Evidence map›Paper›PMID 34980131›Full record

Trial reportMolecular cancer2022

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

Tao Jiang, Jianhua Chen, Xingxiang Xu, Ying Cheng, Gongyan Chen, Yueyin Pan, Yong Fang, Qiming Wang, Yunchao Huang, Wenxiu Yao and 25 more

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase III
In one paragraph

Trial report in Molecular cancer, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03668496 (A Phase III, Randomized,Double-Blind, Multi-center Study to Investigate the Efficacy and Safety of SHR-1210 in Combination With Carboplatin and Paclitaxel Versus Placebo in Combination With Carboplatin and Paclitaxel in First-Line Stage IV Squamous Non-Small Cell Lung Cancer), which is not on this map. Cited by 32 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
32citing papers in PubMed, 1 pooled it
5.4field-weighted citation impact, top 3% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03668496 phase3unknown statusnot on this map

A Phase III, Randomized,Double-Blind, Multi-center Study to Investigate the Efficacy and Safety of SHR-1210 in Combination With Carboplatin and Paclitaxel Versus Placebo in Combination With Carboplatin and Paclitaxel in First-Line Stage IV Squamous Non-Small Cell Lung Cancer

TypeinterventionalSponsorJiangsu HengRui Medicine Co., Ltd.Ran2018 to 2021Enrolled390ConditionsLung Cancer Squamous Cell, Lung Cancer Stage IV, PD-1 Antibody, Chemotherapy EffectArmsSHR-1210, The placebo
3 · Its place in the literature

Who cites it

32 citing papers in PubMed, 1 synthesis or guideline pooled it, 54 citations in OpenAlex.

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  15. Biomarkers for Immunotherapy in Driver-Gene-Negative Advanced NSCLC.International journal of molecular sciences · 2023
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

35 authors at 20 institutions in 1 country.

Tao JiangDepartment of Medical Oncology, Shanghai Pulmonary Hospital, Tongji University School of Medicine, No.507, Zhengmin Road, Shanghai, 200433, China.
Jianhua ChenHunan Cancer Hospital, Changsha, China.
Xingxiang XuNorthern Jiangsu People's Hospital, Yangzhou, China.
Ying ChengJilin Cancer Hospital, Changchun, China.
Gongyan ChenHarbin Medical University Cancer Hospital, Harbin, China.
Yueyin PanAnhui Provincial Hospital, Hefei, China.
Yong FangSir Run Run Shaw Hospital Zhejiang University School of Medicine, Hangzhou, China.
Qiming WangHenan Cancer Hospital, Zhengzhou, China.
Yunchao HuangYunnan Cancer Hospital & The Third Affiliated Hospital of Kunming Medical University & Yunnan Cancer Centre, Kunming, China.
Wenxiu YaoSichuan Provincial Cancer Hospital, Chengdu, China.
Rui WangAnhui Chest Hospital, Hefei, China.
Xingya LiThe First Affiliated Hospital of Zhengzhou University, Zhengzhou, China.
Wei ZhangThe First Affiliated Hospital of Nanchang University, Nanchang, China.
Yanjun ZhangShaanxi Provincial Cancer Hospital, Xi'an, China.
Sheng HuHubei Cancer Hospital, Wuhan, China.
Renhua GuoJiangsu Province Hospital, Nanjing, China.
Jianhua ShiLinYi Cancer Hospital, Linyi, China.
Zhiwu WangTangshan People's Hospital, Tangshan, China.
Peiguo CaoThe Third Xiangya Hospital of Central South University, Changsha, China.
Donglin WangChongqing University Cancer Hospital, Chongqing, China.
Jian FangBeijing Cancer Hospital, Beijing, China.
Hui LuoJiangxi Cancer Hospital, Nanchang, China.
Yi GengBaoji Central Hospital, Baoji, China.
Chunyan XingJinan Central Hospital, Jinan, China.
Dongqing LvTaizhou Hospital of Zhejiang Province, Taizhou, China.
Yiping ZhangZhejiang Cancer Hospital, Hangzhou, China.
Junyan YuHeping Hospital Affiliated to Changzhi Medical College, Changzhi, China.
Shundong CangHenan Provincial People's Hospital, Zhengzhou, China.
Yaxi ZhangGenecast Biotechnology Co., Ltd., Wuxi City, China.
Jiao ZhangGenecast Biotechnology Co., Ltd., Wuxi City, China.
Zeyu YangJiangsu Hengrui Pharmaceuticals Co., Ltd., Shanghai, China.
Wei ShiJiangsu Hengrui Pharmaceuticals Co., Ltd., Shanghai, China.
Jianjun ZouJiangsu Hengrui Pharmaceuticals Co., Ltd., Shanghai, China.
Caicun ZhouDepartment of Medical Oncology, Shanghai Pulmonary Hospital, Tongji University School of Medicine, No.507, Zhengmin Road, Shanghai, 200433, China. caicunzhou_dr@163.com.ORCID 0000-0002-1072-9941
Shengxiang RenDepartment of Medical Oncology, Shanghai Pulmonary Hospital, Tongji University School of Medicine, No.507, Zhengmin Road, Shanghai, 200433, China. harry_ren@126.com.
Jiangsu Hengrui Medicine (China) · CNTongji University · CNZhejiang Cancer Hospital · CNAnhui Provincial Hospital · CNBaoji City Central Hospital · CNCentral South University · CNChangzhi Medical College · CNChongqing University · CNFirst Affiliated Hospital of Zhengzhou University · CNGenecast (China) · CNHarbin Medical University · CNHenan Cancer Hospital · CNHenan Provincial People's Hospital · CNHubei Cancer Hospital · CNHunan Cancer Hospital · CNJiangsu Province Hospital · CNJiangxi Provincial Cancer Hospital · CNJilin Province Tumor Hospital · CNJinan Central Hospital · CNKunming Medical University · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundCamrelizumab 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.

methodsTumor 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.

resultsPretreatment 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.

conclusionOn-treatment bTMB together with its dynamics could serve as a predictive biomarker for camrelizumab plus chemotherapy in patients with advanced LUSC.

trial registrationClinicalTrials.gov identifier: NCT03668496.

Indexed as

Biomarkers, TumorCell-Free Nucleic AcidsAgedAged, 80 and overAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsCarcinoma, Squamous CellCombined Modality TherapyComputational BiologyDNA, NeoplasmFemaleHumansLung NeoplasmsMaleMiddle AgedMolecular Targeted TherapyAntibodies, Monoclonal, HumanizedBiomarkers, TumorcamrelizumabCell-Free Nucleic AcidsDNA, Neoplasmbiomarkerblood tumor mutational burdenimmunotherapylung squamous cell carcinomaPD-1

Identifiers

PMID34980131
PMCPMC8722280
OpenAlexW4206755966

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.