Randomized trial of weekly paclitaxel and cisplatin versus paclitaxel and cisplatin every three weeks in the treatment of elderly advanced NSCLC

OBJECTIVE:To compare the efficacy and toxicity of paclitaxel (PTX) given weekly (TP-QW) and every three weeks (TP-Q3W) with cisplatin (DDP) as the first-line chemotherapy for advanced NSCLC patients of more than 70 years old.METHODS:Sixty patients of more than 70 years old with advanced NSCLC who were randomized into a TP-QW group (n=30) and TP-Q3W group (n=30) received TP-QW and TP-Q3W regiments separately.TP-QW regiment:PTX 80 mg/m2,d1,d8;DDP 20 mg/m2,d1,d8,every 21 days.TP-Q3W regiment:PTX 135 mg/m2,d1;DDP 18 mg/m2,d1-d4,every 21 days.RESULTS:In the TP-QW group,the overall response rate was 40.0% (0 CR,12 PR,16 SD,2PD),whereas in the TP-Q3W group was 33.3%(0 CR,10 PR,17 SD,3 PD).The response rates of the TP-QW group was slightly higher than the TP-Q3W group without statistically significant difference (P=0.280).The median time to progress (TTP) was 4.8 months for TP-QW group versus 4.5 months for the TP-Q3W group.The TTP of two groups was not statistically different (P=0.709).The median survival time (MST) and 1 year survival rate of the TP-QW group was 14.6 months and 56.7% versus 12.7 months and 46.7% in the TP-Q3W group (P=0.208).The TP-QW group got significantly less nausea,vomiting,neurotoxicity and fatigue.CONCLUSIONS:The difference of the efficacy of both groups is not statistically significant.Weekly paclitaxel combined with cisplatin regiment has mild toxicity and is more suitable for the elderly patients and could be conveniently administered in outpatients.