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Efficacy and Safety of Disitamab Vedotin Combined with Programmed Death-1 Inhibitor for Advanced Urothelial Cancer: A Case-Series Study

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Abstract

Introduction

Antibody–drug conjugate (ADC) and programmed death-1 (PD-1) inhibitors play crucial roles in the treatment of advanced urothelial cancer (aUC). Increasingly, combination treatment modalities are used in patients with aUC intolerant to platinum-based chemotherapy (PBC). However, clinical evidence on the efficacy and safety of disitamab vedotin plus PD-1 inhibitors for aUC is limited. This case series aims to address this knowledge gap.

Methods

Patients with aUC who were refractory or intolerant to PBC were included. All patients received combined treatment with disitamab vedotin (one of the ADC drugs) and PD-1 inhibitors for at least three cycles. The clinical characteristics of examination, histopathology, outcomes, and adverse events (AEs) were retrospectively collected.

Results

Among this case series, eight patients received disitamab vedotin plus PD-1 inhibitors, of which three achieved a complete response (CR) and two had a partial response (PR). The most common AE was peripheral neuropathy (4/8); the remaining AEs were mostly of mild to moderate severity or unknown and were manageable by supportive care.

Conclusions

Disitamab vedotin combined with PD-1 inhibitors exhibits a favorable efficacy and safety profile, but subsequent larger cohort clinical studies are required to provide evidence-based medicine for the universal application of this regimen.

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Data Availability

The datasets analyzed during the current study are available from the corresponding author upon reasonable request.

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Acknowledgements

The authors thank the patients and their families.

Authorship.

All named authors meet the International Committee of Medical Journal Editors (ICMJE) criteria for authorship for this article, take responsibility for the integrity of the work, and have given their approval for this version to be published.

Funding

No funding or sponsorship was received for this study or publication of this article. The journal’s Rapid Service Fee was funded by the authors.

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Authors and Affiliations

  1. Department of Urology, Xijing Hospital, The Fourth Military Medical University, 127 Changle West Road, Xi’an, 710032, Shaanxi, China

    Hongfan Zhao, Zhicheng Xu, Chengbin Li, Tong Xu, Jingliang Zhang, Jianhua Jiao, Bo Yang, Rongliang Qin, Lijun Yang, Weijun Qin & Yuming Jing

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  1. Hongfan Zhao
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Contributions

Hongfan Zhao and Yuming Jing: Conceptualization, Data curation, Formal analysis, Writing-original draft, Writing-review and editing, Project administration. Weijun Qin and Lijun Yang: Conceptualization, Data curation, Formal analysis. Zhicheng Xu, Chengbin Li, and Tong Xu: Data curation, Project administration. Rongliang Qin, Bo Yang, Jingliang Zhang, and Jianhua Jiao: Project administration. All authors read and approved the final manuscript.

Corresponding author

Correspondence to Yuming Jing.

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Conflict of Interest

The authors Hongfan Zhao, Zhicheng Xu, Chengbin Li, Tong Xu, Jingliang Zhang, Jianhua Jiao, Bo Yang, Rongliang Qin, Lijun Yang, Weijun Qin, and Yuming Jing have nothing to disclose.

Ethical Approval

This case series was conducted as a retrospective study of normal patient care and is not subject to Institutional Review Board approval. Treatments in this retrospective study were in accordance with guideline indications. Written informed consent was obtained from all patients. In the instances where patients died, consent was secured from the patients’ families.

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Zhao, H., Xu, Z., Li, C. et al. Efficacy and Safety of Disitamab Vedotin Combined with Programmed Death-1 Inhibitor for Advanced Urothelial Cancer: A Case-Series Study. Adv Ther 41, 857–866 (2024). https://doi.org/10.1007/s12325-023-02729-1

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