Effectiveness and Safety of Enfortumab Vedotin Plus Pembrolizumab for Patients Aged 80 Years and Older With Metastatic Urothelial Carcinoma: A Multicenter Retrospective Study.
Enfortumab vedotin plus pembrolizumab (EVP) has become the standard first-line treatment for metastatic urothelial carcinoma (mUC); however, evidence regarding its use in very elderly patients remains limited. We evaluated the effectiveness and safety of EVP in patients aged ≥80 years with mUC.
This multicenter retrospective study included 60 patients with mUC treated with EVP at six institutions in Japan between September 2024 and March 2026. Patients were stratified into two groups according to age at treatment initiation: ≥80 years and <80 years. The primary endpoints were progression-free survival (PFS) and overall survival (OS). Secondary endpoints included objective response rate (ORR), disease control rate (DCR), and treatment-related adverse events (AEs). Continuous variables were compared using the Mann-Whitney U test, while categorical variables were analyzed using the chi-square test or Fisher's exact test. Survival outcomes were estimated using the Kaplan-Meier method and compared using the log-rank test.
Of the 60 patients, 11 (18%) were aged ≥80 years and 49 (82%) were aged <80 years. The ORR was 60% in the ≥80-year group and 64% in the <80-year group (p=0.24), while the DCR was 80% and 84%, respectively (p=0.09). Median PFS was 8.5 months in the ≥80-year group and 12.1 months in the <80-year group (p=0.51). The 12-month OS rate was 50% and 84%, respectively (p=0.19). Grade ≥3 AEs occurred in 9% of older patients and 31% of younger patients (p=0.14).
EVP demonstrated comparable effectiveness and safety in patients aged ≥80 years with mUC. These findings suggest that advanced age alone should not preclude the use of EVP in carefully selected elderly patients.
This multicenter retrospective study included 60 patients with mUC treated with EVP at six institutions in Japan between September 2024 and March 2026. Patients were stratified into two groups according to age at treatment initiation: ≥80 years and <80 years. The primary endpoints were progression-free survival (PFS) and overall survival (OS). Secondary endpoints included objective response rate (ORR), disease control rate (DCR), and treatment-related adverse events (AEs). Continuous variables were compared using the Mann-Whitney U test, while categorical variables were analyzed using the chi-square test or Fisher's exact test. Survival outcomes were estimated using the Kaplan-Meier method and compared using the log-rank test.
Of the 60 patients, 11 (18%) were aged ≥80 years and 49 (82%) were aged <80 years. The ORR was 60% in the ≥80-year group and 64% in the <80-year group (p=0.24), while the DCR was 80% and 84%, respectively (p=0.09). Median PFS was 8.5 months in the ≥80-year group and 12.1 months in the <80-year group (p=0.51). The 12-month OS rate was 50% and 84%, respectively (p=0.19). Grade ≥3 AEs occurred in 9% of older patients and 31% of younger patients (p=0.14).
EVP demonstrated comparable effectiveness and safety in patients aged ≥80 years with mUC. These findings suggest that advanced age alone should not preclude the use of EVP in carefully selected elderly patients.
Authors
Kobari Kobari, Nakajima Nakajima, Saito Saito, Katsurayama Katsurayama, Inakawa Inakawa, Kubota Kubota, Nemoto Nemoto, Nakamura Nakamura, Nishimura Nishimura, Ishihara Ishihara, Yagisawa Yagisawa, Fukuda Fukuda, Yoshida Yoshida, Iizuka Iizuka, Shimmura Shimmura, Hashimoto Hashimoto, Kondo Kondo, Kobayashi Kobayashi, Takagi Takagi
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