伊立替康治疗小细胞肺癌一线标准治疗失败后患者疗效与不良反应观察

Abstract

目的小细胞肺癌(small cell lung cancer,SCLC)是恶性程度极高的肺部肿瘤,其临床特点是一线化疗敏感,但易出现肿瘤复发和转移,而且在一线标准治疗失败后,二线治疗的有效率低,没有标准的二线化疗方案。本研究旨在探讨SCLC一线标准治疗失败后,二线应用伊立替康联合或者不联合顺铂方案化疗的疗效及其安全性。方法收集2015-05-01-2018-03-31北京大学肿瘤医院胸部肿瘤内二科54例一线标准治疗失败的SCLC患者临床病例资料,前瞻性观察二线伊立替康(irinotecan,CPT-11)单用或联合顺铂(IP)方案化疗的疗效与不良反应。随访患者的无进展生存期(progression free survival,PFS),采用Kaplan-Meier法曲线描述,影响因素采用Cox回归法分析。结果化疗的总体客观有效率(objective response rate,ORR)为13.0%(7/54),疾病控制率(disease control rate,DCR)为53.7%(29/54)。中位PFS 2.5个月。化疗后迟发性腹泻发生率为40.7%(22/54),中性粒细胞减少发生率为61.1%(33/54),肝功能异常发生率为18.5%(10/54),恶心呕吐发生率为42.6%(23/54)。IP和CPT-11方案化疗的ORR分别为15.2%和9.5%;DCR分别为60.6%和42.9%;中位PFS分别为2和4个月,差异均无统计学意义,均P>0.05。IP方案的腹泻和中性粒细胞减少不良反应大于CPT-11单药,但差异无统计学意义,P>0.05。Cox回归分析未发现影响PFS的独立危险因素。结论 CPT-11化疗用于SCLC一线标准治疗失败后的DCR较高,不良反应可耐受。IP方案化疗可能优于CPT-11单药化疗,PFS有延长的趋势。

OBJECTIVE To investigate the efficacy and safety of irinotecan combined with or without cisplatin in the treatment of small cell lung cancer(SCLC)after failure of first-line standard therapy.METHODS Patients with SCLC were admitted into the DepartmentⅡ of Thoracic Oncology,Peking University Cancer Hospital.The patients who failed in the first-line treatment were enrolled and the related clinical records were collected.Irinotecan-based chemotherapy was given as the second-line treatment.The efficacy and adverse effects of the regimen were prospectively observed.The differences in efficacy and side effects between irinotecan combined with cisplatin(IP)regimen and CPT-11 single chemotherapy were compared.Chi square test was used to compare enumeration data and composition differences between2 groups.Patients' progression free survival(PFS)were followed up and Kaplan-Meier method was used to analyze PFS.Single factor and Cox regression multivariate analysis were used to analyze the influencing factors of PFS.RESULTS A total of 54 patients with SCLC received second-line irinotecan-based chemotherapy between May 2015 and March 2018,of whom 49(90.7%)were males and the median age was 58 years old.The overall objective response rate(ORR)of chemotherapy was 13.0%(7/54).The disease control rate(DCR)was 53.7%(29/54).Median PFS was 2.5 months.Side effects:the incidence of delayed diarrhea after chemotherapy was 40.7%(22/54),neutropenia was 61.1%(33/54),liver dysfunction was 18.5%(10/54),and nausea and vomiting were 42.6%(23/54).The ORR of IP and CPT-11 regimens was15.2%vs 9.5%.DCR was 60.6%vs 42.9%,and median PFS was 2 months vs 4 months,no statistical differences were found.Side effects of diarrhea and neutropenia in IP group were higher than those in CPT-11 group,but there was no statistical difference.No independent influence factors of PFS were found.CONCLUSIONS After the failure of first-line standard treatment for SCLC,disease control rate of irinotecan-based chemotherapy is high,with adverse effects being tolerated.IP regimen may be better than CPT-11 alone,with a trend of extended PFS.