Implementing geriatric assessment for dose optimization of CDK4/6 inhibitors in older breast cancer patients

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Publicated to:Future Oncology. 20 (37): 2937-2948 - 2024-10-21 20(37), DOI: 10.1080/14796694.2024.2413841

Authors: Valachis, A; Othman, M; Biganzoli, L; Risi, E; Christopoulou, A; Fjermeros, K; Fountzila, E; Geisler, J; Gomez-Bravo, R; Rodriguez, AB; Munoz-Mateu, M; Karihtala, P; Utriainen, M; Kosmidis, P; Koutras, A; Linardou, H; Spathas, N; Lindman, H; Schiza, A; Martínez-Ballestero, I; Meattini, I; Visani, L; Psyrri, A; Ballesteros, S; Aviles, JMR; Basdekis, I; Mastoraki, K; Hay, SD; Jenset, M; Fotis, T; Nanou, C; Fricker, S; Santaholma, M; Graaf, GD; Kanters, T; Lampropoulos, K; Markou, C; Kosmidis, T

Affiliations

Akershus Univ Hosp, Dept Oncol, Lorenskog, Norway - Author

Azienda Osped Univ Careggi, Radiat Oncol Unit, Breast Unit, Florence, Italy - Author

CareAcross Ltd, London, England - Author

Circular Econ Fdn, Brussels, Belgium - Author

Erasmus Univ, Inst Med Technol Assessment, Rotterdam, Netherlands - Author

Eunomia Ltd, Dublin, Ireland - Author

European Univ Cyprus, Nicosia, Cyprus - Author

European Univ Cyprus, Sch Law, Nicosia, Cyprus - Author

Fundacio Clin Recerca Biomed, Barcelona, Spain - Author

Helsinki Univ Hosp, Comprehens Canc Ctr, Dept Oncol, Helsinki, Finland - Author

Hosp Prato, Azienda USL Toscana Ctr, Dept Oncol, Florence, Italy - Author

Hygeia Hosp, Med Oncol Dept 2, Athens 11521, Greece - Author

IDIBAPS, Hosp Clin & Translat Genom & Targeted Therapies So, Med Oncol Dept, Barcelona 08036, Spain - Author

Metropolitan Hosp, Comprehens Clin Trials Ctr, Athens, Greece - Author

Metropolitan Hosp, Oncol Dept 4, Athens, Greece - Author

Natl & Kapodistrian Univ Athens, Attikon Univ Hosp, Fac Med, Dept Internal Med,Sect Med Oncol, Athens, Greece - Author

Orebro Univ, Fac Med & Hlth, Dept Oncol, Orebro, Sweden - Author

Secur Labs Consulting Ltd, Dublin, Ireland - Author

St Andrews Gen Hosp Patras, Dept Med Oncol, Patras, Greece - Author

St Lukes Clin, Dept Med Oncol, Thessaloniki, Greece - Author

Swedish Breast Canc Assoc, Stockholm, Sweden - Author

Univ Appl Sci Northwestern Switzerland, Inst Interact Technol, Windisch, Switzerland - Author

Univ Florence, Dept Expt & Clin Biomed Sci M Serio, Florence, Italy - Author

Univ Helsinki, Helsinki, Finland - Author

Univ Hosp Patras, Dept Med, Div Oncol, Patras, Greece - Author

Univ Nacl Educ Distancia, Studies Aging & Neurodegenerat Dis Res Grp, Madrid, Spain - Author

Univ Oslo, Inst Clin Med, Fac Med, Oslo, Norway - Author

Univ Patras, Dept Elect & Comp Engn, Patras, Greece - Author

Uppsala Univ Hosp, Dept Oncol, Uppsala, Sweden - Author

Uppsala Univ, Dept Immunol Genet & Pathol, Uppsala, Sweden - Author

Abstract

Current evidence from both randomized trials and real-world studies suggests that older patients with advanced hormone receptor-positive/HER2-negative (HR+/HER2) breast cancer derive clinical benefit from the addition of CDK4/6 inhibitors to endocrine therapy. However, a higher risk for adverse events due to CDK4/6 inhibitors among older patients is evident, leading to a trend of initiating CDK4/6 inhibitors at lower dose in clinical practice, though without evidence. The aim of the IMPORTANT-trial, a pragmatic, multinational, open-label, partly decentralized randomized trial is to investigate whether lower starting dose of CDK4/6 inhibitors combined with endocrine therapy is comparable to full dose in older (>= 70 years old) patients with advanced HR+/HER2- breast cancer who are assessed as vulnerable or frail based on comprehensive geriatric assessment.

Keywords

AbemaciclibAbsolute neutrophil countAdjuvant therapyAdvanced breast cancerAgedAged, 80 and overAlanine aminotransferaseAntineoplastic agentAntineoplastic combined chemotherapy protocolsAromatase inhibitorArticleAspartate aminotransferaseBilirubinBreast cancerBreast neoplasmsBreast tumorCancer chemotherapyCancer growthCancer patientCdk4 protein, humanCdk4/6 inhibitorsCdk6 protein, humanClinical evaluationClinical outcomeClinical-trialsComprehensive geriatric assessmentCyclin dependent kinase 4Cyclin dependent kinase 6Cyclin-dependent kinase 4Cyclin-dependent kinase 6Drug dose reductionDrug therapyDrug tolerabilityDrug withdrawalElectrocardiogramEpidermal growth factor receptor 2European organization for research and treatment of cancer quality of life questionnaire core 30European quality of life 5 dimensions 5 level questionnaireFemaleFollow upFulvestrantGeriatric assessmentHistologyHormonal therapyHumanHuman epidermal growth factor receptor 2 negative breast cancerHuman epidermal growth factor receptor 2 positive breast cancerHuman tissueHumansInternational societyLogistic regression analysisLower doseMaleManagemenMetabolismMulticenter studyNutritionOutcome assessmentPalbociclibPathologyPatient-reported outcomePlatelet countProgression free survivalProtein kinase inhibitorProtein kinase inhibitorsPsychological aspectQt intervalQuality of lifeQuestionnaireRandomizationRandomizeRandomizedRandomized controlled trialReceptor, erbb-2RibociclibSample sizeSensitivity analysisSocial interactionSocial supportToxicityTumor markerValidityVery elderly

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The work has been published in the journal Future Oncology due to its progression and the good impact it has achieved in recent years, according to the agency Scopus (SJR), it has become a reference in its field. In the year of publication of the work, 2024 there are still no calculated indicators, but in 2023, it was in position , thus managing to position itself as a Q1 (Primer Cuartil), in the category Medicine (Miscellaneous).

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Según las diferentes agencias de indexación, el número de citas acumuladas por esta publicación hasta la fecha 2025-06-11:

Scopus: 2

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This work has been carried out with international collaboration, specifically with researchers from: Belgium; Cyprus; Finland; Greece; Italy; Netherlands; Norway; Sweden; Switzerland; United Kingdom.

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