Evidence map›Paper›PMID 42168914›Full record

SynthesisBMC cancer2026

Efficacy and risk analysis of monotherapy and dual immunotherapy in dMMR/MSI-H metastatic colorectal cancer: a meta-analysis based on randomized controlled trials.

Shengqian Wang, Renjun Gu, Jiajie Lu, Shenghao Wang, Sijia Tao, Xiaoyu Zhang, Lerou Chen, Yongming An, Xin Gu, Ziyun Li and 1 more

Abstract readMeta-Analysis
In one paragraph

Synthesis in BMC cancer, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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

1 citing paper in PubMed.

  1. Review
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

11 authors.

Shengqian WangFirst Clinical Medical College, Nanjing University of Chinese Medicine, Nanjing, 210023, China.
Renjun GuSchool of Chinese Medicine, Nanjing University of Chinese Medicine, Nanjing, 210023, China.
Jiajie LuCollege of Integrated Traditional Chinese and Western Medicine, Nanjing University of Chinese Medicine, Nanjing, 210023, China.
Shenghao WangSchool of Chinese Medicine, Nanjing University of Chinese Medicine, Nanjing, 210023, China.
Sijia TaoSchool of Acupuncture-Moxibustion and Tuina, Nanjing University of Chinese Medicine, Nanjing, 210023, China.
Xiaoyu ZhangSchool of Chinese Medicine, Nanjing University of Chinese Medicine, Nanjing, 210023, China.
Lerou ChenSchool of Chinese Medicine, Nanjing University of Chinese Medicine, Nanjing, 210023, China.
Yongming AnCollege of Integrated Traditional Chinese and Western Medicine, Nanjing University of Chinese Medicine, Nanjing, 210023, China.
Xin GuSchool of Chinese Medicine, Nanjing University of Chinese Medicine, Nanjing, 210023, China. 290418@njucm.edu.cn.
Ziyun LiSchool of Acupuncture and Tuina, School of Regimen and Rehabilitation, Nanjing University of Chinese Medicine, Nanjing, 210023, China. liziyun0412@126.com.
Minye QuSchool of Chinese Medicine, Nanjing University of Chinese Medicine, Nanjing, 210023, China. minye2008@126.com.

Funding

General Program of Basic Science (Natural Science) Research in Jiangsu Colleges and Universities 24KJB360004LUO Linxiu Faculty Development Foundation Project, Nanjing University of Chinese Medicine LLX202310NATCM's Project of High-level Construction of Key TCM Disciplines 82405261Natural Science Foundation of Jiangsu Province BK20240738The 75th Batch of China Postdoctoral Science Foundation General Program 2024M754279The First Batch of "Double Hundred Program" (Academic Experience Inheritance Project of Renowned Senior Traditional Chinese Medicine Experts), Nanjing University of Chinese Medicine NZYDR (2024) 35Youth Talent Project of Jiangsu Provincial Traditional Chinese Medicine Science and Technology Development Plan QN202206
6 · The paper itself

Abstract

backgroundImmune checkpoint inhibitors (ICIs) have transformed the treatment landscape for metastatic colorectal cancer (mCRC) exhibiting DNA mismatch repair deficiency (dMMR) or microsatellite instability-high (MSI-H). However, the comparative efficacy and safety of monotherapy versus dual immunotherapy remain inadequately quantified. This meta-analysis aims to evaluate the benefits and risks of these strategies by quantitatively synthesizing data from randomized controlled trials (RCTs) to inform clinical decision-making.

designWe systematically searched major databases (PubMed, Web of Science, Cochrane, Embase) from inception to September 2025 for relevant RCTs. Outcomes included objective response rate (ORR), progression-free survival (PFS), overall survival (OS), duration of response (DOR), and adverse events. Statistical analyses were performed using RevMan 5.3 and Stata 18.0.

resultsSix RCTs (1,460 patients) were included. Pooled analysis showed that PD-1/PD-L1 monotherapy significantly improved ORR compared with chemotherapy (OR = 1.52, 95% CI: 1.02-2.27, P = 0.04), based on two RCTs (n = 429), and demonstrated a significantly lower incidence of grade ≥ 3 adverse events (OR = 0.14, 95% CI: 0.08-0.23, P < 0.00001; 2 studies). Dual immunotherapy with nivolumab plus ipilimumab significantly improved ORR versus monotherapy (OR = 1.77, 95% CI: 1.25-2.49, P = 0.001), based on one RCT (n = 582), with a significantly increased toxicity risk (OR = 1.73, 95% CI: 1.22-2.44, P = 0.002). For PFS, KEYNOTE-177 (HR = 0.59, 95% CI: 0.45-0.79) and CheckMate 8HW (HR = 0.62, 95% CI: 0.48-0.81) showed significant benefits, while SAMCO-PRODIGE 54 and CheckMate 9 × 8 did not demonstrate statistically significant PFS improvement. OS hazard ratios across four studies ranged from 0.74 to 1.03, with all 95% confidence intervals crossing 1.0, indicating no statistically significant survival benefit in any individual study. DOR was consistently longer with immunotherapy, with median not reached for pembrolizumab versus 10.6 months for chemotherapy in KEYNOTE-177.

conclusionsEffect estimates for PFS, OS, and DOR generally favored immunotherapy; however, confidence intervals were wide and statistical significance was not consistently observed across trials. PD-1/PD-L1 monotherapy demonstrated a favorable safety profile and a statistically significant improvement in ORR compared with chemotherapy (OR = 1.52, 95% CI: 1.02-2.27, P = 0.04). Dual immunotherapy significantly improved ORR compared with monotherapy (OR = 1.77, 95% CI: 1.25-2.49, P = 0.001), but this benefit was accompanied by significantly increased toxicity (OR = 1.73, 95% CI: 1.22-2.44, P = 0.002) and did not consistently translate into statistically significant PFS or OS benefits across trials. These findings highlight the need for personalized risk-benefit assessment. Future research should focus on biomarker-driven patient selection and strategies to overcome resistance.

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsColorectal NeoplasmsDNA Mismatch RepairImmune Checkpoint InhibitorsImmunotherapyHumansMicrosatellite InstabilityRandomized Controlled Trials as TopicRisk AssessmentTreatment OutcomeImmune Checkpoint InhibitorsdMMR/MSI-HImmune checkpoint inhibitorsMeta-analysisMetastatic colorectal cancer

Identifiers

PMID42168914
PMCPMC13191953

What OpenQuestion holds

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LicenceCC BY-NC-ND
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Registered trials

None linked

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.