A phase II of oxaliplatin, 5 fluorouracil and folinic acid (modification of folfox regimen) in patients with advanced gastric cancer (CGA): Preliminary results

Abstract

4269 Background: Gastric cancer is the second cause of death per cancer in Mexico, with more 5000 deaths/year. There is no standard chemotherapy in CGA but Louvet (J Clin Oncol 2002,20:4543) and Salah-Eddin (J Clin Oncol 2004,22:658) demostrated the efficacy (45% and 43% overall response rate) and acceptable safety of the oxaliplatin/5FU/FA combination. The pupose: to evaluate the toxicity and efficacy of oxaliplatin days 1,15 with 5-fluorouracil and folinic acid days 1,8,15 each 4 weeks. Methods: Ten patients with unresectable CGA and no prior chemotheray were into the study. Patient characteristics were: gender (male 7, female 3); median age 54 years (34–71); median performance status ECOG= 0. Two patients had locally advanced, inoperable disease while 8 had distant metastases (peritoneum 4, liver 2, lung and liver 1, ovary and peritoneum 1). All patients were evaluable for toxicity and response. Outpatient treatment consisted of oxaliplatin 80mg/m2 day 1 and 15, 5FU 500 mg/m2 iv bolus and folinic acid 20 mg/m2 iv bolus days 1,8 and 15, every 4 weeks. Results: A total of 47 courses of chemotherapy were administered. The response: overall response 6 pts (1 complete and 5 partial), stable disease 1 pt and progression 3 pts. Two patients underwent complete surgical resection (1 pt with confirmed complete pathological response). Median survival is 9.5 months. Grade 3/4 toxicities were: neutropenia in 1 pt, peripheral neuropathy in 1 case and venous thrombosis in 1 pt. No toxic deaths were seen. Conclusions: This oxaliplatin/5FU/FA regimen with low dose of fluorouracil and folinc acid in bolus, shows good efficacy and minimum toxicity en CGA patients No significant financial relationships to disclose.