Efficacy of two programmed cell death 1 combination regimens in recurrent and/or metastatic head and neck carcinoma: A real-world retrospective study

Table 1 Demographics and clinical characteristics of the study cohort, n (%)

Characteristics	Total (n = 24)	Anti-PD-1 plus cetuximab (n = 13)	Anti-PD-1 plus anlotinib (n = 11)	P value
Median age, years (IQR)	55.5 (50-68)	51 (46-70)	61 (54.5-67)	0.324
Sex
Male	15 (62.5)	8 (61.5)	7 (63.6)	1.000
Female	9 (37.5)	5 (38.5)	4 (36.4)
Smoking history
Former or current	13 (54.2)	7 (53.8)	6 (54.5)	1.000
Never	11 (45.8)	6 (46.2)	5 (45.5)
Alcohol abuse				1.000
Former or current	8 (33.3)	4 (30.8)	4 (36.4)
Never	16 (66.7)	9 (69.2)	7 (63.6)
Primary tumor site				1.0001
Oral cavity	12 (50.0)	6 (46.2)	6 (54.5)
Oropharynx	2 (8.3)	2 (15.4)	0 (0)
Hypopharynx	4 (16.7)	3 (23.1)	1 (9.1)
Larynx	5 (20.8)	2 (15.4)	3 (27.3)
Nasal cavity	1 (4.2)	0 (0)	1 (9.1)
Recurrence pattern				0.031a
Local or regional recurrence only	20 (83.3)	13 (100.0)	7 (63.6)
With distant metastasis	4 (16.7)	0 (0)	4 (36.4)
P16 immunohistochemistry				0.942
Positive	2 (8.3)	1 (7.7)	1 (9.1)
Negative	14 (58.3)	8 (61.5)	6 (54.5)
Unknown status	8 (33.3)	4 (30.8)	4 (36.4)
Previous radiotherapy				0.482
Yes	22 (91.7)	11 (84.6)	11 (100)
No	2 (8.3)	2 (15.4)	0 (0)
Treatment line				1.000
First	18 (75.0)	10 (76.9)	8 (72.7)
Second	6 (25.0)	3 (23.1)	3 (27.3)
PD-L1 CPS				0.6222
< 1	4 (16.7)	1 (7.7)	3 (27.3)
1-20	2 (8.3)	2 (15.4)	0 (0)
≥ 20	9 (37.5)	6 (46.2)	3 (27.3)
Inadequate tissue sample	9 (37.5)	4 (30.8)	5 (45.5)

¹Oropharynx, hypopharynx, larynx, and nasal cavity” were grouped together as one group for statistical analysis.

²Combined positive score (CPS) of < 1 and CPS of 1-20” were grouped together as one group for statistical analysis.

^aP < 0.05.

PD-1: Programmed cell death 1; CPS: Combined positive score; PD-L1: Programmed death-ligand 1; IQR: Interquartile range.

Table 2 Best overall response, n (%)

	Anti-PD-1 plus cetuximab (n = 11)	Anti-PD-1 plus anlotinib (n = 10)
Best overall response
Complete response	1 (9.1)	0 (0)
Partial response	2 (18.2)	4 (40.0)
Stable disease	7 (63.6)	6 (60.0)
Progressive disease	1 (9.1)	0 (0)
ORR, %	27.3	40.0
DCR, %	90.9	100

PD-1: Programmed cell death 1; ORR: Overall response rate; DCR: Disease control rate.

Table 3 Summary of grade ≥ 3 adverse events

Event, n	Anti-PD-1 plus cetuximab (n = 11)	Anti-PD-1 plus anlotinib (n = 10)
Tumor pain	1	5
Decreased appetite	2	3
Tumor hemorrhage	1	2
Hypertension	0	3
Hypokalemia	0	1
Rash	1	1
Pneumonia	0	1
Diarrhea	0	1
Ascites	1	0

PD-1: Programmed cell death 1.