Objective To evaluate the efficacy of cinobufotalin capsules combined with lcotinib on advanced non-small-cell lung cancer (NSCLC) patients in terms of treatment outcome, quality of life. Methods We enrolled 76 cases of advanced NSCLC received treatment in Department of Respiratory Medicine, Zhoushan Hospital from January 2014 to June 2016 and divided them into two groups based on the random number table: treatment group (n=38) and control group (n=38). Both groups received 3-month lcotinib treatment (125 mg, tid), the treatment group additionally received 3-month treatment with cinobufotalin capsules (500 mg, tid). At the end of treatment, the short-term efficacy, median progression-free survival (PFS), and treatment-induced adverse reactions were evaluated, and quality of life was assessed by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire. Results In the treatment group, partial remission (PR) rate was 47.4% (18/38), stable disease (SD) rate was 39.5% (15/38), and progressive disease (PD) rate was 13.1% (5/38); in the control group, PR rate was 21.1% (8/38), SD rate was 44.7% (17/38), PD rate was 34.2% (13/38). The objective response rate (ORR) of the treatment group was 47.4% (18/38), which was significantly higher than 21.0% (8/38) of the control group (χ2=6.167, P=0.015).The disease control rate (DCR) of the treatment group was 86.8% (33/38), which was significantly higher than 65.8% (25/38) of the control group (χ2=4.833, P=0.031). The incidence of disease progression / death in the treatment group was 34.2% (13/38), which was significantly higher than 13.2% (5/38) of the control group (χ2=4.659, P=0.029). The treatment group scored higher in terms of constitutional function (t=6.467, P<0.05) as well as emotional function (t=12.482, P<0.05) than the control group. Lower occurrence rates of fatigue (χ2=2.117, P<0.05) and pain (χ2=2.098, P<0.05) were identified in the treatment group. Grade Ⅲ-Ⅳrash occurred in two cases in the control group. Two groups had significant difference in the incidence of rash (Z=4.698, P<0.05). Both groups were found with one case of grade Ⅲ-Ⅳ diarrhea. Conclusion Cinobufotalin capsules combined with Icotinib can improve the treatment outcome, prolong the survival time, improve the quality of life and reduce the incidence of rash in advanced NSCLC patients.%目的 探讨华蟾素胶囊联合盐酸埃克替尼片对晚期非小细胞肺癌(NSCLC)患者治疗效果、生活质量的影响.方法 选取2014年1月—2016年6月舟山医院呼吸科收治的76例晚期NSCLC患者,采用随机数字表法将其分为华蟾素胶囊联合盐酸埃克替尼片治疗组(治疗组)和盐酸埃克替尼片治疗组(对照组),各38例.两组均接受盐酸埃克替尼片治疗(125 mg/次,3次/d),治疗组在此基础上联合口服华蟾素胶囊(500 mg/次,3次/d),均完成3个月以上药物治疗.观察两组近期疗效、中位无进展生存期(PFS),采用欧洲癌症治疗与研究组织生活质量测定量表进行生活质量评分并记录毒副作用发生情况.结果 治疗组部分缓解(PR)18例(47.4%),疾病稳定(SD) 15例(39.5%),疾病进展(PD)5例(13.1%);对照组PR 8例(21.1%),SD 17例(44.7%),PD 13例(34.2%).治疗组客观缓解率(ORR)为47.4%(18/38),高于对照组的21.0%(8/38)(χ2=6.167,P=0.015);治疗组疾病控制率(DCR)为86.8%(33/38),高于对照组的65.8%(25/38)(χ2=4.833,P=0.031).截止到2016年10月,治疗组PD/死亡发生率为34.2%(13/38),高于对照组的13.2%(5/38)(χ2=4.659,P=0.029).治疗组躯体功能、情绪功能评分均高于对照组(t=6.467、12.482,P<0.05).治疗组疲倦及疼痛发生率均低于对照组(χ2=2.117、2.098, P<0.05).对照组发生Ⅲ~Ⅳ级皮疹2例,两组Ⅲ~Ⅳ级腹泻患者各1例;两组皮疹发生率比较,差异有统计学意义(Z=4.698,P<0.05).结论 华蟾素胶囊联合盐酸埃克替尼片可提高晚期NSCLC患者治疗效果,延长生存时间,提高生活质量及降低皮疹发生率.
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