ArticleAME case reports2026
Severe renal toxicity following adjuvant envafolimab in a patient with ultra-hypermutated (POLE) stage II colorectal cancer: a case report.
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.
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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.
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