outcome. A KRAS mutation was found in only 1 of 32 (3%) tumour samples analysed. CONCLUSION: Cetuximab plus FUFOX showed an interesting high response rate in metastatic gastric cancer. Cetuximab plus platinum-fluoropyrimidine chemotherapy is at present being investigated in a phase III randomised controlled trial. British Journal of Cancer (2010) 102, 500-505. doi:10.1038/sj.bjc.6605521 www.bjcancer.com Published online 12 January 2010 (C) 2010 Cancer Research UK

Item Type: Article
Uncontrolled Keywords: COLORECTAL-CANCER; GASTROESOPHAGEAL JUNCTION; FOLINIC ACID; K-RAS; INFUSIONAL FLUOROURACIL; CISPLATIN; ADENOCARCINOMA; MUTATIONS; THERAPY; TRIAL; antibody; chemotherapy; cetuximab; EGFR; gastric cancer; KRAS mutation
Subjects: 600 Technology > 610 Medical sciences Medicine
Divisions: Medicine > Lehrstuhl für Innere Medizin I
Depositing User: Dr. Gernot Deinzer
Date Deposited: 07 Aug 2020 08:27
Last Modified: 07 Aug 2020 08:27
URI: https://pred.uni-regensburg.de/id/eprint/25163

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