PMID- 33144920
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20201105
IS  - 1949-2553 (Electronic)
IS  - 1949-2553 (Linking)
VI  - 11
IP  - 42
DP  - 2020 Oct 20
TI  - A systematic review and meta-analysis of selected toxicity endpoints of 
      alpelisib.
PG  - 3793-3799
LID - 10.18632/oncotarget.27770 [doi]
AB  - PURPOSE: Alpelisib is a first-in-class alpha-specific phosphatidylinositol 3-kinase 
      inhibitor approved for the treatment of patients with estrogen receptor-positive 
      metastatic breast cancer. High absolute risk (AR) of relevant toxicities has been 
      observed with this treatment. This meta-analysis aimed to improve the precision 
      of the estimated AR of selected adverse events (AEs) associated with this new 
      agent. MATERIALS AND METHODS: A literature search was conducted in August 2019 to 
      identify trials analyzing the anti-tumor efficacy and toxicity profile of 
      alpelisib. Heterogeneity was assessed by using I (2) statistics. Data were 
      analyzed using random effect meta-analyses for AR. Eleven trials and 511 patients 
      were included. RESULTS: There was no evidence of heterogeneity between studies 
      regarding the AR of most AEs except for all-grade weight loss and grade 3-4 
      stomatitis. The number of serious AEs was clearly reported in only one study, of 
      which the most common was hyperglycemia; the most common all-grade AEs were 
      hyperglycemia (59%), diarrhea (56%), nausea (44%), and rash (38%). Grade 3/4 
      hyperglycemia and rash occurred in 28% and 10% of patients, respectively. No 
      treatment-associated deaths were observed, and 18% of patients had to stop 
      treatment due to toxicities. CONCLUSIONS: Alpelisib is associated with clinically 
      relevant AEs that can lead to treatment discontinuation. The most common AE was 
      hyperglycemia. No treatment-related deaths were observed.
CI  - Copyright: (c) 2020 Shields et al.
FAU - Shields, Misty
AU  - Shields M
AD  - H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL, USA.
FAU - Mo, Qianxing
AU  - Mo Q
AD  - Department of Biostatistics, H. Lee Moffitt Cancer Center and Research Institute, 
      Tampa, FL, USA.
FAU - Armitage, Melissa
AU  - Armitage M
AD  - Department of Pharmacy, H. Lee Moffitt Cancer Center and Research Institute, 
      Tampa, FL, USA.
FAU - Sharpe, Susan C
AU  - Sharpe SC
AD  - Moffitt Biomedical Library, H. Lee Moffitt Cancer Center and Research Institute, 
      Tampa, FL, USA.
FAU - Costa, Ricardo L B
AU  - Costa RLB
AD  - Department of Breast Oncology, H. Lee Moffitt Cancer Center and Research 
      Institute, Tampa, FL, USA.
LA  - eng
PT  - Journal Article
PT  - Review
DEP - 20201020
PL  - United States
TA  - Oncotarget
JT  - Oncotarget
JID - 101532965
PMC - PMC7584237
OTO - NOTNLM
OT  - adverse event
OT  - alpelisib
OT  - diarrhea
OT  - hyperglycemia
OT  - rash
COIS- CONFLICTS OF INTEREST R. L. B. Costa received honorarium from Bristol Meyers 
      Squib, Pfizer, Daiichi Sankyo and Astra Zeneca; and research funding from Bristol 
      Meyers Squib. M. Armitage received honorarium from Daiichi Sankyo. S.C. Sharpe, 
      M. Shields and Q. Mo have no conflict of interests, external funding, or other 
      resources to declare.
EDAT- 2020/11/05 06:00
MHDA- 2020/11/05 06:01
PMCR- 2020/10/20
CRDT- 2020/11/04 05:42
PHST- 2020/08/07 00:00 [received]
PHST- 2020/09/24 00:00 [accepted]
PHST- 2020/11/04 05:42 [entrez]
PHST- 2020/11/05 06:00 [pubmed]
PHST- 2020/11/05 06:01 [medline]
PHST- 2020/10/20 00:00 [pmc-release]
AID - 27770 [pii]
AID - 10.18632/oncotarget.27770 [doi]
PST - epublish
SO  - Oncotarget. 2020 Oct 20;11(42):3793-3799. doi: 10.18632/oncotarget.27770. 
      eCollection 2020 Oct 20.