白蛋白结合型紫杉醇用于HER2阴性晚期胃癌一线化疗中的疗效分析  

Albumin-bound paclitaxel in first-line chemotherapy for patients with HER2-negative advanced gastric cancer

作　　者：司海燕[1] 苟苗苗 赵海清[1] 张勇[1] 戴广海[1] SI Haiyan;GOU Miaomiao;ZHAO Haiqing;ZHANG Yong;DAI Guanghai(Department of Medical Oncology,the First Medical Center,Chinese PLA General Hospital,Beijing 100853,China)

机构地区：[1]解放军总医院第一医学中心肿瘤内科,北京100853

出　　处：《解放军医学院学报》2020年第10期976-982,共7页Academic Journal of Chinese PLA Medical School

摘　　要：目的评估纳米白蛋白结合型紫杉醇(nab-PTX)联合化疗一线治疗HER2阴性的不可切除或复发晚期胃癌患者的有效性和安全性,评价临床特性与患者生存期的相关性。方法选取2011年12月17日-2018年1月10日,本研究入组的44例HER2阴性的晚期胃癌患者,包括34例男性、10例女性,中位年龄57(28~85)岁。其中19例(38.6%)接受了胃造瘘术。组织学类型中分化17例,低分化27例。转移部位肝15例、肺4例、淋巴结19例、骨3例、腹膜6例。以上患者均接受白蛋白结合型紫杉醇联合疗法作为一线治疗。观察患者无进展生存期(progression free survival,PFS)、总生存期(overall survival,OS)、临床特征、客观缓解率(objective response rate,ORR)、疾病控制率(disease control rate,DCR)和治疗相关不良反应。结果治疗周期中位数为4(范围:2~8)。ORR为40.9%,DCR为90.9%。中位PFS为5.1个月(95%CI:3.9~6.3),OS为14.1个月(95%CI:10.7~14.5)。3级/4级毒性反应发生率为15.9%。最常见的3级不良事件为白细胞减少症(chemotherapy-induced leukopenia,CIL)(n=7,15.9%)。1级和2级非血液学毒性反应包括恶心和呕吐(n=16,36.3%)以及手足综合征(n=10,22.7%)、厌食症(n=10,22.7%)、疲乏(n=9,20.4%)、脱发(n=9,20.4%)、外周感觉神经病变(n=6,13.6%)。多因素分析显示中位CEA<5μg/L是OS延长的重要预测因子(HR=3.5,95%CI:1.48~8.23,P=0.004)。与化疗诱发的3级和4级CIL患者相比,发生0~2级CIL患者的PFS和OS有改善的趋势(HR=2.734,95%CI:1.00~7.46,P=0.050;HR=17.79,95%CI:4.7~66.4,P=0.000)。Nab-PTX联合替吉奥胶囊与Nab-PTX联合顺铂的OS有统计学差异(12.5个月vs 17.0个月;HR=0.513,95%CI:0.31~0.84,P=0.005)。早发CIL患者的OS为18.2个月,晚发CIL患者的OS为11.5个月(HR=2.48,95%CI:1.13~5.42,P=0.02)。结论白蛋白结合型紫杉醇联合替吉奥胶囊或联合顺铂可作为HER2阴性的晚期胃癌患者的一线治疗方案。化疗诱发的0~2级CIL和早发CIL的患者预后较好。可根据中位CEObjective To evaluate the efficacy and safety of nanoparticle albumin-bound paclitaxel(nab-paclitaxel)-combined chemotherapy(CT)as first-line for patients with her-2 negative advanced gastric cancer(GC)in Chinese single-center practice and explore the correlation between clinical characteristics and survival.Methods From December 17,2011 to January 10,2018,44 patients who underwent nab-paclitaxel(nab-PTX)combined therapy as first line with HER2-negative advanced GC were included in this study,including 34 males and 10 females with median age of 57 years(28-85 years).Of the 44 cases,19(38.6%)cases underwent percutaneous endoscopic gastrostomy.Moderate differentiation was found in 17 cases and poor differentiation in 27 cases.Liver metastasis was found in 15 cases,lung metastasis in 4 cases,lymph node metastasis in 19 cases,bone metastasis in 3 cases and peritoneal metastasis in 6 cases.All cases had undergone nanoparticle albumin-bound paclitaxel(nab-paclitaxel)-combined chemotherapy(CT)as first-line.The progression free survival(PFS),overall survival(OS),clinical characteristics,objective response rate(ORR),disease control rate(DCR)and treatment-related adverse efects(AEs)were reviewed and evaluated.Results The median number of cycles was 4(range:2-8).Their overall response rate(ORR)was 40.9%and the disease control rate(DCR)was 90.9%.Median progression-free survival(PFS)and overall survival(OS)were 5.1 months(95%CI:3.9-6.3 months)and 14.1 months(95%CI:10.7-14.5 months),respectively.The toxicities associated with nab-PTX combined therapy were generally tolerable with a total grade 3/4 AEs rate of 15.9%.The most common grade 3 adverse events were leukopenia(n=7,15.9%).Grade 1-2 non-hematologic toxicities included nausea and vomiting(n=16,36.3%),hand–foot syndrome(n=10,22.7%),anorexia(n=10,22.7%),fatigue(n=9,20.4%),alopecia(n=9,20.4%),and peripheral sensory neuropathy(n=6,13.6%).According to multivariate analysis,median CEA<5μg/L was a significant predictor for longer OS(HR,3.5;95%CI,1.48-8.23,P=0.004).Patients w

关 键 词：晚期胃癌 白蛋白结合型紫杉醇 一线化疗 无进展生存期 总生存期 

分 类 号：R735.2[医药卫生—肿瘤]