Evidence map›Paper›PMID 42299417›Full record

ArticleAME case reports2026

Severe renal toxicity following adjuvant envafolimab in a patient with ultra-hypermutated (POLE) stage II colorectal cancer: a case report.

Zi Gao, Chi Zhang, Zhen Fang, Jin Liu, Liang Shang, Leping Li

Abstract readCase Reports
In one paragraph

Article in AME case reports, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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

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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

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

6 authors.

Zi Gao *Department of Gastroenterology, Shandong Provincial Hospital, Shandong University, Jinan, China.
Chi Zhang *Department of Gastroenterology, Shandong Provincial Hospital, Shandong University, Jinan, China.
Zhen Fang *Department of Gastrointestinal Surgery, Shandong Provincial Hospital Affiliated to Shandong First Medical University, Jinan, China.
Jin LiuGastroenterology, Shandong Provincial Hospital Affiliated to Shandong First Medical University, Jinan, China.
Liang ShangDepartment of Gastroenterology, Shandong Provincial Hospital, Shandong University, Jinan, China.
Leping LiDepartment of Gastroenterology, Shandong Provincial Hospital, Shandong University, Jinan, China.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: POLE-mutated colorectal cancer (CRC) is a rare molecular subtype featured by ultra-high tumor mutational burden (TMB) and favorable prognosis, and adjuvant systemic therapy is generally not recommended for such patients. However, the safety profile of immune checkpoint inhibitors (ICIs) in early-stage POLE-mutated CRC remains unclear, especially the association between ultra-high TMB and immune-related adverse events (irAEs) lacks clinical evidence. Case Description: We reported a 28-year-old male with stage IIB POLE-mutated microsatellite-stable (MSS) CRC, whose TMB reached an extremely high level of 717 mutations/Mb, PD-L1 combined positive score (CPS) was 8, and KRAS, NRAS, BRAF V600E were all wild-type. Off-label adjuvant PD-L1 inhibitor envafolimab was administered after multidisciplinary discussion and informed consent. After 5 treatment cycles (about 5 weeks), the patient developed grade 2 immune-related acute kidney injury (AKI), with serum creatinine (Scr) peaking at 163 µmol/L and estimated glomerular filtration rate (eGFR) dropping to 49 mL/min. Other causes of renal injury were excluded, and renal biopsy was not performed due to patient refusal. Immunotherapy was discontinued immediately, and systemic corticosteroids combined with renal protective supportive treatment were given. Renal function gradually improved, and at the last follow-up in March 2024, Scr decreased to 104.8 µmol/L and eGFR recovered to 82 mL/min, with no tumor recurrence observed. Conclusions: This case suggests a potential correlation between ultra-high TMB induced by POLE mutation and increased risk of immune-related renal toxicity in the adjuvant setting. For early-stage POLE-mutated CRC with favorable prognosis, off-label adjuvant immunotherapy may bring unnecessary toxicity risks. It is necessary to conduct rigorous patient selection, comprehensive risk-benefit evaluation, and close monitoring of organ function during treatment, so as to provide reference for the standardized clinical application of ICIs in this population.

Indexed as

case reportimmune-related adverse events (irAEs)immunotherapyUltra-high tumor mutational burden (ultra-high TMB)

Identifiers

PMID42299417
PMCPMC13264719

What Socratic holds

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LicenceCC BY-NC-ND
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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 Socratic graph.