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Neoadjuvant Chemoimmunotherapy for the Treatment of Locally Advanced Head and Neck Squamous Cell Carcinoma: A Single-Arm Phase 2 Clinical Trial
PURPOSE: This study aimed to assess the antitumor activity and safety of neoadjuvant chemotherapy combined with PD-1 inhibitor camrelizumab in patients with locally advanced head and neck squamous cell carcinoma (HNSCC). PATIENTS AND METHODS: In this single-center, single-arm, phase 2 trial, patient...
Autores principales: | , , , , , , , , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
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American Association for Cancer Research
2022
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9662919/ https://www.ncbi.nlm.nih.gov/pubmed/35766967 http://dx.doi.org/10.1158/1078-0432.CCR-22-0666 |
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author | Zhang, Zhanjie Wu, Bian Peng, Gang Xiao, Guixiang Huang, Jing Ding, Qian Yang, Chengzhang Xiong, Xingao Ma, Hui Shi, Liangliang Yang, Jinsong Hong, Xiaohua Wei, Jielin Qin, You Wan, Chao Zhong, Yi Zhou, Yan Zhao, Xueyan Leng, Yangming Zhang, Tao Wu, Gang Yao, Min Zhang, Xiaomeng Yang, Kunyu |
author_facet | Zhang, Zhanjie Wu, Bian Peng, Gang Xiao, Guixiang Huang, Jing Ding, Qian Yang, Chengzhang Xiong, Xingao Ma, Hui Shi, Liangliang Yang, Jinsong Hong, Xiaohua Wei, Jielin Qin, You Wan, Chao Zhong, Yi Zhou, Yan Zhao, Xueyan Leng, Yangming Zhang, Tao Wu, Gang Yao, Min Zhang, Xiaomeng Yang, Kunyu |
author_sort | Zhang, Zhanjie |
collection | PubMed |
description | PURPOSE: This study aimed to assess the antitumor activity and safety of neoadjuvant chemotherapy combined with PD-1 inhibitor camrelizumab in patients with locally advanced head and neck squamous cell carcinoma (HNSCC). PATIENTS AND METHODS: In this single-center, single-arm, phase 2 trial, patients with resectable stage III–IVB HNSCC received chemotherapy [albumin-bound paclitaxel 260 mg/m(2) (or docetaxel 75 mg/m(2)) plus cisplatin 75 mg/m(2)] and camrelizumab 200 mg on day 1 of each 21-day cycle for three cycles, followed by surgery, and adjuvant radiotherapy. Co-primary end points were pathological complete response (pCR) rate and safety. RESULTS: Thirty patients were enrolled and completed the neoadjuvant therapy, with an objective response rate (ORR) of 96.7% (29/30). Twenty-seven patients underwent surgery without delay, with an R0 resection rate of 92.6% (25/27). The clinical to pathological downstaging rate was 100% (27/27). The pCR rate was 37.0% [95% confidence interval (CI), 19.4%–57.6%], and the major pathological response (MPR) rate was 74.1% (95% CI, 53.7%–88.9%). The median follow-up duration was 16.1 months (range, 8.3–28.5), and the disease-free survival rate at 12 months was 95.8% (95% CI, 73.9%–99.4%). Grade 3 neoadjuvant therapy–related adverse events included rash (1; 3.3%), pruritis (1; 3.3%), and thrombocytopenia (1; 3.3%), and no grade 4 or 5 treatment-related events occurred. The most common surgical complication was delayed wound healing (5; 18.5%). CONCLUSIONS: Neoadjuvant chemotherapy plus camrelizumab for locally advanced HNSCC showed high ORR, pCR, and MPR rates, with an acceptable safety profile. These data support further evaluation of neoadjuvant chemoimmunotherapy for the treatment of locally advanced HNSCC. |
format | Online Article Text |
id | pubmed-9662919 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | American Association for Cancer Research |
record_format | MEDLINE/PubMed |
spelling | pubmed-96629192023-01-05 Neoadjuvant Chemoimmunotherapy for the Treatment of Locally Advanced Head and Neck Squamous Cell Carcinoma: A Single-Arm Phase 2 Clinical Trial Zhang, Zhanjie Wu, Bian Peng, Gang Xiao, Guixiang Huang, Jing Ding, Qian Yang, Chengzhang Xiong, Xingao Ma, Hui Shi, Liangliang Yang, Jinsong Hong, Xiaohua Wei, Jielin Qin, You Wan, Chao Zhong, Yi Zhou, Yan Zhao, Xueyan Leng, Yangming Zhang, Tao Wu, Gang Yao, Min Zhang, Xiaomeng Yang, Kunyu Clin Cancer Res Clinical Trials: Immunotherapy PURPOSE: This study aimed to assess the antitumor activity and safety of neoadjuvant chemotherapy combined with PD-1 inhibitor camrelizumab in patients with locally advanced head and neck squamous cell carcinoma (HNSCC). PATIENTS AND METHODS: In this single-center, single-arm, phase 2 trial, patients with resectable stage III–IVB HNSCC received chemotherapy [albumin-bound paclitaxel 260 mg/m(2) (or docetaxel 75 mg/m(2)) plus cisplatin 75 mg/m(2)] and camrelizumab 200 mg on day 1 of each 21-day cycle for three cycles, followed by surgery, and adjuvant radiotherapy. Co-primary end points were pathological complete response (pCR) rate and safety. RESULTS: Thirty patients were enrolled and completed the neoadjuvant therapy, with an objective response rate (ORR) of 96.7% (29/30). Twenty-seven patients underwent surgery without delay, with an R0 resection rate of 92.6% (25/27). The clinical to pathological downstaging rate was 100% (27/27). The pCR rate was 37.0% [95% confidence interval (CI), 19.4%–57.6%], and the major pathological response (MPR) rate was 74.1% (95% CI, 53.7%–88.9%). The median follow-up duration was 16.1 months (range, 8.3–28.5), and the disease-free survival rate at 12 months was 95.8% (95% CI, 73.9%–99.4%). Grade 3 neoadjuvant therapy–related adverse events included rash (1; 3.3%), pruritis (1; 3.3%), and thrombocytopenia (1; 3.3%), and no grade 4 or 5 treatment-related events occurred. The most common surgical complication was delayed wound healing (5; 18.5%). CONCLUSIONS: Neoadjuvant chemotherapy plus camrelizumab for locally advanced HNSCC showed high ORR, pCR, and MPR rates, with an acceptable safety profile. These data support further evaluation of neoadjuvant chemoimmunotherapy for the treatment of locally advanced HNSCC. American Association for Cancer Research 2022-08-02 2022-06-29 /pmc/articles/PMC9662919/ /pubmed/35766967 http://dx.doi.org/10.1158/1078-0432.CCR-22-0666 Text en ©2022 The Authors; Published by the American Association for Cancer Research https://creativecommons.org/licenses/by-nc-nd/4.0/This open access article is distributed under the Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International (CC BY-NC-ND 4.0) license. |
spellingShingle | Clinical Trials: Immunotherapy Zhang, Zhanjie Wu, Bian Peng, Gang Xiao, Guixiang Huang, Jing Ding, Qian Yang, Chengzhang Xiong, Xingao Ma, Hui Shi, Liangliang Yang, Jinsong Hong, Xiaohua Wei, Jielin Qin, You Wan, Chao Zhong, Yi Zhou, Yan Zhao, Xueyan Leng, Yangming Zhang, Tao Wu, Gang Yao, Min Zhang, Xiaomeng Yang, Kunyu Neoadjuvant Chemoimmunotherapy for the Treatment of Locally Advanced Head and Neck Squamous Cell Carcinoma: A Single-Arm Phase 2 Clinical Trial |
title | Neoadjuvant Chemoimmunotherapy for the Treatment of Locally Advanced Head and Neck Squamous Cell Carcinoma: A Single-Arm Phase 2 Clinical Trial |
title_full | Neoadjuvant Chemoimmunotherapy for the Treatment of Locally Advanced Head and Neck Squamous Cell Carcinoma: A Single-Arm Phase 2 Clinical Trial |
title_fullStr | Neoadjuvant Chemoimmunotherapy for the Treatment of Locally Advanced Head and Neck Squamous Cell Carcinoma: A Single-Arm Phase 2 Clinical Trial |
title_full_unstemmed | Neoadjuvant Chemoimmunotherapy for the Treatment of Locally Advanced Head and Neck Squamous Cell Carcinoma: A Single-Arm Phase 2 Clinical Trial |
title_short | Neoadjuvant Chemoimmunotherapy for the Treatment of Locally Advanced Head and Neck Squamous Cell Carcinoma: A Single-Arm Phase 2 Clinical Trial |
title_sort | neoadjuvant chemoimmunotherapy for the treatment of locally advanced head and neck squamous cell carcinoma: a single-arm phase 2 clinical trial |
topic | Clinical Trials: Immunotherapy |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9662919/ https://www.ncbi.nlm.nih.gov/pubmed/35766967 http://dx.doi.org/10.1158/1078-0432.CCR-22-0666 |
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