Evidence map›Paper›PMID 36600554›Full record

Trial reportJournal for immunotherapy of cancer2022

Short-term dynamics of circulating tumor DNA predicting efficacy of sintilimab plus docetaxel in second-line treatment of advanced NSCLC: biomarker analysis from a single-arm, phase 2 trial.

Xiao Han, Xiaoyong Tang, Hui Zhu, Dongyuan Zhu, Xiqin Zhang, Xiangjiao Meng, Ying Hua, Zhongtang Wang, Yan Zhang, Wei Huang and 13 more

Erratum issuedOpen access · goldAbstract readClinical Trial, Phase II
PubMed Publisher
In one paragraph

Trial report in Journal for immunotherapy of cancer, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 21 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
21citing papers in PubMed, 4 pooled it
1.8field-weighted citation impact, top 13% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

21 citing papers in PubMed, 4 syntheses or guidelines pooled it, 20 citations in OpenAlex.

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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

23 authors at 2 institutions in 1 country.

Xiao HanDepartment of Internal Medicine Oncology, Shandong Cancer Hospital and Institute, Jinan, Shandong, China.
Xiaoyong TangDepartment of Internal Medicine Oncology, Shandong Cancer Hospital and Institute, Jinan, Shandong, China.
Hui ZhuDepartment of Internal Medicine Oncology, Shandong Cancer Hospital and Institute, Jinan, Shandong, China.
Dongyuan ZhuDepartment of Internal Medicine Oncology, Shandong Cancer Hospital and Institute, Jinan, Shandong, China.
Xiqin ZhangDepartment of Internal Medicine Oncology, Shandong Cancer Hospital and Institute, Jinan, Shandong, China.
Xiangjiao MengDepartment of Radiation Oncology, Shandong Cancer Hospital and Institute Shandong First Medical University and Shandong Academy of Medical Sciences, Jinan, China.
Ying HuaDepartment of Internal Medicine Oncology, Shandong Cancer Hospital and Institute, Jinan, Shandong, China.
Zhongtang WangDepartment of Internal Medicine Oncology, Shandong Cancer Hospital and Institute, Jinan, Shandong, China.
Yan ZhangDepartment of Internal Medicine Oncology, Shandong Cancer Hospital and Institute, Jinan, Shandong, China.
Wei HuangDepartment of Internal Medicine Oncology, Shandong Cancer Hospital and Institute, Jinan, Shandong, China.
Linlin WangDepartment of Internal Medicine Oncology, Shandong Cancer Hospital and Institute, Jinan, Shandong, China.
Shuanghu YuanDepartment of Internal Medicine Oncology, Shandong Cancer Hospital and Institute, Jinan, Shandong, China.
Pinliang ZhangInternal Medicine Department, Shandong Cancer Hospital and Institute, Jinan, Shandong, China.
Heyi GongDepartment of Internal Medicine Oncology, Shandong Cancer Hospital and Institute, Jinan, Shandong, China.
Yulan SunDepartment of Internal Medicine Oncology, Shandong Cancer Hospital and Institute, Jinan, Shandong, China.
Yingjie ZhangDepartment of Internal Medicine Oncology, Shandong Cancer Hospital and Institute, Jinan, Shandong, China.
Zengjun LiuInternal Medicine Department, Shandong Cancer Hospital and Institute, Jinan, Shandong, China.
Xiaomeng DongMedical Department, Amoy Diagnostics Co Ltd, Xiamen, Fujian, China.
Fei GaiMedical Department, Amoy Diagnostics Co Ltd, Xiamen, Fujian, China.
Zhan HuangMedical Department, Amoy Diagnostics Co Ltd, Xiamen, Fujian, China.
Changbin ZhuMedical Department, Amoy Diagnostics Co Ltd, Xiamen, Fujian, China.
Jun GuoDepartment of Internal Medicine Oncology, Shandong Cancer Hospital and Institute, Jinan, Shandong, China zhwang@sdfmu.edu.cn jngj2005@126.com.
Zhehai WangDepartment of Internal Medicine Oncology, Shandong Cancer Hospital and Institute, Jinan, Shandong, China zhwang@sdfmu.edu.cn jngj2005@126.com.ORCID 0000-0002-5021-8580
Shandong Tumor Hospital · CNDian Diagnostics (China) · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveRobust biomarker predicting efficacy of immunotherapy is limited. Circulating tumor DNA (ctDNA) sought to effectively monitor therapeutic response as well as disease progression. This study aims to investigate predictive role of ctDNA short-term dynamic change (6 weeks postimmunotherapy) in a single-arm, phase 2 trial of sintilimab plus docetaxel for previously treated advanced non-small cell lung cancer (NSCLC) patients.

methodsA total of 33 patients with advanced NSCLC with disease progression during or after any first-line treatment were prospectively enrolled between 2019 and 2020. Patients received sintilimab (200 mg, day 1, every 3 weeks) plus docetaxel (75 mg/m

resultsPatients with ctDNA clearance at 6th week had decreased tumor volume, while most patients with positive ctDNA at 6th-week experienced an increase in tumor volume. Positive 6th-week ctDNA was associated with significantly shorter progression-free survival (PFS) (91 vs NR days; p<0.0001) and overall survival (47 vs 467 days; p =0.0039). Clearance of clonal mutations and none new clonal formation at 6th week were associated with longer PFS (mPFS 89 vs 266 days, p =0.003). ctDNA clearance at 6th week was an independent risk factor for progression or death (HR=100 (95% CI 4.10 to 2503.00), p=0.005).

conclusionctDNA status and ctDNA mutation clearance putatively serve as predictive biomarkers for sintilimab combined with docetaxel chemotherapy in pretreated advanced NSCLC patients.

Indexed as

Carcinoma, Non-Small-Cell LungCirculating Tumor DNALung NeoplasmsAntibodies, Monoclonal, HumanizedDisease ProgressionDocetaxelHumansAntibodies, Monoclonal, HumanizedCirculating Tumor DNADocetaxelsintilimabBiomarkers, TumorGenetic MarkersImmunotherapyLung Neoplasms

Identifiers

PMID36600554
OpenAlexW4310747220

What OpenQuestion holds

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Registered trials

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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.