Li Mingyi, Huang He, Tan Jiemei, Lin Daren
Jiangmen Hospital, Sun Yat-sen University, Jiangmen, Guangdong 529000, P.R.China.
Zhongguo Fei Ai Za Zhi. 2006 Oct 20;9(5):452-4. doi: 10.3779/j.issn.1009-3419.2006.05.13.
Paclitaxel plus cisplatin is an effective regimen in the treatment of non-small cell lung cancer (NSCLC), but it has severe adverse toxicities. The aim of this clinical trial is to evaluate the effect and safety of paclitaxel plus oxaliplatin compared with paclitaxel plus cisplatin in the treatment of advanced NSCLC.
From January, 2002 to October, 2004, 83 initially treated patients with advanced NSCLC were randomized into two groups: the trial group was treated with paclitaxel 175mg/m², and oxaliplatin 130mg/m² on day 1;and the control group was treated with paclitaxel 175mg/m² and cisplatin 80mg/m² on day 1. Both of them were repeated every 21 days and 2-6 cycles were given to patients. The evaluation of efficacy and safety was performed after chemotherapy regularly.
All patients were evaluable and received 2 cycles chemotherapy at least. The response rate of the trial group and control group was 34.1% (14/41) and 33.3% (14/42) respectively, median time to progression of them was 6.0 months and 5.5 months, median survival time was 10.7 months and 10.5 months, 1-year survival was 39.0% (16/41) and 40.5% (17/42) respectively. The following adverse effects of the two groups were different: the incidence rate of III+IV leukopenia was 4.9% and 28.6% in the trial group and the control group respectively, III+IV thrombocytopemia was 0 and 14.3%, III+IV nausea and vomiting was 7.3% and 26.2%. The difference of the incidence rate of III+IV nerve abnormality (9.8% and 9.5%), imparied renal function (0 and 7.1%), myalgia and anthralgia (0 and 2.4%) was insignificant.
The regimen of paclitaxel plus oxaliplatin have the similar efficacy and less adverse toxicities as compared to Paclitaxel plus Cisplatin in treatment of advanced NSCLC.
紫杉醇联合顺铂是治疗非小细胞肺癌（NSCLC）的一种有效方案，但具有严重的不良毒性。本临床试验的目的是评估紫杉醇联合奥沙利铂与紫杉醇联合顺铂治疗晚期NSCLC的疗效和安全性。
2002年1月至2004年10月，83例初治晚期NSCLC患者被随机分为两组：试验组在第1天接受紫杉醇175mg/m²和奥沙利铂130mg/m²治疗；对照组在第1天接受紫杉醇175mg/m²和顺铂80mg/m²治疗。两组均每21天重复一次，给予患者2 - 6个周期治疗。化疗后定期进行疗效和安全性评估。
所有患者均可评估，且至少接受了2个周期化疗。试验组和对照组的有效率分别为34.1%（14/41）和33.3%（14/42），中位疾病进展时间分别为6.0个月和5.5个月，中位生存时间分别为10.7个月和10.5个月，1年生存率分别为39.0%（16/41）和40.5%（17/42）。两组的以下不良反应有所不同：试验组和对照组III + IV级白细胞减少的发生率分别为4.9%和28.6%，III + IV级血小板减少症分别为0和14.3%，III + IV级恶心和呕吐分别为7.3%和26.2%。III + IV级神经异常（9.8%和9.5%）、肾功能损害（0和7.1%）、肌痛和关节痛（0和2.4%）的发生率差异无统计学意义。
在治疗晚期NSCLC方面，紫杉醇联合奥沙利铂方案与紫杉醇联合顺铂方案疗效相似，但不良毒性更少。
