Comparative analysis of the efficacy and safety of chemotherapy with oxaliplatin plus fluorouracil/leucovorin between elderly patients over 65 years and younger patients with advanced gastric cancer

A chemotherapy regimen with oxaliplatin, fluorouracil, and leucovorin is commonly used to treat advanced gastric cancer (AGC). This study was designed to compare the efficacy and the safety of oxaliplatin plus fluorouracil/leucovorin administered biweekly (mFOLFOX6) between elderly patients aged over 65 years and younger counterparts with AGC. This analysis included 82 AGC patients (a parts per thousand yen65:31, < 65:51). Patients with previously untreated chemo-na < ve advanced adenocarcinoma of the stomach received oxaliplatin 85 mg/m(2), 5-FU bolus 400 mg/m(2) on day 1 and 5-FU 1,500 mg/m(2), leucovorin 75 mg/m(2) 22 h infusion on days 1 and 2 every 2 weeks. The aim of the study was to compare efficacy and safety, including response rate (RR), progression-free survival (PFS), overall survival, and grade a parts per thousand yen3 adverse events, between patients aged a parts per thousand yen65 years and patients aged < 65 years. Median progression-free survival (PFS) was not significantly different between both groups (a parts per thousand yen65: 5.8 months, < 65: 5.7 months, respectively, HR 0.77, 95% CI: 0.44-1.16, P = 0.18). Median overall survival was not significantly different between both groups (a parts per thousand yen65: 10.3 months, < 65: 9.5 months HR 0.83, 95% CI: 0.50-1.37, P = 0.46). The rate of grade 3 or 4 neutropenia did not differ with age group (a parts per thousand yen65: 51.6%, < 65: 43.1%); nor did the rates of neutropenic fever (a parts per thousand yen65: 16.1%, < 65: 5.9%), and infection without neutropenia (a parts per thousand yen65: 3.2%, < 65: 3.9%). Rates of grade a parts per thousand yen3 toxicities such as thrombocytopenia, nausea/vomiting, or peripheral neuropathy were not significantly different between the two groups. mFOLFOX6 maintains its efficacy and safety in elderly patients aged over 65 years in comparison with AGC patients aged < 65 years. Its judicious use should be considered regardless of age.