Phase II trial of biweekly reduced-dose combination chemotherapy of oxaliplatin/5-fluorouracil/folic acid (Modified FOLFOX) as first-line chemotherapy in elderly patients with metastatic or recurrent gastric cancer

Abstract

e15544 Background: Although combination chemotherapy as ECF (epirubicin, cisplatin, and 5-FU) and DCF (docetaxel, cisplatin, and 5-FU) are effective advanced gastric cancer, but it is too toxic to apply for elderly patients with increased comorbidity. Combination of oxaliplatin and 5-FU has proven to be a effective and tolerable regimen in advanced gastric cancer, and we investigated the efficacy and safety of reduced-dose combination chemotherapy of oxaliplatin/5-FU/folic acid as first-line chemotherapy in elderly patients with metastatic or recurrent gastric cancer. Methods: Elderly patients (≥60 years) with measurable, metastatic or recurrent gastric cancer were enrolled. Patients received oxaliplatin 75mg/m2 (2-hour intravenous infusion on D1), 5-FU 1000mg/m2 (12-hour continuous infusion on D1,2), and folic acid 20mg/m2 (15-minute infusion on D1,2) every 2 weeks. Results: Total 37 patients were enrolled between April 2004 and August 2008. Median age was 67 years old (range, 60 to 80 years), and 22 patients (59.5%) had increased Charlson comorbidity index score (CCI ≥1). Of 36 evaluable patients, 2 patients achieved complete response (CR), and 12 patients partial response (PR) with representing overall response rate of 44.4% (95% CI 27.7- 60.2). Stable disease (SD) was observed in 12 patients (33.3%), and progressive disease in 8 patients (22.3%). The median time to progression was 4.6 months, and median overall survival was 9.2 months. Relative dose intensity was 97.4% in both oxaliplatin and 5-FU. Grade 3 or 4 hematologic toxicities included neutropenia in one patients (2.7%), and anemia in three patients (8.1%). Peripheral neuropathy occurred (grade 2) was only observed in three patients (8.1%). Conclusions: The reduced-dose combination chemotherapy of oxaliplatin/5-FU/folic acid was effective and tolerable in elderly patients with metastatic or recurrent gastric cancer as first-line treatment. No significant financial relationships to disclose.