Clinical impact of drug-drug interactions on abemaciclib in the real-world experience of AB-ITALY study

  1. scagnoli, simone ORCID logo
  2. PISEGNA, SIMONA ORCID logo
  3. Toss, Angela
  4. caputo, roberta ORCID logo
  5. DE LAURENTIIS, Michelino ORCID logo
  6. Palleschi, Michela
  7. de Giorgi, Ugo
  8. Cortesi, Enrico
  9. Fabbri, Agnese
  10. Fabi, Alessandra ORCID logo
  11. paris, ida ORCID logo
  12. Orlandi, Armando
  13. Curigliano, Giuseppe ORCID logo
  14. Criscitiello, Carmen
  15. Garrone, Ornella
  16. Tomasello, Gianluca
  17. D’Auria, Giuliana
  18. Vici, Patrizia
  19. RICEVUTO, Enrico ORCID logo
  20. Domati, Federica
  21. Piombino, Claudia ORCID logo
  22. Parola, Sara
  23. Scafetta, Roberta
  24. Cirillo, Alessio
  25. Taurelli Salimbeni, Beatrice
  26. Di Lisa, Francesca Sofia
  27. Strigari, Lidia ORCID logo
  28. Preissner, Robert
  29. Simmaco, Maurizio
  30. Santini, Daniele
  31. Marchetti, Paolo
  32. Botticelli, Andrea

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1000 Titel
  • Clinical impact of drug-drug interactions on abemaciclib in the real-world experience of AB-ITALY study
1000 Autor/in
  1. scagnoli, simone |
  2. PISEGNA, SIMONA |
  3. Toss, Angela |
  4. caputo, roberta |
  5. DE LAURENTIIS, Michelino |
  6. Palleschi, Michela |
  7. de Giorgi, Ugo |
  8. Cortesi, Enrico |
  9. Fabbri, Agnese |
  10. Fabi, Alessandra |
  11. paris, ida |
  12. Orlandi, Armando |
  13. Curigliano, Giuseppe |
  14. Criscitiello, Carmen |
  15. Garrone, Ornella |
  16. Tomasello, Gianluca |
  17. D’Auria, Giuliana |
  18. Vici, Patrizia |
  19. RICEVUTO, Enrico |
  20. Domati, Federica |
  21. Piombino, Claudia |
  22. Parola, Sara |
  23. Scafetta, Roberta |
  24. Cirillo, Alessio |
  25. Taurelli Salimbeni, Beatrice |
  26. Di Lisa, Francesca Sofia |
  27. Strigari, Lidia |
  28. Preissner, Robert |
  29. Simmaco, Maurizio |
  30. Santini, Daniele |
  31. Marchetti, Paolo |
  32. Botticelli, Andrea |
1000 Verlag Nature Publishing Group UK
1000 Erscheinungsjahr 2024
1000 Publikationstyp
  1. Artikel |
1000 Online veröffentlicht
  • 2024-07-17
1000 Erschienen in
1000 Quellenangabe
  • 10(1):58
1000 Copyrightjahr
  • 2024
1000 Lizenz
1000 Verlagsversion
  • https://doi.org/10.1038/s41523-024-00657-z |
  • https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11297323/ |
1000 Publikationsstatus
1000 Begutachtungsstatus
1000 Sprache der Publikation
1000 Abstract/Summary
  • <jats:title>Abstract</jats:title><jats:p>Abemaciclib demonstrated clinical benefit in women affected by HR+/HER2− advanced breast cancer (aBC). Drug-drug interactions (DDIs) can lead to reduced treatment efficacy or increased toxicity. This retro-prospective study aimed to evaluate outcomes, DDIs’ impact, and toxicities of abemaciclib combined with endocrine therapy in a real-world setting. Patients from 12 referral Italian hospitals with HR+/HER2− aBC who received abemaciclib were included. Clinical data about comorbidities, concurrent medications, outcomes, and adverse events (AE) were collected. Drug-PIN® (Personalized Interactions Network) is a tool recognizing the role of multiple interactions between active and/or pro-drug forms combined with biochemical and demographic patient data. The software was used to define the Drug-PIN score and Drug-PIN tier (green, yellow, dark yellow, and red) for each patient. Univariate and multivariate analyses were performed to identify predictors of patients’ PFS or toxicity. One hundred seventy-three patients were included. 13% of patients had &gt;75years. The overall response rate (ORR) was 63%. The general population’s median PFS (mPFS) was 22 months (mo), while mOS were not reached. Patients treated with abemaciclib in combination with AI and fulvestrant had a mPFS of 36 and 19 mo, respectively. The most common toxicities were diarrhea, asthenia, and neutropenia detected in 63%,49%, and 49% of patients. The number of concomitant medications and comorbidities were not associated with survival outcomes (22 vs 17 mo, <jats:italic>p</jats:italic> = 0.068, <jats:italic>p</jats:italic> = 0.99). Drug-PIN tier from dark yellow to red and Drug-PIN score &gt;12 were associated with shorter PFS compared to no/low-risk DDIs and score &lt;12 (15 vs 23, <jats:italic>p</jats:italic> = 0.005, <jats:italic>p</jats:italic> = 0.0017). Drug interaction was confirmed as an independent biomarker in a multivariate model (<jats:italic>p</jats:italic> = 0.02). No difference in any grade AE, severe toxicities, and diarrhea were detected among different age subgroups. No association was found between Drug-PIN score or Drug-PIN tier and overall toxicity (<jats:italic>p</jats:italic> = 0.44), severe AEs (<jats:italic>p</jats:italic> = 0.11), or drug reduction (<jats:italic>p</jats:italic> = 0.27). The efficacy and safety of abemaciclib plus ET were confirmed in a real-world setting, even in the elderly population and patients with comorbidities. Evaluation of DDIs with Drug-PIN appears to be an independent predictor of PFS.</jats:p>
1000 Sacherschließung
lokal /692/4028/67/1857
lokal Article
lokal /692/700/155
lokal /692/4028/67/1059/602
lokal /692/4028/67/1347
lokal article
1000 Fächerklassifikation (DDC)
1000 Liste der Beteiligten
  1. https://orcid.org/0000-0003-4943-5622|https://orcid.org/0000-0002-6910-9528|https://frl.publisso.de/adhoc/uri/VG9zcywgQW5nZWxh|https://orcid.org/0000-0003-4231-1184|https://orcid.org/0000-0001-9009-1572|https://frl.publisso.de/adhoc/uri/UGFsbGVzY2hpLCBNaWNoZWxh|https://frl.publisso.de/adhoc/uri/ZGUgR2lvcmdpLCBVZ28=|https://frl.publisso.de/adhoc/uri/Q29ydGVzaSwgRW5yaWNv|https://frl.publisso.de/adhoc/uri/RmFiYnJpLCBBZ25lc2U=|https://orcid.org/0000-0002-0758-8033|https://orcid.org/0000-0002-7445-3366|https://frl.publisso.de/adhoc/uri/T3JsYW5kaSwgQXJtYW5kbw==|https://orcid.org/0000-0003-1781-2518|https://frl.publisso.de/adhoc/uri/Q3Jpc2NpdGllbGxvLCBDYXJtZW4=|https://frl.publisso.de/adhoc/uri/R2Fycm9uZSwgT3JuZWxsYQ==|https://frl.publisso.de/adhoc/uri/VG9tYXNlbGxvLCBHaWFubHVjYQ==|https://frl.publisso.de/adhoc/uri/ROKAmUF1cmlhLCBHaXVsaWFuYQ==|https://frl.publisso.de/adhoc/uri/VmljaSwgUGF0cml6aWE=|https://orcid.org/0000-0001-5641-3187|https://frl.publisso.de/adhoc/uri/RG9tYXRpLCBGZWRlcmljYQ==|https://orcid.org/0000-0002-7224-4536|https://frl.publisso.de/adhoc/uri/UGFyb2xhLCBTYXJh|https://frl.publisso.de/adhoc/uri/U2NhZmV0dGEsIFJvYmVydGE=|https://frl.publisso.de/adhoc/uri/Q2lyaWxsbywgQWxlc3Npbw==|https://frl.publisso.de/adhoc/uri/VGF1cmVsbGkgU2FsaW1iZW5pLCBCZWF0cmljZQ==|https://frl.publisso.de/adhoc/uri/RGkgTGlzYSwgRnJhbmNlc2NhIFNvZmlh|https://orcid.org/0000-0003-4293-2298|https://frl.publisso.de/adhoc/uri/UHJlaXNzbmVyLCBSb2JlcnQ=|https://frl.publisso.de/adhoc/uri/U2ltbWFjbywgTWF1cml6aW8=|https://frl.publisso.de/adhoc/uri/U2FudGluaSwgRGFuaWVsZQ==|https://frl.publisso.de/adhoc/uri/TWFyY2hldHRpLCBQYW9sbw==|https://frl.publisso.de/adhoc/uri/Qm90dGljZWxsaSwgQW5kcmVh
1000 Hinweis
  • DeepGreen-ID: 0320e91c208d4acc8b6460dec5797622 ; metadata provieded by: DeepGreen (https://www.oa-deepgreen.de/api/v1/), LIVIVO search scope life sciences (http://z3950.zbmed.de:6210/livivo), Crossref Unified Resource API (https://api.crossref.org/swagger-ui/index.html), to.science.api (https://frl.publisso.de/), ZDB JSON-API (beta) (https://zeitschriftendatenbank.de/api/), lobid - Dateninfrastruktur für Bibliotheken (https://lobid.org/resources/search)
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1000 Erstellt am 2025-02-06T07:43:47.820+0100
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