Biweekly oxaliplatin, fluorouracil and leucovorin versus cisplatin, fluorouracil and leucovorin in patients with advanced gastric cancer.

Abstract

PURPOSE:

To compare a bi-weekly infusion of leucovorin (LV) 5-fluorouracil (5-FU) for 2 days, plus oxaliplatin (LV5- FU2-oxaliplatin) and LV5-FU2-cisplatin (CDDP) regimens with respect to toxicity, objective response rates, time to progression (TTP) and overall survival (OS) in patients with advanced gastric cancer.

PATIENTS AND METHODS:

Patients received LV5-FU2- oxaliplatin (oxaliplatin 85 mg/m(2), day 1; folinic acid 200 mg/m(2), days 1-2; 5-FU 400 mg/m(2), i.v. bolus, days 1-2; 5-FU 600 mg/m(2), 22-hour continuous infusion, days 1-2) or LV5- FU2-CDDP (CDDP 50 mg/m(2), day 1; plus LV5-FU2). A total of 72 patients were enrolled into this study (36 vs. 36).

RESULTS:

A total of 305 cycles were administered in the LV5-FU2-oxaliplatin arm (median 8) and 272 cycles in the LV5-FU2-CDDP arm (median 8). Grades 3-4 toxicity were as follows (LV5-FU2-oxaliplatin %/LV5-FU2-CDDP %; p<0.05): neutropenia 5/49, thrombocytopenia 2/6, anemia 6/16 nausea/vomiting 2/15, and mucositis 0/3. Response rate of LV5-FU2-oxaliplatin was 41% (partial response/PR 41%, stable disease/SD 31%, progressive disease/PD 28%; 95% confidence internal/95% CI 27-58) and of LV5-FU2-CDDP was 25% (PR 25%, SD 36%, PD 39%; 95% CI 14-41; p =0.013). The median TTP of the patients in the LV5-FU2-oxaliplatin arm was 8 months and 6 months for those in the LV5- FU2-CDDP arm (p=0.073). The median survival time of the patients in the LV5-FU2-oxaliplatin arm was 10 months and 7 months for those in the LV5-FU2-CDDP arm (p=0.003).

CONCLUSION:

Our study showed that oxaliplatin may be substituted for cisplatin with LV5-FU2 with favorable safety and efficacy profile. The encouraging results from our study support the effectiveness of oxaliplatin-fluoropyrimidine- containing chemotherapy in gastric cancer and could provide a new core on which to add other agents in future investigations.

• Authors: I Popov, L Radosevic-Jelic, S Jezdic, M Milovic, N Borojevic, S Stojanovic, V Stankovic, T Josifovski, I Kezic
• Journal: Journal of B.U.ON. : official journal of the Balkan Union of Oncology (J BUON) 2008 Oct-Dec Vol. 13 Issue 4 Pg. 505-11 ISSN: 1107-0625 [Print] Cyprus
• PMID: 19145671 (Publication Type: Comparative Study, Journal Article, Research Support, Non-U.S. Gov't)

Chemical References

• Organoplatinum Compounds
• Oxaliplatin
• Cisplatin
• Leucovorin
• Fluorouracil

Topics

• Adult
• Aged
• Antineoplastic Combined Chemotherapy Protocols (administration & dosage)
• Cisplatin (administration & dosage)
• Drug Administration Schedule
• Female
• Fluorouracil (administration & dosage)
• Humans
• Leucovorin (administration & dosage)
• Male
• Middle Aged
• Organoplatinum Compounds (administration & dosage)
• Oxaliplatin
• Stomach Neoplasms (drug therapy, mortality)