4079 Background: The combination chemotherapy of capecitabine and cisplatin showed considerable activity and good feasibility in patients with advanced gastric cancer. Oxaliplatin has a more favorable toxicity profile compared to cisplatin. The purpose of the study is to evaluate the efficacy and toxicity of capecitabine plus oxaliplatin combination chemotherapy in previously untreated patients with advanced gastric carcinoma. Methods: Patients received intravenous oxaliplatin 130 mg/m2 over 2 hours on day 1 plus oral capecitabine 1000 mg/m2 twice daily on days 1–14, every 3 weeks. Treatment was continued until progression of disease or intolerable toxicities with a maximum of 8 cycles. All the measurability and response evaluations were reviewed and confirmed by one investigator. Results: Total 54 patients were enrolled (37 men, 17 women). The median age was 57 years (range 29–70). Among these 54 patients, fifty-two patients were evaluable. A total 311 cycles of chemotherapy were delivered. The overall response rate was 63% (95% CI, 50–76%), with complete response in 2 patient and partial responses in 32 patients. After a median follow-up of 13 months, median progression-free survival was 5.8 months (95% CI, 4.4–7.2 months); median overall survival was 11.9 months (95% CI, 8.8–15.1 months). The treatment was generally well tolerated. The most common haematological adverse event was anaemia (70% of patients). Grade 3- 4 neutropenia was observed in 4 patients and neutropenic fever was experienced in only 1 patient. Four patients had G3 thrombocytopenia, which was accompanied by G3 gastrointestinal bleeding. The most common non-haematological toxicities were neuropathy (70%), vomiting (50%), diarrohea (33%), and hand-foot syndrome (39%). But, G3–4 toxicities were rare. There was one treatment related death which was associated with grade IV neutropenic sepsis. Conclusion: XELOX was active and well tolerated as a first-line therapy for advanced gastric carcinoma. No significant financial relationships to disclose.
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.
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