Irinotecan combined with infusional 5-fluorouracil and folinic acid (folfiri) in patients with metastatic gastric cancer resistant to cisplatin-containing chemotherapy

Abstract

4146 Background: irinotecan is an active drug for pretreated gastric cancer patients. It resulted particularly effective when combined with cisplatin, but no reference regimen exists for patients progressive after cisplatin. Activity and toxicity of FOLFIRI is well known in metastatic colorectal cancer patients. Therefore, we studied the tolerability and activity of this regimen in patients with metastatic gastric carcinoma progressive after chemotherapy containing cisplatin. Patients and methods: Patients with histologically proven gastric cancer, measurable or evaluable disease, age ≤ 75 years, PS 0–2 (ECOG), were enrolled. The regimen included irinotecan 180 mg/m2 i.v. over 90' + Folinic Acid 200 mg/m2 i.v. over two hours + 5-Fluorouracil (5-FU) 400 mg/m2 i.v. bolus + 5-FU 2400 mg/m2 i.v. continuous infusion over 46 hours, and was repeated every two weeks. Restaging was performed after 4 courses. Responsive patients could be treated until progression. Results: From June 2002 to August 2003 twenty-seven consecutive patients were treated. Informed consent was obtained from all patients. Progressive disease after a cisplatin-based first-line chemotherapy or within six months after a neo-/adjuvant chemotherapy was present in all patients. Previous treatments were: Epirubicin,Cisplatin,5-FU (ECF) in 15 patients, Taxotere,Cisplatin,5-FU (TCF) in five, Taxotere,Cisplatin (TC) in seven. Four out of the 27 patients were refractory to neo-/adjuvant chemotherapy. Eighty-eight courses were administered (median per patient 5; range 1–14). Grade (G) 4 neutropenia in two patients was the only G3–4 toxicity. Quality of life evaluation in over half of the patients is ongoing. Five objective responses and nine stable diseases were obtained (intent to treat). Four patients showed a stable disease for > four months. One patient is not evaluable because too early. Conclusion: FOLFIRI is a proposable second-line chemotherapy in metastatic gastric cancer patients resistant to cisplatin-containing chemotherapy. Phase II and III studies in chemotherapy-naive patients are warranted. No significant financial relationships to disclose.