1Division of Hematology and Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea
2Division of Hematology-Oncology, Department of Internal Medicine, Chungbuk National University Hospital, Cheongju, Korea
3Department of Urology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea
4Department of Pathology and Translational Genomics, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea
5Department of Radiology and Center for Imaging Sciences, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea
6Department of Radiation Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea
Copyright © 2023 by the Korean Cancer Association
This is an Open-Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.
Ethical Statement
The study protocol was reviewed and approved by the institutional review board of Samsung Medical Center (Seoul, Korea) (SMC IRB No. 2017-01-006) and conducted in accordance with the ethical principles per the Declaration of Helsinki as well as with the Korean guidance on Good Clinical Practice (KGCP). The study (ONO-4538-X41) was registered in advance (CRIS.nih.go.kr, KCT0003804) and all patients gave written informed consent.
Author Contributions
Conceived and designed the analysis: Jeong BC, Park SH.
Collected the data: Jeong BC, Song W, Sung HH, Hong JY, Park SH.
Contributed data or analysis tools: Kim H, Kwon GY, Kim CK, Park W, Pyo H, Park SH.
Performed the analysis: Kim H, Hong J, Kwon GY, Kim CK, Park W, Pyo H, Park SH.
Wrote the paper: Kim H, Park SH.
Statistical analysis: Hong J.
Drafting the manuscript: Kim H, Park SH.
Critical revision of the manuscript: Kim H, Jeong BC, Hong J, Kwon GY, Kim CK, Park W, Pyo H, Song W, Sung HH, Hong JY, Park SH.
Obtaining funding: Park SH.
Administrative support and supervision: Jeong BC, Park SH.
Conflicts of Interest
Conflict of interest relevant to this article was not reported.
Baseline characteristics of all enrolled patients
No. (%) (n=51) | |
---|---|
Age (yr), median (range) | 66 (48–84) |
Sex | |
Male | 43 (84.3) |
Female | 8 (15.7) |
Disease status | |
Newly diagnosed | 41 (80.4) |
Previous non-muscle-invasive disease | 10 (19.6) |
Clinical T category | |
T2 | 33 (64.7) |
T3 | 13 (25.5) |
T4a | 5 (9.8) |
Histology | |
Pure urothelial carcinoma | 44 (86.3) |
Squamous differentiation | 4 (7.8) |
Micropapillary variant | 3 (5.9) |
Differentiation | |
Low grade | 2 (3.9) |
High grade | 49 (96.1) |
PD-L1 22C3 IHC CPS > 1% (n=37) | 15 (40.5) |
ECOG performance status | |
0 | 38 (74.5) |
1 | 13 (25.5) |
CPS, combined positive score; ECOG, Eastern Cooperative Oncology Group; IHC, immunohistochemistry; PD-L1, programmed death-ligand 1.
Maximum grade adverse events during the neoadjuvant therapy
All grades | Grade 3 or 4 | |
---|---|---|
Fatigue | 22 (43.1) | 0 |
Nausea | 22 (43.1) | 0 |
Skin rash | 13 (25.5) | 0 |
Pruritus | 12 (23.5) | 0 |
Asthenia | 10 (19.6) | 0 |
Alopecia | 8 (15.7) | 0 |
Constipation | 8 (15.7) | 0 |
Hiccup | 7 (13.7) | 0 |
Oral mucositis | 5 (9.8) | 0 |
Anorexia | 4 (7.8) | 0 |
Diarrhea | 3 (5.9) | 0 |
Vomiting | 3 (5.9) | 0 |
Neutropenia | 38 (74.5) | 16 (31.4) |
Thrombocytopenia | 33 (64.7) | 12 (23.5) |
Anemia | 33 (64.7) | 3 (5.9) |
Infection | 10 (19.6) | 2 (3.9) |
Liver enzyme elevation | 5 (9.8) | 0 |
Creatinine elevation | 5 (9.8) | 0 |
Values are presented as number (%).
Responses to neoadjuvant nivolumab plus gemcitabine/cisplatin chemotherapy
Total (n=51) | Cystectomy (n=34) | Chemoradiotherapy (n=12) | |
---|---|---|---|
Clinical complete response (cCR) | 30 (58.8) | 18 (66.7) | 12 (100) |
Pathologic complete response (ypCR) | 12 (23.5) | 12 (35.3) | |
Pathologic downstaging (≤ ypT1) | 22 (43.1) | 22 (64.7) |
Values are presented as number (%).
CPS, combined positive score; ECOG, Eastern Cooperative Oncology Group; IHC, immunohistochemistry; PD-L1, programmed death-ligand 1.
Values are presented as number (%).
Values are presented as number (%).