Anlotinib as a third-line or further treatment for recurrent or metastatic nasopharyngeal carcinoma: a single-arm, phase 2 clinical trial

Table 3 Frequent treatment-related adverse events occurring in ≥ 5% of the study patients (N = 38)

Adverse events	All grades	Grade 3 or higher
TRAEs
Serious TRAE	1 (2.6)
Leading to anlotinib dose reduction	19 (50.0)
Leading to anlotinib treatment interruption	4 (10.5)
Leading to treatment termination	4 (10.5)
Anlotinib-related AEs causing death	0
Hand-foot syndrome^a	24 (63.2)	9 (23.7)
Hypothyroidism	23 (60.5)	0
Hypertension	21 (55.3)	3 (7.9)
Oral mucositis^b	18 (47.4)	8 (21.1)
Cholesterol elevation	17 (43.6)	0
Triglyceride elevation	15 (39.5)	3 (7.9)
Bleeding^c	13 (34.2)	0
Proteinuria	13 (34.2)	0
Fatigue	10 (25.6)	0
GGT elevation	10 (26.3)	2 (5.3)
Anemia	9 (23.7)	2 (5.3)
Creatine elevation	8 (21.1)	2 (5.3)
Anorexia	7 (18.4)	0
AST elevation	5 (13.2)	1 (2.6)
ALT elevation	4 (10.5)	1 (2.6)
Nausea	3 (7.9)	0
Neutropenia	3 (7.9)	1 (2.6)
TBIL elevation	2 (5.3)	1 (2.6)
Pharynx necrosis	2 (5.3)	2 (5.3)
Rash	1 (2.6)	0

Data are expressed in N (%)
There were two cases of pharyngeal necrosis (1 grade 3; 1 asymptomatic and intervention not indicated)
AE Adverse event, ALT Alanine aminotransferase, AST Aspartate aminotransferase, GGT Gamma-glutamyl transpeptidase, TBIL Total bilirubin, TRAE Treatment-related adverse event
^aFor hand-foot syndrome, 7 patients with grade 3 TRAE lead to anlotinib dose reduction or treatment interruption
^bFor oral mucositis, 6 grade 3 events required anlotinib dose reduction
^cSites of grade 1–2 bleeding were the nasopharynx (n = 8), the oropharynx (n = 2), and the urinary tract (n = 3)

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