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dc.contributor.authorHarbeck, N
dc.contributor.authorIyer, S
dc.contributor.authorTurner, N
dc.contributor.authorCristofanilli, M
dc.contributor.authorRo, J
dc.contributor.authorAndré, F
dc.contributor.authorLoi, S
dc.contributor.authorVerma, S
dc.contributor.authorIwata, H
dc.contributor.authorBhattacharyya, H
dc.contributor.authorPuyana Theall, K
dc.contributor.authorBartlett, CH
dc.contributor.authorLoibl, S
dc.date.accessioned2021-06-11T11:37:41Z
dc.date.available2021-06-11T11:37:41Z
dc.identifier.citationAnnals of oncology : official journal of the European Society for Medical Oncology, 2016, 27 (6), pp. 1047 - 1054
dc.identifier.issn0923-7534
dc.identifier.urihttps://repository.icr.ac.uk/handle/internal/4616
dc.identifier.eissn1569-8041
dc.identifier.eissn1569-8041en_US
dc.identifier.doi10.1093/annonc/mdw139
dc.identifier.doi10.1093/annonc/mdw139en_US
dc.description.abstractBackground In the PALOMA-3 study, palbociclib plus fulvestrant demonstrated improved progression-free survival compared with fulvestrant plus placebo in hormone receptor-positive, HER2- endocrine-resistant metastatic breast cancer (MBC). This analysis compared patient-reported outcomes (PROs) between the two treatment groups.Patients and methods Patients were randomized 2 : 1 to receive palbociclib 125 mg/day orally for 3 weeks followed by 1 week off (n = 347) plus fulvestrant (500 mg i.m. per standard of care) or placebo plus fulvestrant (n = 174). PROs were assessed on day 1 of cycles 1-4 and of every other subsequent cycle starting with cycle 6 using the EORTC QLQ-C30 and its breast cancer module, QLQ-BR23. High scores (range 0-100) could indicate better functioning/quality of life (QoL) or worse symptom severity. Repeated-measures mixed-effect analyses were carried out to compare on-treatment overall scores and changes from baseline between treatment groups while controlling for baseline. Between-group comparisons of time to deterioration in global QoL and pain were made using an unstratified log-rank test and Cox proportional hazards model.Results Questionnaire completion rates were high at baseline and during treatment (from baseline to cycle 14, ≥95.8% in each group completed ≥1 question on the EORTC QLQ-C30). On treatment, estimated overall global QoL scores significantly favored the palbociclib plus fulvestrant group [66.1, 95% confidence interval (CI) 64.5-67.7 versus 63.0, 95% CI 60.6-65.3; P = 0.0313]. Significantly greater improvement from baseline in pain was also observed in this group (-3.3, 95% CI -5.1 to -1.5 versus 2.0, 95% CI -0.6 to 4.6; P = 0.0011). No significant differences were observed for other QLQ-BR23 functioning domains, breast or arm symptoms. Treatment with palbociclib plus fulvestrant significantly delayed deterioration in global QoL (P < 0.025) and pain (P < 0.001) compared with fulvestrant alone.Conclusion Palbociclib plus fulvestrant allowed patients to maintain good QoL in the endocrine resistance setting while experiencing substantially delayed disease progression.Clinical trial registration NCT01942135.
dc.formatPrint-Electronic
dc.format.extent1047 - 1054
dc.languageeng
dc.language.isoeng
dc.rights.urihttps://creativecommons.org/licenses/by-nc/4.0
dc.subjectHumans
dc.subjectBreast Neoplasms
dc.subjectPiperazines
dc.subjectPyridines
dc.subjectEstradiol
dc.subjectReceptor, erbB-2
dc.subjectReceptors, Estrogen
dc.subjectAntineoplastic Combined Chemotherapy Protocols
dc.subjectDisease-Free Survival
dc.subjectQuality of Life
dc.subjectAdult
dc.subjectAged
dc.subjectMiddle Aged
dc.subjectFemale
dc.subjectDrug-Related Side Effects and Adverse Reactions
dc.subjectPatient Reported Outcome Measures
dc.subjectFulvestrant
dc.titleQuality of life with palbociclib plus fulvestrant in previously treated hormone receptor-positive, HER2-negative metastatic breast cancer: patient-reported outcomes from the PALOMA-3 trial.
dc.typeJournal Article
dcterms.dateAccepted2016-03-17
rioxxterms.versionVoR
rioxxterms.versionofrecord10.1093/annonc/mdw139
rioxxterms.licenseref.urihttps://creativecommons.org/licenses/by-nc/4.0
dc.relation.isPartOfAnnals of oncology : official journal of the European Society for Medical Oncology
pubs.issue6
pubs.notesNot known
pubs.organisational-group/ICR
pubs.organisational-group/ICR/Primary Group
pubs.organisational-group/ICR/Primary Group/ICR Divisions
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Breast Cancer Research
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Breast Cancer Research/Molecular Oncology
pubs.organisational-group/ICR
pubs.organisational-group/ICR/Primary Group
pubs.organisational-group/ICR/Primary Group/ICR Divisions
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Breast Cancer Research
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Breast Cancer Research/Molecular Oncology
pubs.publication-statusPublished
pubs.volume27en_US
pubs.embargo.termsNot known
icr.researchteamMolecular Oncology
icr.researchteamMolecular Oncologyen_US
dc.contributor.icrauthorTurner, Nicholasen


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