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Avelumab maintenance in patients with metastatic urothelial carcinoma in a real-life expanded-access program
Deniz Tural1, Oğuzcan Özkan2, Eda Eylemer Mocan3
1Medical Oncology, Koç University Hospital, Istanbul, Turkey.
Background:
This study evaluates the real-world efficacy and safety of avelumab maintenance therapy in patients with metastatic urothelial carcinoma (mUC) who did not progress following first-line platinum-based chemotherapy, using data from the Expanded Access Program (EAP).
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.
