Impact of adjuvant intraarterial chemotherapy on survival for patients with stage IIIA-IIIB bladder urothelial carcinoma after radical cystectomy: An open-label, prospective, randomized clinical trial.

• DOI: 10.1200/jco.2025.43.5_suppl.772
• Publication Date: 2025-02-18T14:40:47Z
• Authors: Zhaohui Zhou; Lijuan Jiang; Kai Yao; Xiangdong Li; Wei Chen; Bin Wang; Yanxia Shi; Zike Qin; Hui Han; Yunlin Ye; Fangjian Zhou; Zhuowei Liu
• Keywords: Adjuvant Chemotherapy

772 Background: The aim of this trial was to evaluate the survival benefit adjuvant intraarterial chemotherapy (IAC) in patients who received radical cystectomy (RC) and pathologically confirmed stage IIIA-IIIB bladder urothelial carcinoma. Methods: This a multicenter, randomized study. Patients with (pT3-4 or positive node) disease after RC were randomly assigned (1:1) IAC group observation group. Adjuvant cisplatin gemcitabine (GC) performed through percutaneous catheter system. GC regimen consisted 800 mg/m² 25 on days 1, 8, 15 every 28 for three cycles. primary endpoint recurrence-free (RFS). secondary overall (OS). designed detect 20% improvement 5-year RFS, from 35% 55% (HR: 0.57), two-sided significance level 0.05 80% power. Considering 10% loss follow-up, calculated sample size 212 (106 each arm), be accrued over 7 years. Survival curves estimated using Kaplan–Meier method compared log-rank test. Results: interim analysis cancelled 8th year enrolling 186 due poor accruals. Based actual accrual interval, recalculated, reducing target 184 approximately 100 events. One hundred eighty-six two arms (93 93 group). median age 63 years (quartiles 57-70), 169 (91%) being male. Among patients, 110 (59%) had pT3 disease, 51 (27%) pT4 disease. Lymph node involvement (LNI) 54.3% total, comparable between groups (54% vs. 55%). With follow-up 77.9 months, 106 (57%) experienced recurrence (48 58 In intention-to-treat (ITT) population, significantly prolonged RFS 0.66, 95% CI: 0.45-0.96; p = 0.031), 47.7% (95% 38.0%-60.0%) 35.2% 26.5%-46.8%) OS better as group, although reaches statistical significance only per-protocol population (PP) 0.60, 0.39-0.94; 0.025). Grade 3/4 treatment-related adverse events occurred 34.6% lower incidence grade leukopenia (9.0%) thrombocytopenia (3.9%) observed when intravenous chemotherapy. Conclusions: improved carcinoma, good safety tolerability profile. also among PP population. Clinical information: NCT01627197 .