国产多西紫杉醇联合顺铂治疗晚期非小细胞肺癌的临床研究

Clinical research of domestic docetaxel combined with cisplatin in the treatment of advanced non-small cell lung cancer

目的:观察国产多西紫杉醇(docetaxel艾素)联合顺铂(DDP)方案(DP方案)治疗晚期非小细胞肺癌(NSCLC)的近期疗效和毒副反应.方法:对经病理学或细胞学确诊的晚期NSCLC患者38例,采用DP方案化疗:多西紫杉醇35mg/m2,静脉滴入1h,d1和d8,用多西紫杉醇24h前口服地塞米松7.5mg,2次/d,连服3d;DDP80mg/m2,静脉滴入,d2和d3,21d为1个周期,至少2个周期评价疗效.结果:在38例中完全缓解(CR)1例,部分缓解(PR)13例,无变化(NC)16例,进展(PD)8例,总有效率(RR)为36.8%.其中初治组有效率为52.3%(11/21),有1例CR;复治组有效率为17.6%(3/17),无CR病例,中位生存期为11mo,两组差异有统计学意义(P<0.05).疾病进展时间为5.9mo,1a生存率及2a生存率分别为44.7%和23.7%.毒副反应主要为骨髓抑制、消化系统反应.大部分患者为Ⅰ或Ⅱ度,耐受性较好.结论:多西紫杉醇联合DDP治疗晚期NSCLC近期疗效较好、毒副反应轻且耐受好.

AIM： To evaluate the short-term efficacy and toxicity of domestic docetaxel combined with cisplatin （DDP） in the treatment of advanced non-small cell lung cancer （NSCLC）. METHODS： Thirty-eight patients with advanced NSCLC firmly diagnosed pathologically and cytologically received 1 h intravenous drip infusion of docetaxel 35 mg/m2 on day 1, 8, oral administration of 7.5 mg dexamethasone at 24 h before docetaxel infusion, 2/d, for consecutive 3 d, and intravenous drip infusion of DDP （ 80 mg/m2 ） on d 2 and 3. The chemotherapy was repeated every 21 d. All the patients were eveluated after at least 2 cycles. RESULTS： Objective response was obtained in 36.8% （14/38） of the patients （ 1 complete and 13 partial responses） , whereas 16 patients had no change and 8 patients were progressive. Significant difference existed between the naive patients and the retreated patients in overall effective rate （52. 3% vs 17.6% , P 〈 0.05 ）. Median survival time and median time to disease progression was 11 months and 5.9 months respectively. The 1-year and 2-year survival rates were 44.7% and 23.7% respectively. The main toxicities included myelosuppression, nausea, vomiting and diarrhea. The severities of these side effects were grade I , II and well tolerable. CONCLUSION： Docetaxel combined with DDP is effective in the treatment of advanced NSCLC, with mild to moderate side effects.