Randomized controlled clinical trial of nedaplatin combined with gemcitabine and cisplatin combined with gemcitabine in the treatment of advanced lung squamous cell carcinoma

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 101 cases advanced untreated patients from September 2012 to December 2013 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 + GEM treatment. 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% (18/63) in the observation group and 15.6% (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=0.17, P=0.68). The incidence of Ⅲ-Ⅳ grade nausea and vomiting was lower in the observation group, compared with the control group (14.5% vs. 56.3%, χ2=19.02, 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. Key words: Lung neoplasms; Cisplatin; Nedaplatin; Gemcitabine