PMID- 37055875
OWN - NLM
STAT- MEDLINE
DCOM- 20230522
LR  - 20230522
IS  - 1744-764X (Electronic)
IS  - 1474-0338 (Linking)
VI  - 22
IP  - 4
DP  - 2023 Apr
TI  - An update on safety evaluation of immune-based combinations in patients with 
      advanced renal cell carcinoma.
PG  - 279-291
LID - 10.1080/14740338.2023.2203486 [doi]
AB  - INTRODUCTION: Significant advances have been made in the first-line therapy of 
      metastatic renal cell carcinoma (mRCC) since the approval of immune-based 
      combinations, including nivolumab plus ipilimumab or cabozantinib, and 
      pembrolizumab plus axitinib or lenvatinib. AREAS COVERED: The aim of this review 
      is to compare the different safety profiles of first-line immune-based 
      combinations versus sunitinib across the four respective pivotal trials 
      (CheckMate 214, CheckMate 9ER, KEYNOTE-426, and CLEAR), with a particular 
      attention to patients' health-related quality of life (HRQoL) assessment. EXPERT 
      OPINION: The concurrent use of an immune-checkpoint inhibitor (ICI) with a 
      tyrosine kinase inhibitor (TKI) as a first-line treatment strategy for mRCC has 
      highlighted the unmet clinical need for prompt detection and consequently proper 
      management of adverse events (AEs), both immune-related and TKI-induced. 
      Overlapping AEs, such as hypertransaminasemia, are most challenging to manage, 
      and evidence is still outlined from clinical practice. The specific patterns of 
      toxicities of the approved first-line immune-based combinations, along with the 
      impact of these interventions on patients' HRQoL, demand a deeper consideration 
      by physicians while choosing the appropriate treatment for each individual mRCC 
      patient. Both safety profile and HRQoL evaluation could be exploited to guide the 
      first-line treatment selection in this setting.
FAU - Rosellini, Matteo
AU  - Rosellini M
AD  - Medical Oncology, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, 
      Italy.
AD  - Department of Medical and Surgical Sciences, University of Bologna Bologna, 
      Bologna, Italy.
FAU - Tassinari, Elisa
AU  - Tassinari E
AD  - Medical Oncology, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, 
      Italy.
AD  - Department of Medical and Surgical Sciences, University of Bologna Bologna, 
      Bologna, Italy.
FAU - Marchetti, Andrea
AU  - Marchetti A
AD  - Medical Oncology, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, 
      Italy.
AD  - Department of Medical and Surgical Sciences, University of Bologna Bologna, 
      Bologna, Italy.
FAU - Tateo, Valentina
AU  - Tateo V
AD  - Medical Oncology, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, 
      Italy.
AD  - Department of Medical and Surgical Sciences, University of Bologna Bologna, 
      Bologna, Italy.
FAU - Nuvola, Giacomo
AU  - Nuvola G
AD  - Medical Oncology, SCIAS Hospital de Barcelona, Barcelona, Spain.
FAU - Rizzo, Alessandro
AU  - Rizzo A
AD  - Struttura Semplice Dipartimentale di Oncologia Medica per la Presa in Carico 
      Globale del Paziente Oncologico "Don Tonino Bello," I.R.C.C.S. Istituto Tumori 
      "Giovanni Paolo II", Bari, Italy.
FAU - Massari, Francesco
AU  - Massari F
AD  - Medical Oncology, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, 
      Italy.
AD  - Department of Medical and Surgical Sciences, University of Bologna Bologna, 
      Bologna, Italy.
FAU - Mollica, Veronica
AU  - Mollica V
AD  - Medical Oncology, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, 
      Italy.
AD  - Department of Medical and Surgical Sciences, University of Bologna Bologna, 
      Bologna, Italy.
LA  - eng
PT  - Journal Article
PT  - Review
DEP - 20230416
PL  - England
TA  - Expert Opin Drug Saf
JT  - Expert opinion on drug safety
JID - 101163027
RN  - V99T50803M (Sunitinib)
RN  - 31YO63LBSN (Nivolumab)
RN  - 0 (Protein Kinase Inhibitors)
SB  - IM
MH  - Humans
MH  - *Carcinoma, Renal Cell/pathology
MH  - *Kidney Neoplasms/pathology
MH  - Quality of Life
MH  - Sunitinib/adverse effects
MH  - Nivolumab
MH  - Protein Kinase Inhibitors/therapeutic use
OTO - NOTNLM
OT  - Adverse events
OT  - immune checkpoint inhibitors
OT  - immune-based combinations
OT  - immune-related adverse events
OT  - metastatic renal cell carcinoma
OT  - patient-reported outcomes
OT  - quality of life
OT  - safety
EDAT- 2023/04/14 06:00
MHDA- 2023/05/22 06:42
CRDT- 2023/04/13 23:52
PHST- 2023/05/22 06:42 [medline]
PHST- 2023/04/14 06:00 [pubmed]
PHST- 2023/04/13 23:52 [entrez]
AID - 10.1080/14740338.2023.2203486 [doi]
PST - ppublish
SO  - Expert Opin Drug Saf. 2023 Apr;22(4):279-291. doi: 10.1080/14740338.2023.2203486. 
      Epub 2023 Apr 16.