Prognostic Significance of Hypoalbuminemia in Maintenance Avelumab Therapy After First-Line Chemotherapy for Metastatic Urothelial Carcinoma: A Multicenter Real-World Study (YUSHIMA Study).
International journal of urology : official journal of the Japanese Urological Association2026 Apr
Rie Muta, Hiroshi Fukushima, Hajime Tanaka, Noboru Numao, Yuki Nakamura, Atsushi Yoshinaga, Naoko Kawamura, Ichiro Yonese, Keita Izumi, Takanobu Yamamoto, Sho Uehara, Kotaro Suzuki, Masahiro Toide, Ryoji Takazawa, Saori Araki, Soichiro Yoshida, Yasuhisa Fujii
Abstract
OBJECTIVES: Maintenance avelumab therapy after first-line induction chemotherapy is a viable option in the evolving treatment paradigm for metastatic urothelial carcinoma (mUC); however, the clinical determinants of its efficacy remain unknown. Here, we explored the prognostic factors of maintenance avelumab therapy for mUC using a multicenter real-world database.
METHODS: The review of the multicenter database identified 59 patients with mUC who did not progress during first-line chemotherapy and subsequently received maintenance avelumab therapy. Progression-free survival (PFS) and overall survival (OS) after the initiation of avelumab were analyzed, and prognostic factors were explored.
RESULTS: The median age was 70 years, and the primary lesion was the bladder in 28 (47.5%) patients. In the first-line chemotherapy, gemcitabine plus cisplatin was administered in 40 (67.8%) patients. The number of chemotherapy cycles was 2-3/4/5/6 in 7 (11.9%)/22 (37.3%)/6 (10.2%)/24 (40.7%) patients. With a median follow-up period of 13.2 months, 38 (64.4%) patients progressed and 20 (33.9%) died. The median PFS and OS were 6.1 months and not reached, respectively. Multivariable analysis demonstrated that hypoalbuminemia was the only independent predictor of poor PFS (hazard ratio, 2.70; p = 0.013). Patients with hypoalbuminemia showed significantly shorter median PFS (3.3 vs. 12.0 months; p = 0.004) and OS (9.3 months vs. not reached; p < 0.001) compared to those with normal albumin.
CONCLUSIONS: Hypoalbuminemia was an independent prognostic factor in patients with mUC who were treated with maintenance avelumab therapy. Efforts to preserve nutritional status and avoid hypoalbuminemia may help optimize its efficacy.
Keywords
HumansMaleAgedFemaleMiddle AgedAntibodies, Monoclonal, HumanizedCarcinoma, Transitional CellPrognosisHypoalbuminemiaProgression-Free SurvivalAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsGemcitabineRetrospective StudiesDeoxycytidineMaintenance ChemotherapyUrinary Bladder NeoplasmsCisplatinTreatment Outcome
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