替吉奥维持治疗晚期非小细胞肺癌临床疗效观察  

Clinical Observation of S-1 as Maintenance Treatment for Advanced Non-small Cell Lung Cancer

作　　者：刘萍[1] 

机构地区：[1]郑州大学第二附属医院肿瘤科,河南省郑州市450014

出　　处：《中国全科医学》2013年第9期1038-1040,共3页Chinese General Practice

摘　　要：目的观察替吉奥维持治疗晚期非小细胞肺癌(NSCLC)的疗效和不良反应。方法选取2009年10月—2012年1月我院收治的88例ⅢB～Ⅳ期NSCLC患者,均已接受4个周期的一线化疗并获得部分缓解(PR)或稳定(SD)。将患者随机分为对照组和试验组,各44例。对照组给予吉西他滨维持治疗:吉西他滨1 000 mg/m2,第1天、第8天静脉滴注,21 d为1个周期。试验组给予替吉奥维持治疗:替吉奥80 mg.m-2.d-1,第1～14天,21 d为1个周期。每2个周期复查1次,治疗4个周期后评价两组近期疗效、生活质量及毒副作用,观察至疾病进展。结果(1)两组患者均完成4个周期的维持治疗,对照组完全缓解(CR)2例,PR 12例,SD 20例,进展(PD)10例;试验组CR 1例,PR 14例,SD 18例,PD 11例,两组近期疗效比较,差异无统计学意义(u=0.0534,P=0.9574)。(2)生活质量:对照组显效10例,有效12例,稳定11例,无效11例;试验组显效11例,有效15例,稳定12例,无效6例,两组患者生活质量比较,差异无统计学意义(u=0.9679,P=0.3331)。(3)治疗过程中,试验组Ⅲ～Ⅳ级粒细胞减少、恶心呕吐的发生率分别为4.5%(2/44)和2.3%(1/44),均低于对照组的18.2%(8/44)和18.2%(8/44),而Ⅲ～Ⅳ级腹泻的发生率18.2%(8/44)则高于对照组的2.3%(1/44),两组上述毒副作用发生率比较,差异均有统计学意义(P<0.05)。(4)对照组与试验组中位无进展生存期(PFS)分别为6.5个月及6.0个月,差异无统计学意义(P>0.05)。结论替吉奥维持治疗晚期NSCLC的近期疗效及患者的生活质量与吉西他滨相当,但临床毒副作用轻微,PFS不劣于吉西他滨维持治疗。Objective To observe the clinical efficacy and toxicity of S - 1 as maintenance therapy in advanced non small -cell lung cancer （NSCLC） . Methods A total of 88 patients with advanced NSCLC achieving partial response or stable disease after 4 cycles of standard chemotherapy were enrolled in this study. These patients were received from October 2009 to Jan- uary 2012 and divided into two groups randomly. Control group （gemcitabine maintenance group, n =44） ： gemcitabine was ad- ministered 1 000 mg/m2, dl and d8 , 21 days for a cycle. Treatment group （ S - 1 maintenance group, n = 44） ： S - 1 was ad- ministered 80 mg·m^-2·d^-1 from dl to d14, 21 days for a cycle. Reexamination once two cycles. Efficacy, life quality and tox- icities were evaluated after 4 cycles. Regular observations and follow - up were performed in both groups. Results （ 1 ） Patients in both groups completed 4 cycles of maintenance therapy. Numbers of complete response, partial response, stable disease, pro- gression disease of patients in the control group were 2, 12, 20 and 10 respectively. As for the treatment group, the dates were 1, 14, 18 and 11 respectively. There was no significant difference in efficacy between the two groups （P 〉0. 05） . （2） Life quality： as for the control group, 10 cases were significantly effective, 12 cases were effectual, 11 cases were stable and 11 cases were unfruitful. When come to control group, the dates were 11, 15, 12 and 6 respectively. There was no significant difference between the two groups （ u = 0. 9679, P = 0. 3331 ） . （3） The incidence of Ⅲ-Ⅳ grade nausea and leucocytopenia in treatment group were 4. 5% （2/44） and 2. 3% （ 1/44）, which were significantly lower than those in control group [ 18. 2% （8/44） and 18. 2% （8/44）% ; While the occurrence of diarrhea （ 18. 2% （8/44） ] in treatment group was significantly higher than that [2. 3% （1/44） ] in control group （P 〈0.05） . （4） The median PFS was 6. 5 months and 6. 0 months

关 键 词：癌 非小细胞肺 替吉奥 吉西他滨 治疗结果 

分 类 号：R734.2[医药卫生—肿瘤]