The comparison of mFOLFOX-6, mDCF, mFOLFIRINOX in the first-line treatment of advanced gastric cancer
ANNALS OF ONCOLOGY(2020)
摘要
The prognosis of patients (pts) with advanced gastric cancer is poor. There is no single, global standard regimen for the first-line treatment of metastatic disease. We performed a randomized trial to evaluate the safety and efficacy of first-line mFOLFOX-6, mDCF, mFOLFIRINOX in metastatic gastric cancer pts. Pts were randomly assigned to mFOLFOX-6 (оxaliplatin 85 mg/m2 IV on day 1, folinic acid 400 mg/m2 IV on day 1, fluorouracil (5-FU) 400 mg/m2 IV bolus, 5-FU 2400 mg/m2 IV continuous infusion over 46 hours), mDCF (docetaxel 40 mg/m2 IV on day 1, cisplatin 40 mg/m2 IV on day 1, 5-FU 2000 mg/m2 IV continuous infusion over 48 hours) and mFOLFIRINOX (Irinotecan 180 mg/m2 IV on day 1, оxaliplatin 85 mg/m2 IV on day 1, Folinic acid 200 mg/m2 IV on day 1, 5-FU 250 mg/m2 IV bolus, 5-FU 2200 mg/m2 IV continuous infusion over 46 hours). The primary endpoint was overall survival. Sample size: 178 pts in each arm to decrease rate of progression in mFOLFOXIRI/mDCF arms comparative to mFOLFOX-6 arm (HR 0.75, α = 0.05; β = 0.80; 10% of estimated data loss). We included 50 pts in the preliminary analysis: 20 pts in mFOLFOX-6 arm, 17 pts in mDCF arm, 13 pts in mFOLFIRINOX arm. Median age was 61 years (27-74). No complete responses were achieved. Disease control rate was 85% (17/20) in mFOLFOX-6 arm, 58,8% (10/17) in mDCF arm, 84% (11/13) in mFOLFIRINOX. Partial response rate was 30% (6/20) in mFOLFOX-6 arm, 17.6% (3/17) in mDCF arm, 23% (3/13) in mFOLFIRINOX arm. Pts in the mFOLFIRINOX arm had more frequent reduction in chemotherapy doses 61,5% (8/13) vs 15% (3/20) in mFOLFOX-6 arm and 17,7% (3/17) in mDCF arm. Grade 3–4 neutropenia was observed in 30% (6/20) of cases in mFOLFOX-6 arm, 23,5% (4/17) - in mDCF arm, 38,5% (5/13) - in mDCF arm. Pts in mFOLFIRINOX arm and mDCF arm received G-CSF. Rates of grade 3/4 non-hematologic adverse events (asthenia, cardiotoxicity, hepatotoxicity) were 46,2% (6/13) in mFOLFIRINOX arm, 5% (1/20) in mFOLFOX-6 arm. mFOLFOX was comparable in efficacy to three-drug chemotherapy regimens (mFOLFOXIRI/mDCF) in the first-line setting of advanced gastric cancer. mDCF arm was closed and changed to FLOT arm.
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