Evidence map›Paper›PMID 35016012›Full record

ReviewBreast (Edinburgh, Scotland)2022

A multidisciplinary approach to optimizing care of patients treated with alpelisib.

Hope S Rugo, Mario E Lacouture, Marcus D Goncalves, Umesh Masharani, Matti S Aapro, Joyce A O'Shaughnessy

Registry-linked trialOpen access · goldAbstract readReview
In one paragraph

Review in Breast (Edinburgh, Scotland), 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05455619 (Study to Assess the Safety and Efficacy of Evexomostat), which is not on this map. Cited by 13 papers.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed
2.6field-weighted citation impact, top 9% of its field
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.

NCT05455619 phase1 / phase2recruitingnot on this map

Study to Assess the Safety and Efficacy of Evexomostat (SDX-7320) in Combination With A PI3K or Akt Inhibitor Plus Fulvestrant in Patients With HR+, HER2-, Metastatic Breast Cancer With PI3K Pathway Alteration(s)

TypeinterventionalSponsorSynDevRx, Inc.Ran2022 to 2027Enrolled52ConditionsHR+/HER2-negative Breast Cancer, Metastatic Breast CancerArmsEvexomostat
3 · Its place in the literature

Who cites it

13 citing papers in PubMed, 25 citations in OpenAlex.

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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

6 authors at 6 institutions in 2 countries.

Hope S RugoDepartment of Medicine (Hematology/Oncology), University of California San Francisco Helen Diller Family Comprehensive Cancer Center, San Francisco, CA, USA. Electronic address: Hope.Rugo@ucsf.edu.
Mario E LacoutureDermatology Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA. Electronic address: LacoutuM@mskcc.org.
Marcus D GoncalvesDivision of Endocrinology, Weill Department of Medicine, Weill Cornell Medicine, New York, NY, USA. Electronic address: mdg9010@med.cornell.edu.
Umesh MasharaniDepartment of Medicine (Endocrinology), University of California San Francisco, San Francisco, CA, USA. Electronic address: umesh.masharani@ucsf.edu.
Matti S AaproDepartment of Oncology, Genolier Cancer Centre, Clinique de Genolier, Genolier, Switzerland. Electronic address: maapro@genolier.net.
Joyce A O'ShaughnessyBaylor University Medical Center Texas Oncology, US Oncology, Dallas, TX, USA. Electronic address: joyce.oshaughnessy@usoncology.com.
Clinique de Genolier · CHCornell University · USMemorial Sloan Kettering Cancer Center · USTexas Oncology · USUCSF Helen Diller Family Comprehensive Cancer Center · USUniversity of California, San Francisco · US

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Hongbiao Carl Lekaye · 1985 to 2026
$347.4M
NCI NIH HHS P30 CA008748
6 · The paper itself

Abstract

purposeThe oral, α-specific phosphatidylinositol-3-kinase (PI3Kα) inhibitor alpelisib is the first PI3K inhibitor approved for the treatment of advanced breast cancer. As alpelisib is a relatively new therapeutic option, specific guidance and a multidisciplinary approach are needed to provide optimal patient care. The primary objective of this manuscript is to provide comprehensive guidance on minimizing and managing adverse events (AEs) for patients with advanced breast cancer who are receiving alpelisib.

methodsClinical studies, prescribing information, published literature, and relevant guidelines were reviewed to provide recommendations on the prevention and management of alpelisib-associated AEs.

resultsThe most common AEs associated with alpelisib in the phase 3 SOLAR-1 trial were hyperglycemia and rash (which are considered on-target effects of PI3Kα inhibition) and gastrointestinal AEs, including diarrhea, nausea, and decreased appetite. These AEs require regular monitoring, early recognition, and prompt initiation of appropriate treatment. In addition, there are effective strategies to reduce the onset and severity of frequently observed AEs-in particular, onset of hyperglycemia and rash may be reduced by lifestyle changes (such as reduced intake of carbohydrates and regular exercise) and antihistamine prophylaxis, respectively. To reduce risk of severe hyperglycemia, it is essential to achieve adequate glycemic control prior to initiation of alpelisib treatment.

conclusionOverall, alpelisib-associated AEs are generally manageable with prompt recognition, regular monitoring, and appropriate intervention, preferably with a multidisciplinary approach.

Indexed as

Breast NeoplasmsPhosphatidylinositol 3-KinasesAntineoplastic Combined Chemotherapy ProtocolsFemaleHumansThiazolesAlpelisibPhosphatidylinositol 3-KinasesThiazolesAE managementAlpelisibBreast cancerPIK3CA

Identifiers

PMID35016012
PMCPMC8749445
OpenAlexW4200186137

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

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.