TY - JOUR
T1 - Avelumab First-line Maintenance for Advanced Urothelial Carcinoma
T2 - Long-term Analyses of Patient-reported Outcomes and Quality-adjusted Time Without Symptoms or Toxicity from the JAVELIN Bladder 100 Trial
AU - Grivas, Petros
AU - Aragon-Ching, Jeanny B.
AU - Bellmunt, Joaquim
AU - Loriot, Yohann
AU - Climent Duran, Miguel A.
AU - Sridhar, Srikala S.
AU - Su, Po Jung
AU - Park, Se Hoon
AU - Kopyltsov, Evgeny
AU - Yamamoto, Yoshiaki
AU - Jacob, Natalia
AU - Hoffman, Jason
AU - Tyroller, Karin
AU - Manitz, Juliane
AU - Kearney, Mairead
AU - Schlichting, Michael
AU - Powles, Thomas
N1 - Publisher Copyright:
Copyright © 2025 The Authors. Published by Elsevier B.V. All rights reserved.
PY - 2025/8/1
Y1 - 2025/8/1
N2 - BACKGROUND AND OBJECTIVE: In JAVELIN Bladder 100, avelumab first-line maintenance plus best supportive care (BSC) significantly prolonged overall survival versus BSC alone, with no detrimental impact on quality of life (QOL), in patients with advanced urothelial carcinoma without progression following first-line platinum-based chemotherapy. We report long-term analyses of patient-reported outcomes (PROs) in patients treated with avelumab (any duration or ≥12 mo) and a post hoc analysis comparing quality-adjusted time without symptoms or toxicity (Q-TWiST) between arms. METHODS: PROs were assessed using National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy Bladder Symptom Index-18 (FBlSI-18) and EuroQol 5-level EQ-5D (EQ-5D-5L). Q-TWiST was calculated as the utility-weighted sum of mean time in three health states: time with all-cause grade 3/4 toxicity prior to progression, time without grade 3/4 toxicity or symptoms of progression, and time after progression. KEY FINDINGS AND LIMITATIONS: In the overall avelumab plus BSC arm (n = 350) and the subgroup treated for ≥12 mo (n = 118), completion rates for PRO assessments during treatment were >80%. FBlSI-18 total and EQ-5D-5L index scores remained stable throughout 24 mo of treatment, with no clinically important changes from baseline. The mean Q-TWiST was 18.46 mo with avelumab plus BSC versus 15.13 mo with BSC alone (22% relative improvement). Limitations include open-label trial design and small patient numbers at later cycles. CONCLUSIONS AND CLINICAL IMPLICATIONS: Patients receiving avelumab had preserved health-related QOL and control of cancer-related symptoms with manageable toxicity, further supporting avelumab first-line maintenance as the recommended treatment for advanced urothelial carcinoma not progressed after platinum-based chemotherapy.
AB - BACKGROUND AND OBJECTIVE: In JAVELIN Bladder 100, avelumab first-line maintenance plus best supportive care (BSC) significantly prolonged overall survival versus BSC alone, with no detrimental impact on quality of life (QOL), in patients with advanced urothelial carcinoma without progression following first-line platinum-based chemotherapy. We report long-term analyses of patient-reported outcomes (PROs) in patients treated with avelumab (any duration or ≥12 mo) and a post hoc analysis comparing quality-adjusted time without symptoms or toxicity (Q-TWiST) between arms. METHODS: PROs were assessed using National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy Bladder Symptom Index-18 (FBlSI-18) and EuroQol 5-level EQ-5D (EQ-5D-5L). Q-TWiST was calculated as the utility-weighted sum of mean time in three health states: time with all-cause grade 3/4 toxicity prior to progression, time without grade 3/4 toxicity or symptoms of progression, and time after progression. KEY FINDINGS AND LIMITATIONS: In the overall avelumab plus BSC arm (n = 350) and the subgroup treated for ≥12 mo (n = 118), completion rates for PRO assessments during treatment were >80%. FBlSI-18 total and EQ-5D-5L index scores remained stable throughout 24 mo of treatment, with no clinically important changes from baseline. The mean Q-TWiST was 18.46 mo with avelumab plus BSC versus 15.13 mo with BSC alone (22% relative improvement). Limitations include open-label trial design and small patient numbers at later cycles. CONCLUSIONS AND CLINICAL IMPLICATIONS: Patients receiving avelumab had preserved health-related QOL and control of cancer-related symptoms with manageable toxicity, further supporting avelumab first-line maintenance as the recommended treatment for advanced urothelial carcinoma not progressed after platinum-based chemotherapy.
KW - Bladder cancer
KW - Clinical trial
KW - Immunotherapy
KW - Maintenance
KW - Patient-reported outcomes
KW - Phase 3
KW - Quality of life
KW - Urothelial carcinoma
UR - https://www.scopus.com/pages/publications/105016596289
U2 - 10.1016/j.euo.2025.04.004
DO - 10.1016/j.euo.2025.04.004
M3 - Article
C2 - 40318950
AN - SCOPUS:105016596289
SN - 2588-9311
VL - 8
SP - 941
EP - 951
JO - European urology oncology
JF - European urology oncology
IS - 4
ER -
