Evidence map›Paper›PMID 35596833›Full record

ArticleInvestigational new drugs2022

Rare ocular toxicity induced by pertuzumab/QL1209 in healthy chinese subjects: case reports and whole-exome sequencing analysis.

Junlong Ma, Wenjing Chen, Zhanqing Hu, Jie Huang, Chengxian Guo, Chan Zou, Guoping Yang

Abstract readCase Reports
PubMed Publisher
In one paragraph

Article in Investigational new drugs, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.5field-weighted citation impact, top 34% of its field
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

2 citing papers in PubMed, 5 citations in OpenAlex.

  1. Review
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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

7 authors at 2 institutions in 1 country.

Junlong MaCenter of Clinical Pharmacology, Third Xiangya Hospital, Central South University, Changsha, 410013, Hunan, China.
Wenjing ChenCenter of Clinical Pharmacology, Third Xiangya Hospital, Central South University, Changsha, 410013, Hunan, China.
Zhanqing HuCenter of Clinical Pharmacology, Third Xiangya Hospital, Central South University, Changsha, 410013, Hunan, China.
Jie HuangCenter of Clinical Pharmacology, Third Xiangya Hospital, Central South University, Changsha, 410013, Hunan, China.
Chengxian GuoCenter of Clinical Pharmacology, Third Xiangya Hospital, Central South University, Changsha, 410013, Hunan, China.
Chan ZouCenter of Clinical Pharmacology, Third Xiangya Hospital, Central South University, Changsha, 410013, Hunan, China. zouchan@csu.edu.cn.
Guoping YangCenter of Clinical Pharmacology, Third Xiangya Hospital, Central South University, Changsha, 410013, Hunan, China. ygp9880@126.com.
Central South University · CNThird Xiangya Hospital · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Pertuzumab is a recombinant anti-HER2 humanized monoclonal antibody widely used for the adjuvant treatment of HER2-positive breast cancer. Its safety is well established with the most common adverse effects being diarrhea and rash. To our knowledge, severe pertuzumab-induced ocular adverse events have never been reported. Herein, we describe several cases of pertuzumab/QL1209 (pertuzumab biosimilar)-induced blurred vision in healthy Chinese male subjects after a single injection of 420 mg pertuzumab/QL1209. Persistent optic nerve damage and vision loss occurred in the most severe case even after ophthalmic treatment. We conducted whole-exome sequencing (WES) of DNA samples from 5 cases and 13 controls to analyze the potential genetic factors and identified some associated variants (rs80303690 in RBM24, rs117375173 in CASR, rs1805097 in IRS2, and rs1227049 in CDH23). Furthermore, Kyoto Encyclopedia of Genes and Genomes (KEGG) pathways and Gene Ontology (GO) terms gene enrichment analyses were carried out for differentially expressed genes clustered in the PI3K/AKT/mTOR and Ras/Raf/MAPK signaling pathways, which were exactly activated by HER2 phosphorylation. In summary, this is the first report describing the occurrence of ocular toxicity induced by pertuzumab in the Chinese population and exploring the possible genetic mechanisms. These findings could provide evidence for clinicians to raise concerns about the risk of ocular toxicity with the clinical use of pertuzumab.

Indexed as

Antineoplastic AgentsBreast NeoplasmsAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsChinaErb-b2 Receptor Tyrosine KinasesExome SequencingHumansMalePhosphatidylinositol 3-KinasesRNA-Binding ProteinsToxic Optic NeuropathyTrastuzumabAntibodies, Monoclonal, HumanizedAntineoplastic AgentsErb-b2 Receptor Tyrosine KinasespertuzumabPhosphatidylinositol 3-KinasesRBM24 protein, humanRNA-Binding ProteinsTrastuzumabBreast cancerGenetic mechanismsOcular toxicityPertuzumabWES

Identifiers

PMID35596833
OpenAlexW4281249613

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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.