PMID- 37914609
OWN - NLM
STAT- MEDLINE
DCOM- 20240311
LR  - 20240409
IS  - 1938-0682 (Electronic)
IS  - 1558-7673 (Linking)
VI  - 22
IP  - 2
DP  - 2024 Apr
TI  - Real-World Treatment Patterns and Clinical Outcomes Among Patients With Advanced 
      Renal Cell Carcinoma.
PG  - 115-125.e3
LID - S1558-7673(23)00220-3 [pii]
LID - 10.1016/j.clgc.2023.09.009 [doi]
AB  - BACKGROUND: Nearly 30% of new renal cell carcinoma (RCC) cases are diagnosed at 
      an advanced or metastatic stage. Recent approvals of immunotherapies (IO) have 
      significantly impacted patient care, but real-world outcomes of these treatments 
      have not been widely evaluated. METHODS: Eligible physicians abstracted 
      demographic and clinical data from patient medical records for patients with 
      advanced clear and non-clear cell RCC (aRCC) who initiated treatment between 
      January 1, 2018, and December 31, 2020. Overall survival (OS) and 
      progression-free survival (PFS) were estimated by the Kaplan-Meier method. A 
      multivariate Cox regression model was developed to assess the impact of treatment 
      category on clinical outcomes while controlling for International Metastatic RCC 
      Database Consortium (IMDC) risk category, histology, and other patient 
      characteristics. RESULTS: A total of 498 patients were included (201 from US, 62 
      from Canada, 58 from UK, 59 from France, 58 from Germany, 60 from Spain). Of 
      these, 250 received tyrosine kinase inhibitor (TKI) monotherapy, 197 received 
      immunotherapy (IO) combination (119 IO+TKI, 78 IO+IO), and 32 received IO 
      monotherapy as first-line treatment for aRCC; 19 patients received various other 
      regimens. 16% of patients had a favorable IMDC risk score. Based on results of 
      multivariable Cox regression, PFS (hazard ratio [HR] [95% confidence interval 
      (CI)]: 0.50 [0.36-0.72]) (P < .001) and time to next treatment (TTNT) were 
      significantly longer (HR [95% CI]: 0.54 [0.39-0.73]) (P < .001) for patients 
      treated with IO combination versus TKI monotherapy. IO combination had a 
      numerically reduced, but statistically insignificant, risk of death versus TKI 
      monotherapy (HR: 0.66; P = .114). IO+TKI combination was associated with 
      significantly longer PFS and reduced risk of progression (HR: 0.52; P = .04) 
      versus IO+IO combination; similar results were observed for TTNT (HR: 0.57; P = 
      .03). CONCLUSION: Our evaluation of real-world treatment outcomes in aRCC 
      revealed that IO + TKI combination is associated with improved PFS and prolonged 
      TTNT compared with TKI monotherapy and IO+IO combination.
CI  - Copyright (c) 2023. Published by Elsevier Inc.
FAU - Esterberg, Elizabeth
AU  - Esterberg E
AD  - RTI Health Solutions, Research Triangle Park, NC. Electronic address: 
      eesterberg@rti.org.
FAU - Iyer, Shrividya
AU  - Iyer S
AD  - Eisai Inc, Nutley, NJ.
FAU - Nagar, Saurabh P
AU  - Nagar SP
AD  - RTI Health Solutions, Research Triangle Park, NC.
FAU - Davis, Keith L
AU  - Davis KL
AD  - RTI Health Solutions, Research Triangle Park, NC.
FAU - Tannir, Nizar M
AU  - Tannir NM
AD  - MD Anderson Cancer Center, Houston, TX.
LA  - eng
PT  - Journal Article
DEP - 20231006
PL  - United States
TA  - Clin Genitourin Cancer
JT  - Clinical genitourinary cancer
JID - 101260955
RN  - 0 (Protein Kinase Inhibitors)
SB  - IM
MH  - Humans
MH  - *Carcinoma, Renal Cell/drug therapy/pathology
MH  - *Kidney Neoplasms/drug therapy
MH  - Treatment Outcome
MH  - Protein Kinase Inhibitors/therapeutic use
MH  - Proportional Hazards Models
MH  - Retrospective Studies
OTO - NOTNLM
OT  - Advanced renal cell carcinoma
OT  - Combination therapy
OT  - Immunotherapy
OT  - Real-world evidence
OT  - Tyrosine kinase inhibitors
COIS- Disclosure SPN, KLD, and EE are full-time employees of RTI Health Solutions, an 
      independent nonprofit research organization, that was retained by Eisai, Inc. to 
      conduct the research that is the subject of this manuscript. Their compensation 
      is unconnected to the studies on which they work. SI is an employee of Eisai, 
      Inc. NMT has received honoraria from Eisai Medical Research, 
      Bristol-Myers-Squibb, Intellisphere, Oncorena, Merck Sharp & Dohme, Neoleukin, 
      Exelixis, and AstraZeneca. He serves as a consultant and/or on a scientific 
      advisory committee for Bristol-Myers-Squibb, Eli Lilly, Eisai Medical Research, 
      Oncorena, Merck, Sharp & Dohme, and Nektar Therapeutics. He has received research 
      funding from Bristol-Myers-Squibb, Nektar Therapeutics, Arrowhead 
      Pharmaceuticals, Novartis, Calithera Biosciences, and Exelixis.
EDAT- 2023/11/02 00:42
MHDA- 2024/03/11 06:42
CRDT- 2023/11/01 22:59
PHST- 2023/07/21 00:00 [received]
PHST- 2023/09/27 00:00 [revised]
PHST- 2023/09/28 00:00 [accepted]
PHST- 2024/03/11 06:42 [medline]
PHST- 2023/11/02 00:42 [pubmed]
PHST- 2023/11/01 22:59 [entrez]
AID - S1558-7673(23)00220-3 [pii]
AID - 10.1016/j.clgc.2023.09.009 [doi]
PST - ppublish
SO  - Clin Genitourin Cancer. 2024 Apr;22(2):115-125.e3. doi: 
      10.1016/j.clgc.2023.09.009. Epub 2023 Oct 6.