安罗替尼联合信迪利单抗治疗复发转移食管鳞癌初步临床研究
摘要
目的探讨安罗替尼联合信迪利单抗治疗复发转移食管鳞癌的疗效和安全性。方法将我院 2019 年 6 月至 2022 年 10 月收治的 78 例复发转移食管癌患者,随机分为安罗替尼联合信迪利单抗治疗组(联合组) 与安罗替尼单药治疗组(单药组)。联合治疗组:安罗替尼 10 ~ 12mg, 每日 1 次,口服,第 1 ~ 14 天,1 周 期 21 天;同期联合信迪利单抗 200 mg 静脉注射每 21 天 1 次;单药治疗组:安罗替尼 10 ~ 12 mg, 每日 1 次, 口服,第 1 ~ 14 天,1 周期 21 天;按不良反应耐受情况,调整安罗替尼剂量;治疗 2 周期全面复查,评价疗效; 对比观察疗效及安全性。结果全部 78 例研究对象,均完成 2 周期以上治疗,达到评价目的,CR0%,PR17 例 (21.79%),SD24 例(30.77%),PD37 例(47.44%),RR17 例(21.79%),DCR 41 例(52.56%),mPFS 4.5 个月,mOS 7.2 个月;安罗替尼联合信迪利单抗治疗组,RR 30%,DCR 67.5%,mPFS 7.8 月,mOS11.8 月; 安罗替尼单药治疗组,RR 13.2%,DCR 36.8%,mPFS 4.2 月,mOS 6.8 月;两组比较,统计学处理,RR 比较: 95% 可信区间下线 3 ~ 6(对照组)/13 ~ 23(治疗组);DCR 比较:95% 可信区间下线 16 ~ 28(对照组) /39 ~ 73(治疗组);差方显性检验,X2 值 =5.8757,> 3.84,P < 0.05,统计学有显著差异;结论安罗替尼 联合信迪利单抗治疗复发转移食管鳞癌与单药安罗替尼比较,具有较好疗效,安全性良好,值得临床进一步研究。参考
[1]. 郑荣寿 , 孙可欣 , 张思维 , 等 .2015 年中国恶
性肿瘤流行情况分析 [J]. 中华肿瘤杂志 ,2019,41(1):19-
28.
[2]. 刘尚国 , 白玉 , 赵宝生 , 等 . 复发转移食管癌
患者的预后因素分析 [J]. 中华肿瘤杂志 ,2014,36(11):
143-147.
[3].NCCN 临床实践指南 : 食管癌和胃食管交界
处癌(2020.v1)2020.03.18;
[4].2021 版 CSCO 食管癌诊疗指南 ,2021.04. 23 ~
24;.
[5]. 王俊 , 冉凤鸣 , 金兵 , 等 . 安罗替尼治疗恶性
肿瘤的临床研究进展 [J]. 中国肿瘤 ,2019,28(5):359-366.
[6].KELLY R J,SMITH K N,ANAGNOSTOU V,et
al.Neoadjuvant nivolumab plus concurrent chemoradiation
in stage II/III esophageal/gastroesophageal junction
cancer[J].Journal of Clinical Oncology,2019,37(4_
suppl):142.
[7].KOJIMA T,K MURO,FRANCOIS E,et
al.Pembrolizumab versus chemotherapy as secondline therapy for advanced esophageal cancer:Phase
III KEYNOTE-181 study[J].Journal of Clinical
Oncology,2019,37(4_suppl):2.
[8].CHEN J,LUO S,QIN S,et al.Pembrolizumab
versus Chemotherapy in Patients with Advanced/
Metastatic Adenocarcinoma or Squamous Cell Carcinoma
of the Esophagus as Second-line Therapy:Analysis of
the Chinese Sub-group in KEYNOTE-181.2019
ESMO,abstract,760--761..
[9].KATO K,CHO BC,TAKAHASHI M,et
al.Nivolumab versus chemotherapy in patients with
advanced oesophageal squamous cell carcinoma refractory
or intolerant to previous chemotherapy(ATTRACTION-
3):a multicentre,randomised,open-label,phase 3
trial[published correction appears in Lancet Oncol.2019
Nov;20(11):613].Lancet Oncol.2019,20(11):1506-1517.
[10]XU J,LI Y,FAN Q,et al.Sintilimab in patients
with advanced esophageal squamous cell carcinoma
refractory to previous chemotherapy:A randomized,openlabel phase II trial(ORIENT-2)[J].Journal of Clinical
Oncology,2020,38(15_suppl):4511.
[11]GU Y,CHEN X,WANG D,et al.175P A
study of neoadjuvant sintilimab combined with triplet
chemotherapy of lipo-paclitaxel,cisplatin,and S-1 for
resectable esophageal squamous cell carcinoma(ESCC)-
ScienceDirect[J].Annals of Oncology,2020,31.
[12]ZHANG B,QI L,WANG X,et al.Phase
II clinical trial using camrelizumab combined with
apatinib and chemotherapy as the first-line treatment of
advanced esophageal squamous cell carcinoma[J]Cancer
Communications,,2020,40(12):10
[13]ZHANG B,QI L,WANG X,et al.Phase II
clinical trial usingCamrelizumabcombined with apatinib
and chemotherapy as the first-line treatment of advanced
esophageal squamous cell carcinoma.Cancer Commun(Lo
nd).2020,40(12):711-720.
[14]HUANG J,XU JM,CHEN Y,et al.Camreli
zumabversus investigator’s choice of chemoterapy
as second-line therapy for advanced or metastatic
oesophageal squamous cell carcinoma(ESCORT):a
multicentre,randomised,open-label,phase 3 study.Lancet
Oncol.2020,21(6):832-842.
[15]HUANG J,XIAO J,FANG W,et al.Anlotinib
for previously treated advanced or metastatic esophageal
squamous cell carcinoma:A double-blind randomized
phase 2 trial[J].Cancer Medicine,2021,(6).
[16] 杨晓利 , 王彩玲 , 夏金 , 等 . 安罗替尼联合紫
杉醇和顺铂一线治疗晚期食管鳞癌的疗效分析 [J]. 肿
瘤防治研究 ,2021,48(7):4.
[17] 张晓东 , 沈琳 , 李洁 , 等 . 放化疗联合与单独
化疗对晚期食管癌生存期影响的比较 [J]. 中华肿瘤杂
志 ,2007,29(6):4.
[18]HONG Y,WU T,LU P,et al.Real-world
effectiveness of anlotinib in combination with PD-1
inhibitors as second-line or later therapy for advanced
or metastatic oesophageal squamous cell carcinoma.2022
ASCO GI.
[19]MISSIAEN R,MAZZONE M,BERGERS
G.The reciprocal function and regulation of tumor vessels
and immune cells offers new therapeutic opportunities in
cancer[J].Semin Cancer Biol,2018,52(Pt 2):107-116.
[20]LUPO G,CAPORARELLO N,OLIVIERI
M,et al.Anti-angiogenic Therapy in Cancer:Downsides
and New Pivots for Precision Medicine[J].Front
Pharmacol,2017,7:519.
[21]HUANG Y,KIM BYS,CHAN CK,etal.
Improving immune-vascular crosstalk for cancer
immunotherapy[J].Nat Rev Immunol,2018,18(3):195-203.