[Randomized clinical study comparing gemcitabine and oxaliplatin versus gemcitabine and cisplatin for advanced non-small cell lung cancer in elderly patients].

Background: In most instances, advanced non-small cell lung cancer (NSCLC) is treated with primary chemotherapy. Many chemotherapy regimens can palliate cancer-related symptoms. Quality of life and modestly improved survival are very important especially for elderly patients. This clinical trial is to compare the efficacy and toxicity of gemcitabine and oxaliplatin (GO) versus gemcitabine and cisplatin (GP) in treatment of advanced NSCLC in elderly patients.

Methods: A total of 42 patients with advanced NSCLC diagnosed pathologically were randomly divided into GO group (gemcitabine 1000mg/m² on days 1, 8; oxaliplatin 65mg/m² on days 1, 8) and GP group (gemcitabine 1000mg/m² on days 1, 8; cisplatin 30mg/m² on days 1-3), 28 days as a cycle. All patients received two cycles of chemotherapy at least.

Results: In GO group, the response rate was 55.0%. Whereas in GP group, the response rate was 40.9%. The difference in response rate was not statistically significant between the two groups (P > 0.05). The median survival duration was 11.2 months in GO group and 11.8 months in GP group. The 1-year survival rate was 45% in GO group and 50% in GP group (P > 0.05). The main toxicities were well tolerated. Leukopenia and nausea/vomiting at grade III+IV, and alopecia and impaired renal function at grade I+II occurred more frequently in GP group than those in GO group (P < 0.05).

Conclusions: Both of the two regimens are feasible, well-tolerated and effective in treatment of advanced NSCLC in elderly patients. GO regimen may be safer than GP regimen.