国际肿瘤学杂志

国际肿瘤学杂志 ›› 2017, Vol. 44 ›› Issue (1): 15-18.doi: 10.3760/cma.j.issn.1673-422X.2017.01.004

• 论著 • 上一篇    下一篇

奈达铂联合吉西他滨与顺铂联合吉西他滨一线治疗晚期肺鳞状细胞癌随机对照临床研究

张晶,陈群,柯明耀,庄锡斌,石琴,雍雅智,黄诚   

  1. 350014 福州，福建省肿瘤医院胸部肿瘤内科(张晶、黄诚)；福州市肺科医院肿瘤内科(陈群、石琴)；厦门市第二医院呼吸中心(柯明耀、雍雅智)；福建省泉州市第一医院呼吸科(庄锡斌)
  • 出版日期:2017-01-08 发布日期:2016-12-07
  • 通讯作者: 黄诚，Email: cheng671@sina.com E-mail:cheng671@sina.com

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

Zhang Jing, Chen Qun, Ke Mingyao, Zhuang Xibin, Shi Qin, Yong Yazhi, Huang Cheng   

  1. Department of Thoracic Medical Oncology, Fujian Provincial Tumor Hospital, Fuzhou 350014, China
  • Online:2017-01-08 Published:2016-12-07
  • Contact: Huang Cheng, Email: cheng671@sina.com E-mail:cheng671@sina.com

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摘要： 目的  与 一线标准方案顺铂联合吉西他滨(DDP+GEM)进行比较，评价奈达铂联合吉西他滨(NDP+GEM)治疗晚期肺鳞状细胞癌的疗效与不良反应。方法  2012年9月至2013年12月，依照入组标准入组101例ⅢB及Ⅳ期肺鳞状细胞癌初治患者，按随机数字表法分为两组：研究组69例患者接受NDP+GEM治疗，对照组32例患者接受DDP+GEM治疗。评价两组患者的近期有效率(RR)、疾病控制率(DCR)、无进展生存期(PFS)和不良反应。结果  研究组和对照组RR分别为28.6%(18/63)和15.6%(5/32)，DCR分别为81.0%(51/63)和68.8%(22/32)，差异均无统计学意义(χ2=1.36，P=0.24；χ2=1.67，P=0.20)，中位PFS分别为4.52个月和4.01个月，差异无统计学意义(χ2=0.09，P=0.73)。不良反应主要为骨髓抑制，两组发生率差异无统计学意义(33.3%∶37.5%，χ2=0.17，P=0.68)，研究组Ⅲ～Ⅳ级恶心呕吐发生率低于对照组，差异有统计学意义(14.5%∶56.3%，χ2=19.02，P=0.05)。结论  NDP+GEM方案治疗晚期肺鳞状细胞癌的有效率与DDP+GEM方案相当，但不良反应明显降低，提示NDP+GEM可作为肺鳞状细胞癌的一线治疗方案，值得进一步开展研究。

关键词: 肺肿瘤, 顺铂, 奈达铂, 吉西他滨

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