PMID- 37813699
OWN - NLM
STAT- MEDLINE
DCOM- 20240216
LR  - 20240410
IS  - 1938-0682 (Electronic)
IS  - 1558-7673 (Linking)
VI  - 22
IP  - 1
DP  - 2024 Feb
TI  - Adverse Events of Cabozantinib Plus Nivolumab Versus Ipilimumab Plus Nivolumab.
PG  - e122-e127.e1
LID - S1558-7673(23)00205-7 [pii]
LID - 10.1016/j.clgc.2023.09.003 [doi]
AB  - INTRODUCTION: Recently, many agents and combinations for metastatic and advanced 
      renal cell carcinoma have been approved. This study aims to highlight the 
      comprehensive differences in adverse events (AEs) between cabozantinib (CAB) plus 
      nivolumab (NIVO) and ipilimumab (IPI) plus NIVO based on a real-world big 
      dataset. MATERIAL AND METHODS: We downloaded AE datasets of IPI + NIVO and CAB + 
      NIVO from the Food and Drug Administration Adverse Event Reporting System 
      database. We used the Medical Dictionary for Regulatory Activities to treat each 
      AE as a preferred term and grouped it into the System Organ Class (SOC). We 
      performed logistic regression analyses to compare IPI + NIVO and CAB + NIVO. 
      RESULTS: The incidence rates of 7 types of toxicities were higher for CAB + NIVO 
      than for IPI + NIVO. On the other hand, the incidence rates of 3 types of 
      toxicities were higher for IPI + NIVO than for CAB + NIVO. Serious AEs were 
      higher in patients receiving IPI + NIVO. CONCLUSION: Our findings suggest that 
      both combination therapies presented a disproportionate distribution of 
      toxicities in several SOC. These findings may help clinicians select suitable 
      therapy for the individual and improve the safety profile in patients with 
      advanced renal cell carcinoma receiving NIVO + IPI and NIVO + CAB in a real-world 
      setting.
CI  - Copyright (c) 2023 Elsevier Inc. All rights reserved.
FAU - Blas, Leandro
AU  - Blas L
AD  - Department of Urology, Graduate School of Medical Sciences, Kyushu University, 
      Fukuoka, Japan.
FAU - Shiota, Masaki
AU  - Shiota M
AD  - Department of Urology, Graduate School of Medical Sciences, Kyushu University, 
      Fukuoka, Japan. Electronic address: shiota.masaki.101@m.kyushu-u.ac.jp.
FAU - Tsukahara, Shigehiro
AU  - Tsukahara S
AD  - Department of Urology, Graduate School of Medical Sciences, Kyushu University, 
      Fukuoka, Japan.
FAU - Nagakawa, Shohei
AU  - Nagakawa S
AD  - Department of Urology, Graduate School of Medical Sciences, Kyushu University, 
      Fukuoka, Japan.
FAU - Matsumoto, Takashi
AU  - Matsumoto T
AD  - Department of Urology, Graduate School of Medical Sciences, Kyushu University, 
      Fukuoka, Japan.
FAU - Eto, Masatoshi
AU  - Eto M
AD  - Department of Urology, Graduate School of Medical Sciences, Kyushu University, 
      Fukuoka, Japan.
LA  - eng
PT  - Journal Article
DEP - 20230918
PL  - United States
TA  - Clin Genitourin Cancer
JT  - Clinical genitourinary cancer
JID - 101260955
RN  - 31YO63LBSN (Nivolumab)
RN  - 0 (Ipilimumab)
RN  - 1C39JW444G (cabozantinib)
RN  - 0 (Anilides)
RN  - 0 (Pyridines)
SB  - IM
MH  - Humans
MH  - Nivolumab
MH  - Ipilimumab
MH  - *Carcinoma, Renal Cell/secondary
MH  - Antineoplastic Combined Chemotherapy Protocols/adverse effects
MH  - *Kidney Neoplasms/pathology
MH  - *Anilides
MH  - *Pyridines
OTO - NOTNLM
OT  - Adverse Event Reporting System
OT  - Food and Drug Administration
OT  - Kidney neoplasm
COIS- Disclosure Masaki Shiota received honoraria from Janssen Pharmaceutical, 
      AstraZeneca, Astellas Pharma, Sanofi, and Bayer and research funding support from 
      Daiichi Sankyo. Masatoshi Eto received honoraria from Ono Pharmaceutical, Takeda 
      Pharmaceutical, Novartis, Pfizer, Bristol-Myers Squibb, Janssen Pharmaceutical, 
      MSD, Merck, Eisai, AstraZeneca, and Astellas Pharma and research funding support 
      from Ono Pharmaceutical, Bayer, Astellas Pharma, Sanofi, and Takeda 
      Pharmaceutical.
EDAT- 2023/10/10 00:42
MHDA- 2024/02/16 06:43
CRDT- 2023/10/09 22:19
PHST- 2023/06/28 00:00 [received]
PHST- 2023/09/13 00:00 [revised]
PHST- 2023/09/16 00:00 [accepted]
PHST- 2024/02/16 06:43 [medline]
PHST- 2023/10/10 00:42 [pubmed]
PHST- 2023/10/09 22:19 [entrez]
AID - S1558-7673(23)00205-7 [pii]
AID - 10.1016/j.clgc.2023.09.003 [doi]
PST - ppublish
SO  - Clin Genitourin Cancer. 2024 Feb;22(1):e122-e127.e1. doi: 
      10.1016/j.clgc.2023.09.003. Epub 2023 Sep 18.