Efficacy and Safety of Apatinib in Treatment of Unresectable Intrahepatic Cholangiocarcinoma: An Observational Study

Figures & data

Table 1 Baseline Clinical Characteristics of Patients

Characteristics	Value
Gender, n (%)
Male	8(80.0)
Mean±SD	58.7±7.85
Female	2(20.0)
Age (years)
Median	56
Range	46–71
Weight
≥60kg	5(50.0)
<60kg	5(50.0)
Etiology, n (%)
HBV	3(30.0)
Unknow	7(70.0)
ECOG, n (%)
1	7(70.0)
2	3(30.0)
Child–Pugh class, n (%)
A	7(70.0)
B	3(30.0)
Serum CA19-9, n (%)
≥27U/mL	6(60.0)
<27U/mL	4(40.0)
Tumor size(cm), n (%)
Mean±SD	6.84±4.41
≥5cm	7(70.0)
<5cm	3(30.0)
Number of tumors, n (%)
1–3	4(40.0)
>3	6(60.0)
Macroscopic vascular invasion, n (%)
Yes	3(30.0)
No	7(70.0)
Metastatic sites, n (%)
Regional lymph nodes	10(100.0)
Distant lymph nodes	3(30.0)
Lung	6(60.0)
Bone	4(40.0)
Biliary drainage
Yes	2(20.0)
No	8(80.0)
Previous therapy, n (%)
No	5(50.0)
Chemotherapy	1(10.0)
Radiotherapy	1(10.0)
Resection and chemoradiotherapy	2(20.0)
TACE	1(10.0)
Disease stage, n (%)
IIIB	3(30.0)
IV	7(70.0)

Abbreviations: HBV, hepatitis B virus; ECOG, Eastern Cooperative Oncology Group; CA19-9, carbohydrate antigen 19–9; TACE, transarterial chemoembolization.

Table 2 Treatment Responses

Treatment Responses	All Patients Enrolled (n=10)
CR	0
PR	4(40%)
SD	4(40%)
PD	2(20%)
ORR (95% CI)	40%(26–88%)
DCR (95% CI)	80%(44–97%)

Abbreviations: CR, complete response; PR, partial response; SD, stable disease; PD, progressive disease; ORR, objective response rate = CR+PR/CR+PR+SD+PD; DCR, disease control rate = CR+PR+SD/CR+PR+SD+PD; CI, confidence interval.

Figure 1 Progression-free survival of apatinib in treatment of ICC.

Figure 2 Overall survival of apatinib in treatment of ICC.

Table 3 Possible Treatment-Related Adverse Events of Apatinib in the Safety Population

CTCAE Grade	I,n(%)	II,n(%)	III,n(%)
Non-haematological
Fatigue	4(40%)	1(10%)	1(10%)
Anorexia	2(20%)	1(10%)	0
Vomiting	1(10%)	0	0
Diarrhea	1(10%)	0	0
Hoarseness	3(30%)	0	0
Hypertension	2(20%)	4(40%)	2(20%)
Hand-foot syndrome	4(40%)	2(20%)	2(20%)
Mucositis	3(30%)	1(10%)	0
Proteinuria	4(40%)	1(10%)	0
Hypoproteinemia	5(50%)	1(10%)	0
Hyperbilirubinaemia	2(20%)	1(20%)	0
Alanine aminotransferase increased	5(50%)	1(10%)	0
Aspartate aminotransferase increased	4(40%)	2(20%)	0
Haematological
Anaemia	2(20%)	1(10%)	0
Neutropenia	1(10%)	1(10%)	1(10%)
Thrombocytopenia	1(10%)	1(10%)	0

Abbreviation: CTCAE, Common Terminology Criteria for Adverse Events.