TY - JOUR
T1 - Phase II study of weekly oxaliplatin plus infusional fluorouracil and folinic acid (FUFOX regimen) as first-line treatment in metastatic gastric cancer
AU - Lordick, F.
AU - Lorenzen, S.
AU - Stollfuss, J.
AU - Vehling-Kaiser, U.
AU - Kullmann, F.
AU - Hentrich, M.
AU - Zumschlinge, R.
AU - Dietzfelbinger, H.
AU - Thoedtmann, J.
AU - Hennig, M.
AU - Seroneit, T.
AU - Bredenkamp, R.
AU - Duyster, J.
AU - Peschel, C.
N1 - Funding Information:
This study was supported by a grant from the Sanofi-Synthelabo GmbH, Berlin, Germany. We thank Dr Matthias Suermondt and Dr Marco Schupp for their support. We also thank our research nurses Mrs Nadine Roethling and Mrs Brigitte Lang for their excellent work.
PY - 2005/7/25
Y1 - 2005/7/25
N2 - 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.
AB - 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.
KW - First-line
KW - Fluorouracil
KW - Metastatic gastric cancer
KW - Oxaliplatin
UR - http://www.scopus.com/inward/record.url?scp=23744457430&partnerID=8YFLogxK
U2 - 10.1038/sj.bjc.6602697
DO - 10.1038/sj.bjc.6602697
M3 - Article
C2 - 16012522
AN - SCOPUS:23744457430
SN - 0007-0920
VL - 93
SP - 190
EP - 194
JO - British Journal of Cancer
JF - British Journal of Cancer
IS - 2
ER -