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dc.contributorVall d'Hebron Barcelona Hospital Campus
dc.contributor.authorAlbanell, Joan
dc.contributor.authorPérez-García, José Manuel
dc.contributor.authorGil-Gil, Miguel J.
dc.contributor.authorRuiz Borrego, Manuel
dc.contributor.authorComerma Blesa, Laura
dc.contributor.authorBellet Ezquerra, Meritxell
dc.contributor.authorCurigliano, Giuseppe
dc.date.accessioned2023-04-25T05:59:35Z
dc.date.available2023-04-25T05:59:35Z
dc.date.issued2023-01-04
dc.identifier.citationAlbanell J, Pérez-García JM, Gil-Gil M, Curigliano G, Ruíz-Borrego M, Comerma L, et al. Palbociclib Rechallenge for Hormone Receptor-Positive/HER-Negative Advanced Breast Cancer: Findings from the Phase II BioPER Trial. Clin Cancer Res. 2023 Jan 4;29(1):67–80.
dc.identifier.issn1557-3265
dc.identifier.urihttps://hdl.handle.net/11351/9405
dc.descriptionHormone receptor; Advanced breast cancer
dc.description.abstractPurpose: To assess the efficacy and exploratory biomarkers of continuing palbociclib plus endocrine therapy (ET) beyond progression on prior palbociclib-based regimen in patients with hormone receptor–positive/HER2-negative (HR+/HER2−) advanced breast cancer (ABC). Patients and Methods: The multicenter, open-label, phase II BioPER trial included women who had experienced a progressive disease (PD) after having achieved clinical benefit on the immediately prior palbociclib plus ET regimen. Palbociclib (125 mg, 100 mg, or 75 mg daily orally for 3 weeks and 1 week off as per prior palbociclib-based regimen) plus ET of physician's choice were administered in 4-week cycles until PD or unacceptable toxicity. Coprimary endpoints were clinical benefit rate (CBR) and percentage of tumors with baseline loss of retinoblastoma (Rb) protein expression. Additional endpoints included safety and biomarker analysis. Results: Among 33 patients enrolled, CBR was 34.4% [95% confidence interval (CI), 18.6–53.2; P < 0.001] and 13.0% of tumors (95% CI, 5.2–27.5) showed loss of Rb protein expression, meeting both coprimary endpoints. Median progression-free survival was 2.6 months (95% CI, 1.8–6.7). No new safety signals were reported. A signature that included baseline mediators of therapeutic resistance to palbociclib and ET (low Rb score, high cyclin E1 score, ESR1 mutation) was independently associated with shorter median progression-free survival (HR, 22.0; 95% CI, 1.71–282.9; P = 0.018). Conclusions: Maintaining palbociclib after progression on prior palbociclib-based regimen seems to be a reasonable, investigational approach for selected patients. A composite biomarker signature predicts a subset of patients who may not derive a greater benefit from palbociclib rechallenge, warranting further validation in larger randomized controlled trials.
dc.language.isoeng
dc.publisherAmerican Association for Cancer Research
dc.relation.ispartofseriesClinical Cancer Research;29(1)
dc.rightsAttribution-NonCommercial-NoDerivatives 4.0 International
dc.rights.urihttp://creativecommons.org/licenses/by-nc-nd/4.0/
dc.sourceScientia
dc.subjectMama - Càncer - Tractament
dc.subjectMedicaments antineoplàstics - Ús terapèutic
dc.subject.meshBreast Neoplasms
dc.subject.mesh/drug therapy
dc.subject.meshAntineoplastic Combined Chemotherapy Protocols
dc.titlePalbociclib Rechallenge for Hormone Receptor-Positive/HER-Negative Advanced Breast Cancer: Findings from the Phase II BioPER Trial
dc.typeinfo:eu-repo/semantics/article
dc.identifier.doi10.1158/1078-0432.CCR-22-1281
dc.subject.decsneoplasias de la mama
dc.subject.decs/farmacoterapia
dc.subject.decsprotocolos de quimioterapia antineoplásica combinada
dc.relation.publishversionhttps://doi.org/10.1158/1078-0432.CCR-22-1281
dc.type.versioninfo:eu-repo/semantics/publishedVersion
dc.audienceProfessionals
dc.contributor.organismesInstitut Català de la Salut
dc.contributor.authoraffiliation[Albanell J] Medical Oncology Department, Hospital del Mar, Barcelona, Spain. Cancer Research Program, IMIM (Hospital del Mar Medical Research Institute), Barcelona, Spain. Centro de Investigacion Biomédica en Red de Oncología (CIBERONC-ISCIII), Madrid, Spain. Universitat Pompeu Fabra, Barcelona, Spain. GEICAM, Spain. [Pérez-García JM] International Breast Cancer Center (IBCC), Quironsalud Group, Barcelona, Spain. Medica Scientia Innovation Research (MEDSIR), Barcelona, Spain and Ridgewood, New Jersey. [Gil-Gil M] GEICAM, Spain. Catalan Institute of Oncology, Breast Cancer Unit, Medical Oncology Department, IDIBELL, Barcelona, Spain. [Curigliano G] Istituto Europeo di Oncologia, IRCCS, Milano, Italy. University of Milano, Department of Oncology and Hemato-Oncology, Milano, Italy. [Ruíz-Borrego M] GEICAM, Spain. Hospital Universitario Virgen del Rocío, Sevilla, Spain. [Comerma L] Cancer Research Program, IMIM (Hospital del Mar Medical Research Institute), Barcelona, Spain. Pathology Department, Hospital del Mar, Barcelona, Spain. [Bellet M] Vall d’Hebron Hospital Universitari, Barcelona, Spain. Vall d’Hebron Institute of Oncology (VHIO), Barcelona, Spain
dc.identifier.pmid36165912
dc.identifier.wos000908868900001
dc.rights.accessrightsinfo:eu-repo/semantics/openAccess


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