ArticleScientific reports2026
Efficacy and safety of RC48 alone or combined with PD-1 inhibitors in high-risk non-muscle invasive bladder cancer.
Article in Scientific reports, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
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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.
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Who cites it
1 citing paper in PubMed.
- Efficacy of Disitamab Vedotin in Treating HER2 2+/FISH-Bladder Cancer: A Case Report.Clinical case reports · 2026Article
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14 authors.
Funding
Abstract
High-risk non-muscle invasive bladder cancer (HR-NMIBC) presents a significant therapeutic challenge due to its high recurrence and progression rates, particularly in patients with human epidermal growth factor receptor 2 (HER2) expression who are unresponsive to or ineligible for Bacillus Calmette–Guérin (BCG) therapy. This study aimed to evaluate the efficacy and safety of the HER2-targeted antibody-drug conjugate (ADC), Disitamab Vedotin (RC48), alone or in combination with PD-1 inhibitors, as a systemic bladder-sparing approach in a real-world HR-NMIBC cohort. We conducted a multicenter, retrospective, real-world study involving 32 patients with HR-NMIBC who received RC48 alone (n = 3) or in combination with PD-1 inhibitors (n = 29) between June 2022 and December 2024. Eligibility criteria included BCG-unresponsive (n = 7) or BCG-ineligible (n = 25). Data were collected on demographics, clinical characteristics, treatment responses, and adverse events. The primary endpoint was complete response rate (CRR). Secondary endpoints included event-free survival (EFS), duration of complete response (DoCR), 6-month bladder preservation rate, and safety. At a median follow-up of 13.3 months, the overall CRR was 71.9% (23/32; 95% CI: 53.3%–86.3%). In the BCG-unresponsive and BCG-ineligible subgroups, CRRs were 85.7% (6/7) and 68.0% (17/25), respectively. The median EFS for the overall cohort was 22.1 months (95% CI: 16.7–27.4), with no significant difference between the BCG subgroups (P = 0.98). Among the 23 responders, the median DoCR was 16.9 months (95% CI: 13.1–20.7). Treatment-related adverse events (TRAEs) occurred in 53.1% of patients, primarily Grade 1–2 peripheral neuropathy (21.9%) and rash (21.9%). Grade ≥ 3 TRAEs were rare (6.3%). In this real-world study, RC48-based systemic therapy, particularly in combination with PD-1 inhibitors, demonstrates promising preliminary activity and a manageable safety profile in BCG-unresponsive or BCG-ineligible HR-NMIBC. Large prospective trials are required to confirm long-term durability and the optimal role of this systemic approach.
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