Impact of Relative Dose Intensity of Enfortumab Vedotin for Advanced Urothelial Carcinoma DOI Open Access
Nobuki Furubayashi, Takahito Negishi,

Manabu Mochida

et al.

In Vivo, Journal Year: 2024, Volume and Issue: 39(1), P. 411 - 418

Published: Dec. 31, 2024

The impact of enfortumab vedotin (EV) dose reduction and/or interruption on its efficacy for advanced urothelial carcinoma (UC) is unclear.

Language: Английский

NECTIN4 Amplification Is Frequent in Solid Tumors and Predicts Enfortumab Vedotin Response in Metastatic Urothelial Cancer DOI Creative Commons
Niklas Klümper, Ngoc Khanh Tran,

Stefanie Zschäbitz

et al.

Journal of Clinical Oncology, Journal Year: 2024, Volume and Issue: 42(20), P. 2446 - 2455

Published: April 24, 2024

PURPOSE The anti-NECTIN4 antibody-drug conjugate enfortumab vedotin (EV) is approved for patients with metastatic urothelial cancer (mUC). However, durable benefit only achieved in a small, yet uncharacterized patient subset. NECTIN4 located on chromosome 1q23.3, and 1q23.3 gains represent frequent copy number variations (CNVs) cancer. Here, we aimed to evaluate amplifications as genomic biomarker predict EV response mUC. MATERIALS AND METHODS We established NECTIN4-specific fluorescence situ hybridization (FISH) assay assess the predictive value of CNVs multicenter EV-treated mUC cohort (mUC-EV, n = 108). were correlated membranous protein expression, treatment responses, outcomes. also assessed prognostic measured biopsies non–EV-treated (mUC-non-EV, 103). Furthermore, queried Cancer Genome Atlas (TCGA) data sets (10,712 across 32 types) CNVs. RESULTS are events muscle-invasive bladder (TCGA set: approximately 17%) (approximately 26% our cohorts). In mUC-EV, amplification represents stable alteration during progression associates enhanced expression. Ninety-six percent (27 28) demonstrated objective responses compared 32% (24 74) nonamplified subgroup ( P < .001). multivariable Cox analysis adjusted age, sex, Bellmunt risk factors, led 92% reduction death (hazard ratio, 0.08 [95% CI, 0.02 0.34]; mUC-non-EV, not associated TCGA Pan-Cancer that occur frequently other cancers, example, 5%-10% breast lung cancers. CONCLUSION predictors long-term survival

Language: Английский

Citations

28

Impact of Skin Adverse Events on Prognosis in Patients With Locally Advanced or Metastatic Urothelial Carcinoma Treated With Enfortumab Vedotin: A Real‐World Multicenter Study DOI Open Access

Kai Ozaki,

Hayato Yamamoto,

Yuya Sekine

et al.

International Journal of Urology, Journal Year: 2025, Volume and Issue: unknown

Published: March 3, 2025

ABSTRACT Objective We aimed to investigate the impact of skin adverse events (AEs) enfortumab vedotin (EV) on prognosis in patients with locally advanced or metastatic urothelial carcinoma real‐world practice. Methods This study analyzed data from 115 carcinoma. evaluated association between EV dose and AEs these patients. The progression‐free survival (PFS) overall (OS) was assessed using Kaplan–Meier curves Cox regression analysis. Results median PFS OS were 8.1 14.5 months, respectively. reduction observed 68 (59.1%) An estimated amount first, second, seventh cycles 95%, 85%, 81%, 69 (60%) cases, they within 1 month 53 (76.8%) cases. Patients had significantly longer compared those without AEs. Multivariable analysis showed a significant prolonged OS. Conclusions Skin associated AEs, although required 59.1% Careful adjustment may be crucial for long‐term use optimizing oncological outcomes.

Language: Английский

Citations

2

Enfortumab vedotin following platinum-based chemotherapy and immune checkpoint inhibitors for advanced urothelial carcinoma: response, survival and safety analysis from a multicentre real-world Japanese cohort DOI
Makito Miyake, Nobutaka Nishimura,

Yuki Oda

et al.

Japanese Journal of Clinical Oncology, Journal Year: 2023, Volume and Issue: 54(3), P. 329 - 338

Published: Nov. 20, 2023

Real-world evidence regarding enfortumab vedotin for unresectable or metastatic urothelial carcinoma is scarce, particularly in Japan. We investigated real-world data focusing on patient background, previous treatments, response, survival and adverse events patients receiving vedotin.

Language: Английский

Citations

23

Peripheral neuropathy and nerve electrophysiological changes with enfortumab vedotin in patients with advanced urothelial carcinoma: a prospective multicenter cohort study DOI
Rikiya Taoka,

Masaki Kamada,

Kazuyoshi Izumi

et al.

International Journal of Clinical Oncology, Journal Year: 2024, Volume and Issue: 29(5), P. 602 - 611

Published: Feb. 28, 2024

Language: Английский

Citations

11

Enfortumab vedotin–related cutaneous toxicity correlates with overall survival in patients with urothelial cancer: a retrospective experience DOI Creative Commons
Evangelia Vlachou, Burles A. Johnson, David J. McConkey

et al.

Frontiers in Oncology, Journal Year: 2024, Volume and Issue: 14

Published: June 12, 2024

Enfortumab vedotin (EV) is an antibody drug conjugate approved for advanced urothelial cancer, consisting of a monomethyl auristatin E payload linked to human monoclonal targeting nectin-4. No validated biomarker predictive or correlated with response exists EV. Cutaneous toxicity among the most common EV-related toxicities and typically emerges in early cycles. This retrospective experience patients cancer treated EV monotherapy evaluated whether cutaneous improved outcomes including progression-free (PFS) overall (OS) survival rate (ORR).

Language: Английский

Citations

9

Progress in systemic therapy for advanced-stage urothelial carcinoma DOI
Rosa Nadal, Begoña P. Valderrama, Joaquim Bellmunt

et al.

Nature Reviews Clinical Oncology, Journal Year: 2023, Volume and Issue: 21(1), P. 8 - 27

Published: Nov. 9, 2023

Language: Английский

Citations

22

Clinical Outcomes of Enfortumab Vedotin in Advanced Urothelial Carcinoma With Prior AvelumabVersusPembrolizumab Therapy DOI Creative Commons
Akinori Minato, Nobuki Furubayashi,

Toshihisa Tomoda

et al.

Anticancer Research, Journal Year: 2024, Volume and Issue: 44(8), P. 3419 - 3426

Published: July 26, 2024

Background/Aim: This study retrospectively evaluated whether enfortumab vedotin (EV) monotherapy is effective as a late-line treatment according to prior type in patients with advanced urothelial carcinoma (UC). Patients and Methods: We assessed consecutive from the Uro-Oncology Group Kyushu population lower upper urinary tract cancer treated EV after platinum-based chemotherapy immune checkpoint inhibitor therapy failure between December 2021 March 2024. In particular, receiving avelumab maintenance or pembrolizumab before for UC were analyzed compared response rate, progression-free survival (PFS), overall (OS). Results: Of 80 enrolled patients, 31 49 received therapy, respectively. The groups had comparable objective rates (48.4% vs. 44.9%, p=0.820) disease control (77.4% 67.3%, p=0.448). These two showed no significant difference PFS initiation of (median: 6.4 months 4.2 months, p=0.184); meanwhile, group better OS than 16.0 10.2 p=0.019). Moreover, median first-line was longer (40.3 24.7 p=0.054). On multivariate analysis, reduced mortality risk by 47% (95% confidence interval=0.27-1.03; p=0.059). Conclusion: provides favorable outcomes UC.

Language: Английский

Citations

6

Association between response to enfortumab vedotin and peripheral neuropathy in urothelial carcinoma patients: a multicenter retrospective study DOI

Nozomi Hayakawa,

Eiji Kikuchi, Go Kaneko

et al.

Japanese Journal of Clinical Oncology, Journal Year: 2024, Volume and Issue: 54(11), P. 1194 - 1200

Published: June 14, 2024

Abstract Background Enfortumab vedotin (EV) was approved for patients with metastatic urothelial carcinoma (mUC) who progressed after anticancer therapy on September 2021 in Japan. The association between the occurrence of EV-related side effects and clinical outcome remains to be elucidated. Methods We identified 97 mUC treated EV at our five institutions from date approval March 2023. median follow-up period 7.0 months. retrospectively analyzed efficacy safety EV. Results age 71 years old, 39% had PS 1 or more, 56.7% primary tumor upper urinary tract. Overall response rate (ORR) therapy, progression-free survival (PFS), overall (OS) were 43.3%, 7.52 months, 12.78 respectively. Any grade treatment-related skin disorder, dysgeusia, peripheral neuropathy, gastrointestinal hyperglycemia occurred 61 (62.9%), 36 (37.1%), 34 (35.1%), 29 (29.9%), 18 (18.6%) patients, EV-associated neuropathy significantly higher ORR (58.8% vs. 34.9%, P = .032) longer PFS (8.05 6.31 .017) OS (not reached 11.57 .008, respectively) than those without. treatment presence peritoneal dissemination factors independently associated (hazard ratio 0.46, .008 hazard raito 3.83, .004, 0.30, .005 4.53, .002, respectively). Conclusions might patients.

Language: Английский

Citations

5

Cutaneous and Renal Toxicities of Enfortumab Vedotin for Advanced Urothelial Carcinoma: The UROKYU Study DOI Creative Commons
Nobuki Furubayashi, Akinori Minato,

Toshihisa Tomoda

et al.

Anticancer Research, Journal Year: 2024, Volume and Issue: 44(7), P. 3025 - 3032

Published: June 26, 2024

Background/Aim: The clinical outcomes associated with cutaneous toxicity and changes in the renal function of patients receiving enfortumab vedotin (EV) for advanced urothelial carcinoma (UC) is unclear. Patients Methods: We retrospectively analyzed relationship between EV-related toxicity, influence on 58 UC who received EV after failure platinum-based chemotherapy immune checkpoint inhibitors from December 2021 to July 2023. Results: There were no differences overall response disease control rates any grade without (p=0.605 p>0.99, respectively) nor ≥3 (p>0.99 p=0.173, respectively). Progression-free survival was not significantly (5.4 vs. 5.6 months, p=0.557) (2.7 p=0.053). Overall (11.8 8.9 p=0.389), (4.6 11.4 p=0.168). incidence higher ICI-related (88.9% 36.7%, p=0.008). significant difference serum creatinine levels treatment (p=0.211). Divided into two groups according their function, using a cut-off 2 mg/dl, there either group (p=0.187 p=0.938). Conclusion: did affect outcomes, although it occurred experienced inhibitor-related toxicity. function.

Language: Английский

Citations

4

Enfortumab vedotin for metastatic urothelial carcinoma: Comprehensive treatment outcomes and prognostic insights from a multicenter real-world study (YUSHIMA study) DOI Creative Commons
Yuki Nakamura, Hajime Tanaka, Noboru Numao

et al.

Clinical Genitourinary Cancer, Journal Year: 2025, Volume and Issue: unknown, P. 102301 - 102301

Published: Jan. 1, 2025

Language: Английский

Citations

0