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- Title
Neoadjuvant Nivolumab Plus Gemcitabine/Cisplatin Chemotherapy in Muscle-Invasive Urothelial Carcinoma of the Bladder.
- 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
- Abstract
Purpose The activity and safety of neoadjuvant nivolumab plus gemcitabine/cisplatin (N+GC) were tested in patients with muscleinvasive bladder urothelial carcinoma (MIBC). Materials and Methods In a prospective phase II trial, patients with cT2-T4a N0 MIBC who were eligible for cisplatin and medically appropriate to undergo radical cystectomy (RC) were enrolled. Treatment with nivolumab 3 mg/kg on days 1 and 15 plus GC (cisplatin 70 mg/m2 on day 1, and gemcitabine 1,000 mg/m2 on days 1, 8, and 15) was repeated every 28 days up to 3 or 4 cycles, depending on the surgery schedules. The primary endpoint was pathologic complete response (pCR, ypT0). Secondary endpoints included pathologic downstaging (= ypT1), disease-free survival (DFS), and safety. Results Between September 2019 and October 2020, 51 patients were enrolled. Neoadjuvant N+GC was well tolerated. Among 49 patients who completed neoadjuvant N+GC, clinical complete response (cCR) was achieved in 59% of intent-to-treat (ITT) population. RC was performed in 34 (69%) patients. pCR was achieved in 24% (12/49) of ITT population and 35% (12/34) of RC patients. Median DFS was not reached. Over a median follow-up of 24 months, 12 patients experienced disease recurrence and were treated with palliative therapy or surgery. Although 12 patients declined surgery and were treated with concurrent chemoradiotherapy, DFS was longer in patients with cCR after neoadjuvant therapy than those without. Preoperative programmed death-ligand 1 (PD-L1) did not correlate with pCR or pathologic downstaging rates. Conclusion Neoadjuvant N+GC was feasible and provided meaningful pathologic responses in patients with MIBC, regardless of baseline PD-L1 expression (ONO-4538-X41; CRIS.nih.go.kr, KCT0003804).
- Subjects
TRANSITIONAL cell carcinoma; NIVOLUMAB; PROGRAMMED death-ligand 1; CISPLATIN; GEMCITABINE; CHEMORADIOTHERAPY; URINARY diversion
- Publication
Cancer Research & Treatment, 2023, Vol 55, Issue 2, p636
- ISSN
1598-2998
- Publication type
Article
- DOI
10.4143/crt.2022.343