1. ¹Clinic Rechts der Isar, Technical University of Munich, Ismaninger Str. 22, 81675 Munich, Germany
2. ²Oncological Outpatient Clinic, Heilig-Geist-Gasse 411, 84028 Landshut, Germany
3. ³University Clinic of Regensburg, Franz-Josef-Strauss-Allee 11, 93053 Regensburg, Germany
4. ⁴Clinic Harlaching, Sanatoriumsplatz 2, 81545 Munich, Germany
5. ⁵Clinic Traunstein, Cuno-Niggl-Str. 3, 83278 Traunstein, Germany
6. ⁶Schindlbeck-Clinic, Seestr. 43, 82211 Herrsching, Germany
7. ⁷Sanofi-Aventis Group, Potsdamer Str. 8, 10785 Berlin, Germany
8. ⁸Center for Clinical Studies, Ismaninger Str. 22, 81675 Munich, Germany

Correspondence: Dr F Lordick, E-mail: f.lordick@lrz.tu-muenchen.de

Received 27 April 2005; Revised 8 June 2005; Accepted 9 June 2005; Published online 12 July 2005.

Abstract

Oxaliplatin plus fluorouracil/folinic acid (5-FU/FA) every 2 weeks has shown promising activity in advanced gastric cancer. This study assessed the efficacy and safety of weekly oxaliplatin plus 5-FU/FA (FUFOX regimen) in the metastatic setting. Patients with previously untreated metastatic gastric cancer received oxaliplatin (50 mg m^-2) plus FA (500 mg m^-2, 2-h infusion) followed by 5-FU (2000 mg m^-2, 24-h infusion) given on days 1, 8, 15 and 22 of a 5-week cycle. The primary end point of this multicentre phase II study was the response rate according to RECIST criteria. A total of 48 patients were enrolled. Median age was 62 years and all patients had metastatic disease, with a median number of three involved organs. The most common treatment-related grade 3/4 adverse events were diarrhoea (17%), deep vein thrombosis (15%), neutropenia (8%), nausea (6%), febrile neutropenia (4%), fatigue (4%), anaemia (4%), tumour bleeding (4%), emesis (2%), cardiac ischaemia (2%) and pneumonia (2%). Grade 1/2 sensory neuropathy occurred in 67% of patients but there were no episodes of grade 3 neuropathy. Intent-to-treat analysis showed a response rate of 54% (95% CI, 39–69%), including two complete responses. At a median follow-up of 18.1 months (range 11.2–26.2 months), median survival is 11.4 months (95% CI, 8.0–14.9 months) and the median time to progression is 6.5 months (95% CI, 3.9–9.2 months). The weekly FUFOX regimen is well tolerated and shows notable activity as first-line treatment in metastatic gastric cancer.