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A phase II study of biweekly oxaliplatin plus infusional 5-fluorouracil and folinic acid (FOLFOX-4) as first-line treatment of advanced gastric cancer patients
Open accessAbstract
The aim of the study was to assess the toxicity and the clinical activity of biweekly oxaliplatin in combination with infusional 5-fluorouracil (5-FU) and folinic acid (FA) administered every 2 weeks (FOLFOX-4 regimen) in patients with advanced gastric cancer (AGC). A total of 61 previously untreated AGC patients were treated with oxaliplatin 85 mg m(-2) on day 1, FA 200 mg m(-2) as a 2 h infusion followed by bolus 5-FU 400 mg m(-2) and a 22 h infusion of 5-FU 600 mg m(-2), repeated for 2 consecutive days every 2 weeks. All patients were assessable for toxicity and response to treatment. Four (7%) complete responses and 19 partial responses were observed (overall response rate, 38%). Stable disease was observed in 22 (36%) patients, with progressive disease in the other six (10%) patients. Median time to progression (TTP) and median overall survival (OS) were 7.1 and 11.2 months, respectively. National Cancer Institute Common Toxicity Criteria grade 3 and 4 haematologic toxicities were neutropenia, anaemia and thrombocytopenia in 36, 10 and 5% of the patients, respectively. Grade 3 peripheral neuropathy was recorded in three (5%) patients. FOLFOX-4 is an active and well-tolerated chemotherapy. Response rate (RR), TTP and OS were comparable with those of other oxaliplatin-based regimens, suggesting a role for this combination in gastric cancer.
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Optimal two-stage designs for phase II clinical trials.
Simon, R. (1989) · Controlled Clinical Trials · doi:10.1016/0197-2456(89)90015-9 · Cited by 3,636
Cited by
Al-Batran, S.-E., Hartmann, J. T., Probst, S., Schmalenberg, H., Hollerbach, S., Hofheinz, R., Rethwisch, V., Seipelt, G., Homann, N., Wilhelm, G., et al. (2008) · Journal of Clinical Oncology · doi:10.1200/jco.2007.13.9378 · Cited by 782
Catalano, V., Labianca, R., Beretta, G. D., Gatta, G., de Braud, F., & Van Cutsem, E. (2009) · Critical Reviews in Oncology/Hematology · doi:10.1016/j.critrevonc.2009.01.004 · Cited by 365
Metadata
- Authors
- De Vita, F., Orditura, M., Matano, E., Bianco, R., Carlomagno, C., Infusino, S., Damiano, V, Simeone, E., Diadema, M. R., Lieto, E., Castellano, P., Pepe, S., De Placido, S., Galizia, G., Di Martino, N., Ciardiello, F., Catalano, G., & Bianco, A. R.
- Venue
- British Journal of Cancer
- Published
- 2005-04-26
- Volume
- 92
- Issue
- 9
- Pages
- 1644-1649
- ISSN
- 0007-0920 (ISSN-L)
- 1532-1827
- OpenAlex
- W2060704373
- Cited by
- 179
- References
- 1
- FWCI
- 12.33
- Type
- journal article
- Language
- en
- Open access
- hybrid
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- CoChat. (2026). Citation check: A phase II study of biweekly oxaliplatin plus infusional 5-fluorouracil and folinic acid (FOLFOX-4) as first-line treatment of advanced gastric cancer patients. https://app.cochat.ai/papers/10.1038/sj.bjc.6602573
- The paper
- De Vita, F., Orditura, M., Matano, E., Bianco, R., Carlomagno, C., Infusino, S., Damiano, V, Simeone, E., Diadema, M. R., Lieto, E., Castellano, P., Pepe, S., De Placido, S., Galizia, G., Di Martino, N., Ciardiello, F., Catalano, G., & Bianco, A. R. (2005). A phase II study of biweekly oxaliplatin plus infusional 5-fluorouracil and folinic acid (FOLFOX-4) as first-line treatment of advanced gastric cancer patients. British Journal of Cancer. https://doi.org/10.1038/sj.bjc.6602573
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Contains information from the Semantic Scholar Academic Graph Datasets, made available under the ODC Attribution License (ODC-BY 1.0).
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