Prospective Randomized Phase Ⅱ Study of FOLFIRI versus FOLFOX7 in Advanced Gast
PUBLISHED: 2015-11-27  354 total views, 1 today

Qiu Li1, Feng Wen1, Chengya Zhou2, Meng Qiu1, Jiyan Liu1, Jing Chen2Cheng 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


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