阿帕替尼治疗肝门胆管癌26例临床疗效分析

目的评价阿帕替尼治疗肝门胆管癌的疗效。方法收集2016年7月至2019年1月我院收治的肝门胆管癌患者26例,口服阿帕替尼(250~425 mg/d),并发梗阻性黄疸患者给予经皮肝穿刺导道引流(PTCD)术降黄治疗,观察并分析疗效及评价安全性。结果26例患者完全缓解(CR)为0,部分缓解(PR)率为23.1%(6例),稳定(SD)率为42.3%(11例),疾病进展(PD)率为34.6%(9例);客观反应率(ORR)为23.1%(6例),疾病控制率(DCR)为65.4%(17例)。中位总生存期(mOS)为9.3个月,中位无进展生存期(mPFS)为4.9个月。门脉受累患者(8例)较未受累患者(18例)平均PFS及OS明显缩短(1.6个月vs.4.9个月,5.7个月vs.11.3个月),差异有统计学意义(P<0.05)。肿瘤Bismuth-Corlette分型(Ⅱ、Ⅲ、Ⅳ型)PFS、OS比较差异有统计学意义(P<0.05)。病灶大小≤5 cm(12例)较>5 cm(14例)平均PFS明显增加(5.0个月vs.3.0个月,P<0.01),而平均OS比较差异无统计学意义(10.8个月vs.8.5个月,P=0.27)。性别、年龄(>60岁,≤60岁)、肿瘤TNM分期(Ⅱ、Ⅲ、Ⅳ期)对疗效影响差异无统计学意义。常见不良反应包括蛋白尿18例(69.2%),高血压17例(65.4%),手足综合征12例(46.2%),骨髓抑制11例(42.3%),腹泻7例(26.9%);Ⅲ~Ⅳ级不良反应:高血压4例(15.4%),蛋白尿3例(11.5%),骨髓抑制2例(7.7%)。结论阿帕替尼治疗肝门胆管癌具有一定疗效,不良反应可控,门脉是否受累、Bismuth-Corlette分型、肿瘤大小可能是疗效的独立影响因素。

Clinical efficacy of apatinib in the treatment of hilar cholangiocarcinoma:analysis of 26 cases

Objective To evaluate the efficacy of apatinib in the treatment of hilar cholangiocarcinoma.Methods Totally 26 cases of hilar cholangiocarcinoma treated from July 2016 to January 2019 in our hospital were collected.Apatinib(250~425 mg/D)was taken orally.Patients with obstructive jaundice were treated with PTCD to reduce jaundice.The therapeutic effect and safety were observed and analyzed.Results There were 0 case of CR,6 cases of PR(23.1%),11 cases of SD(42.3%)and 9 cases of PD(34.6%).The ORR was 23.1%(n=6),and DCR was 65.4%(n=17).The median overall survival time(mOS)was 9.3 months,and the median progression-free survival time(mPFS)was 4.9 months.The mean PFS and OS of patients with portal vein involvement(n=8)were significantly shorter than those of patients without portal vein involvement(n=8)(1.6 months vs.4.9 months,5.7 months vs.11.3 months,P<0.05).There were significant differences in the PFS and OS among the different Bismuth-Corlette types(Ⅱ,ⅢandⅣ)(P<0.05).The mean PFS of patients with focus size less than or equal to 5 cm(n=12)was higher than that of patients with focus size greater than 5 cm(n=14)(5.0 months vs.3.0 months,P<0.01),but there was no significant difference in the mean OS(10.8 months vs 8.5 months,P=0.27).There was no significant difference in the influence of different gender or age(>60 years,<60 years),or of different tumor stage(stageⅡ,ⅢandⅣ)on the efficacy(P<0.05).The common adverse reactions included proteinuria(n=18,69.2%),hypertension(n=17,65.4%),hand-foot syndrome(n=12,46.2%),myelosuppression(n=11,42.3%),diarrhea(n=7,26.9%);GradeⅢ~Ⅳadverse reactions included hypertension(n=4,15.4%),proteinuria(n=3,11.5%)and myelosuppression(n=2,7.7%).Conclusion Apatinib is effective in the treatment of hilar cholangiocarcinoma,with controllable side effects.Tumor size,Bismuth-Corlette classification and portal vein involvement may be the independent affecting factors for the efficacy.