{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,1,31]],"date-time":"2026-01-31T06:52:52Z","timestamp":1769842372428,"version":"3.49.0"},"reference-count":15,"publisher":"Oxford University Press (OUP)","issue":"7","license":[{"start":{"date-parts":[[2023,4,22]],"date-time":"2023-04-22T00:00:00Z","timestamp":1682121600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2023,7,5]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:p>Alpelisib is a specific oral PI3K inhibitor used combined with fulvestrant for the treatment of patients with HR+\/HER2\u2013\/PIK3CA-mutated metastatic breast cancer. Adverse drug reactions with alpelisib are common, including hyperglycemia and rash. Here we describe extraordinary and life-threatening reactions beyond skin rash in two patients with progressive PIK3CA-mutated metastatic cancer in whom alpelisib was initiated. Case-A (vaginal cancer): After 10 days on treatment, she developed dry eyes, generalized rash and itching. Alpelisib was interrupted and symptomatic treatment initiated. Because of an initial tumor response, a rechallenge was done. Ninety minutes after a reduced dose of alpelisib, she developed an anaphylactic reaction with angioedema, hypotension, and skin rash. Case-B (breast cancer): After 11 days on treatment, she developed skin rash and alpelisib was interrupted. At re-initiation, she felt tingles in her face and ears and some skin erythema. Given the mild rash, a second rechallenge with premedication was performed. Ninety minutes after a reduced dose of alpelisib, she developed a type-1 allergic reaction with angioedema, tingles, and skin rash. In both cases, a type-1 allergic reaction was diagnosed and symptomatic treatment was initiated, alpelisib was permanently discontinued and the patients fully recovered the next week(s). This report underlines the critical importance to consider type-I allergic reactions in the differential diagnosis in cases of rash associated with alpelisib. Even if a reaction develops after days on treatment, a type-I allergic reaction cannot be excluded. A rechallenge can be dangerous and should always be well contemplated or even avoided.<\/jats:p>","DOI":"10.1093\/oncolo\/oyad092","type":"journal-article","created":{"date-parts":[[2023,4,22]],"date-time":"2023-04-22T21:07:05Z","timestamp":1682197625000},"page":"e493-e497","source":"Crossref","is-referenced-by-count":2,"title":["Beyond Skin Rash: Alpelisib-Induced Anaphylactic Reactions"],"prefix":"10.1093","volume":"28","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-4096-0917","authenticated-orcid":false,"given":"Tim","family":"Schutte","sequence":"first","affiliation":[{"name":"Amsterdam UMC location Vrije Universiteit Amsterdam, Department of Medical Oncology , de Boelelaan, Amsterdam , The Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Laurien J","family":"Zeverijn","sequence":"additional","affiliation":[{"name":"The Netherlands Cancer Institute, Division of Molecular Oncology and Immunology , CX Amsterdam , The Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Birgit S","family":"Geurts","sequence":"additional","affiliation":[{"name":"The Netherlands Cancer Institute, Division of Molecular Oncology and Immunology , CX Amsterdam , The Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Gijsbrecht F","family":"de Wit","sequence":"additional","affiliation":[{"name":"The Netherlands Cancer Institute, Division of Molecular Oncology and Immunology , CX Amsterdam , The Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Marleen","family":"Kok","sequence":"additional","affiliation":[{"name":"The Netherlands Cancer Institute, Department of Medical Oncology , CX Amsterdam , The Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Frans L","family":"Opdam","sequence":"additional","affiliation":[{"name":"The Netherlands Cancer Institute, Department of Medical Oncology , CX Amsterdam , The Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"286","published-online":{"date-parts":[[2023,4,22]]},"reference":[{"issue":"6","key":"2023070520005939900_CIT0001","doi-asserted-by":"crossref","first-page":"667","DOI":"10.1080\/14656566.2021.1873952","article-title":"Alpelisib for the treatment of PIK3CA-mutated, hormone receptor-positive, HER2-negative metastatic breast cancer","volume":"22","author":"Leenhardt","year":"2021","journal-title":"Expert Opin Pharmacother"},{"issue":"20","key":"2023070520005939900_CIT0002","doi-asserted-by":"crossref","first-page":"1929","DOI":"10.1056\/NEJMoa1813904","article-title":"Alpelisib for PIK3CA-mutated, hormone receptor-positive advanced breast cancer","volume":"380","author":"Andre","year":"2019","journal-title":"N Engl J Med"},{"issue":"1","key":"2023070520005939900_CIT0003","doi-asserted-by":"crossref","first-page":"227","DOI":"10.1007\/s10549-020-05726-y","article-title":"Dermatologic adverse events related to the PI3Kalpha inhibitor alpelisib (BYL719) in patients with breast cancer","volume":"183","author":"Wang","year":"2020","journal-title":"Breast Cancer Res Treat"},{"key":"2023070520005939900_CIT0004","author":"Agency"},{"issue":"10","key":"2023070520005939900_CIT0005","doi-asserted-by":"crossref","first-page":"2975","DOI":"10.1158\/1078-0432.CCR-18-3160","article-title":"A phase II randomized study of neoadjuvant letrozole plus alpelisib for hormone receptor-positive, human epidermal growth factor receptor 2-negative breast cancer (NEO-ORB)","volume":"25","author":"Mayer","year":"2019","journal-title":"Clin Cancer Res"},{"issue":"9","key":"2023070520005939900_CIT0006","doi-asserted-by":"crossref","first-page":"634","DOI":"10.1038\/s41417-020-0164-0","article-title":"PIK3CA gene aberrancy and role in targeted therapy of solid malignancies","volume":"27","author":"Willis","year":"2020","journal-title":"Cancer Gene Ther"},{"issue":"1","key":"2023070520005939900_CIT0007","doi-asserted-by":"crossref","first-page":"45","DOI":"10.1186\/s13058-020-01284-9","article-title":"Frequency and spectrum of PIK3CA somatic mutations in breast cancer","volume":"22","author":"Martinez-Saez","year":"2020","journal-title":"Breast Cancer Res"},{"issue":"7418","key":"2023070520005939900_CIT0008","doi-asserted-by":"crossref","first-page":"61","DOI":"10.1038\/nature11412","article-title":"Comprehensive molecular portraits of human breast tumours","volume":"490","author":"Cancer Genome Atlas","year":"2012","journal-title":"Nature"},{"issue":"6","key":"2023070520005939900_CIT0009","doi-asserted-by":"crossref","first-page":"561","DOI":"10.1016\/j.ccr.2005.05.014","article-title":"Mutant PIK3CA promotes cell growth and invasion of human cancer cells","volume":"7","author":"Samuels","year":"2005","journal-title":"Cancer Cell"},{"issue":"december","key":"2023070520005939900_CIT0010","doi-asserted-by":"crossref","first-page":"36","DOI":"10.1016\/j.semcancer.2019.02.002","article-title":"PIK3CA in cancer: the past 30 years","volume":"59","author":"Arafeh","year":"2019","journal-title":"Semin Cancer Biol"},{"issue":"2","key":"2023070520005939900_CIT0011","doi-asserted-by":"crossref","first-page":"127","DOI":"10.1016\/j.annonc.2020.10.597","article-title":"The complex balance of PI3K inhibition","volume":"32","author":"Vanacker","year":"2021","journal-title":"Ann Oncol"},{"issue":"2","key":"2023070520005939900_CIT0012","doi-asserted-by":"crossref","first-page":"197","DOI":"10.1016\/j.annonc.2020.10.596","article-title":"Phase III randomized study of taselisib or placebo with fulvestrant in estrogen receptor-positive, PIK3CA-mutant, HER2-negative, advanced breast cancer: the SANDPIPER trial","volume":"32","author":"Dent","year":"2021","journal-title":"Ann Oncol"},{"key":"2023070520005939900_CIT0013","doi-asserted-by":"crossref","first-page":"726785","DOI":"10.3389\/fonc.2021.726785","article-title":"Case report: Alpelisib-induced drug reaction with eosinophilia and systemic symptoms: a rare manifestation of a common side effect","volume":"11","author":"Majeed","year":"2021","journal-title":"Front Oncol"},{"issue":"1","key":"2023070520005939900_CIT0014","doi-asserted-by":"crossref","first-page":"1","DOI":"10.1111\/bcp.12297","article-title":"Immediate-type hypersensitivity drug reactions","volume":"78","author":"Stone","year":"2014","journal-title":"Br J Clin Pharmacol"},{"key":"2023070520005939900_CIT0015","first-page":"183","article-title":"Ch. 7. Measuring serum tryptase after suspected anaphylaxis","volume-title":"National Clinical Guideline Centre (UK) Drug Allergy: Diagnosis and Management of Drug Allergy in Adults, Children and Young People","author":"(UK) NIfHaCE.","year":"2014"}],"container-title":["The Oncologist"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/academic.oup.com\/oncolo\/article-pdf\/28\/7\/e493\/50825951\/oyad092.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"syndication"},{"URL":"https:\/\/academic.oup.com\/oncolo\/article-pdf\/28\/7\/e493\/50825951\/oyad092.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,7,5]],"date-time":"2023-07-05T20:01:34Z","timestamp":1688587294000},"score":1,"resource":{"primary":{"URL":"https:\/\/academic.oup.com\/oncolo\/article\/28\/7\/e493\/7136676"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2023,4,22]]},"references-count":15,"journal-issue":{"issue":"7","published-online":{"date-parts":[[2023,4,22]]},"published-print":{"date-parts":[[2023,7,5]]}},"URL":"https:\/\/doi.org\/10.1093\/oncolo\/oyad092","relation":{},"ISSN":["1083-7159","1549-490X"],"issn-type":[{"value":"1083-7159","type":"print"},{"value":"1549-490X","type":"electronic"}],"subject":[],"published-other":{"date-parts":[[2023,7,1]]},"published":{"date-parts":[[2023,4,22]]}}}