ESMO Congress 2024 | OncologyPRO

Abstract 864P

Background

This study aimed to assess the activity and safety of neoadjuvant TIS plus Chemo in patients(pts) with resectable LA-HNSCC.

Methods

In this single-arm, phase II trial (NCT06235918), pts with stage T3-4 or N2 resectable HNSCC received TIS combined with nab-paclitaxel and carboplatin for 2 cycles prior to surgery. The primary endpoint was pathological complete response (pCR) rate. Secondary endpoints included major pathologic response rate (MPR), objective response rate (ORR), 3-years disease-free survival rates, 3-years overall survival rates and safety. Exploratory predictive efficacy biomarkers include circulating tumor cells (CTCs) and T cell senescence.

Results

Between April 2023 and Apirl 2024, 28 pts were enrolled and administrated the neoadjuvant therapy, with an ORR of 77.3% (17/22). The baseline characteristics were shown in the table. After neoadjuvant treatment, 22 pts underwent surgery and 21(95.5%) pts achieved R0 resection. Among the 22 pts,10 (45.5%) pts achieved pCR. T cell senescence and CTCs concentration and dynamic changes at baseline and after neoadjuvant treatment were compared between pCR and non-pCR pts. CTCs level decreased in 66.7% (4/6) of pts in the pCR group, compared to 37.5% (3/8) of pts in the non-pCR group. T cell senescence level decreased in 66.7% (4/6) of pts in the pCR group, compared to 44.4% (4/9) of pts in the non-pCR group. No pts had grade 3 treatment-related adverse events (AEs) and no unexpected immune-related AEs were observed. Table: 864P

Variables	Number of pts(%)	%
Male/Female	27/1	-
Age (range, years)	59.5(29-73)	-
Primary site
larynx	15	53.6
Oropharynx	8	28.6
hypopharynx	3	10.7
Oral Cavity	2	7.1
Smoking status
Current or former	16	57.1
Never	12	42.9
Alcohol
YES	13	46.4
NO	15	53.6
ECOG
0-1	28	100
T stage
T2	6	21.4
T3	12	42.9
T4	10	35.7
N stage
N0	3	10.7
N1	8	28.6
N2	14	50.0
N3	3	10.7
Stage
II	2	7.1
III	9	32.1
IV	17	60.7

Conclusions

Neoadjuvant TIS and Chemo showed promising activity and manageable safety profile in pts with resectable LA HNSCC. T cell senescence and CTC might be potential predictors for the efficacy.