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Al-Batran, S E; Hartmann, J T; Probst, S; Schmalenberg, H; Hollerbach, S; Hofheinz, R; Rethwisch, V; Seipelt, G; Homann, N; Wilhelm, G; Schuch, G; Stoehlmacher, J; Derigs, H G; Hegewisch-Becker, S; Grossmann, J; Pauligk, C; Atmaca, A; Bokemeyer, C; Knuth, A; Jäger, E (2008). Phase III trial in metastatic gastroesophageal adenocarcinoma with fluorouracil, leucovorin plus either oxaliplatin or cisplatin: a study of the Arbeitsgemeinschaft Internistische Onkologie. Journal of Clinical Oncology, 26(9):1435-1442.

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Abstract

PURPOSE: This study was designed to compare fluorouracil, leucovorin, and oxaliplatin with fluorouracil, leucovorin, and cisplatin in patients with advanced gastric cancer. PATIENTS AND METHODS: Patients with previously untreated advanced adenocarcinoma of the stomach or esophagogastric junction were randomly assigned to receive either fluorouracil 2,600 mg/m(2) via 24-hour infusion, leucovorin 200 mg/m(2), and oxaliplatin 85 mg/m(2) (FLO) every 2 weeks or fluorouracil 2,000 mg/m(2) via 24-hour infusion, leucovorin 200 mg/m(2) weekly, and cisplatin 50 mg/m(2) every 2 weeks (FLP). The primary end point was progression-free survival (PFS). RESULTS: Two hundred twenty patients (median age, 64 years; metastatic, 94%) were randomly assigned. FLO was associated with significantly less (any grade) anemia (54% v 72%), nausea (53% v 70%), vomiting (31% v 52%), alopecia (22% v 39%), fatigue (19% v 34%), renal toxicity (11% v 34%), thromboembolic events (0.9% v 7.8%), and serious adverse events related to the treatment (9% v 19%). FLP was associated with significantly less peripheral neuropathy (22% v 63%). There was a trend toward improved median PFS with FLO versus FLP (5.8 v 3.9 months, respectively; P = .077) and no significant difference in median overall survival (10.7 v 8.8 months, respectively). However, in patients older than 65 years (n = 94), treatment with FLO resulted in significantly superior response rates (41.3% v 16.7%; P = .012), time to treatment failure (5.4 v 2.3 months; P < .001), and PFS (6.0 v 3.1 month; P = .029) and an improved OS (13.9 v 7.2 months) as compared with FLP, respectively. CONCLUSION: FLO reduced toxicity as compared with FLP. In older adult patients, FLO also seemed to be associated with improved efficacy.

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Additional indexing

Contributors:Arbeitsgemeinschaft Internistische Onkologie
Item Type:Journal Article, refereed, original work
Communities & Collections:04 Faculty of Medicine > University Hospital Zurich > Clinic for Oncology
DDC:610 Medicine & health
Language:English
Date:20 March 2008
Deposited On:14 Jan 2009 08:46
Last Modified:23 Nov 2012 16:34
Publisher:American Society of Clinical Oncology
ISSN:0732-183X
Additional Information:Full text at http://jco.ascopubs.org/cgi/content/abstract/26/9/1435
Publisher DOI:10.1200/JCO.2007.13.9378
PubMed ID:18349393

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