A risk analysis of alpelisib-induced hyperglycemia in patients with advanced solid tumors and breast cancer.

"Declarations Ethics approval and consent to participateAll participants in each trial provided written informed consent. All trials were approved by an independent ethics committee and institutional review board at each site and were conducted per the Declaration of Helsinki and Good Clinical Practice. Consent for publicationAll named authors have contributed to the manuscript and agreed to its submission. Competing interestsJordi Rodón reports receiving consulting and travel fees from Novartis, Eli Lilly, Orion Pharmaceuticals, Servier Pharmaceuticals, Peptomyc, Merck Sharp & Dohme, Kelun Pharmaceutical/Klus Pharma, Spectrum Pharmaceuticals Inc, Pfizer, Roche Pharmaceuticals, Ellipses Pharma, NovellusDx, Ionctura and Molecular Partners (including serving on the scientific advisory board from 2015-present), receiving research funding from Blueprint Pharmaceuticals, Bayer and Novartis; David Demanse, Huilin Hu, Dragica Vuina, Cornelia Quadt report employment and stock ownership from Novartis; Hope S. Rugo reports grants from Plexxikon, Macrogenics, OBI Pharma, Eisai, Pfizer, Novartis, Eli Lilly, GlaxoSmithKline, Genentech, Celsion, Merck; fees for travel, accommodations, and expenses from Novartis, Roche/Genentech, OBI Pharma, Bayer, and Pfizer; speaker’s bureau for Genomic Health; Howard A. Burris, Rafael Simó, Melissa F. Wellons have nothing to report; Azeez Farooki reports being a member of a data safety monitoring board for a current Novartis study; Fabrice André reports research funding from AstraZeneca, Lilly, Novartis, Pfizer, Roche; Dejan Juric reports scientific advisory board for Novartis, Genentech, Eisai, Ipsen, EMD Serono. Competing interests Jordi Rodón reports receiving consulting and travel fees from Novartis, Eli Lilly, Orion Pharmaceuticals, Servier Pharmaceuticals, Peptomyc, Merck Sharp & Dohme, Kelun Pharmaceutical/Klus Pharma, Spectrum Pharmaceuticals Inc, Pfizer, Roche Pharmaceuticals, Ellipses Pharma, NovellusDx, Ionctura and Molecular Partners (including serving on the scientific advisory board from 2015-present), receiving research funding from Blueprint Pharmaceuticals, Bayer and Novartis; David Demanse, Huilin Hu, Dragica Vuina, Cornelia Quadt report employment and stock ownership from Novartis; Hope S. Rugo reports grants from Plexxikon, Macrogenics, OBI Pharma, Eisai, Pfizer, Novartis, Eli Lilly, GlaxoSmithKline, Genentech, Celsion, Merck; fees for travel, accommodations, and expenses from Novartis, Roche/Genentech, OBI Pharma, Bayer, and Pfizer; speaker’s bureau for Genomic Health; Howard A. Burris, Rafael Simó, Melissa F. Wellons have nothing to report; Azeez Farooki reports being a member of a data safety monitoring board for a current Novartis study; Fabrice André reports research funding from AstraZeneca, Lilly, Novartis, Pfizer, Roche; Dejan Juric reports scientific advisory board for Novartis, Genentech, Eisai, Ipsen, EMD Serono."

"http://dx.doi.org/10.13039/100008272Novartis Pharmaceuticals Corporation"

"Conclusions: A risk model using 5 clinically relevant baseline characteristics was able to identify patients at higher or lower probability for developing alpelisib-induced hyperglycemia. Early identification of patients who may be at higher risk for hyperglycemia may improve management (including monitoring and early intervention) and potentially lead to improved outcomes.: Registration: ClinicalTrials.gov: NCT01219699 (registration date: October 13, 2010; retrospectively registered), ClinicalTrials.gov: NCT02437318 (registration date: May 7, 2015); ClinicalTrials.gov: NCT03056755 (registration date: February 17, 2017)."