Abstract: Objective To compare the efficacy and safety of gemcitabine alone or in combination with Rh-endostatin as a first-line treatment for elderly patients with advanced non-small cell lung cancer（NSCLC）. Methods A total of 128 elderly patients with pathology-confirmed，advanced NSCLC were recruited between 1 April 2009 and 31 May 2013 and randomized to receive gemcitabine alone （n=62） or gemcitabine with Rh-endostatin（n=66）. Therapeutic efficacy was evaluated strictly according to RECIST criteria after 2 treatment cycles，and median survival time（mOS）and median progression-free survival（mPFS）were recorded. Per-cycle safety and efficacy were evaluated for all subjects according to NCICTC 3.0 criteria. Results In the group receiving combination therapy，11 cases were PR，36 were SD，and 15 were PD.In the gemcitabine-alone group，6 cases were PR，26 were SD，and 24 were PD. Overall response rate was similar between the combination group and gemcitabine-alone group，in terms of both ITT（16.7% vs 9.7%，P=0.326） and PP（17.7% vs 10.7%，P=0.278）. However，the two groups differed significantly in DCR（PP）（75.8% vs 57.1%，P=0.031） and mPFS（4.0 vs 3.7 months，P=0.027），and mOS was similar between the two groups（9.1 vs 8.5 months，P=0.418）. Major toxic effects included bone marrow aplasia，such as neutropenia and anemia，which generally correlated with the chemotherapy regimen（most were G 1/2；a few were G 3/4）. Conclusion The combination of gemcitabine and Rh-endostatin offers therapeutic benefits to elderly patients with advanced NSCLC and may be reasonably tolerated by most patients.

Key words: Lung neoplasm, Non-small cell lung cancer, Recombinant human endostatin, Elderly, Single-agent chemotherapy