Evidence map›Paper›PMID 39075531›Full record

Trial reportBMC medicine2024

Postoperative radiotherapy with docetaxel versus cisplatin for high-risk oral squamous cell carcinoma: a randomized phase II trial with exploratory analysis of ITGB1 as a potential predictive biomarker.

Wen Jiang, Lan Chen, Rongrong Li, Jiang Li, Shengjin Dou, Lulu Ye, Yining He, Zhen Tian, Yanli Yao, Guopei Zhu

Registry-linked trialAbstract readClinical Trial, Phase IIRandomized Controlled TrialComparative Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMC medicine, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02923258 (Postoperative Radiation and Concurrent Chemotherapy With Weekly Docetaxel Versus Cisplatin in Patients With High-risk Oral Cavity Cancer), which is not on this map. Cited by 13 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed, 2 pooled it
–field-weighted citation impact
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.

NCT02923258 phase2 / phase3completednot on this map

Postoperative Radiation and Concurrent Chemotherapy With Weekly Docetaxel Versus Cisplatin in Patients With High-risk Oral Cavity Cancer: a Randomized Phase II Clinical Trial

TypeinterventionalSponsorShanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong UniversityRan2018 to 2023Enrolled224ConditionsOral Cavity Squamous Cell CarcinomaArmsDocetaxel, Cisplatin, IMRT
3 · Its place in the literature

Who cites it

13 citing papers in PubMed, 2 syntheses or guidelines pooled it.

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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

10 authors.

Wen Jiang *Department of Oral and Maxillofacial-Head Neck Oncology, Division of Radiation Oncology, College of Stomatology, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai Jiao Tong University, Shanghai, China.
Lan Chen *Department of Oral and Maxillofacial-Head Neck Oncology, College of Stomatology, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai Jiao Tong University, Shanghai, China.
Rongrong Li *Department of Oral and Maxillofacial-Head Neck Oncology, Division of Radiation Oncology, College of Stomatology, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai Jiao Tong University, Shanghai, China.
Jiang LiDepartment of Oral Pathology, College of Stomatology, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai Jiao Tong University, Shanghai, China.
Shengjin DouDepartment of Oral and Maxillofacial-Head Neck Oncology, Division of Radiation Oncology, College of Stomatology, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai Jiao Tong University, Shanghai, China.
Lulu YeDepartment of Oral and Maxillofacial-Head Neck Oncology, Division of Radiation Oncology, College of Stomatology, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai Jiao Tong University, Shanghai, China.
Yining HeBiostatistics Office of Clinical Research Unit, Shanghai Ninth People's Hospital, Shanghai JiaoTong University School of Medicine, Shanghai, China.
Zhen TianDepartment of Oral Pathology, College of Stomatology, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai Jiao Tong University, Shanghai, China.
Yanli YaoDepartment of Oral and Maxillofacial-Head Neck Oncology, College of Stomatology, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai Jiao Tong University, Shanghai, China. yaoyanli@shsmu.edu.cn.
Guopei ZhuDepartment of Oral and Maxillofacial-Head Neck Oncology, Division of Radiation Oncology, College of Stomatology, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai Jiao Tong University, Shanghai, China. antica@gmail.com.

Funding

Beijing Xisike Clinical Oncology Research Foundation Y-XD2019-110Chinese Academy of Medical Sciences (CAMS) Innovation Fund for Medical Sciences (CIFMS) 2019-I2M-5-037Innovative Research Team of High-level Local Universities in Shanghai SSMU-ZLCX20180500, SHSMU-ZLCX20212300Project of Shanghai Municipal Health Commission 20194Y0298Shanghai Clinical Research Center for Oral Diseases 19MC1910600
6 · The paper itself

Abstract

backgroundOral squamous cell carcinoma (OSCC) causes significant mortality and morbidity worldwide. Surgical resection with adjuvant radiotherapy remains the standard treatment for locally advanced resectable OSCC. Results from landmark trials have established postoperative concurrent cisplatin-radiotherapy (Cis-RT) as the standard treatment for OSCC patients with high-risk pathologic features. However, cisplatin-related toxicity limits usage in clinical practice. Given the need for effective but less toxic alternatives, we previously conducted a single-arm trial showing favorable safety profiles and promising efficacy of concurrent docetaxel-radiotherapy (Doc-RT).

methodsIn this randomized phase 2 trial, we aimed to compare Doc-RT with the standard Cis-RT in postoperative OSCC patients. Eligible patients had AJCC stage III-IV resectable OSCC with high-risk pathologic features. Two hundred twenty-four patients were enrolled and randomly assigned to receive concurrent Doc-RT or Cis-RT. The primary endpoint was 2-year disease-free survival (DFS). Secondary endpoints included overall survival (OS), locoregional-free survival (LRFS), distant metastasis-free survival (DMFS), and adverse events (AEs). Integrin β1 (ITGB1) expression was analyzed as a biomarker for efficacy.

resultsAfter a median 28.8-month follow-up, 2-year DFS rates were 63.7% for Doc-RT arm and 56.1% for Cis-RT arm (p = 0.55). Meanwhile, Doc-RT demonstrated comparable efficacy to Cis-RT in OS, LRFS, and DMFS. Doc-RT resulted in fewer grade 3 or 4 hematological AEs. Low ITGB1 was associated with improved Doc-RT efficacy versus Cis-RT.

conclusionsThis randomized trial directly compared Doc-RT with Cis-RT for high-risk postoperative OSCC patients, with comparable efficacy and less toxicity. ITGB1 merits further validation as a predictive biomarker to identify OSCC patients most likely to benefit from Doc-RT. Findings indicate docetaxel may be considered as a concurrent chemoradiation option in this setting.

trial registrationwww. CLINICALTRIALS: gov . NCT02923258 (date of registration: October 4, 2016).

Indexed as

CisplatinDocetaxelIntegrin beta1Mouth NeoplasmsAdultAgedAntineoplastic AgentsBiomarkers, TumorCarcinoma, Squamous CellFemaleHumansMaleMiddle AgedTreatment OutcomeAntineoplastic AgentsBiomarkers, TumorCisplatinDocetaxelIntegrin beta1Itgb1 protein, humanDocetaxelIntegrin beta 1 (ITGB1)Oral squamous cell carcinomaPharmacogenomicsPostoperative chemoradiotherapy

Identifiers

PMID39075531
PMCPMC11287860

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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.