替莫唑胺二线治疗复发的广泛期小细胞肺癌的疗效观察

Observation on the efficacy of temozolomide in second-line treatment of extensive small cell lung cancer who relapsed

目的:观察45~85岁广泛期小细胞肺癌患者经一线化疗后6个月内复发,二线给予替莫唑胺单药对比紫杉醇联合顺铂的疗效及安全性。方法:选取2013年1月至2018年6月在本研究中心就诊的经一线化疗后达完全缓解(CR)或部分缓解(PR)后在6个月内复发的广泛期小细胞肺癌患者72例,随机分为两组,实验组(n=36)给予替莫唑胺150 mg/m^2,d1~5/q28 d;对照组(n=36)给予紫杉醇175 mg/m^2 d1、8联合顺铂75 mg/m^2,d2~4/q21 d。结果:实验组与对照组对比,有效率(ORR)为30%vs 25%(P=0.599),疾病控制率(DCR)为39%vs 33%(P=0.624);两组比较中位无进展生存时间(PFS)为3个月vs 3.9个月(P=0.660),而两组间中位总生存时间(OS)为8个月vs 7.3个月(P=0.704)。以上均无统计学差异(P>0.05)。实验组的胃肠道反应、周围神经损伤、Ⅲ-Ⅳ度骨髓抑制及其他不良反应明显低于对照组,差异有统计学意义(P<0.05)。结论:替莫唑胺对比TP方案化疗疗效无明显差异,而不良反应小,患者耐受性好,是经一线治疗后6个月内复发的广泛期小细胞肺癌患者可选择的二线化疗方案。

Objective:To evaluate the efficacy and toxicity of single drug temozolomide vs TP used for patients who have relapsed after first-line chemotherapy drugs within 6 months of extensive small cell lung cancer patients,whose ages range from 45 to 85 years.Methods:72 patients with extensive small cell lung cancer were diagnosed in our hospital between January 2013 and June 2018,who reached CR or PR after first-line chemotherapy(EP) and recurrence within 6 months.The patients were randomly divided into 2 groups.Experimental group(n=36) received temozolomide capsule(150 mg/m^2,d1~5/q28 d).And control group(n=36) received TP chemotherapy(paclitaxel 175 mg/m^2 d1,8 and cisplatin 75 mg/m^2,d2~4/q21 d).Results:For experimental group and control group,the ORR was 30% vs 25%(P=0.599),and the DCR was 39% vs 33%(P=0.624).The mPFS was 3 months vs 3.9 months(P=0.660),and the mOS was 8 months vs 7.3 months(P=0.704).There was no statistical difference(P>0.05).The gastrointestinal reaction,peripheral nerve injury and the degree of bone marrow suppression(grade Ⅲ-Ⅳ) of the experimental group were significantly lower than the control group(P<0.05).Conclusion:There was no significant difference in the efficacy of temozolomide vs TP.However,temozolomide has fewer adverse reactions and well tolerated.It is a second-line chemotherapy regimen for patients with extensive SCLC who have relapsed within 6 months after first-line treatment.