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


Authors: Wang, D. G.; Barrios, D. M.; Blinder, V. S.; Bromberg, J. F.; Drullinsky, P. R.; Funt, S. A.; Jhaveri, K. L.; Lake, D. E.; Lyons, T.; Modi, S.; Razavi, P.; Sidel, M.; Traina, T. A.; Vahdat, L. T.; Lacouture, M. E.
Article Title: Dermatologic adverse events related to the PI3Kα inhibitor alpelisib (BYL719) in patients with breast cancer
Abstract: Purpose: Rash develops in approximately 50% of patients receiving alpelisib for breast cancer, often requiring dose modifications. Here, we describe the clinicopathologic, laboratory, and management characteristics of alpelisib-related dermatologic adverse events (dAEs). Methods: A single center-retrospective analysis was conducted. Data were abstracted from electronic medical records. Results: A total of 102 patients (mean age 56 years, range 27–83) receiving alpelisib most frequently in combination with endocrine therapy (79, 77.5%) were included. We identified 41 (40.2%) patients with all-grade rash distributed primarily along the trunk (78%) and extremities (70%) that developed approximately within two weeks of treatment initiation (mean 12.8 ± 1.5 days) and lasted one-week (mean duration 7.1 ± 0.8 days). Of 29 patients with documented morphology of alpelisib-related dAEs, 26 (89.7%) had maculopapular rash. Histology showed perivascular and interface lymphocytic dermatitis. All-grade rash correlated with an increase in serum eosinophils from 2.7 to 4.4%, p < 0.05, and prophylaxis with non-sedating antihistamines (n = 43) was correlated with a reduction of grade 1/2 rash (OR 0.39, p = 0.09). Sixteen (84.2%) of 19 patients with grade 3 dAEs resulted in interruption of alpelisib, which were managed with antihistamines, topical and systemic corticosteroids. We did not observe rash recurrence in 12 (75%) patients who were re-challenged. Conclusions: A maculopapular rash associated with increased blood eosinophils occurs frequently with alpelisib. While grade 3 rash leads to alpelisib therapy interruption, dermatologic improvement is evident with systemic corticosteroids; and most patients can continue oncologic treatment at a maintained or reduced dose upon re-challenge with alpelisib. © 2020, Springer Science+Business Media, LLC, part of Springer Nature.
Keywords: rash; pi3k; adverse event; pik3ca; alpelisib; byl719
Journal Title: Breast Cancer Research and Treatment
Volume: 183
Issue: 1
ISSN: 0167-6806
Publisher: Springer  
Date Published: 2020-08-01
Start Page: 227
End Page: 237
Language: English
DOI: 10.1007/s10549-020-05726-y
PUBMED: 32613539
PROVIDER: scopus
PMCID: PMC7398571
DOI/URL:
Notes: Article -- Export Date: 3 August 2020 -- Source: Scopus
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MSK Authors
  1. Mario E Lacouture
    457 Lacouture
  2. Jacqueline Bromberg
    141 Bromberg
  3. Diana E Lake
    89 Lake
  4. Victoria Susana Blinder
    110 Blinder
  5. Tiffany A Traina
    249 Traina
  6. Shanu Modi
    264 Modi
  7. Komal Lachhman Jhaveri
    199 Jhaveri
  8. Linda T Vahdat
    43 Vahdat
  9. Pedram Razavi
    170 Razavi
  10. Samuel Aaron Funt
    133 Funt
  11. Dulce M Barrios
    13 Barrios
  12. Diana G Wang
    9 Wang
  13. Tomas Gerard Lyons
    10 Lyons