Evidence map›Paper›PMID 40999345›Full record

Observational studyBMC cancer2025

Clinicopathological and molecular correlates of clinical benefit from disitamab vedotin (RC48), a HER-2-targeting antibody-drug conjugate, in metastatic urothelial carcinoma: a multi-center, real-world study.

Zhaopei Liu, Kaifeng Jin, Ziyue Xu, Han Zeng, Xiaohe Su, Jingtong Xu, Yawei Ding, Hailong Liu, Yu Zhu, Le Xu and 3 more

Abstract readMulticenter StudyObservational Study
PubMed Full text at PMC Publisher
In one paragraph

Observational study in BMC cancer, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed, 1 pooled it
–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

2 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. 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

13 authors.

Zhaopei Liu *Department of Urology, Fudan University Shanghai Cancer Center, Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, China.ORCID http://orcid.org/0000-0002-5288-5037
Kaifeng Jin *NHC Key Laboratory of Glycoconjugate Research, Department of Biochemistry and Molecular Biology, School of Basic Medical Sciences, Fudan University, Shanghai, China.
Ziyue Xu *Department of Urology, Fudan University Shanghai Cancer Center, Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, China.ORCID http://orcid.org/0000-0001-8634-520X
Han ZengNHC Key Laboratory of Glycoconjugate Research, Department of Biochemistry and Molecular Biology, School of Basic Medical Sciences, Fudan University, Shanghai, China.
Xiaohe SuNHC Key Laboratory of Glycoconjugate Research, Department of Biochemistry and Molecular Biology, School of Basic Medical Sciences, Fudan University, Shanghai, China.
Jingtong XuDepartment of Immunology, School of Basic Medical Sciences, Fudan University, Shanghai, China.
Yawei DingDepartment of Immunology, School of Basic Medical Sciences, Fudan University, Shanghai, China.
Hailong LiuDepartment of Urology, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.
Yu ZhuDepartment of Urology, Fudan University Shanghai Cancer Center, Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, China.
Le XuDepartment of Urology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.
Jiejie Xu *NHC Key Laboratory of Glycoconjugate Research, Department of Biochemistry and Molecular Biology, School of Basic Medical Sciences, Fudan University, Shanghai, China. jjxufdu@fudan.edu.cn.
Zewei Wang *Department of Urology, Zhongshan Hospital, Fudan University, Shanghai, China. zwwang12@fudan.edu.cn.
Yuan Chang *Department of Urology, Fudan University Shanghai Cancer Center, Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, China. yuanchang@fudan.edu.cn.

Funding

Fudan University Shanghai Cancer Center for Outstanding Youth Scholars Foundation YJYQ201802National Natural Science Foundation of China 82002670Shanghai Municipal Health Bureau Project 202340127Shanghai Municipal Natural Science Foundation 22ZR1413400Shanghai Sailing Program 21YF1407000
6 · The paper itself

Abstract

introductionDisitamab Vedotin (DV), a HER-2-targeting antibody-drug conjugate, has exhibited substantial clinical advantages in individuals with metastatic urothelial carcinoma (mUC). Nonetheless, the extent of therapeutic efficacy in real-world scenarios for mUC patients and the specific patient profiles with the most benefit from DV remain unclear.

methodsIn this multi-center, retrospective, observational study, a total of 30 patients with mUC were included between April 2021 and March 2024 from three distinct hospitals, along with clinicopathological features and targeted sequencing data. Our analysis encompassed the assessment of the objective response rate (ORR), progression-free survival (PFS), overall survival (OS), and the incidence of treatment-related adverse events (TrAEs).

resultsIn the general population, the median follow-up time was 12.1 months, and the median OS was not reached with a 12-month OS rate of 86.7%. The median PFS was 12.2 months (95% confidence interval [CI]: 6.6-17.7 months), with an ORR of 42.3% (95% CI: 23.4%-63.1%) and a DCR of 73.1% (95% CI: 55.2%-88.4%). Higher HER-2 expression is correlated with prolonged clinical benefit from DV (Log-rank P = 0.082. HER-2 IHC 2+ & 3 + vs. IHC 1+: Median PFS: 13.1 vs. 4.6 months; Response rate: 60.0% vs. 0.0%). History of durable response to platinum-based chemotherapy can also imply longer PFS and better response rate (Log-rank P = 0.086. Median PFS: 14.2 vs. 3.6 months. Response rate: 50.0% vs. 10.0%). Moreover, higher mutation burden (TMB) is closely related to better outcomes from DV therapy (Log-rank P = 0.011. Median PFS: 12.8 vs. 4.6 months. Response rate: 71.4% vs. 11.1%. Firth's penalized multivariable Cox regression: P = 0.015. Hazard Ratio: 0.165. 95% CI: 0.026-0.717).

conclusionIn conclusion, patients with higher HER-2 expression, positive responses to chemotherapy, or elevated TMB are more likely to benefit from DV. These discoveries support the rationale for employing HER-2 antibody-drug conjugates (ADCs) for mUC patients.

Indexed as

Antibodies, Monoclonal, HumanizedCarcinoma, Transitional CellErb-b2 Receptor Tyrosine KinasesImmunoconjugatesUrologic NeoplasmsAdultAgedAged, 80 and overAntibodies, MonoclonalFemaleHumansMaleMiddle AgedNeoplasm MetastasisOligopeptidesProgression-Free SurvivalAntibodies, MonoclonalAntibodies, Monoclonal, Humanizeddisitamab vedotinERBB2 protein, humanErb-b2 Receptor Tyrosine KinasesImmunoconjugatesOligopeptidesAntibody-drug conjugatesDrug responseHER-2Metastatic urothelial carcinomaOutcome research

Identifiers

PMID40999345
PMCPMC12465952

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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.