دورية أكاديمية
Addition of Niraparib to Best Supportive Care as Maintenance Treatment in Patients with Advanced Urothelial Carcinoma Whose Disease Did Not Progress After First-line Platinum-based Chemotherapy: The Meet-URO12 Randomized Phase 2 Trial
| العنوان: | Addition of Niraparib to Best Supportive Care as Maintenance Treatment in Patients with Advanced Urothelial Carcinoma Whose Disease Did Not Progress After First-line Platinum-based Chemotherapy: The Meet-URO12 Randomized Phase 2 Trial |
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| المؤلفون: | Vignani F., Tambaro R., De Giorgi U., Giannatempo P., Bimbatti D., Carella C., Stellato M., Atzori F., Aieta M., Masini C., Hamzaj A., Ermacora P., Veccia A., Scandurra G., Gamba T., Ignazzi G., Pignata S., Di Napoli M., Lolli C., Procopio G., Pierantoni F., Zonno A., Santini D., Di Maio M. |
| المساهمون: | Vignani, F., Tambaro, R., De Giorgi, U., Giannatempo, P., Bimbatti, D., Carella, C., Stellato, M., Atzori, F., Aieta, M., Masini, C., Hamzaj, A., Ermacora, P., Veccia, A., Scandurra, G., Gamba, T., Ignazzi, G., Pignata, S., Di Napoli, M., Lolli, C., Procopio, G., Pierantoni, F., Zonno, A., Santini, D., Di Maio, M. |
| بيانات النشر: | ELSEVIER |
| سنة النشر: | 2023 |
| المجموعة: | Padua Research Archive (IRIS - Università degli Studi di Padova) |
| مصطلحات موضوعية: | Maintenance treatment, Niraparib, Urothelial carcinoma |
| الوصف: | Background: Platinum-based chemotherapy (PBCT) is the standard first-line treatment for advanced urothelial carcinoma (UC). Potential cross-sensitivity can be hypothesized between platinum drugs and poly-ADP ribose-polymerase (PARP) inhibitors.Objective: To compare maintenance treatment with the PARP inhibitor niraparib plus best supportive care (BSC) versus BSC alone in patients with advanced UC without dis-ease progression after first-line PBCT.Design, setting, and participants: Meet-URO12 is a randomized, multicenter, open-label phase 2 trial. Patients with advanced UC, without disease progression after four to six cycles of PBCT, with Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1, were enrolled between August 2019 and March 2021. Randomization was strat-ified by ECOG performance status (0/1) and response to PBCT (objective response/stable disease).Intervention: Patients were randomized (2:1) to experimental arm A (niraparib 300 or 200 mg daily according to body weight and baseline platelets, plus BSC) or control arm B (BSC alone).Outcome measurements and statistical analysis: The primary endpoint was progression -free survival (PFS). The analysis was performed on an intention-to-treat basis. The sec-ondary endpoints reported in this primary analysis are progression-free rate at 6 mo and safety (adverse event rate).Results and limitations: Fifty-eight patients were randomized (39 in arm A and 19 in arm B). The median age was 69 yr, ECOG performance status was 0 in 66% and 1 in 34%; and the best response with chemotherapy was objective response in 55% and stable disease in 45%. The median PFS was 2.1 mo in arm A and 2.4 mo in arm B (hazard ratio 0.92; 95% confidence interval 0.49-1.75, p = 0.81). The 6-mo progression-free rates were 28.2% and 26.3%, respectively. The most common adverse events with niraparib were anemia (50%, grade [G]3 11%), thrombocytopenia (37%, G3-4 16%), neutropenia (21%, G3 5%), fatigue (32%, G3 16%), constipation (32%, G3 3%), mucositis (13%, G3 3%), and nausea ... |
| نوع الوثيقة: | article in journal/newspaper |
| اللغة: | English |
| العلاقة: | info:eu-repo/semantics/altIdentifier/pmid/36216658; info:eu-repo/semantics/altIdentifier/wos/WOS:000989352400026; volume:83; issue:1; firstpage:82; lastpage:89; numberofpages:8; journal:EUROPEAN UROLOGY; https://hdl.handle.net/11577/3501621Test; info:eu-repo/semantics/altIdentifier/scopus/2-s2.0-85139599100 |
| DOI: | 10.1016/j.eururo.2022.09.025 |
| الإتاحة: | https://doi.org/10.1016/j.eururo.2022.09.025Test https://hdl.handle.net/11577/3501621Test |
| رقم الانضمام: | edsbas.AADE61CF |
| قاعدة البيانات: | BASE |
| DOI: | 10.1016/j.eururo.2022.09.025 |
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