Evidence map›Paper›PMID 33144920›Full record

ReviewOncotarget2020

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

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

Abstract readReview
In one paragraph

Review in Oncotarget, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

12 citing papers in PubMed.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors.

Misty ShieldsH. Lee Moffitt Cancer Center and Research Institute, Tampa, FL, USA.
Qianxing MoDepartment of Biostatistics, H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL, USA.
Melissa ArmitageDepartment of Pharmacy, H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL, USA.
Susan C SharpeMoffitt Biomedical Library, H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL, USA.
Ricardo L B CostaDepartment of Breast Oncology, H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeAlpelisib 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

methodsA 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

resultsThere 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.

conclusionsAlpelisib is associated with clinically relevant AEs that can lead to treatment discontinuation. The most common AE was hyperglycemia. No treatment-related deaths were observed.

Indexed as

adverse eventalpelisibdiarrheahyperglycemiarash

Identifiers

PMID33144920
PMCPMC7584237

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.