Efficacy analysis of postoperative adjuvant chemotherapy for resectable biliary tract cancer

doi:10.3877/cma.j.issn.2095-3232.2022.04.013

Abstract

Abstract:

Objective

To evaluate the efficacy of postoperative adjuvant chemotherapy for resectable biliary tract cancer (BTC).

Methods

Clinical data of 151 patients with BTC who underwent surgery in Eastern Hepatobiliary Surgery Hospital affiliated to Naval Medical University from January 2017 to November 2019 were retrospectively analyzed. Among them, 84 patients were male and 67 female, aged (58±6) years on average. The informed consents of all patients were obtained and the local ethical committee approval was received. According to whether postoperative adjuvant chemotherapy was delivered, all patients were divided into the chemotherapy group (n=104) and non-chemotherapy group (n=47). According to whether chemotherapy regimen contained gemcitabine (G), patients in the chemotherapy group were further divided into G-containing regimen (n=89) and G-free regimen subgroups (n=15). The impact of postoperative adjuvant chemotherapy and different chemotherapy regimens on the recurrence-free survival (RFS) was assessed. Survival analysis was conducted by Kaplan-Meier method and Tarone-Ware test. The influencing factors of postoperative RFS were analyzed by Cox proportional hazards regression model.

Results

The follow-up duration was ranged from 6 to 24 months, with a median of 15 months. The median RFS was 13 months in the chemotherapy group and 6 months in the non-chemotherapy group. Postoperative adjuvant chemotherapy significantly improved the RFS of patients (χ²=13.286, P<0.05). Cox regression analysis showed that decline of postoperative CA19-9 to normal range was a protective factor of RFS (HR=0.375, 95%CI: 0.204-0.691, P<0.05), whereas chemotherapy regimen exerted no effect on RFS (HR=1.603, 95%CI: 0.706-3.636, P>0.05).

Conclusions

Postoperative adjuvant chemotherapy can prevent recurrence and improve the survival of resectable BTC patients. Nevertheless, chemotherapy regimen exerts no effect upon the recurrence. The failure of postoperative CA19-9 decline to normal range is an independent risk factor for the recurrence of resectable BTC. Postoperative follow-up should be strengthened for these patients.

Key words: Bile duct neoplasms, Chemotherapy, Prognosis, Gemcitabine

Chenjie Tao, Xiyun Chen, Cheng Lou, Wei Wei, Guang Yang, Yulong Dong, Tianmei Zeng, Peipei Shang, Zhengang Yuan. Efficacy analysis of postoperative adjuvant chemotherapy for resectable biliary tract cancer[J]. Chinese Journal of Hepatic Surgery(Electronic Edition), 2022, 11(04): 390-394.

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References 22

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指标		化疗组	非化疗组	统计值	P值
年龄(岁)		57±9	58±8	t=0.920	0.339
男性(例)		60	24	χ²=0.576	0.448
肿瘤部位(例)				χ²=2.877	0.411
	肝内胆管癌	41	15
	肝门部胆管癌	14	4
	远端胆管癌	11	9
	胆囊癌	38	19
肿瘤分期(例)				χ²=3.999	0.406
	Ⅰ期	15	8
	Ⅱ期	31	12
	Ⅲ期	38	12
	Ⅳ期	20	15
肿瘤分化程度(例)				χ²=1.807	0.405
	低分化	12	7
	中-低分化	17	4
	中分化	75	36
手术切缘阴性(例)		92	40	χ²=0.331	0.565
淋巴结转移(例)		48	22	χ²=0.006	0.940

指标		化疗组	非化疗组	统计值	P值
年龄(岁)		57±9	58±8	t=0.920	0.339
男性(例)		60	24	χ²=0.576	0.448
肿瘤部位(例)				χ²=2.877	0.411
	肝内胆管癌	41	15
	肝门部胆管癌	14	4
	远端胆管癌	11	9
	胆囊癌	38	19
肿瘤分期(例)				χ²=3.999	0.406
	Ⅰ期	15	8
	Ⅱ期	31	12
	Ⅲ期	38	12
	Ⅳ期	20	15
肿瘤分化程度(例)				χ²=1.807	0.405
	低分化	12	7
	中-低分化	17	4
	中分化	75	36
手术切缘阴性(例)		92	40	χ²=0.331	0.565
淋巴结转移(例)		48	22	χ²=0.006	0.940

因素	b	SE(b)	Wald χ²	HR	95%CI	P
CA19-9正常^a	-0.981	0.311	9.910	0.375	0.204~0.691	0.002
性别（男）	-0.164	0.274	0.358	0.849	0.496~1.452	0.550
年龄＜55岁	-0.160	0.273	0.343	0.852	0.500~1.454	0.558
肿瘤分期（Ⅳ期）	0.186	0.169	1.206	1.205	0.864~1.679	0.272
分化程度（中低分化）	0.196	0.186	1.113	1.217	0.845~1.753	0.291
淋巴结转移	0.305	0.297	1.055	1.357	0.758~2.430	0.304
切缘阴性	0.532	0.405	1.726	1.702	0.770~3.764	0.189
化疗方案（含G）	0.472	0.418	1.274	1.603	0.706~3.636	0.259

因素	b	SE(b)	Wald χ²	HR	95%CI	P
CA19-9正常^a	-0.981	0.311	9.910	0.375	0.204~0.691	0.002
性别（男）	-0.164	0.274	0.358	0.849	0.496~1.452	0.550
年龄＜55岁	-0.160	0.273	0.343	0.852	0.500~1.454	0.558
肿瘤分期（Ⅳ期）	0.186	0.169	1.206	1.205	0.864~1.679	0.272
分化程度（中低分化）	0.196	0.186	1.113	1.217	0.845~1.753	0.291
淋巴结转移	0.305	0.297	1.055	1.357	0.758~2.430	0.304
切缘阴性	0.532	0.405	1.726	1.702	0.770~3.764	0.189
化疗方案（含G）	0.472	0.418	1.274	1.603	0.706~3.636	0.259

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