Objectives: We retrospectively assessed the combination of biweekly irinotecan with 5-fluorouracil (5-FU), and leucovorin (LV) as salvage chemotherapy in patients with advanced gastric cancer (AGC) previously treated with fluoropyrimidine (F), platinum (P), and taxane (T).
Methods: Between October 2003 and February 2006, all 131 patients with AGC were treated with irinotecan (150 mg/m(2) on day 1), along with either FOLFIRI-1 (ie, LV (20 mg/m(2) bolus) before 5-FU (1000 mg/m(2) continuous infusion over 6-hour) on days 1-2), or FOLFIRI-2 (ie, LV (20 mg/m(2) bolus) before 5-FU (400 mg/m(2) bolus) followed by 22-hour continuous infusion of 600 mg/m(2) on days 1-2), or FOLFIRI-3 (ie, 5-FU (400 mg/m(2) bolus) followed by 46-hour continuous infusion of 2400 mg/m(2) 5-FU and 100 mg/m(2) LV). Cycles were repeated every 2 weeks.
Results: The median age of the patients was 52 years (range, 19-70 years). Patients received a median of 4 cycles of chemotherapy (range, 1-21 cycles). Of the 97 patients with measurable disease, 1 (1.0%) achieved a complete response, and 11 (11.3%) achieved partial responses, making the overall response rate 12.3%. The median time to progression (TTP) was 2.2 months (95% CI, 1.9-2.6 months) and the median overall survival (OS) was 6.2 months (95% CI, 5.6-6.9 months). Good performance status (P = 0.046), fewer metastatic sites (P < 0.001), and longer time to progression of previous chemotherapy (P = 0.006) were independent prognostic factors affecting OS. OS was longer with the FOLFIRI-1 regimen but not with statistical significance (P = 0.064). The treatments were generally well tolerated.
Conclusions: In actual clinical practice, biweekly irinotecan with 5-FU and LV had modest activity and tolerability in AGC patients previously treated with F, P, and T.