Efficacy of irinotecan in combination with 5-fluorouracil (FOLFIRI) in metastatic gastric adenocarcinoma (MGA)

15539 Background: The most commonly used schedules for MGA are 5FU in combination with CDDP with or without Epirubicin (ECF) or Docetaxel (TCF). Irinotecan combined with 5FU (FOLFIRI regimen) was reported as active and well tolerated in a French randomized phase II study (Bouché, JCO 2004). The aim of this retrospective study was to evaluate the FOLFIRI regimen in a larger series of MGA patients (pts). Methods: Between 05/99 and 03/07, 219 pts from 13 French centers (162 males (72%), median age: 62 years, range: 25–88) were treated with at least one cycle of FOLFIRI. Primary tumour sites were 127 (58%) stomach and 92 (42%) gastroesophageal junction. The WHO status was 0 or 1 in 81% of pts and 95 (43%) pts were asymptomatic. One hundred forty two pts (65%) were treated in first- line (including 42 pts previously exposed to chemotherapy as (neo)adjuvant therapy). The 77 others pts (35%) received FOLFIRI as second- (n = 60) or later- (n=17) line for MGA. Results: Median number of chemotherapy cycles was 6 (range: 1–28). Grade 3 or 4 toxicities per patient were respectively: neutropenia 19%, mucositis 2%, nausea 5%, vomiting 6%, diarrhea 5%. There was one toxic death due to neutropenia. For the 147 pts treated as first-line, response rate was 34.7% (95% CI: 24.8 - 44.6, 92 measurable pts), median PFS was 5.8 months and median overall survival was 12.9 months (1-yr survival: 55%). For the 92 pts treated as second- or later-line, response rate was 18.2% (95% CI: 7.8 - 28.6, 55 measurable pts), median PFS was 4.0 months and median overall survival was 9.5 months (1-yr survival: 39%). Conclusions: These retrospective data 1- confirm the interesting activity and good tolerance of FOLFIRI regimen in MGA as first-line as well as later-line; 2- justify the ongoing prospective multicenter French phase III study, comparing FOLFIRI followed at progression by ECC (Epirubicine, Cisplatin, Capecitabine) versus the opposite sequence in MGA. No significant financial relationships to disclose.