卡培他滨治疗化疗失败的非小细胞肺癌对照研究

背景与目的:晚期非小细胞肺癌(non-small cell lung cancer,NSCLC)二线治疗效果不佳,可选择的方案有限。尽管单药多西他赛已经被证实能使患者获益,但其缓解期和生存期均较短,因此探索两药联合治疗方案对化疗失败的NSCLC患者有重要临床意义。本文旨在评价卡培他滨联合多西他赛治疗化疗失败的NSCLC患者的疗效并观察不良反应。方法:48例化疗失败的患者随机分为两组,卡培他滨联合多西他赛组(联合组)23例:卡培他滨625 mg/m2,每日2次,第5～18天,多西他赛30 mg/m2,第1、8天。单药多西他赛组(单药组)25例:多西他赛35 mg/m2,第1、8天。主要研究终点为至肿瘤进展时间(time to progression,TTP),次要研究终点为总生存期(overall survival,OS)、有效率(response rate,RR)和疾病控制率(disease controlrate,DCR)。结果:两组中位TTP、中位生存期(MST)和1年总生存率分别为7个月、12个月、47.6%和3个月、12个月、39.6%。联合组中位TTP明显长于单药组,差异有统计学意义(χ2=4.763,P=0.029)。联合组和单药组的RR和DCR分别为:13.0%(3/23)、78.3%(18/23)和12.0%(3/25)、76%(19/25),差异无统计学意义(P>0.05)。两组不良反应均较轻,主要是粒细胞减少、乏力、恶心。联合组未出现严重手足综合征。结论:与单药组相比,联合组患者TTP显著延长,获得了较好的DCR,且不良反应较轻,其对长期生存的作用值得在Ⅲ期试验中研究。

Controlled clinical study of capecitabine combined with docetaxel and docetaxel alone in previously treated patients with non-small cell lung cancer

Background and purpose:The treatment efficacy for previously treated patients with advanced non-small cell lung cancer(NSCLC) is still unsatisfied and treatment options available are limited.Docetaxel(TXT) alone as a second line treatment for NSCLC has been validated to be beneficial to patients.However the duration and survival time is short.Investigation of the two-drug combination regimens on previously treated NSCLC has important clinical significance.This study is to evaluate the efficacy of capecitabine(CAPE) combined with TXT in previously treated patients with advanced NSCLC and to observe the side effects.Methods:Forty-eight NSCLC patients who failed previous chemotherapy were randomized into two groups: CAPE combined with TXT(CT group) and TXT alone(T group).Patients in CT group received chemotherapy as follows: capecitabine 625 mg/m2,p.o.bid,d5-d18,docetaxel 30 mg/m2,d1,d8,while patients in T groups: docetaxel 30 mg/m2,d1,d8.Primary end point was time to progression(TTP),and second end points were overall survival(OS),response rate(RR) and disease control rate(DCR).Results:TTP,median survival time(MST) and 1-year OS in the CT group and T group were 7 months,12 months,47.6% and 3 months,12 months,39.6%,respectively.TTP in CT group was significantly longer than that in T group(χ2=4.763,P=0.029).RR and DCR in the CT group and T group were 13.0%(3/23),78.3%(18/23) and 12.0%(3/25),76%(19/25),respectively.The difference was not significant(P>0.05).The main side effects in two groups were neutropenia,fatigue and nausea and all the toxicities were mild to modest.No severe hand-feet syndrome appeared in CT group.Conclusion:Compared with TXT alone,CAPE combined with TXT for previously treated NSCLC achieved significant longer TTP and good DCR.The side effects of CAPE combined with TXT were tolerable.The long-term survival of this combined regimen was warranted to be further evaluated in a phase Ⅲ trial.