PMID- 32975057
OWN - NLM
STAT- MEDLINE
DCOM- 20201016
LR  - 20201016
IS  - 1976-2437 (Electronic)
IS  - 0513-5796 (Print)
IS  - 0513-5796 (Linking)
VI  - 61
IP  - 10
DP  - 2020 Oct
TI  - Tolerability of Alternative Dosing Schedules for Sunitinib: A Systematic Review 
      and Meta-Analysis.
PG  - 837-843
LID - 10.3349/ymj.2020.61.10.837 [doi]
AB  - PURPOSE: The standard schedule for sunitinib treatment is 4 weeks on and 2 weeks 
      off (4/2) in first-line treatment for metastatic renal cell carcinoma (mRCC). 
      Schedule modifications, including 2 weeks on and 1 week off (2/1), appear to 
      reduce the total number of treatment-related adverse events (TRAEs) without 
      compromising efficacy. Even though TRAEs can qualitatively differ from each 
      other, it is not clear as to what effects a 2/1 schedule has on individual TRAEs. 
      MATERIALS AND METHODS: This meta-analysis included one randomized controlled 
      trial (RCT) and four non-randomized controlled studies (non-RCTs) that compared 
      the two schedules in parallel. The primary objective was to estimate risk of 
      individual adverse events (AEs) with a sunitinib 2/1 schedule versus a 4/2 
      schedule. Seven representative AEs were evaluated as standard data for the RCT 
      and as weighted pooling data of the non-RCTs. Random effects modelling with 
      Review Manager v5.3 was used to pool study-level data using the inverse-variance 
      of each study as the weight. RESULTS: The five selected studies included a total 
      of 484 patients with mRCC. Risk ratios for fatigue for a 2/1 schedule were 
      significantly lower than those for a 4/2 schedule 0.69 [95% confidence intervals 
      (CI), 0.51, 0.95] in the RCT and 0.77 (95% CI, 0.63, 0.94) in the non-RCTs. 
      Other TRAEs, except diarrhea and anorexia, also tended to decrease in both sets. 
      Efficacy outcomes were comparable between 2/1 and standard schedules. CONCLUSION: 
      This meta-analysis suggests that a 2/1 schedule of sunitinib lowers the risk of 
      fatigue and the occurrence other AEs without compromising efficacy.
CI  - (c) Copyright: Yonsei University College of Medicine 2020.
FAU - Kang, Hee Jung
AU  - Kang HJ
AUID- ORCID: 0000-0002-0541-8444
AD  - Department of Clinical Development, Kairos Bioconsulting LLC, Rockville, MD, USA.
FAU - Lee, Soohyeon
AU  - Lee S
AUID- ORCID: 0000-0001-9665-062X
AD  - Department of Medical Oncology, Korea University Anam Hospital, Korea University 
      College of Medicine, Seoul, Korea. Soohyeon_lee@korea.ac.kr.
LA  - eng
PT  - Journal Article
PT  - Meta-Analysis
PT  - Systematic Review
PL  - Korea (South)
TA  - Yonsei Med J
JT  - Yonsei medical journal
JID - 0414003
RN  - 0 (Antineoplastic Agents)
RN  - V99T50803M (Sunitinib)
SB  - IM
MH  - Antineoplastic Agents/*therapeutic use
MH  - Carcinoma, Renal Cell/*drug therapy/pathology
MH  - Drug Administration Schedule
MH  - Female
MH  - Humans
MH  - Kidney Neoplasms/*drug therapy/pathology
MH  - Male
MH  - Middle Aged
MH  - Sunitinib/*therapeutic use
MH  - Treatment Outcome
PMC - PMC7515783
OTO - NOTNLM
OT  - Sunitinib
OT  - drug administration schedule
OT  - meta-analysis
OT  - renal cell carcinoma
COIS- The authors have no potential conflicts of interest to disclose.
EDAT- 2020/09/26 06:00
MHDA- 2020/10/21 06:00
PMCR- 2020/10/01
CRDT- 2020/09/25 06:10
PHST- 2020/04/03 00:00 [received]
PHST- 2020/06/07 00:00 [revised]
PHST- 2020/06/08 00:00 [accepted]
PHST- 2020/09/25 06:10 [entrez]
PHST- 2020/09/26 06:00 [pubmed]
PHST- 2020/10/21 06:00 [medline]
PHST- 2020/10/01 00:00 [pmc-release]
AID - 61.837 [pii]
AID - 10.3349/ymj.2020.61.10.837 [doi]
PST - ppublish
SO  - Yonsei Med J. 2020 Oct;61(10):837-843. doi: 10.3349/ymj.2020.61.10.837.