替吉奥治疗晚期非小细胞肺癌三线及以上患者的疗效分析

Efficacy of S-1 in Advanced Non-small Cell Lung Cancer Patients Treated with More Than Two Lines of Chemotherapy

背景与目的晚期非小细胞肺癌一二线治疗后进展,目前尚无标准的治疗方案,替吉奥作为安全低毒的第三代氟脲嘧啶衍生物,对肺癌具有一定疗效,本研究旨在探讨替吉奥在晚期三线及以上非小细胞肺癌患者中的疗效。方法回顾性分析105例2014年1月-2017年4月我院收治的使用替吉奥单药或联合方案治疗三线及以上晚期非小细胞肺癌患者的临床资料,替吉奥使用方法:体表面积<1.25 m2,每日80 mg;1.25 m^2-1.5 m^2,每日100 mg;≥1.5 m^2,每日120 mg,分2次口服,连续使用1 d-14 d,21 d为1个周期。可联合铂类或其他第三代化疗药物。每周期根据实体瘤疗效评价标准(Response Evaluation Criteria in Solid Tumors,RECIST)1.1标准评价近期疗效,采用Kaplan-Meier方法统计生存数据。结果替吉奥单药治疗42例,联合用药63例,中位治疗线数4(3-11),中位周期数2(1-14)。无完全缓解患者,部分缓解患者4例,疾病稳定患者34例,疾病进展患者67例。客观有效率3.81%,疾病控制率36.19%。中位无进展生存期1.90个月(95%CI:0.67-10.83),单药或联合治疗疗效相似(疾病控制率:28.56%vs 41.27%,P=0.185),肝转移患者预后更差(中位无进展生存期:1.40个月vs 1.93个月,P=0.042)。结论在晚期非小细胞肺癌患者三线及以上抗肿瘤治疗中,替吉奥具有一定疗效,联合用药不能进一步提高疗效,替吉奥单药可作为多程治疗后患者的选择之一。

Background and objective There is no standard treatment for advanced non-small cell lung cancer（NSCLC） after the failure of two lines of chemotherapy, S-1 as the third generation of fluorouracil derivate with well safety and low toxicity, presented some efficacy in lung cancer treatment. The aim of this study is to explore the efficacy of S-1 for advanced NSCLC patients treated with two or more prior chemotherapy regimens. Methods We performed a retrospective analysis of 105 NSCLC patients treated with S-1 monotherapy or S-1 contained chemotherapy as the third or more line of treatment in our hospital from January 2014 to April 2017. S-1 was administrated orally twice daily for 2 weeks, followed by one week of rest, the dose of drug was determined by body surface area（1.25 m^2, 80 mg/d; 1.25 m^2-1.5 m^2, 100 mg/d; ≥1.5 m^2, 120 mg/d）, platinum or the third-generation chemotherapy drugs could be combinedly used. Clinical response was assigned every cycle according to Response Evaluation Criteria in Solid Tumors（RECIST） version 1.1, Kaplan-Meier analysis was used to estimate progression-free survival（PFS）. Results 42 patients received S-1 monotherapy, the other 63 patients received combined regimens, the median treatment line was 4（3-11） and the median treatment cycle was 2（1-14）. No complete response（CR） were observed, there were 4 patients with partial response（PR）, 34 patients with stable disease（SD） and 67 patients with progressive disease（PD）, the objective response rate（ORR） was 3.81%, disease control rate（DCR） was 36.19%. The median PFS was 1.90 months（0.67 months-10.83 months）, no difference between monotherapy and combined group（DCR：28.56% vs 41.27%, P=0.185）, the liver metastasis showed poorer PFS（1.40 months vs 1.93 months, P=0.042）. Conclusion S-1 presented some activity in advanced NSCLC treated with more than two lines of treatment. The addition of other drugs cannot improve efficacy. S-1 monotherapy can be used as a choice for heavily-treated patients.