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Neoadjuvant immunochemotherapy for locally advanced resectable oral squamous cell carcinoma: a prospective single-arm trial (Illuminate Trial).

Authors :
Yingying Huang
Jingjing Sun
Jun Li
Dongwang Zhu
Minjun Dong
Shengjin Dou
Yong Tang
Wentao Shi
Qi Sun
Tongchao Zhao
Zhihang Zhou
Xinyu Zhou
Ying Liu
Jiang Li
Guopei Zhu
Ding Zhang
Yanan Chen
Qi Zhu
Wutong Ju
Laiping Zhong
Source :
International Journal of Surgery; Aug2023, Vol. 109 Issue 8, p2220-2227, 8p
Publication Year :
2023

Abstract

Background: Locally advanced oral squamous cell carcinoma (LAOSCC) is associated with a high rate of recurrence and poor survival. Given the recent successes of neoadjuvant immunochemotherapy (NAICT) in solid tumors, it is promising to use this treatment modality to achieve a better pathological response and improve the survival of LAOSCC, and clinical evidence is needed to assess its safety and efficacy. Patients and Methods: A prospective trial of NAICT with toripalimab (PD-1 inhibitor) and albumin paclitaxel/cisplatin (TTP) was conducted in patients with clinical stage III and IVA OSCC. Intravenous albumin paclitaxel (260 mg/m²), cisplatin (75 mg/m²), and toripalimab (240 mg) were given in sequence on day 1 of each 21 day cycle for two cycles, followed by radical surgery and risk-adapted adjuvant (chemo)radiotherapy. The primary endpoints were safety and major pathological response (MPR). Targeted next generation sequencing and multiplex immunofluorescence were performed to assess clinical molecular characteristics and the tumor immune microenvironment in the pre-NAICT and post-NAICT tumor samples. Results: Twenty patients were enrolled. NAICT was well-tolerated with a low incidence of grades 3-4 adverse events in three patients. The completion rates of NAICT and subsequent R0 resection were 100%. The MPR rate was 60%, including a 30% pathological complete response. MPR was achieved in all four patients with a combined positive score of PD-L1> 10. The density of tertiary lymphatic structure in post-NAICT tumor samples predicted the pathological response to NAICT. During the median 23- month follow-up, the disease-free survival was 90%, and the overall survival was 95%. Conclusions: NAICT with the TTP protocol in LAOSCC is feasible and well tolerated, with a promising MPR and no obstruction on subsequent surgery. This trial is supportive of further randomized trials using NAICT in LAOSCC. [ABSTRACT FROM AUTHOR]

Details

Language :
English
ISSN :
17439191
Volume :
109
Issue :
8
Database :
Supplemental Index
Journal :
International Journal of Surgery
Publication Type :
Academic Journal
Accession number :
179866658
Full Text :
https://doi.org/10.1097/JS9.0000000000000489