Evidence map›Paper›PMID 39019916›Full record

ArticleNPJ breast cancer2024

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

Simone Scagnoli, Simona Pisegna, Angela Toss, Roberta Caputo, Michelino De Laurentiis, Michela Palleschi, Ugo de Giorgi, Enrico Cortesi, Agnese Fabbri, Alessandra Fabi and 22 more

Erratum issuedAbstract read
In one paragraph

Article in NPJ breast cancer, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 10 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Article
  3. Article
  4. Clinical experience and satisfaction in patients with advanced breast cancer participating in the abemaciclib patient support program in Spain: a prospective observational study.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2026
    Observational
  5. Article
  6. Review
  7. Article
  8. Review
  9. Article
  10. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

32 authors.

Simone ScagnoliDepartment of Radiological, Oncological and Pathological Science, "Sapienza" University of Rome, Rome, Italy.ORCID http://orcid.org/0000-0003-4943-5622
Simona PisegnaDepartment of Experimental Medicine, Sapienza University, Rome, Italy. simona.pisegna@uniroma1.it.ORCID http://orcid.org/0000-0002-6910-9528
Angela TossDepartment of Oncology and Hematology, Azienda Ospedaliero-Universitaria di Modena, Modena, Italy.
Roberta CaputoDepartment of Breast and Thoracic Oncology, Division of Breast Medical Oncology, Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) Pascale, Naples, Italy.ORCID http://orcid.org/0000-0003-4231-1184
Michelino De LaurentiisDepartment of Breast and Thoracic Oncology, Division of Breast Medical Oncology, Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) Pascale, Naples, Italy.ORCID http://orcid.org/0000-0001-9009-1572
Michela PalleschiIRCCS Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" IRST Meldola IT, Meldola, Italy.
Ugo de GiorgiIRCCS Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" IRST Meldola IT, Meldola, Italy.
Enrico CortesiDepartment of Radiological, Oncological and Pathological Science, "Sapienza" University of Rome, Rome, Italy.
Agnese FabbriUOC Belcolle Hospital, Viterbo, Italy.
Alessandra FabiPrecision Medicine in Senology, Department of Women Child and Public Health, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.ORCID http://orcid.org/0000-0002-0758-8033
Ida ParisDivision of Gynecologic Oncology, Department of Woman and Child Health and Public Health, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome, Italy.ORCID http://orcid.org/0000-0002-7445-3366
Armando OrlandiFondazione Policlinico Universitario Agostino Gemelli IRCCS Comprehensive Cancer Center, Unit of Medical Oncology, Rome, Italy.
Giuseppe CuriglianoDivision of New Drugs and Early Drug Development for Innovative Therapies, European Institute of Oncology, IRCCS, Milan, Italy.ORCID http://orcid.org/0000-0003-1781-2518
Carmen CriscitielloDivision of New Drugs and Early Drug Development for Innovative Therapies, European Institute of Oncology, IRCCS, Milan, Italy.
Ornella GarroneFondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, SC Oncologia Medica, Milan, Italy.
Gianluca TomaselloFondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, SC Oncologia Medica, Milan, Italy.
Giuliana D'AuriaSandro Pertini Hospital Unit of Medical Oncology, Rome, Italy.
Patrizia ViciIstituto di Ricovero e Cura a Carattere Scientifico (IRCCS) Istituto Nazionale Tumori Regina Elena, UOSD Sperimentazioni di fase IV IT, Rome, Italy.
Enrico RicevutoUniversity of L'Aquila, L'Aquila, Italy.ORCID http://orcid.org/0000-0001-5641-3187
Federica DomatiDepartment of Medical and Surgical Sciences, University of Modena and Reggio Emilia, Modena, Italy.
Claudia PiombinoDepartment of Oncology and Hematology, Azienda Ospedaliero-Universitaria di Modena, Modena, Italy.ORCID http://orcid.org/0000-0002-7224-4536
Sara ParolaDepartment of Breast and Thoracic Oncology, Division of Breast Medical Oncology, Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) Pascale, Naples, Italy.
Roberta ScafettaUniversità Campus Biomedico, Rome, Italy.
Alessio CirilloDepartment of Radiological, Oncological and Pathological Science, "Sapienza" University of Rome, Rome, Italy.
Beatrice Taurelli SalimbeniDivision of New Drugs and Early Drug Development for Innovative Therapies, European Institute of Oncology, IRCCS, Milan, Italy.
Francesca Sofia Di LisaIstituto di Ricovero e Cura a Carattere Scientifico (IRCCS) Istituto Nazionale Tumori Regina Elena, UOSD Sperimentazioni di fase IV IT, Rome, Italy.
Lidia StrigariIRCSS AOU Bologna, Bologna, Italy.ORCID http://orcid.org/0000-0003-4293-2298
Robert PreissnerInstitute of Physiology and Science-IT, Charité-Universitätsmedizin Berlin, Berlin, Germany.
Maurizio SimmacoLaboratory of Clinical Biochemistry, Sant'Andrea University Hospital, Rome, Italy.
Daniele SantiniDepartment of Medico-Surgical Sciences and Biotechnologies, Sapienza University of Rome, Rome, Italy.
Paolo MarchettiIstituto Dermopatico dell'Immacolata IRCCS, Rome, Italy.
Andrea BotticelliDepartment of Radiological, Oncological and Pathological Science, "Sapienza" University of Rome, Rome, Italy.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

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 >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, p = 0.068, p = 0.99). Drug-PIN tier from dark yellow to red and Drug-PIN score >12 were associated with shorter PFS compared to no/low-risk DDIs and score <12 (15 vs 23, p = 0.005, p = 0.0017). Drug interaction was confirmed as an independent biomarker in a multivariate model (p = 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 (p = 0.44), severe AEs (p = 0.11), or drug reduction (p = 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.

Identifiers

PMID39019916
PMCPMC11254918

What Socratic holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.