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On-treatment blood TMB as predictors for camrelizumab plus chemotherapy in advanced lung squamous cell carcinoma: biomarker analysis of a phase III trial.

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机构: [1]Department of Medical Oncology, Shanghai Pulmonary Hospital, Tongji University School of Medicine, No.507, Zhengmin Road, Shanghai, 200433, China. [2]Hunan Cancer Hospital, Changsha, China. [3]Northern Jiangsu People's Hospital, Yangzhou, China. [4]Jilin Cancer Hospital, Changchun, China. [5]Harbin Medical University Cancer Hospital, Harbin, China. [6]Anhui Provincial Hospital, Hefei, China. [7]Sir Run Run Shaw Hospital Zhejiang University School of Medicine, Hangzhou, China. [8]Henan Cancer Hospital, Zhengzhou, China. [9]Yunnan Cancer Hospital &The Third Affiliated Hospital of Kunming Medical University & Yunnan Cancer Centre, Kunming, China. [10]Sichuan Provincial Cancer Hospital, Chengdu, China. [11]Anhui Chest Hospital, Hefei, China. [12]The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China. [13]The First Affiliated Hospital of Nanchang University, Nanchang, China. [14]Shaanxi Provincial Cancer Hospital, Xi'an, China. [15]Hubei Cancer Hospital, Wuhan, China. [16]Jiangsu Province Hospital, Nanjing, China. [17]LinYi Cancer Hospital, Linyi, China. [18]Tangshan People's Hospital, Tangshan, China. [19]The Third Xiangya Hospital of Central South University, Changsha, China. [20]Chongqing University Cancer Hospital, Chongqing, China. [21]Beijing Cancer Hospital, Beijing, China. [22]Jiangxi Cancer Hospital, Nanchang, China. [23]Baoji Central Hospital, Baoji, China. [24]Jinan Central Hospital, Jinan, China. [25]Taizhou Hospital of Zhejiang Province, Taizhou, China. [26]Zhejiang Cancer Hospital, Hangzhou, China. [27]Heping Hospital Affiliated to Changzhi Medical College, Changzhi, China. [28]Henan Provincial People's Hospital, Zhengzhou, China. [29]Genecast Biotechnology Co., Ltd., Wuxi City, China. [30]Jiangsu Hengrui Pharmaceuticals Co., Ltd., Shanghai, China
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Camrelizumab plus chemotherapy significantly prolonged progression-free survival (PFS) and overall survival (OS) compared to chemotherapy alone as first-line treatment in advanced lung squamous cell carcinoma (LUSC) in the phase III trial (CameL-sq), which has become an option of standard-of-cares for Chinese patients with advanced LUSC. However, the predictive biomarkers remain unknown.Tumor tissue samples at baseline, and peripheral blood samples at baseline (pretreatment) and after two cycles of treatment (on-treatment) were prospectively collected from 270 LUSC patients from the CameL-sq study. Blood tumor mutation burden (bTMB) and its dynamics were analyzed to explore their predictive values.Pretreatment bTMB was not associated with objective response, PFS and OS in camrelizumab or placebo plus chemotherapy groups. Low on-treatment bTMB was associated with significantly better objective response (73.8% vs 27.8%, P < 0.001), PFS (median, 9.1 vs 4.1 months; P < 0.001) and OS (median, not reached vs 8.0 months; P < 0.001) in camrelizumab plus chemotherapy group whereas it did not correlate with objective response and PFS in chemotherapy alone group. Importantly, on-treatment bTMB level could discriminate patients of initially radiological stable disease who would long-term benefit from camrelizumab plus chemotherapy (low vs high, median OS, 18.2 vs 7.8 months; P = 0.001). Combing on-treatment bTMB and its dynamics improved the ability for predicting the efficacy of camrelizumab plus chemotherapy.On-treatment bTMB together with its dynamics could serve as a predictive biomarker for camrelizumab plus chemotherapy in patients with advanced LUSC.ClinicalTrials.gov identifier: NCT03668496.© 2021. The Author(s).

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出版当年[2022]版:
大类 | 1 区 医学
小类 | 1 区 肿瘤学 1 区 生化与分子生物学
最新[2023]版:
大类 | 1 区 医学
小类 | 1 区 生化与分子生物学 1 区 肿瘤学
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出版当年[2022]版:
Q1 BIOCHEMISTRY & MOLECULAR BIOLOGY Q1 ONCOLOGY
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Q1 BIOCHEMISTRY & MOLECULAR BIOLOGY Q1 ONCOLOGY

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第一作者机构: [1]Department of Medical Oncology, Shanghai Pulmonary Hospital, Tongji University School of Medicine, No.507, Zhengmin Road, Shanghai, 200433, China.
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