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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(1 000 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 & OBJECTIVE: Regional lymph node metastasis is significantly associated with prognosis in patients with non-small cell lung cancer (NSCLC). This study was designed to compare the efficacy of paclitaxel plus cisplatin (LP) with gemcitabine Short-term efficacy and long-term survival and side effects of first-line treatment of gemcitabine plus cisplatin (GP) with regional lymph node metastases in NSCLC. Methods: A total of 55 patients (LP group and GP group, 29 and 26, respectively) were enrolled in this study. Paclitaxel liposomes (175 mg / m2) and cisplatin (75 mg / m2) Gemcitabine (1 000 mg / m2) combined with cisplatin (75 mg / m2) for treatment, 21 d for a cycle. Results: For primary lung cancer, the objective response rates of LP and GP were 37.9% and 30.8% respectively, and the disease control rates were 93.1% and 80.8% respectively, with no significant difference (P> 0.05). For regional lymph node metastasis , And the objective response rates in LP and GP groups were 44.8% and 15.4%, respectively (P = 0.022). The disease control rate (93.1%) in LP group was higher than that in GP group (73.1%), with no statistical difference Significance (P = 0.101). The median survival of the LP and GP groups was 17.0 months and 12.0 months, respectively, with significant difference (P <0.05). The 1-year survival rates of the two groups were 86.2% (25/29) and 57.7% 15/26), the difference was statistically significant (P = 0.039). The incidence of thrombocytopenia and gastrointestinal reaction in LP group was significantly lower than that in GP group (P <0.05), while the incidence of anemia, neutropenia, liver and kidney dysfunction and anaphylaxis were not significantly different between the two groups (P> 0.05 ). Conclusion: For NSCLC patients with regional lymph node metastasis, the LP regimen may benefit patients with less adverse reactions and better tolerability. It is worth further study and clinical application.