A phase II study of modified FOLFOX as first-line chemotherapy for metastatic gastric cancer in elderly patients with associated diseases

摘要

Background: Elderly patients are generally underrepresented in the study populations of combination chemotherapy trials. This study evaluates the efficacy and safety of a modified FOLFOX regimen in elderly patients with metastatic gastric cancer and presenting associated disease(s). Methods: A total of 43 patients aged ≥70 years received oxaliplatin 85 mg/m2 together with 6S-leucovorin 200 mg/m2 on day 1, followed by a 46-h infusion of 5-fluorouracil 2,400 mg/m2, every 2 weeks. Assessment of response was performed every four cycles according to RECIST criteria. Results: Median patient age was 74 years (range, 70-83 years). Overall response rate was 34.9 % [95 % confidence interval (CI), 20.6-49.1, with 3 complete responses and 12 partial responses. Grade 3 neutropenia occurred in 4 patients (9.3 %), fatigue in 3 patients (7.0 %), and vomiting in 2 patients (4.6 %). Grade 2 and 3 peripheral neuropathy was observed in 5 patients (11.6 %) and 1 patient (2.3 %), respectively. No treatment-related death was observed. Median progression-free and overall survival were 6.8 and 10.5 months, respectively. Conclusions: This modified FOLFOX regimen is an active and well-tolerated treatment for elderly patients with metastatic gastric cancer and also represents a good therapeutic option in patients with associated disease(s).