Randomized controlled clinical trial of nedaplatin combined with gemcitabine and cisplatin combined ;with gemcitabine in the treatment of advanced lung squamous cell carcinoma / 国际肿瘤学杂志

ABSTRACT

Objective To explore the efficacy and adverse reaction of nedaplatin (NDP)+gemcitabine (GEM)and cisplatin (DDP)+GEM for advanced lung squamous cell carcinoma.Methods A total of 1 01 cases advanced untreated patients from September 201 2 to December 201 3 were randomly divided into 2 groups using random number table method:69 patients in the observation group accepted NDP+GEM treatment and 32 patients in the control group received DDP +GEMtreatment.The objective response rate (RR),disease control rate (DCR ) and progression-free survival (PFS ) and adverse reaction were collected and evaluated. Results RR was 28.6%(1 8/63)in the observation group and 1 5.6%(5/32)in the control group,DCR was 81 .0%(51/63)in the observation group and 68.8%(22/32)in the control group (χ2 =1 .36,P=0.24;χ2 =1 .67,P=0.20).The median PFS was 4.52 months and 4.01 months in the observation group and control group (χ2 =0.09,P=0.73).The major adverse reaction was myelosuppression in both groups (33.3% vs.37.5%,χ2 =0.1 7,P=0.68).The incidence ofⅢ-Ⅳ grade nausea and vomiting was lower in the observation group, compared with the control group (1 4.5%vs.56.3%,χ2 =1 9.02,P=0.05).Conclusion NDP combined with GEM in advanced lung squamous cell carcinoma of the first-line treatment has equivalent efficacy to DDP+GEM, with lower incidence of adverse reaction,which is worthy of further dissemination of research.