OBJECTIVETo investigate the efficiency, time to progression (TTP), overall survival (OS) and toxicity of epirubicin combined with DDP and 5-Fu (PELF regimen) for the treatment of advanced gastric cancer.

METHODSTotally, 101 patients with histopathologically confirmed advanced gastric cancer were enrolled and treated with PELF regimen in this study. Among them, 37 cases received adjuvant chemotherapy after R0 resection and 64 cases only received palliative chemotherapy without surgical resection. The regimen comprised of intravenous (i.v.) administration of epirubicin 50-80 mg/m2 for palliative chemotherapy or 40-50 mg/m2 for postoperative adjuvant chemotherapy on D1; i.v. infusion of cisplatin 10-20 mg/m2 in 2 hours on D1-D5; i.v. infusion of 5-Fu 425-600 mg/m2 for palliative chemotherapy or 425-500 mg/m2 for adjuvant chemotherapy in 4 hours for 5 days or continuous infusion for 120 hours; i.v. infusion of leucovorin (LV) 100-200 mg/m2 in 2 hours on D1-D5. This regimen was repeated every 3 to 4 weeks, and the first evaluation was done after two cycles.

RESULTSOf the 37 patients who received adjuvant chemotherapy after R0 resection, 17 were still alive without recurrence, while 19 died of the disease. The median disease free survival time was 36.1 months and 5-year survival rate was 36.0%. Among the 64 cases who received only palliative chemotherapy, 47 patients were treated with this regimen as a first-line therapy and 34 patients were evaluable for response. The overall response rate was 26.5%, median time to progression (TTP) and overall survival (OS) was 6.6 and 13.7 months, respectively. Of the 17 patients who received this regimen as a second-line therapy, 10 were evaluable with an overall response rate of 20.0%. The median time to progression (TTP) in patients of this group was 5.1 months and median overall survival (OS) was 8.9 months. All the 101 patients were assessable for toxicity according to WHO criteria. The rate of grade 3 or 4 neutropenia, anemia and thromobocytopenia was 19.8%, 1.0% and 2.0%, respectively.

CONCLUSIONThe regimen of epirubicin combined with DDP and 5-Fu is effective, well tolerable and safe for advanced gastric cancer patients either as adjuvant or as palliative therapy.