ArticleBMC cancer2025
RC48-ADC monotherapy or in combination with immunotherapy for locally advanced or metastatic urothelial carcinoma with HER2 low and null expression: a multicenter, real-world, retrospective study.
Article in BMC cancer, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers, 2 of them syntheses that pooled it.
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Who cites it
12 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Efficacy and safety of antibody-drug conjugate based therapy in locally advanced or metastatic urothelial carcinoma: a systematic review and network meta-analysis of emerging clinical evidence.Frontiers in immunology · 2026Pooled it
- The efficacy and safety of disitamab vedotin plus immunotherapy in locally advanced or metastatic solid tumors: a systematic review and meta-analysis.Frontiers in immunology · 2026Pooled it
- Histological Subtypes and Divergent Differentiation of Urothelial Carcinoma: Histology, Genomics, and Management Implications.European urology · 2026Review
- Post-Treatment NLR and SII Associations with Response and Progression-Free Survival After Neoadjuvant Disitamab Vedotin Plus PD-1 Blockade in Muscle-Invasive Bladder Cancer: A Real-World Cohort Study.Diagnostics (Basel, Switzerland) · 2026Article
- Efficacy of Disitamab Vedotin in Treating HER2 2+/FISH-Bladder Cancer: A Case Report.Clinical case reports · 2026Article
- Real-world efficacy and safety of disitamab vedotin (RC48) plus PD-1 inhibitors in advanced urothelial carcinoma: a single-center retrospective study.Translational andrology and urology · 2026Article
- Radiomics and deep learning fusion model based on multiphasic CT for predicting HER2 expression status in bladder urothelial carcinoma: a multicenter study.Translational andrology and urology · 2026Article
- Targeted therapies for urothelial carcinoma: From FGFR inhibitors to next‑generation antibody-drug conjugates (Review).International journal of oncology · 2026Review
- Application of antibody-drug conjugates in locally advanced or metastatic urothelial carcinoma: mechanisms, treatment-related adverse events, and management strategies.Frontiers in pharmacology · 2026Review
- Case Report: early regression and bladder-intact survival after limited-course immunotherapy-based systemic therapy in two patients with clinically staged bulky muscle-invasive bladder cancer.Frontiers in immunology · 2026Article
- Article
- Real-world efficacy and safety of disitamab vedotin monotherapy or in combination with PD-1 inhibitors in locally advanced or metastatic upper tract urothelial carcinoma: a multicenter retrospective study.Frontiers in immunology · 2025Article
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Authors and funding
13 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundApproximately half of urothelial carcinoma (UC) patients exhibit low or null HER2 expression. Limited data are available on the efficacy of anti-HER2 RC48-ADC (Disitamab Vedotin) in HER2 low and null advanced UC.
methodsPatients with locally advanced or metastatic UC (la/mUC) with HER2 low (IHC 1+) and null (IHC 0) expression who received RC48-ADC monotherapy or in combination with programmed cell death protein 1 (PD-1) inhibitors were enrolled in this multi-center, retrospective study. The primary endpoint was objective response rate (ORR). Secondary endpoints included disease control rate (DCR), progression-free survival (PFS), overall survival (OS), and adverse events (AEs).
resultsA total of 27 patients were included, with a median age of 64 years, and 17 (63%) were male. Seven (26.0%) patients received RC48-ADC alone, and 20 (74.1%) received RC48-ADC combined with a PD-1 inhibitor. Eight (30.8%) patients achieved partial response (PR), and twelve (46.2%) exhibited stable disease (SD). The ORR was 30.8%, and DCR was 76.9%. The median PFS and OS were 7.4 months and 13.8 months, one-year PFS and OS rates were 29.1% and 57.2%, respectively. Both RC48 monotherapy and combination were well-tolerated. Grade 3 AEs occurred in 4 (14.8%) patients received combination treatment, including 2 cases of anemia, 1 case of increased serum creatinine, and 1 case of autoimmune encephalitis. No grade 3 or higher AEs were observed in RC48-ADC monotherapy.
conclusionRC48-ADC demonstrated favorable efficacy and manageable safety in la/mUC patients with HER2 low and null expression in real-world settings. Prospective studies with large sample size are warranted to validate this finding.
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