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A systematic review and meta-analysis of selected toxicity endpoints of alpelisib

Misty Shields, Qianxing Mo, Melissa Armitage, Susan C. Sharpe and Ricardo L.B. Costa _

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Oncotarget. 2020; 11:3793-3799. https://doi.org/10.18632/oncotarget.27770

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Abstract

Misty Shields1, Qianxing Mo2, Melissa Armitage3, Susan C. Sharpe4 and Ricardo L.B. Costa5

1 H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL, USA

2 Department of Biostatistics, H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL, USA

3 Department of Pharmacy, H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL, USA

4 Moffitt Biomedical Library, H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL, USA

5 Department of Breast Oncology, H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL, USA

Correspondence to:

Ricardo L.B. Costa,email: [email protected]

Keywords: alpelisib; adverse event; hyperglycemia; rash; diarrhea

Received: August 07, 2020     Accepted: September 24, 2020     Published: October 20, 2020

Copyright: © 2020 Shields et al. This is an open access article distributed under the terms of the Creative Commons Attribution License (CC BY 3.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

ABSTRACT

Purpose: Alpelisib is a first-in-class α-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 I2 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.


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