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Females with advanced bladder cancer show significantly better progression-free survival on enfortumab vedotinWomen with bladder cancer show better outcomes on specific treatment

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Key Takeaway
Note that while females show significantly better progression-free survival on enfortumab vedotin, evidence is limited.

This meta-analysis synthesized data from 17 studies to evaluate sex-specific outcomes in patients with advanced or metastatic urothelial cancer, including muscle-invasive bladder cancer, treated with enfortumab vedotin. The primary analysis focused on progression-free survival (PFS) and overall survival (OS) to determine if sex influenced treatment efficacy.

Results showed no significant sex-specific difference in overall survival (HR 0.88; 95% CI, 0.73-1.06; P =.17). However, a significant association was found for progression-free survival, where female sex was associated with a better outcome (HR 0.67 unadjusted; HR 0.41 adjusted for publication bias; P <.001).

The authors noted several limitations, including limited data for secondary outcomes such as disease-free survival, cancer-specific survival, and event-free survival. Additionally, significant publication bias was suggested for progression-free survival, and the overall risk of bias was assessed as moderate. Due to these factors, the evidence for improved progression-free survival in women is considered very limited. Clinical application of these findings should be approached with caution given the moderate risk of bias and limited data volume.

How this fits prior evidence

This meta-analysis addresses a gap in understanding sex-specific responses to enfortumab vedotin in urothelial cancer. While previous evidence noted that enfortumab vedotin-related cutaneous toxicity and neuropathy may correlate with improved outcomes in urothelial carcinoma, this study specifically identifies a significant association between female sex and improved progression-free survival (HR 0.67 unadjusted; HR 0.41 adjusted). However, the evidence for this sex-specific benefit remains very limited.

Living with advanced bladder cancer is a heavy burden, and finding a treatment that works effectively is vital for every patient. A review of 17 studies looked at how the drug enfortumab vedotin affects men and women with advanced or metastatic urothelial cancer. The goal was to see if sex influenced how well the treatment worked over time.

The data showed that women had a significantly better progression-free survival compared to men. This means that, during the study period, women were less likely to see their cancer progress. However, the researchers noted that the evidence for this specific finding is very limited. They also found no significant difference between men and women when looking at overall survival.

While the results for women are promising, the study had some hurdles. There was a moderate risk of bias and a lot of publication bias regarding the progression-free survival data. Additionally, there was very little data available to confirm results for other measures like disease-free survival or cancer-specific survival. Because the evidence is limited, these findings are currently a starting point for understanding how this treatment affects different patients.

What this means for you:
Women with advanced bladder cancer may have better progression-free survival on enfortumab vedotin, though evidence is limited.

Common questions

Does this treatment work differently for men and women?

The study found that women had a significantly better progression-free survival compared to men when treated with enfortumab vedotin. However, researchers noted that the evidence for this specific finding is very limited. When looking at overall survival, no significant difference was found between men and women.

What is progression-free survival?

Progression-free survival is a measure of the length of time a patient lives without their cancer getting worse or spreading. In this study, women showed a significantly better outcome in this area compared to men, though the evidence for this finding is currently limited.

How certain are these results for bladder cancer patients?

The evidence for better outcomes in women is described as very limited. The study also noted a moderate risk of bias and significant publication bias regarding the progression-free survival data. Because of these factors, the findings should be viewed with caution.

Study Details

Study typeMeta analysis
EvidenceLevel 1
PublishedOct 2026
View Original Abstract ↓
Women have poorer survival rates in advanced, metastatic, or muscle-invasive bladder cancer (MIBC) than men. Enfortumab vedotin (EV) has changed the therapy and outcomes of MIBC and advanced bladder cancer dramatically. Therefore, the primary aim of this systematic review and meta-analysis was to evaluate sex-specific differences in disease-free (DFS), progression-free (PFS), cancer-specific survival (CSS), event-free survival (EFS), and overall survival (OS) in those patients. In October 2025, we performed a systematic literature search using MEDLINE via PubMed, Embase, and Cochrane Library. This study was prospectively registered at PROSPERO (CRD420251064260). The detailed review protocol is accessible via CRD. The systematic literature search identified 249 studies, of which 17 fulfilled the inclusion criteria. No significant sex-specific difference was observed for OS (10 studies; hazard ratio [HR] 0.88; 95% confidence interval [CI], 0.73-1.06; P = .17; I² = 32%). For PFS (8 studies), female sex was associated with a significantly better outcome (HR 0.67; 95% CI, 0.57-0.78; P < .001; I² = 0%). Because the funnel plot suggested a significant publication bias, we conducted adjustment analyses, which yielded an HR of 0.41 (95% CI, 0.24-0.57; P < .001). Only limited data were available for DFS, CSS, and EFS. Overall, the risk of bias was assessed as moderate. There is very limited evidence that women have a significantly better PFS than men during treatment with EV for bladder cancer. Further studies should incorporate explicit sex-specific analyses, eg, hormonal levels or genetic aspects, which are needed.
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