Simplified FOLFIRI in pre-treated patients with metastatic gastric cancer.

Purpose: Second-line chemotherapy in patients with metastatic gastric cancer (MGC) pre-treated with cisplatin is not a standard option. We studied a combination of irinotecan, fluorouracil and folates.

Methods: Patients progressive to cisplatin-based chemotherapy were enrolled. Irinotecan 180 mg/m(2), folinic acid 200 mg/m(2), and fluorouracil 400 mg/m(2) were given on day 1, immediately followed by fluorouracil 2,400 mg/m(2) 46 h continuous infusion (simplified FOLFIRI), every 2 weeks.

Results: Between June 2002 and May 2003, 28 patients were treated. Median age was 57 years (range 38-68). Most patients had a distal primary (90%), and metastatic disease (71%). Partial response was obtained in six patients (21%, 95% CI 8-41) and stable disease in eight (21%, 95% CI 13-41). Among the six responsive patients three were refractory to docetaxel. At a median follow-up of 2.9 years median time to progression was 4 months (95% CI: 2-5), and median overall survival was 5 months (95% CI 4-9). Toxicity was mild, without treatment-related deaths or life-treating adverse events.

Conclusions: Simplified FOLFIRI was moderately active and well tolerated in unselected patients with MGC pre-treated with cisplatin-based chemotherapy. Its role in patients refractory to taxanes is promising and warrants further investigation.