Clinical Effectiveness of Tislelizumab With Gemcitabine/Cisplatin Versus Gemcitabine/Cisplatin Alone as Adjuvant Therapy for High-Risk Muscle-Invasive Urothelial Carcinoma: A Real-World Study

IF 2.9 2区医学 Q2 ONCOLOGY

Cancer Medicine Pub Date : 2025-02-20 DOI:10.1002/cam4.70661

Yanjun Wang, Kaihua Zhong, Xingliang Tan, Qianghua Zhou, Lijuan Jiang, Kai Yao, Zhiming Wu

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Abstract

Background

Muscle-invasive urothelial carcinoma (MIUC) is a highly aggressive cancer associated with poor prognosis. Despite advancements in treatment, the optimal therapeutic approach remains unclear. Immune checkpoint inhibitors, when added to chemotherapy, have shown promise in improving patient outcomes.

Aims

This study aimed to evaluate the efficacy and safety of adjuvant tislelizumab combined with gemcitabine/cisplatin (Tisle+GC) compared to GC alone in patients with high-risk MIUC.

Materials & Methods

We conducted a retrospective analysis of 117 patients with histologically confirmed pT3/4 and pN+ MIUC treated at our center between October 2016 and March 2023. Eligible patients received either Tisle+GC or GC alone, excluding those with prior neoadjuvant therapy. We compared disease-free survival (DFS), overall survival (OS), and treatment-related adverse events (AEs) between the two groups using Cox proportional hazards models and Kaplan–Meier estimates.

Results

The Tisle+GC group showed significantly longer median DFS (19.08 vs. 9.06 months, HR = 0.114, p < 0.001) and OS (20.07 vs. 10.63 months, HR = 0.083, p = 0.026) compared to the GC group. Nerve tract invasion was identified as a significant predictor of poor outcomes (HR = 22.1, p = 0.003). Both groups experienced manageable grade 1–2 immune-related AEs, with pruritus being the most common, followed by liver function abnormalities and thyroid disturbances. Nonhematologic toxicities in the Tisle+GC group included elevated aspartate aminotransferase and hyponatremia, while the GC group mainly reported vomiting. No treatment-related fatalities occurred.

Discussion

The addition of tislelizumab to GC chemotherapy significantly improved both DFS and OS in high-risk MIUC patients. The safety profile was manageable, with immune-related AEs being predictable and not life-threatening. The findings support the potential of Tisle+GC as an effective adjuvant therapy.

Conclusion

Tisle+GC is a promising adjuvant treatment for high-risk MIUC, offering improved survival outcomes with a manageable safety profile. Further prospective studies are needed to confirm these results and establish the long-term benefits of this combination therapy.

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来源期刊

Cancer Medicine ONCOLOGY-

CiteScore

5.50

自引率

2.50%

发文量

907

审稿时长

19 weeks

期刊介绍： Cancer Medicine is a peer-reviewed, open access, interdisciplinary journal providing rapid publication of research from global biomedical researchers across the cancer sciences. The journal will consider submissions from all oncologic specialties, including, but not limited to, the following areas: Clinical Cancer Research Translational research ∙ clinical trials ∙ chemotherapy ∙ radiation therapy ∙ surgical therapy ∙ clinical observations ∙ clinical guidelines ∙ genetic consultation ∙ ethical considerations Cancer Biology: Molecular biology ∙ cellular biology ∙ molecular genetics ∙ genomics ∙ immunology ∙ epigenetics ∙ metabolic studies ∙ proteomics ∙ cytopathology ∙ carcinogenesis ∙ drug discovery and delivery. Cancer Prevention: Behavioral science ∙ psychosocial studies ∙ screening ∙ nutrition ∙ epidemiology and prevention ∙ community outreach. Bioinformatics: Gene expressions profiles ∙ gene regulation networks ∙ genome bioinformatics ∙ pathwayanalysis ∙ prognostic biomarkers. Cancer Medicine publishes original research articles, systematic reviews, meta-analyses, and research methods papers, along with invited editorials and commentaries. Original research papers must report well-conducted research with conclusions supported by the data presented in the paper.