Nab-paclitaxel （abraxane）-based chemotherapy to treat elderly patients with advanced non-small-cell lung cancer： a single center, randomized and open-label clinical trial

Background:The purpose of this study is to evaluate the clinical efficacy and safety of abraxane-based chemotherapy with/without nedaplatin in elderly patients with non-small-cell lung cancer(NSCLC).Materials and methods:From October 2009 to January 2013,48 elderly patients(>65 years) with NSCLC were investigated in this clinical trial.The patients were randomized and equally allocated into arms A and AP:(A) abraxane(130 mg/m~2,days 1,8);(B) abraxane + nedaplatin(20 mg/m~2 days 1-3,q3w).The parameters of objective response rate(ORR),disease control rate(DCR),progression-free survival(PFS),overall survival(OS) and side effects were evaluated between two arms.Results:Over 80%of the patients completed four cycles of chemotherapy.The total ORR was 21.3%,DCR was 55.3%,PFS 4.5 months and OS 12.6 months.No significant difference was found between arms A and AP in terms of ORR(16.7%vs.26.1%,P=0.665) or DCR(55.3%vs.56.5%,P=0.871).The median PFS in arm A was 3.3 months[25-75%confidence interval(CI):3.1-7.2]and 5.5 months(25-75%CI:3.2-7.0) in arm AP with no statistical significance(P=0.640).The median OS in arm A was 12.6 months(25-75%CI:5.7-26.2) and 15.1 months(25-75%CI:6.4-35.3) in arm AP with no statistical significance(P=0.770).The side effects were mainly grade 1-2.The incidence of grade 3-4 toxicities was 29.1%in arm A and 62.5%in arm AP with a statistical significance(P=0.020).Conclusions:Compared with combined therapy,abraxane alone chemotherapy was beneficial for elderly NSCLC patients with better tolerability and less adverse events,whereas did not significantly differ in terms of ORR,DCR,PFS or OS.