紫杉醇脂质体联合顺铂对比吉西他滨联合顺铂一线治疗伴有区域淋巴结转移的晚期非小细胞肺癌的临床研究

摘要

背景与目的：区域淋巴结转移与非小细胞肺癌(non-small cell lung cancer，NSCLC)患者预后显著相关，本研究旨在比较紫杉醇脂质体联合顺铂(liposomal paclitaxel plus cisplatin，LP)与吉西他滨联合顺铂(gemcitabine plus cisplatin，GP)一线治疗伴有区域淋巴结转移的NSCLC的近期疗效、远期生存及不良反应。方法：共随机入组55例患者(LP组和GP组分别为29例和26例)，分别采用注射用紫杉醇脂质体(175 mg/m2)联合顺铂(75 mg/m2)和注射用吉西他滨(1000 mg/m2)联合顺铂(75 mg/m2)进行治疗，21 d为1个周期。结果：对于肺癌原发灶，LP和GP组客观缓解率分别为37.9%和30.8%，疾病控制率分别为93.1%和80.8%，差异无统计学意义(P＞0.05)；对于区域转移的淋巴结，LP和GP组的客观缓解率分别为44.8%和15.4%，差异有统计学意义(P=0.022)；LP组疾病控制率(93.1%)高于GP组(73.1%)，差异无统计学意义(P=0.101)。LP和GP组的中位生存期分别为17.0个月和12.0个月，差异有统计学意义(P＜0.05)，两组患者1年生存率分别为86.2%(25/29)和57.7%(15/26)，差异有统计学意义(P=0.039)。LP组血小板减少、胃肠道反应发生率明显低于GP组(P＜0.05)，而贫血、粒细胞减少、肝肾功能损伤、过敏反应等发生率两组差异无统计学意义(P＞0.05)。结论：对于伴有区域淋巴结转移的NSCLC患者，LP方案可能更能使患者获益，不良反应更轻，耐受性好，值得进一步研究和临床推广应用。%Background and purpose: Regional lymph node metastasis was significantly associated with the prognosis of patients with non-small cell lung cancer (NSCLC). This study was designed to compare paclitaxel liposome plus cisplatin (LP) with gemcitabine and cisplatin (GP) in patients with regional lymph node metastasis of advanced NSCLC as a ifrst-line treatment. Methods:A total of 55 patients were randomly assigned to receive either liposomal paclitaxel (175 mg/m2) and cisplatin (75 mg/m2) or gemcitabine (1 000 mg/m2) and cisplatin (75 mg/m2) every 3 weeks. Results:Objective response rate (ORR) of lung primary foci was 37.9%in the LP arm and 30.8%in the GP arm (P>0.05) and the disease control rate (DCR) was 91.3%and 80.8%respectively (P>0.05);ORR of regional metastasis lymph node was higher in the LP arm (44.8%vs 15.4%, P<0.05).There was no signiifcant difference in DCR (93.1%vs 73.1%, P=0.101), although slight trends favoring paclitaxel liposome were seen;There was signiifcant difference in median overall survival (17.0 vs 12.0 months, P<0.05). LP was associated with significantly less thrombocytopenia and gastrointestinal side effects (P<0.05), but no signiifcant difference was observed in hyphemia, leucopenia, hepatotoxicity, renal toxicity and allergic reactions (P>0.05). Conclusion: Liposomal paclitaxel plus cisplatin is superior to gemcitabine plus cisplatin with less toxicity and better tolerated, it deserves further research and clinic application for patients with regional lymph node metastasis of advanced NSCLC.