Neoadjuvant Nivolumab Plus Gemcitabine/Cisplatin Chemotherapy in Muscle-Invasive Urothelial Carcinoma of the Bladder

• DOI: 10.4143/crt.2022.343
• Publication Date: 2022-10-06T11:25:05Z
• Authors: Hongsik Kim; Byong Chang Jeong; Joohyun Hong; Ghee Young Kwon; Chan Kyo Kim; Won Park; Hongryull Pyo; Wan Song; Hyun Hwan Sung; Jung Yong Hong; Se Hoon Park
• Keywords: Neoadjuvant Therapy; Clinical endpoint

The activity and safety of neoadjuvant nivolumab plus gemcitabine/cisplatin (N+GC) were tested in patients with muscle-invasive bladder urothelial carcinoma (MIBC).In a prospective phase II trial, cT2-T4a N0 MIBC who eligible for cisplatin medically appropriate to undergo radical cystectomy (RC) enrolled. Treatment 3 mg/kg on days 1 15 GC (cisplatin 70 mg/m2 day 1, gemcitabine 1,000 8, 15) was repeated every 28 up or 4 cycles, depending the surgery schedules. primary endpoint pathologic complete response (pCR, ypT0). Secondary endpoints included downstaging (≤ ypT1), disease-free survival (DFS), safety.Between September 2019 October 2020, 51 Neoadjuvant N+GC well tolerated. Among 49 completed N+GC, clinical (cCR) achieved 59% intent-to-treat (ITT) population. RC performed 34 (69%) patients. pCR 24% (12/49) ITT population 35% (12/34) Median DFS not reached. Over median follow-up 24 months, 12 experienced disease recurrence treated palliative therapy surgery. Although declined concurrent chemoradiotherapy, longer cCR after than those without. Preoperative programmed death-ligand (PD-L1) did correlate rates.Neoadjuvant feasible provided meaningful responses MIBC, regardless baseline PD-L1 expression (ONO-4538-X41; CRIS.nih.go.kr, KCT0003804).