Evidence map›Paper›PMID 39550213›Full record

ArticleThe oncologist2025

Real-world application of disitamab vedotin (RC48-ADC) in patients with breast cancer with different HER2 expression levels: efficacy and safety analysis.

Ke Wang, Ting Xu, Jing Wu, Yuan Yuan, Xiaoxiang Guan, Chengjun Zhu

Abstract readMulticenter Study
In one paragraph

Article in The oncologist, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers.

0numbers the graph read from it
0cells of the map it votes in
10citing 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

10 citing papers in PubMed.

  1. Review
  2. Article
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  4. Article
  5. Review
  6. Article
  7. Review
  8. Observational
  9. Escalation and optimisation of primary breast cancer treatment with antibody-drug conjugates.Translational breast cancer research : a journal focusing on translational research in breast cancer · 2025
    Review
  10. 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

6 authors.

Ke WangDepartment of Oncology, The First Affiliated Hospital of Nanjing Medical University, Nanjing 210009, People's Republic of China.ORCID 0009-0005-9353-5542
Ting XuDepartment of Chemotherapy, Jiangsu Cancer Hospital, Jiangsu Institute of Cancer Research, The Affiliated Cancer Hospital of Nanjing Medical University, Nanjing 210009, People's Republic of China.ORCID 0009-0004-2138-0572
Jing WuDepartment of Oncology, The First Affiliated Hospital of Nanjing Medical University, Nanjing 210009, People's Republic of China.
Yuan YuanDepartment of Chemotherapy, Jiangsu Cancer Hospital, Jiangsu Institute of Cancer Research, The Affiliated Cancer Hospital of Nanjing Medical University, Nanjing 210009, People's Republic of China.ORCID 0000-0002-2060-5969
Xiaoxiang GuanDepartment of Oncology, The First Affiliated Hospital of Nanjing Medical University, Nanjing 210009, People's Republic of China.ORCID 0000-0001-6145-0046
Chengjun ZhuDepartment of Oncology, The First Affiliated Hospital of Nanjing Medical University, Nanjing 210009, People's Republic of China.ORCID 0000-0002-2867-562X

Funding

Clinical Capacity Enhancement Project JSPH-MB-2022-18National Natural Science Foundation of China 61973335
6 · The paper itself

Abstract

backgroundDisitamab vedotin (RC48-ADC), an antibody-drug conjugate (ADC), combines specific antibody disitamab with cytotoxicity monomethyl auristatin E to effectively target the human epidermal growth factor receptor 2 (HER2) protein on tumor cells for precise elimination. Recent studies have demonstrated that RC48-ADC offers therapeutic benefits for patients with HER2-positive and HER2-low-expression breast cancer (BC). However, a thorough exploration of its efficacy and safety in real-world settings for patients with metastatic breast cancer (mBC) is currently lacking.

methodsThis retrospective, multicenter, real-world study included patients with mBC who received RC48-ADC from September 2021 to March 2024. These patients include HER2-positive BC and HER2-low-expression BC. The primary endpoint was progression-free survival (PFS). Secondary endpoints included overall survival (OS), restricted mean survival time, objective response rate (ORR), and disease control rate (DCR). Factors affecting efficacy and the occurrence of treatment-related adverse events (TRAE) were evaluated.

resultsThe study included a cohort of 89 patients with mBC, with 48 of those being identified as HER2-positive. As of March 2024, 22 deaths were recorded, with an immature median OS. Total PFS varied from 1.0 to 31.2 months, with a median of 5.5 months (95% CI, 4.368-6.632). HER2-positive patients exhibited prolonged PFS compared with HER2-low-expression patients (6.6 months vs 4.1 months, P = .023). The overall ORR stood at 25.8% (95% CI, 0.178-0.358), with higher rates observed in HER2-positive patients compared with HER2-low-expression patients (31.3% vs 19.5%). Similarly, the overall DCR was 78.7% (95% CI, 0.691-0.859), with HER2-positive patients demonstrating superior DCR compared with HER2-low-expression patients (83.3% vs 73.2%). Notably, HER2 expression emerged as the primary determinant of RC48-ADC efficacy. The most prevalent TRAE among all patients included leukopenia (21.3%) and alopecia (20.2%).

conclusionRC48-ADC showcases promising efficacy and manageable safety in patients with both HER2-positive and HER2-low-expression mBC.

Indexed as

Breast NeoplasmsErb-b2 Receptor Tyrosine KinasesImmunoconjugatesAdultAgedAged, 80 and overAntibodies, MonoclonalCohort StudiesFemaleHumansMiddle AgedOligopeptidesRetrospective StudiesAntibodies, Monoclonaldisitamab vedotinERBB2 protein, humanErb-b2 Receptor Tyrosine KinasesImmunoconjugatesOligopeptidesantibody-drug conjugatebreast cancerdisitamab vedotinHER2

Identifiers

PMID39550213
PMCPMC12395257

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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.