A Head-to-Head Comparison of the First-Line Treatments for Locally Advanced or Metastatic Urothelial Cancer: Is There Still a Role for Chemotherapy? DOI Open Access
Lorenzo Gasperoni,

L. Del Bono,

Andrea Ossato

et al.

Cancers, Journal Year: 2024, Volume and Issue: 16(13), P. 2400 - 2400

Published: June 29, 2024

Background: Patients with locally advanced/metastatic urothelial cancer have been conventionally treated platinum-based chemotherapy. Recently, numerous new treatments proposed to improve overall survival (OS) and reduce adverse effects, but no direct head-to-head comparisons among these agents are available. Methods: The evaluated in our analyses included (a) monotherapy immune checkpoint inhibitors (ICI); (b) combinations of an ICI chemotherapy; (c) other drugs. Using OS as the endpoint, a series indirect were performed rank most effective regimens against both chemotherapy each other. Our analysis was based on application artificial intelligence software program (IPDfromKM method) that reconstructs individual patient data from information reported graphs Kaplan–Meier curves. Results: A total five studies published six articles included. In main analysis, nivolumab plus showed better compared (HR = 0.70, 95% CI: 0.59–0.82), while durvalumab tremelimumab benefit 0.95, CI 0.82–1.11). More interestingly, enfortumab vedotin pembrolizumab significantly prolonged alone 0.53, 0.45–0.63) 0.76, 0.60–0.97). Discussion conclusion: Among for advanced metastatic cancer, best efficacy terms OS. results support use this combination first-line treatment setting.

Language: Английский

Tumor-shrinking effects of enfortumab vedotin between primary urothelial carcinoma and metastatic organs DOI Creative Commons
Daiki Ikarashi, Tatsuya Kawamura,

Keita OGASAWARA

et al.

Frontiers in Oncology, Journal Year: 2025, Volume and Issue: 14

Published: Jan. 29, 2025

Objective This study aimed to determine and compare the tumor shrinkage rate its durability by enfortumab vedotin treatment between primary urothelial carcinoma metastatic organs. Methods We retrospectively evaluated in 39 Japanese patients treated with for advanced carcinoma. also periods of maintenance (the period when best response was maintained) regrowth from growth confirmation) Results Measurable organs included lung 17, lymph node 22, liver 6, bone 5 cases. Primary lesion detected 20 The mean rates lung, node, liver, metastases sites were 21% (−212 100), 13% (−130 86), −8.5% (−158 85), −64% (−250 21), 22% (−38 79), respectively. maintained 5.9 (0.7–14) months metastases, 8.3 (2.6–14.5) 3.6 0.7 1.8 (0.7–5.4) sites, 7.3 (2.2–19.4), 4.8 (2.0–8.9), 2.8, 6.5, 2.5 (1.1–5.9) months, Conclusions Enfortumab showed significant tumor, whereas limited tumor.

Language: Английский

Citations

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Nectin-4-directed antibody-drug conjugates (ADCs): Spotlight on preclinical and clinical evidence DOI

Mohammad Javad Khosravanian,

Yousef Mirzaei,

Ali Hussein Mer

et al.

Life Sciences, Journal Year: 2024, Volume and Issue: 352, P. 122910 - 122910

Published: Sept. 1, 2024

Language: Английский

Citations

7
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
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
Enfortumab Vedotin With or Without Pembrolizumab in Metastatic Urothelial Carcinoma DOI Creative Commons

Shugo Yajima,

Kohei Hirose, Hitoshi Masuda

et al.

JAMA Network Open, Journal Year: 2025, Volume and Issue: 8(3), P. e250250 - e250250

Published: March 11, 2025

Importance Metastatic urothelial carcinoma (mUC) presents a therapeutic challenge with poor outcome. Enfortumab vedotin has emerged as promising treatment, necessitating comprehensive evaluation of its effectiveness and safety. Objective To synthesize the available evidence on enfortumab vedotin, both monotherapy in combination pembrolizumab, an mUC treatment for purpose guiding clinical decision-making future research. Data Sources Cochrane Library, MEDLINE (via PubMed), Google Scholar, Web Science were searched from database inception to August 31, 2024. Major conference abstracts 2019 2024 also included. Search strategy used Medical Subject Heading terms free-text keywords related vedotin. Study Selection Randomized trials prospective studies investigating adult patients Eleven met inclusion criteria. Extraction Synthesis Two independent reviewers extracted data assessed study quality using Risk Bias tool 2 Non-Randomized Studies Interventions tool. The meta-analysis random effects model, while network was performed frequentist approach. Main Outcomes Measures Primary outcomes disease control rate (DCR), objective response (ORR), 1-year survival rate. Results 11 included (3 randomized [27.3%] 8 nonrandomized [72.7%]) involved 2128 patients. Of these patients, 563 (26.5%) received plus 814 (38.3%) without 751 (35.3%) chemotherapy. pembrolizumab associated pooled DCR 86% (95% CI, 83%-89%), ORR 68% 64%-71%), 79% 75%-82%). had 73% 70%-76%), 43% 40%-47%), 52% 48%-56%). Network revealed that significantly outperformed chemotherapy (odds ratio [OR], 3.47; 95% 1.49-8.09; P = .004) (OR, 2.32; 1.75-3.06; < .001). Conclusions Relevance In this systematic review meta-analysis, showed high rates first-line settings, benefit later lines therapy. These findings underscore importance personalized approaches, research is warranted refine vedotin–based therapies management.

Language: Английский

Citations

0
Clinical significance of the dose modification of enfortumab vedotin monotherapy for advanced urothelial carcinoma DOI
Akinori Minato,

T Takaba,

Yoshihiro Sugita

et al.

Japanese Journal of Clinical Oncology, Journal Year: 2025, Volume and Issue: unknown

Published: March 31, 2025

Abstract Objective This study aimed to assess the influence of modifying dose enfortumab vedotin (EV) monotherapy in patients with advanced urothelial carcinoma (UC). Methods We retrospectively evaluated consecutive metastatic UC who had received EV following platinum-based chemotherapy and immune checkpoint inhibitor therapy at our institution between December 2021 June 2024. The relative intensity (RDI), reason for adjustments, overall survival (OS) were analyzed. Results Overall, 49 enrolled, which 16 (32.7%), 21 (42.9%), 12 (24.4%) RDI >80%, 60%–80%, <60%, respectively. was discontinued 3 (6.1%), interrupted 22 (44.9%), reduced 26 (53.1%) patients. In particular, because adverse events (AEs) 77% patients, patient preference or attending physician’s discretion 23%. reduction occurred AEs 23% discretion. median duration exposure <60% 3.8, 4.8, 7.8 months, These three groups showed no significant difference OS from introduction (median, 8.8 months vs. 12.9 15.1 months; P = .104). response 9.9 < 60%. Conclusion cases effective management, decreasing during does not negatively impact outcomes.

Language: Английский

Citations

0
Treatment-related skin reactions in enfortumab vedotin as a surrogate marker of survival and treatment response DOI Creative Commons
Jun Nagayama, Satoshi Inoue,

Hiroki Sai

et al.

International Journal of Clinical Oncology, Journal Year: 2024, Volume and Issue: 30(2), P. 267 - 276

Published: Dec. 16, 2024

Language: Английский

Citations

2
Physical, but not laboratory, treatment‐related adverse events are associated with favorable outcomes of enfortumab vedotin for advanced urothelial carcinoma: A landmark analysis DOI Creative Commons
Satoru Taguchi, Taketo Kawai,

Y. Ambe

et al.

International Journal of Urology, Journal Year: 2024, Volume and Issue: unknown

Published: Nov. 22, 2024

Abstract Background While the occurrence of immune‐related adverse events has been recognized as a prognostic marker in patients receiving immune checkpoint inhibitors, significance treatment‐related (trAEs) undergoing antibody–drug conjugates such enfortumab vedotin (EV) is controversial. Methods We reviewed 106 with advanced urothelial carcinoma who were treated EV therapy at 10 institutions between 2021 and 2023. Associations clinical parameters overall survival progression‐free assessed using Cox proportional hazards model. For assessment trAEs, landmark analysis was conducted to minimize immortal time bias. Results Of patients, 55 (51.9%) experienced disease progression 44 (41.5%) died during follow‐up period. Any grade ≥3 trAEs occurred 94 (88.7%) respectively. Common included skin disorders (74.5%), gastrointestinal (62.3%), fatigue (50.0%), peripheral neuropathy (36.8%), hematological (37.7%). One patient interstitial pneumonia (grade 5). According 88 survived for 2 months or more, significantly associated longer survival. Furthermore, when classified into “physical trAEs” “laboratory disorders, former while latter shorter Conclusions Physical, but not laboratory, are favorable outcomes carcinoma. Both managing utilizing them markers key points use EV.

Language: Английский

Citations

1
Characterizing ADRs of Enfortumab vedotin and Erdafitinib in bladder cancer treatment: a descriptive analysis from WHO-VigiAccess DOI Creative Commons

Yuanbin Huang,

Meiqi Xu, Xiuli Ma

et al.

Frontiers in Pharmacology, Journal Year: 2024, Volume and Issue: 15

Published: Dec. 6, 2024

Introduction Enfortumab vedotin (EV) and Erdafitinib are effective therapeutic drugs for bladder cancer patients following post-chemotherapy immunotherapy. This study assessed adverse drug reactions (ADRs) from both drugs, comparing their safety profiles to guide clinical use. Methods A retrospective descriptive analysis was conducted on ADR reports EV the World Health Organization (WHO)-VigiAccess database. Data patient demographics, system organ classes (SOCs), global regions, symptoms, ADRs frequencies were analyzed compared. Results As of 2024, 3,438 identified (2,257 1,181 Erdafitinib). The number reaction is significantly higher than that Erdafitinib. Among them, SOC with most signals gastrointestinal disorders, top five being nausea, dry mouth, abdominal pain, diarrhea. reported events (AEs) as follows: skin subcutaneous tissue disorders (20.70%), general administration site conditions (14.23%), nervous (11.12%), (7.78%), metabolism nutrition (6.47%). In contrast, AEs are: (25.36%), (10.94%), (10.19%), eye (9.21%), injury poisoning procedural complications (7.31%). Conclusion Our compared potential novel between Erdafitinib, providing key insights into highlighting need personalized treatment strategies based individual risk factors.

Language: Английский

Citations

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