Avelumab maintenance in patients with metastatic urothelial carcinoma in a real-life expanded-access program.
Обработка статьи · этапы, ошибки и управление
Ошибки и ограничения
История · было → стало
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Tural Deniz, Özkan Oğuzcan, Eylemer Mocan Eda, Kapar Caner, Yaslikaya Sendag, Tatlı Ali Murat, Akdağ Goncagül, Demir Hacer, Bilgetekin Irem, Selcukbiricik Fatih, Köse Fatih, Sari Murat, Erdem Gökmen Umut, Sucuoğlu İşleyen Zehra, Arslan Cagatay, Celik Sinemis, Evrensel Türkkan, Erman Mustafa, Kazaz Seher Nazli, Ozturk Banu, Çelik Halil, Özen Miraç, Erel Pınar, Can Şancı Pervin, Ergün Yaküp, Taban Hakan, Kuzu Ömer Faruk, Ulaş Kahya Burcu, Arslan Ahmet Melih, Sakin Abdullah, Araz Murat, Okutur Kerem, Akgül Fahri, Mirili Cem, Sevinç Alper, Atalah Fatih, Düzköprü Yakup, Gülbağcı Burcu, Yaşar Serkan, Kandemir Nurten, Kosku Hakan, Aydın Esra, Erdem Dilek, Guliyev Murad, Çulha Yaşar, Şahin Berksoy, Gürsoy Pınar, Ürün Yüksel
Аннотация
PATIENTS AND METHODS: Safety and effectiveness were assessed in patients who received at least one cycle of avelumab. The primary endpoints were overall survival (OS) and progression-free survival (PFS), while secondary endpoints included safety. PFS and OS were estimated using the Kaplan-Meier method.
RESULTS: The 12-month OS rate was 78% (95% CI, 74.5%-79%), with the median OS not reached. The 12-month PFS rate was 32% (95% CI, 29%-35%), and the median PFS was 5.3 months (95% CI, 3.4-7.1). Univariate analysis showed a median PFS of 2.9 months in patients with liver metastases versus 5.4 months in those without (p = 0.001), 2.8 months in patients with hemoglobin levels below 10 mg/dL versus 5.3 months in those above (p = 0.06), and 8.8 months in patients with lymph node - only metastases versus 4.1 months in patients with metastases at other sites (p = 0.05). No significant differences in PFS were observed based on chemotherapy type (cisplatin vs. carboplatin, p = 0.7), chemotherapy cycle count (≤4 vs. > 4 cycles, p = 0.4), or first-line chemotherapy response (complete response vs. partial response/stable disease, p = 0.4).
CONCLUSIONS: Avelumab demonstrated efficacy and tolerability as maintenance therapy for mUC patients without progression following first-line platinum-based chemotherapy.