Zhang Li, Zhang Yang, Li Ning, Xu Fei, Pan Zhen-Kui, Guan Zhong-Zhen
Department of Medical Oncology, Cancer Center, Sun Yat-sen University, Guangzhou Guangdong, 510060, P.R.China.
Ai Zheng. 2004 Nov;23(11 Suppl):1455-8.
BACKGROUND & OBJECTIVE: Although platin-based chemotherapy has become a standard treatment for non-small cell lung cancer (NSCLC), its severe toxicities limit clinical application, and a new replacement is required. The study was to evaluate the efficacy, survival rate and toxicity between the combination of gemcitabine and cisplatin (GP arm) and the combination of gemcitabine and vinorelbine (GN arm) in the treatment of advanced NSCLC.
Eighty-two patients with locally advanced or metastatic NSCLC were enrolled into this study. 42 patients and 40 patients were randomized into GP group and GN group respectively. The patients' characteristics were similar between the two groups. They were treated with gemcitabine (1 000 mg/m(2) d(1), d(8)) plus cisplatin (80 mg/m(2), d(1)) in GP group, or gemcitabine plus vinorelbine (25 mg/m(2) d(1), d(8)) in GN group. The chemotherapy was repeated every 3 weeks as a cycle. Every patient was treated two cycles at least.
An objective response rate of 28.6% was observed in GP arm versus 25% in GN arm (P=0.346). The 1-year survival rate was 64% in GP arm and 66% in GN arm. The median survival time was 9.87 months for GN arm and 8.78 months for GP arm. Nausea and vomiting were the major dose-limiting toxicity. The incidence of grade III/IV nausea and vomiting was significantly higher in the GP arm than in the GN arm (P=0.000). The Leukopenia incidence was similar in two groups (P=0.130).
The efficacy of GN regimen (platinum-free regimen) was similar to that of GP regimen, but the toxicity of GN regimen is lighter than that of GP regimen.
尽管铂类化疗已成为非小细胞肺癌（NSCLC）的标准治疗方法，但其严重毒性限制了临床应用，需要新的替代方案。本研究旨在评估吉西他滨与顺铂联合方案（GP组）和吉西他滨与长春瑞滨联合方案（GN组）治疗晚期NSCLC的疗效、生存率及毒性。
82例局部晚期或转移性NSCLC患者纳入本研究。42例患者和40例患者分别随机分为GP组和GN组。两组患者特征相似。GP组患者接受吉西他滨（1000mg/m²，第1、8天）加顺铂（80mg/m²，第1天）治疗，GN组患者接受吉西他滨加长春瑞滨（25mg/m²，第1、8天）治疗。化疗每3周重复1次为1个周期。每位患者至少接受2个周期治疗。
GP组客观缓解率为28.6%，GN组为25%（P = 0.346）。GP组1年生存率为64%，GN组为66%。GN组中位生存时间为9.87个月，GP组为8.78个月。恶心和呕吐是主要的剂量限制性毒性。GP组Ⅲ/Ⅳ级恶心和呕吐发生率显著高于GN组（P = 0.000）。两组白细胞减少发生率相似（P = 0.13）。
GN方案（无铂方案）疗效与GP方案相似，但GN方案毒性比GP方案轻。
