A Multicenter, Single-Arm, Prospective Trial to Evaluate Efficacy and Safety of Dose-Dense Methotrexate, Vinblastine, Doxorubicin, and Carboplatin (DD-MVACarbo) Chemotherapy for Cisplatin-Ineligible Patients with Advanced Urothelial Cancer: Study Protocol of the CARBUNCLE Trial DOI Creative Commons
Makito Miyake,

Satoshi Anai,

Yusuke Iemura

et al.

Methods and Protocols, Journal Year: 2024, Volume and Issue: 7(4), P. 58 - 58

Published: July 29, 2024

Unresectable, metastatic, advanced urothelial carcinoma (aUC) is an aggressive disease and treated with platinum-containing first-line chemotherapy, followed by immune checkpoint inhibitors antibody–drug conjugates. Response to chemotherapy a vital priority in sequential treatment strategies because better response associated subsequent therapies. Gemcitabine plus carboplatin conventionally recommended for cisplatin-ineligible patients. This multicenter, single-arm prospective trial will investigate whether dose-dense methotrexate, vinblastine, doxorubicin, (DD-MVACarbo) superior gemcitabine terms of efficacy platinum-naïve, patients aUC. After screening registration, total 46 be this novel regimen. The primary endpoint the objective rate. secondary endpoints include control rate, patient-reported outcomes, adverse events. No evidence intervention available as July 2024. results are expected change standard care improve management

Language: Английский

Oncologic Outcomes of Patients with Immune Checkpoint Inhibitor Resistant Urothelial Carcinoma Treated with Enfortumab Vedotin and the Impact of Neutrophil-to-Lymphocyte Ratio and Dysgeusia on Overall Survival: A Retrospective Multicenter Cohort Study in Japan DOI Open Access
Keita Nakane,

Kazuki Taniguchi,

Minori Nezasa

et al.

Cancers, Journal Year: 2024, Volume and Issue: 16(15), P. 2648 - 2648

Published: July 25, 2024

Randomized phase III trial results have demonstrated enfortumab vedotin (EV), an antibody–drug conjugate (ADC) consisting of anti-Nectin-4 human IgG1 monoclonal antibody and monomethyl auristatin E, is a useful treatment for patients with locally advanced or metastatic urothelial carcinoma (la/mUC) that progressed after immune checkpoint inhibitor (ICI) therapies. This multicenter retrospective cohort study aimed to identify predictive factors the efficacy EV therapy prolonged overall survival (OS) in clinical practice. included la/mUC who received ICI treatment. Patients subsequently treatment, those non-EV chemotherapy, no were defined as EV, non-EV, best supportive care (BSC) groups, respectively. The median OS was 20, 15, 7 months BSC respectively (p < 0.001). had complete partial response significantly compared stable progressive disease. Univariate analysis showed age, neutrophil-to-lymphocyte ratio (NLR), dysgeusia, rash independent predictors improvement. NLR dysgeusia multivariate analysis. without these both factors. In real-world practice, effective

Language: Английский

Citations

1

A Multicenter, Single-Arm, Prospective Trial to Evaluate Efficacy and Safety of Dose-Dense Methotrexate, Vinblastine, Doxorubicin, and Carboplatin (DD-MVACarbo) Chemotherapy for Cisplatin-Ineligible Patients with Advanced Urothelial Cancer: Study Protocol of the CARBUNCLE Trial DOI Creative Commons
Makito Miyake,

Satoshi Anai,

Yusuke Iemura

et al.

Methods and Protocols, Journal Year: 2024, Volume and Issue: 7(4), P. 58 - 58

Published: July 29, 2024

Unresectable, metastatic, advanced urothelial carcinoma (aUC) is an aggressive disease and treated with platinum-containing first-line chemotherapy, followed by immune checkpoint inhibitors antibody–drug conjugates. Response to chemotherapy a vital priority in sequential treatment strategies because better response associated subsequent therapies. Gemcitabine plus carboplatin conventionally recommended for cisplatin-ineligible patients. This multicenter, single-arm prospective trial will investigate whether dose-dense methotrexate, vinblastine, doxorubicin, (DD-MVACarbo) superior gemcitabine terms of efficacy platinum-naïve, patients aUC. After screening registration, total 46 be this novel regimen. The primary endpoint the objective rate. secondary endpoints include control rate, patient-reported outcomes, adverse events. No evidence intervention available as July 2024. results are expected change standard care improve management

Language: Английский

Citations

1