泰索帝及健择分别联合顺铂治疗晚期非小细胞肺癌随机对照临床研究

Randomized trial of docetaxol plus cisplatin versus gemzar plus cispltain in treating advanced non-small cell lung cancer

目的：探讨新药泰素帝联合顺铂（DC）及健择联合顺铂（GC）治疗晚期NSCLC疗效及不良反应。方法：采用随机对照研究的方法观察经两个方案治疗后40例患者的缓解率（RR），疾病进展时间（TTP）、中位生存时间（MST）和1年、2年生存率。40例患者中DC组21例，GC组19例。结果：DC组CR 1例、PR9例、RR47．7％，TTP4．6个月，MST10．6个月（95％CI，9．3～11．3个月）。GC组无CR，PR8例，RR42．1％，TTP4．7个月，MST11．3个月，（95％CI，6．8～14．8个月）。两组疗效比较差异无统计学意义，P=0．71。GC组1、2年生存率分别为34．1％、11．2％，DC组分别为38．1％、15．3％．两组生存率差异无统计学意义，P=0．89。DC组不良反应以粒细胞下降为主，GC组以乏力和血小板降低为主要表现，但均可耐受。无治疗相关性死亡。结论：泰素帝或健择联合顺铂治疗晚期NSCLC具有较好的耐受性和较高的临床缓解率，并获得较高的1年和2年生存率，两组疗效和生存率差异无统计学意义。

OBJECTIVE： To explore the efficacies of docetaxol plus cisplatin and gemzar plus cisplatin in the treatmeut of advanced NSCLC, and observe their cytotoxicities. METHODS： A total of 40 advanced NSCLC patients were randomized into 2 groups, 21 in DC group （docetaxol plus cisplatin） and 19 in GC group （gemzar plus cisplatin）, and received the relevant treatments. The RR, time to progression （TTP）, median survival time （MST）, and 1-and 2 year survival rates of the patients were investigated and analyzed. RE- SULTS： RR was 47.7% in DC group with 1 case of complete remission （CR） and 9 cases of partial remission （PR）, and 42. 1% in GC group with 8 cases of PR. TTP was 4.6 months in DC group and 4.7 months in GC group. MST was 10.6 months in DC group [95% confidence interval （CI）, 9.3- 11.3 months], and 11.3 months in GC group （95% CI,6.8- 14.8 months）. The 1 and 2 year survival rates were 38. 1% and 15.3$ in DC group, and 34. 1% and 11.2% in GC group. The differences of RR and survival rate between the 2 groups were not significant, P=0.71,P=0.89. The major cytotoxicity in DC group was leakopenia; the major cytotocities of GC group were fatigue and thrombocytopenia. All adverse reactions were tolerable. There was no death during the trentment. CONCLUSION： DC and GC regimens may enhance the remission rate of NSCLC patients with tolerable adverse reaction, and improve the short-term survival rate, but the differences of therapeutic effects between DC and GC groups are not significant.