Phase II trial of infusional fluorouracil, leucovorin, oxaliplatin, and irinotecan (FOLFOXIRI) as first-line treatment for advanced gastric cancer.

Abstract

The efficacy of chemotherapy for advanced gastric cancer with palliative intent compared with supportive care alone is now widely accepted. However, the best choice of chemotherapy regimen for patients with advanced gastric cancer is still a matter of controversy and requires further investigation. This study is performed to evaluate the efficacy and safety of the FOLFOXIRI regimen (oxaliplatin 85 mg/m as a 2-h intravenous infusion, irinotecan 165 mg/m as a 90-min infusion, leucovorin 200 mg/m as a 2-h infusion, 5-fluorouracil 3200 mg/m as a 48-h continuous infusion on day 1, every 2 weeks) as first-line treatment for advanced gastric cancer. Forty-seven (95.9%) of the 49 patients were assessable for response. Two cases of complete response and 29 cases of partial response were confirmed, giving an overall response rate of 63.3% [95% confidence interval (CI): 49.8-76.8%]. The median time to progression and overall survival for all patients were 7.3 months (95% CI: 6.0-8.6 months) and 11.9 months (95% CI: 9.4-14.4 months), respectively. The estimate of overall survival at 12 months was 42.9% (95% CI: 29.0-56.7%). Most patients experienced neutropenia during their course of therapy with 49% of patients (n=23) for grade 3/4 neutropenia. Grade 3 nausea/vomiting, stomatitis, and diarrhea were observed in 20 (42.6%), two (4.3%), and five (10.6%) patients, respectively. Yet, no grade 4 nonhematologic toxicity was observed. The FOLFOXIRI combination is a tolerated treatment modality with promising activity in previously untreated advanced gastric cancer patients.

• Authors: Weiguo Cao, Weiping Yang, Guying Lou, Jinsong Jiang, Mei Geng, Wenqi Xi, Hao Li, Tao Ma, Yening Jin
• Journal: Anti-cancer drugs (Anticancer Drugs) Vol. 20 Issue 4 Pg. 287-93 (Apr 2009) ISSN: 1473-5741 [Electronic] England
• PMID: 19177020 (Publication Type: Clinical Trial, Phase II, Journal Article)

Chemical References

• Organoplatinum Compounds
• Leucovorin
• Fluorouracil
• Camptothecin

Topics

• Adult
• Aged
• Antineoplastic Combined Chemotherapy Protocols (administration & dosage, adverse effects, therapeutic use)
• Camptothecin (administration & dosage, analogs & derivatives)
• Disease Progression
• Female
• Fluorouracil (administration & dosage)
• Follow-Up Studies
• Gastrointestinal Diseases (chemically induced)
• Humans
• Infusions, Intravenous
• Leucovorin (administration & dosage)
• Male
• Middle Aged
• Neutropenia (chemically induced)
• Organoplatinum Compounds (administration & dosage)
• Stomach Neoplasms (drug therapy)
• Survival Rate
• Treatment Outcome
• Young Adult