Evidence map›Paper›PMID 30453169›Full record

SynthesisEuropean journal of cancer (Oxford, England : 1990)2019

Evaluation of objective response, disease control and progression-free survival as surrogate end-points for overall survival in anti-programmed death-1 and anti-programmed death ligand 1 trials.

Run-Cong Nie, Fo-Ping Chen, Shu-Qiang Yuan, Ying-Shan Luo, Shi Chen, Yong-Ming Chen, Xiao-Jiang Chen, Ying-Bo Chen, Yuan-Fang Li, Zhi-Wei Zhou

Abstract readMeta-AnalysisSystematic Review
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In one paragraph

Synthesis in European journal of cancer (Oxford, England : 1990), 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 37 papers, 10 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
37citing papers in PubMed, 10 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.

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

37 citing papers in PubMed, 10 syntheses or guidelines pooled it.

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  2. Treatments for renal cell carcinoma: NICE Pilot Treatment Pathways Appraisal.Health technology assessment (Winchester, England) · 2026
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

10 authors.

Run-Cong NieDepartment of Gastric Surgery, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China.
Fo-Ping ChenDepartment of Radiation Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Guangzhou, China.
Shu-Qiang YuanDepartment of Gastric Surgery, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China.
Ying-Shan LuoDepartment of Radiation Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Guangzhou, China.
Shi ChenDepartment of Gastric Surgery, The 6th Affiliated Hospital, Sun Yat-sen University, Guangzhou, China.
Yong-Ming ChenDepartment of Gastric Surgery, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China.
Xiao-Jiang ChenDepartment of Gastric Surgery, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China.
Ying-Bo ChenDepartment of Gastric Surgery, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China.
Yuan-Fang LiDepartment of Gastric Surgery, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China. Electronic address: liyuanf@sysucc.org.cn.
Zhi-Wei ZhouDepartment of Gastric Surgery, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China. Electronic address: zhouzhw@sysucc.org.cn.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundWe aimed to assess whether the Response Evaluation Criteria in Solid Tumors (RECIST) criteria-based objective response rate (ORR), disease control rate (DCR) and progression-free survival (PFS) could be valid surrogate end-points for overall survival (OS) in anti-programmed death-1 (PD-1)/programmed death ligand 1 (PD-L1) trials.

methodsWe systematically reviewed phase 2 and phase 3 trials of anti-PD-1/PD-L1 drug trials of advanced or recurrent solid tumours that reported OS and at least one of the RECIST criteria-based end-points. We used Spearman rank correlation to evaluate the strength of the association between these end-points and OS and a linear regression model, weighted by the sample size, to assess the association between the treatment effect on these end-points and OS. We also performed sensitivity analyses and a leave-one-out cross-validation approach to evaluate the robustness of our findings.

resultsForty-three qualifying trails comprising 15,088 patients were eligible. PFS showed good correlation with OS (squared Spearman rank correlation coefficient [r

conclusionsNo RECIST criteria-based end-points could be a valid surrogate for OS. At present, we proposed to set OS as the primary end-point in anti-PD-1/PD-L1 drug trials of advanced or recurrent solid tumours.

Indexed as

Antineoplastic Agents, ImmunologicalB7-H1 AntigenClinical Trials, Phase II as TopicClinical Trials, Phase III as TopicEndpoint DeterminationHumansNeoplasmsProgrammed Cell Death 1 ReceptorProgression-Free SurvivalResearch DesignResponse Evaluation Criteria in Solid TumorsSignal TransductionTime FactorsAntineoplastic Agents, ImmunologicalB7-H1 AntigenCD274 protein, humanPDCD1 protein, humanProgrammed Cell Death 1 ReceptorOverall survivalPD-1PD-L1Progression-free survivalRECIST criteriaSurrogate end-point

Identifiers

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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.