Qiu Li¹, Feng Wen¹, Chengya Zhou², Meng Qiu¹, Jiyan Liu¹, Jing Chen², Cheng Yi¹, Zhiping Li¹, Deyun Luo¹, Feng Xu¹, Xiaohong Cai², Feng Bi¹

¹West China Hospital,Sichuan University, ²oncology department,Sichuan Cancer Hospital

Objective:The purpose was to compare folinic acid,5-fluorouracil (5-FU), and irinotecan (mFOLFIRI; arm A) with folinic acid,5-FU, and oxaliplatin (mFOLFOX7; arm B) as first-line treatments in patients(pts) with locally advanced or metastatic gastric adenocarcinoma in an open,randomized, phase II, two-center study. Method: Previously untreatedmetastatic or recurrent gastric adenocarcinoma pts with measurable diseasereceived a 2-hour infusion of folinic acid 200 mg/m² followed by a46-hour infusion of 5-FU 2,400 mg/m² every 2 weeks either withirinotecan 150 mg/m² (arm A) or oxaliplatin 85 mg/m² (armB) as a 2-hour infusion on day 1 every 2 weeks. The second-line treatment waspredefined (mFOLFOX7 for arm A and mFOLFIRI for arm B). The primary endpointwas progression-free survival (PFS), and the secondary endpoints were overallsurvival (OS), the disease control rate (DCR) and toxicity. Result: Intotal, 200 pts were included (median age, 53 years; 72% male). The evaluablepopulation consisted of 128 patients (54 in arm A; 74 in arm B). The median PFSof arm A was 2.9 months (95% CI: 1.9 to 4.1 months) versus 4.1 months (95% CI,3.2 to 4.8 months) for arm B, the differences in which were not significant (P=0.109).The median OS was 9.9 months (range, 6.0 to 13.5 months) for arm A versus 12.0months for arm B (range, 10.3 to 13.7; P=0.431). The disease controlrates (DCRs) for arm A and arm B were 59.3% and 66.3%, respectively (P=0.850).In subgroup analysis of the patients who completed both treatment lines perprotocol, the median OS was 11.0 months (95% CI, 5.1 to 16.9 months) for themFOLFIRI/mFOLFOX7 group and 20.2 months (95% CI, 13.4 to 26.6 months) for themFOLFOX7/mFOLFIRI group, and the difference was statistically significant (P=0.030).Both regimens were well-tolerated with acceptable and manageable toxicities,such as neutropenia, sensory neuropathy, diarrhea and alopecia. Conclusion: Therewas no significant difference between the two groups in the median PFS or DCR.However, mFOLFOX7 followed by mFOLFIRI might have a better median OS.

Key Words: Advanced GastricAdenocarcinoma  FOLFIRI  FOLFOX7