Paclitaxel for second-line treatment of squamous cell carcinoma of the head and neck: A multicenter retrospective Italian study

Table 1 Intention to treat population characteristics, n (%)

Characteristics
Median age in years (minimum-maximum)	57.8 (37.8-82.7)
Sex
Female	15 (14)
Male	92 (86)
Eastern cooperative oncology group performance status
0	4 (3)
1	89 (84)
2	14 (13)
Location of primary tumor
Larynx	27 (25)
Oropharynx	33 (31)
Hypopharynx	29 (27)
Oral cavity	18 (17)
Body mass index
Overweight, ≥ 25.0	26 (24)
Normal, 18.5-25.0	38 (36)
Underweight, ≤ 18.5	43 (40)
Caregiver
Yes	66 (62)
No	41 (38)
Alcohol
Yes	41 (38)
No	66 (62)
Smoking
Yes	45 (42)
No	62 (58)
Human papillomavirus
Yes	11 (11)
No	46 (49)
Unknown	50 (40)

Table 2 Previous therapies, n (%)

Chemotherapy type
Cisplatin-based	52 (48)
Carboplatin-based	50 (47)
Cetuximab also	66 (62)
Other chemotherapy	5 (5)
Maintenance with cetuximab
Yes	48 (45)
No	59 (55)
Previous radiotherapy
Yes	100 (94)
No	7 (6)
Best response of maintenance
Complete response	1 (1)
Partial response	28 (27)
Stabilization of disease	18 (16)
Disease progression	60 (56)

Table 3 Median progression-free survival and overall survival in the subgroup analyses

Survival rate	Low BMI	Normal BMI	Smoking	Non-smoking	Alcohol	No alcohol
Median progression-free survival	2	3.5	2.96	4.23	3.1	3.5
Median overall survival	4.1	7	5.47	7.79	5.8	6.8

BMI: Body mass index.

Table 4 Adverse events during paclitaxel treatment, n (%)

Adverse event	All grades	Grade 3-4
Acne-like rash	4 (7)	0
Anemia	49 (46)	14 (12)
Mucositis	38 (36)	10 (12)
Peripheral neuropathy	17 (15)	3 (2)
Asthenia	42 (39)	12 (14)
Neutropenia	30 (28)	7 (6)

Table 5 Disease control rate as per Response Evaluation Criteria in Solid Tumors criteria, n (%)

Clinical endpoint
Complete response	1 (1)
Partial response	26 (25)
Overall response	27 (26)
Stable disease	28 (26)
Disease control rate	55 (52)
Progressive disease	52 (48)

Table 6 Palliative chemotherapy data and salvage chemotherapy after immunotherapy

Ref.	n	Baseline characteristics	ChT regimen	Objective response rate	Overall survival	Progression-free survival
Vermorken, 2007	1031	Median age 57 years; male 82; median KPS 80; locoregional only 52	Cetuximab	13	5.9 months	2.3 months
Grau, 2009	60	Median age 59.5 years; male 91.7; KPS 0 1.7; locoregional only 51.7	Paclitaxel	43.3	5.2 months	6.2 months
Tahara, 2011	72	Median age 61 years; male 77.8; KPS 0 66.7; locoregional only n/a	Paclitaxel	33.3	14.3 months	/
Fayette, 2010	66	Median age 60.7 years; male 89; KPS 0 6; locoregional only 58	Paclitaxel, paclitaxel combination	30	7.8 months	3.9 months
Catimel, 1994	40	Median age 55 years; male 32; KPS 0 11; locoregional only 26	Docetaxel	32	/	/
Saleh, 2019	82	Median age 58 years; Male 84; KPS 0 45-55; locoregional only 41	Taxane, taxane cetuximab +/- platinum, taxane platinum, EXTREME, docetaxel-platinum-cetuximab, carboplatin cetuximab, carboplatin paclitaxel	30	7.8 months	3.6 months
Kurosaki, 2021	22	Median age 65 years; male 59.1; KPS 0 22.7; locoregional only 31.8	Cetuximab-paclitaxel, carboplatin fluorouracil cetuximab	40.9	14.5 months	5.2 months
Pestana, 2020	43	Median age n/a; male 90.7; KPS 0; locoregional only 83.7	Cetuximab, single agent ChT, ChT + cetuximab, ChT + other agents	42	8.41 months	4.24 months
Cabezas-Camarero, 2021	23	Median age 65 years; male 73.9; KPS 0 4.3; locoregional only 17.4	ERBITAX, EXTREME, CARBITAX, cisplatin-cetuximab	56.5	12 months	6 months
Harrington, 2023	311	Median age; male; KPS 0; locoregional only	Taxane-based, non-taxane-based (antimetabolite, platinum-based)	N/A	N/A	Pembrolizumab alone; taxane-based: 9.8 months; non-taxane-based: 9.5 months; pembrolizumab-ChT; taxane-based: 12.7 months; non-taxane-based: 12.5 months

¹Intention to treat population only.

ChT: Chemotherapy; KPS: Karnofsky Performance Scale; N/A: Not applicable.