{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,13]],"date-time":"2026-10-13T22:43:15Z","timestamp":1791931395884,"version":"4.3.4"},"reference-count":25,"publisher":"SAGE Publications","license":[{"start":{"date-parts":[[2023,1,1]],"date-time":"2023-01-01T00:00:00Z","timestamp":1672531200000},"content-version":"unspecified","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/100004319","name":"Pfizer","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100004319","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100004325","name":"AstraZeneca","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100004325","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Ther Adv Med Oncol"],"published-print":{"date-parts":[[2023,1]]},"abstract":"<jats:sec>\n                    <jats:title>Background:<\/jats:title>\n                    <jats:p>In the FLIPPER trial, palbociclib\/fulvestrant significantly improved progression-free survival (PFS) compared with placebo\/fulvestrant in postmenopausal women with HR+\/HER2\u2212 advanced breast cancer (ABC).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Objective:<\/jats:title>\n                    <jats:p>We assessed health-related quality of life (QoL) using patient-reported outcomes (PROs).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Design and methods:<\/jats:title>\n                    <jats:p>In this phase II double-blinded study, PROs were assessed at baseline after every three cycles and at the end of the treatment using the European Organisation for Research and Treatment of Cancer QLQ-C30 and QLQ-BR23. Time to deterioration (TTD) in global health status (GHS)\/QoL was defined as a decrease of \u2a7e10\u2009points. Changes from baseline (CFB) and TTD were analysed using linear mixed-effect and Cox regression models, respectively.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results:<\/jats:title>\n                    <jats:p>Of the 189 randomised (1:1) patients, 178 (94%) completed \u2a7e1 post-baseline assessment; 50% received \u2a7e22 cycles of study treatment, with a questionnaire compliance &gt;90%. Mean baseline scores were comparable between arms. GHS\/QoL scores were maintained throughout the palbociclib\/fulvestrant treatment. CFB showed significant differences for GHS\/QoL, appetite loss, constipation and systemic therapy side effect scores favouring placebo\/fulvestrant. TTD in GHS\/QoL was delayed in placebo\/fulvestrant versus palbociclib\/fulvestrant [30.3 versus 11.1\u2009months; adjusted hazard ratio (aHR): 1.57, 95% CI: 1.03\u20132.39, p\u2009=\u20090.036]; this difference was not significant in patients with progressive disease (aHR: 1.2, 95% CI: 0.6\u20132.2, p\u2009=\u20090.658). No statistically significant differences in TTD were found for the other QLQ-C30 and QLQ-BR23 scales.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions:<\/jats:title>\n                    <jats:p>Although TTD in GHS\/QoL was prolonged with placebo\/fulvestrant, no differences were observed on other functional or symptom scales. This finding and the improvement in PFS support the combination of palbociclib\/fulvestrant as a beneficial therapeutic option for HR+\/HER2\u2212 ABC.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration number:<\/jats:title>\n                    <jats:p>Sponsor Study Code: GEICAM\/2014-12 EudraCT Number: 2015-002437-21 ClinTrials.gov reference: NCT02690480<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/17588359221148921","type":"journal-article","created":{"date-parts":[[2023,1,20]],"date-time":"2023-01-20T01:58:00Z","timestamp":1674179880000},"update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":12,"title":["Quality of life with palbociclib plus fulvestrant\n                    <i>versus<\/i>\n                    placebo plus fulvestrant in postmenopausal women with endocrine-sensitive hormone receptor-positive and HER2-negative advanced breast cancer: patient-reported outcomes from the FLIPPER trial"],"prefix":"10.1177","volume":"15","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-0229-6987","authenticated-orcid":false,"given":"Ariadna","family":"Tibau","sequence":"first","affiliation":[{"name":"Hospital de la Santa Creu i Sant Pau, Institut d\u2019Investigaci\u00f3 Biom\u00e8dica Sant Pau, and Departament de Medicina de la Universitat Aut\u00f2noma de Barcelona, C\/ Sant Quint\u00ed, 89, Barcelona 08041, Spain"},{"name":"GEICAM Spanish Breast Cancer Group, Madrid, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"M. Teresa","family":"Mart\u00ednez","sequence":"additional","affiliation":[{"name":"GEICAM Spanish Breast Cancer Group, Madrid, Spain"},{"name":"Hospital Cl\u00ednico Universitario de Valencia, Instituto de Investigaci\u00f3n Sanitaria-INCLIVA, Valencia, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Manuel","family":"Ramos","sequence":"additional","affiliation":[{"name":"GEICAM Spanish Breast Cancer Group, Madrid, Spain"},{"name":"Centro Oncol\u00f3gico de Galicia, Coru\u00f1a, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Luis","family":"De La Cruz-Merino","sequence":"additional","affiliation":[{"name":"GEICAM Spanish Breast Cancer Group, Madrid, Spain"},{"name":"Hospital Universitario Virgen de la Macarena, Medicine Department-Universidad de Sevilla, Sevilla, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ana","family":"Santaballa","sequence":"additional","affiliation":[{"name":"GEICAM Spanish Breast Cancer Group, Madrid, Spain"},{"name":"Hospital Universitario y Polit\u00e9cnico La Fe, Valencia, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Miriam","family":"O\u2019Connor","sequence":"additional","affiliation":[{"name":"University Hospital Waterford, Waterford, Ireland"},{"name":"Cancer Trials Ireland, Dublin, Ireland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Noelia","family":"Mart\u00ednez-Ja\u00f1ez","sequence":"additional","affiliation":[{"name":"GEICAM Spanish Breast Cancer Group, Madrid, Spain"},{"name":"Hospital Universitario Ram\u00f3n y Cajal, Madrid, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fernando","family":"Moreno","sequence":"additional","affiliation":[{"name":"GEICAM Spanish Breast Cancer Group, Madrid, Spain"},{"name":"Hospital Cl\u00ednico Universitario San Carlos, Madrid, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Isaura","family":"Fern\u00e1ndez","sequence":"additional","affiliation":[{"name":"GEICAM Spanish Breast Cancer Group, Madrid, Spain"},{"name":"Hospital \u00c1lvaro Cunqueiro, Vigo, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Juan Antonio","family":"Virizuela","sequence":"additional","affiliation":[{"name":"GEICAM Spanish Breast Cancer Group, Madrid, Spain"},{"name":"Hospital Quir\u00f3nSalud Sagrado Coraz\u00f3n, Sevilla, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jes\u00fas","family":"Alarc\u00f3n","sequence":"additional","affiliation":[{"name":"GEICAM Spanish Breast Cancer Group, Madrid, Spain"},{"name":"Hospital Universitari Son Espases, Palma de Mallorca, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Juan","family":"de La Haba-Rodr\u00edguez","sequence":"additional","affiliation":[{"name":"GEICAM Spanish Breast Cancer Group, Madrid, Spain"},{"name":"Instituto Maimonides de Investigacion Biomedica, Hospital Reina Sofia Hospital, Universidad de C\u00f3rdoba, Spain"},{"name":"Centro de Investigaci\u00f3n Biom\u00e9dica en Red de Oncolog\u00eda, CIBERONC-ISCIII, Madrid, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pedro","family":"S\u00e1nchez-Rovira","sequence":"additional","affiliation":[{"name":"GEICAM Spanish Breast Cancer Group, Madrid, Spain"},{"name":"Hospital Universitario de Ja\u00e9n, Ja\u00e9n, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Cinta Rosa","family":"Albacar","sequence":"additional","affiliation":[{"name":"GEICAM Spanish Breast Cancer Group, Madrid, Spain"},{"name":"Hospital Universitario Sant Joan de Reus, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Coralia","family":"Bueno Mui\u00f1o","sequence":"additional","affiliation":[{"name":"GEICAM Spanish Breast Cancer Group, Madrid, Spain"},{"name":"Hospital Infanta Cristina 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