Evidence map›Paper›PMID 41194034›Full record

SynthesisBMC cancer2025

Clinical significance and minimal clinically important differences for the survival outcomes in randomized clinical trials of lung cancer.

Yi-Lin Fu, Zi-Yang Tang, Ying-Ying Zhu, Qian-Wen Liu, Meng-Yang Zhang, Cong Gu, Ying Deng, Su Li, Jin-Xin Zhang, Ji-Bin Li

Abstract readMeta-AnalysisSystematic Review
In one paragraph

Synthesis in BMC cancer, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–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

3 citing papers in PubMed.

  1. Article
  2. Review
  3. Article
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.

Yi-Lin Fu *School of Public Health, Sun Yat-sen University, Guangzhou, P. R. China.
Zi-Yang Tang *Department of Clinical Research, Sun Yat-sen University Cancer Center, 651 Dong Feng East Road, Guangzhou, 510060, P. R. China.
Ying-Ying ZhuClinical Research Design Division, Clinical Research Center, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, P. R. China.
Qian-Wen LiuDepartment of Thoracic Surgery, State Key Laboratory of Oncology in South China, Guangdong Provincial Clinical Research Center for Cancer, Sun Yat-sen University Cancer Center, Guangzhou, China.
Meng-Yang ZhangSchool of Public Health, Sun Yat-sen University, Guangzhou, P. R. China.
Cong GuSchool of Public Health, Sun Yat-sen University, Guangzhou, P. R. China.
Ying DengSchool of Public Health, Sun Yat-sen University, Guangzhou, P. R. China.
Su LiDepartment of Clinical Research, Sun Yat-sen University Cancer Center, 651 Dong Feng East Road, Guangzhou, 510060, P. R. China.
Jin-Xin ZhangSchool of Public Health, Sun Yat-sen University, Guangzhou, P. R. China.
Ji-Bin LiDepartment of Clinical Research, Sun Yat-sen University Cancer Center, 651 Dong Feng East Road, Guangzhou, 510060, P. R. China. lijib@sysucc.org.cn.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAlthough the number of clinical trials on lung cancer is rapidly increasing, the clinical benefits have not received sufficient attention. This study aims to assess the clinical benefits and estimate the minimal clinically important differences (MCIDs) for overall survival (OS) and progression-free survival (PFS) to provide quantitative guidance for treatment decisions and study design in lung cancer trials.

methodsThis study systematically searched lung cancer randomized controlled trials (RCTs) from PubMed, Embase, and the Cochrane Library. The clinical benefits were estimated using the frameworks of the European Society for Medical Oncology - Magnitude of Clinical Benefit Scale (ESMO-MCBS) and the American Society of Clinical Oncology - Value Framework (ASCO-VF). The MCIDs for OS and PFS were calculated using the distribution-based method. The differences in clinical benefits of lung cancer trials between the MCIDs and the two frameworks were compared.

resultsA total of 319 lung cancer RCTs were included. The mean improved OS and PFS were 2.28 and 1.76 months between the interventional and control groups, respectively. Around 15.79% of trials with OS as the primary endpoint were rated as grades 4 or above, and only 6.02% of trials with PFS as the primary endpoint reached grade 4 by ESMO-MCBS. The overall MCIDs for OS and PFS in non-small cell lung cancer (NSCLC) were 7.66 and 3.11 months, while 2.29 and 1.13 months in small cell lung cancer (SCLC), respectively. A total of 79.61% of RCTs evaluating OS (5.92% with clinical benefits and 73.68% without clinical benefits) and 68.26% evaluating PFS (3.59% with clinical benefits and 64.67% without clinical benefits) were consistently identified as reaching clinical benefits by the MCIDs and two frameworks.

conclusionsAlthough lung cancer RCTs showed statistically significant improvement in OS and PFS, most trials did not show clinical benefits, with a limited increase in survival months. A fair-to-moderate consistency of clinical benefits classification was observed between the MCIDs and the two frameworks. Further explorations into MCID are anticipated to deepen our understanding and promote its application in the future.

Indexed as

Clinical RelevanceLung NeoplasmsMinimal Clinically Important DifferenceRandomized Controlled Trials as TopicHumansProgression-Free SurvivalTreatment OutcomeASCO-VFClinical benefitsESMO-MCBSLung cancer trialsMCID

Identifiers

PMID41194034
PMCPMC12587515

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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.