Clinical application of GEMOX combined with target-immunity therapy in patients with advanced biliary tract cancer

doi:10.3969/j.issn.1004-583X.2024.05.004

Abstract

Abstract:

Objective To evaluate the clinical efficacy and safety of gemcitabine and oxaliplatin (GEMOX) combined with target-immunity therapy (lenvatinib and programmed cell death 1 [PD-1] monoclonal antibody) in patients with advanced biliary tract cancer (BTC). Methods Twenty-four patients with advanced BTC received GEMOX combined with target-immunity therapy visited Integrative Oncology Department or Hepatobiliary Surgery Department of our hospital from January 2015 to January 2024 were recruited. The primary end points were set as overall survival (OS) and progression-free survival (PFS), and the secondary end points were objective response rate (ORR), disease control rate (DCR) and safety. The safety and overall clinical efficacy of GEMOX combined with target-immunity therapy regimen on advanced BTC were comprehensively evaluated via tumor marker indexes (carcinoembryonic antigen [CEA], carbohydrate antigen 125 [CA125], CA199), adverse reactions rates, quality of life scores, imaging indicators, and other data. Results None of the 24 patients had complete remission (CR). ORR was 33.3% (8/24, 8 patients had PR), DCR was 66.7% (16/24; 8 patients had SD and 8 patients had PD, respectively), median OS was 13 months and median PFS was 8 months. After treatment, the levels of CA199 were significantly lower than those before treatment (P<0.05). The incidence of adverse events in 24 patients were rash (14/24, 58.3%), leucopenia (22/24, 91.6%), anemia (20/24, 83.3%). One patient had serious adverse events and withdrew from treatment, one patient died of biliary obstruction with infection during treatment. Conclusion GEMOX combined with target-immunity therapy regimen is safe and effective in the treatment of advanced BTC, it may be used clinically.

Key words: biliary tract neoplasms, recurrence and metastasis, chemotherapy, targeting, immunization, clinical application

CLC Number:

R735.8

Wu Xiaomin, Fang Yipeng, Zhang Zhen, Zhang Ye, Jin Cheng. Clinical application of GEMOX combined with target-immunity therapy in patients with advanced biliary tract cancer[J]. Clinical Focus, 2024, 39(5): 408-412.

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URL: https://huicui.hebmu.edu.cn/EN/10.3969/j.issn.1004-583X.2024.05.004

https://huicui.hebmu.edu.cn/EN/Y2024/V39/I5/408

Figures/Tables 8

References 23

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序号	性别	分期	病理类型	是否转移	转移部位
1	女	Ⅳ	胆囊癌	是	肝脏
2	女	Ⅳ	肝内胆管癌	是	肝脏
3	男	Ⅳ	肝内胆管癌	是	肝脏
4	男	Ⅳ	胆囊癌	是	肝脏
5	女	Ⅳ	胆囊癌	是	第16组淋巴结
6	女	Ⅳ	肝内胆管癌	是	肝脏
7	男	Ⅳ	胆囊癌	是	肝脏
8	男	Ⅳ	肝门部胆管癌	是	肝脏
9	男	Ⅳ	胆囊癌	是	第16组淋巴结
10	男	Ⅳ	肝门部胆管癌	是	肝脏
11	女	Ⅳ	胆管下段癌	是	肝脏
12	男	Ⅳ	肝内胆管癌	是	肝脏
13	女	Ⅳ	胆囊癌	是	肝脏
14	女	Ⅳ	肝门部胆管癌	是	肝脏
15	男	Ⅳ	肝内胆管癌	是	肝脏
16	男	Ⅳ	胆管下段癌	是	肝脏
17	女	Ⅳ	胆囊癌	是	第16组淋巴结
18	女	Ⅳ	肝门部胆管癌	是	肝脏
19	男	Ⅳ	肝内胆管癌	是	肝脏
20	男	Ⅳ	胆管下段癌	是	肝脏
21	男	Ⅳ	胆囊癌	是	第16组淋巴结
22	男	Ⅳ	肝内胆管癌	是	肝脏
23	女	Ⅳ	胆管下段癌	是	肝脏
24	男	Ⅳ	肝内胆管癌	是	肝脏

序号	性别	分期	病理类型	是否转移	转移部位
1	女	Ⅳ	胆囊癌	是	肝脏
2	女	Ⅳ	肝内胆管癌	是	肝脏
3	男	Ⅳ	肝内胆管癌	是	肝脏
4	男	Ⅳ	胆囊癌	是	肝脏
5	女	Ⅳ	胆囊癌	是	第16组淋巴结
6	女	Ⅳ	肝内胆管癌	是	肝脏
7	男	Ⅳ	胆囊癌	是	肝脏
8	男	Ⅳ	肝门部胆管癌	是	肝脏
9	男	Ⅳ	胆囊癌	是	第16组淋巴结
10	男	Ⅳ	肝门部胆管癌	是	肝脏
11	女	Ⅳ	胆管下段癌	是	肝脏
12	男	Ⅳ	肝内胆管癌	是	肝脏
13	女	Ⅳ	胆囊癌	是	肝脏
14	女	Ⅳ	肝门部胆管癌	是	肝脏
15	男	Ⅳ	肝内胆管癌	是	肝脏
16	男	Ⅳ	胆管下段癌	是	肝脏
17	女	Ⅳ	胆囊癌	是	第16组淋巴结
18	女	Ⅳ	肝门部胆管癌	是	肝脏
19	男	Ⅳ	肝内胆管癌	是	肝脏
20	男	Ⅳ	胆管下段癌	是	肝脏
21	男	Ⅳ	胆囊癌	是	第16组淋巴结
22	男	Ⅳ	肝内胆管癌	是	肝脏
23	女	Ⅳ	胆管下段癌	是	肝脏
24	男	Ⅳ	肝内胆管癌	是	肝脏

项目	0级	1级	2级	3级	4级
皮肤	无	红斑	干性脱水、水疱、瘙痒	湿性皮炎、溃疡	剥脱性皮炎、坏死、需手术
白细胞下降(×10⁹)	≥4.0	3.0~3.9	2.0~2.9	1.0~1.9	<1.0
贫血(HB g/L)	≥110	95~109	80~94	65~79	<65

项目	0级	1级	2级	3级	4级
皮肤	无	红斑	干性脱水、水疱、瘙痒	湿性皮炎、溃疡	剥脱性皮炎、坏死、需手术
白细胞下降(×10⁹)	≥4.0	3.0~3.9	2.0~2.9	1.0~1.9	<1.0
贫血(HB g/L)	≥110	95~109	80~94	65~79	<65

组别	例数	CEA(μg/L)	CA125(kU/L)	CA199(kU/L)
治疗前	24	72.85±207.99	33.50±38.31	148.09±174.12
治疗后	24	8.91±13.52	32.56±45.07	67.16±59.07
t值		1.59	0.073	3.217
P值		0.125	0.942	0.004