Dermatologic adverse events related to the PI3Kα inhibitor alpelisib (BYL719) in patients with breast cancer

Wang, Diana G.; Barrios, Dulce M.; Blinder, Victoria S.; Bromberg, Jacqueline; Drullinsky, Pamela; Funt, Samuel A.; Jhaveri, Komal; Lake, Diana; Lyons, Tomas; Modi, Shanu; Razavi, Pedram; Sidel, Michelle; Traina, Tiffany A.; Vahdat, Linda T.; Lacouture, Mario E.

doi:10.1007/s10549-020-05726-y

Cited by 25 publications

(45 citation statements)

References 31 publications

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“…It was the second most frequent (20.1%) grade 3 or 4 Adverse Event (AE) leading to discontinuation of alpelisib in 3.2% of patients. A retrospective review of four randomized clinical trials, studying alpelisib in metastatic breast cancer, evaluated 102 patients with alpelisib-related dermatologic AE ( 7 ). In this analysis, only one case of DRESS was reported in the context of alpelisib rechallenge in a patient who previously stopped the drug due to a rash ( 7 ), which is different from our patient who developed the rash on first exposure to alpelisib.…”

Section: Discussionmentioning

confidence: 99%

“…A retrospective review of four randomized clinical trials, studying alpelisib in metastatic breast cancer, evaluated 102 patients with alpelisib-related dermatologic AE ( 7 ). In this analysis, only one case of DRESS was reported in the context of alpelisib rechallenge in a patient who previously stopped the drug due to a rash ( 7 ), which is different from our patient who developed the rash on first exposure to alpelisib. DRESS syndrome usually manifests 2–3 weeks after the introduction of the culprit drug as a maculopapular morbilliform exanthema and fever ( 9 ), similar to our patient in whom the latent period was 12 days.…”

Section: Discussionmentioning

confidence: 99%

“…Rash was the second most common side effect amongst the reported grade 3 or higher adverse events ( 6 ). Alpelisib-induced DRESS is a rare but life-threatening side effect with only one case reported in the literature of a patient who presented with this complication within 24 h of being re-challenged with a reduced dose of alpelisib after she had already cleared the initial rash ( 7 ). Here we present the first case of alpelisib-induced DRESS syndrome as an early and initial manifestation of dermatologic adverse event associated with this targeted agent.…”

Section: Introductionmentioning

confidence: 99%

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Case Report: Alpelisib-Induced Drug Reaction With Eosinophilia and Systemic Symptoms: A Rare Manifestation of a Common Side Effect

et al. 2021

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Alpelisib is a PIK3a inhibitor approved for the treatment of metastatic ER+ breast cancer in combination with fulvestrant. Although rash is a common side effect of this medication, we present the first case of drug reaction with eosinophilia and systemic symptoms (DRESS) upon initial exposure to alpelisib. Here we describe the clinical-pathological findings and management of our patient with alpelisib-induced life-threatening DRESS syndrome. The goal of this case report is to highlight association of alpelisib with DRESS syndrome, in clinical practice, so that alpelisib can be immediately stopped and treatment for this serious condition promptly initiated.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Case Report: Alpelisib-Induced Drug Reaction With Eosinophilia and Systemic Symptoms: A Rare Manifestation of a Common Side Effect

et al. 2021

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“…• In clinical studies, the median time to rash onset was approximately 2 weeks after starting alpelisib treatment. 9,11 • In the retrospective study, median duration of rash was 7 days. 11 -In SOLAR-1, the median time to improvement by at least 1 grade in patients with grade ≥3 rash was 11 days.…”

Section: Characteristics Of Rashmentioning

confidence: 94%

“…-A single-center retrospective study evaluated data from 4 randomized trials and postapproval treatment records involving ABC patients who received alpelisib-based treatments (most frequently combined with endocrine therapy; N=102), with the purpose of characterizing alpelisib-associated cutaneous toxicities and describing management strategies. 11 • Alpelisib prescribing information and other available literature are also included.…”

Section: Methodsmentioning

confidence: 99%

Incidence, Characteristics, and Management of Alpelisib-Associated Rash in Patients With Advanced Breast Cancer

Patel

Seminario‐Vidal

2020

J of Skin

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Incidence of Cutaneous Adverse Events With Phosphoinositide 3-Kinase Inhibitors as Adjuvant Therapy in Patients With Cancer

et al. 2022

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ImportanceThe phosphoinositide 3-kinase (PI3K) pathway is among the most frequently activated pathways in human cancers. As the use of PI3K inhibitors for cancer treatment grows, there is increasing need for understanding the cutaneous effects associated with these therapies.ObjectiveTo systematically review the published literature reporting incidence of cutaneous adverse events with PI3K inhibitors and to provide pooled incidence estimates using meta-analysis.Data SourcesThis systematic review and meta-analysis was conducted using the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) reporting guidelines. The literature search concerned entries through September 2021 in the following sources: PubMed, Cochrane registry, ClinicalTrials.gov, and evidence from the NHS UK and Trip medical database. To analyze PI3K inhibitors’ cutaneous adverse events incidence, only randomized clinical trials (RCTs) were considered. The search strategy used the following keywords: (prevalence OR incidence OR epidemiology) and (phosphoinositide 3 kinase inhibitors OR PI3K inhibitors). No language restriction was applied. Analysis was conducted on July 1, 2022.Study SelectionStudies included phase 2 and phase 3 RCTs that reported incidence of cutaneous adverse events associated with use of PI3K inhibitors.Data Extraction and MeasuresData extracted included sex, medication name and class, sample size, rash incidence, and grade. The bias risk was assessed by the Cochrane tool for risk of bias assessment in RCTs.Main Outcomes and MeasuresThe primary outcome was incidence of PI3K inhibitor cutaneous adverse events (with 95% CIs) among the overall population and among subgroups. Between-study heterogeneity was assessed using the I2 statistic.ResultsThe analysis found the incidence of PI3K inhibitor cutaneous events of any grade to be 29.30% in the intervention group, translating to a pooled odds ratio (OR) for incidence of cutaneous adverse events of any grades of 2.55 (95% CI, 1.74-3.75). Incidence of severe grade (grade ≥3) of rash in the intervention group was estimated to be 6.95%, yielding a pooled Peto OR of 4.64 (95% CI, 2.70-7.97). Subgroup analyses revealed that the incidence of severe cutaneous adverse events (grade ≥3) was higher with the use of Pan-class-1 PI3K inhibitors (OR, 6.67; 95% CI, 4.28-10.38) than isoform-selective PI3K inhibitors (OR, 6.37; 95% CI, 3.25-12.48).Conclusions and RelevanceThis systematic review and meta-analysis identified an overall incidence of PI3K inhibitor cutaneous adverse events of any grade to be 29.30% with a pooled OR of 2.55; (95% CI, 1.74-3.75). These findings clarify the risk of cutaneous adverse events associated with this important class of anticancer therapies.

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Dermatologic adverse events related to the PI3Kα inhibitor alpelisib (BYL719) in patients with breast cancer

Cited by 25 publications

References 31 publications

Case Report: Alpelisib-Induced Drug Reaction With Eosinophilia and Systemic Symptoms: A Rare Manifestation of a Common Side Effect

Case Report: Alpelisib-Induced Drug Reaction With Eosinophilia and Systemic Symptoms: A Rare Manifestation of a Common Side Effect

Incidence, Characteristics, and Management of Alpelisib-Associated Rash in Patients With Advanced Breast Cancer

Incidence of Cutaneous Adverse Events With Phosphoinositide 3-Kinase Inhibitors as Adjuvant Therapy in Patients With Cancer

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