dc.contributor.author | Cristofanilli, M | |
dc.contributor.author | Rugo, HS | |
dc.contributor.author | Im, S-A | |
dc.contributor.author | Slamon, DJ | |
dc.contributor.author | Harbeck, N | |
dc.contributor.author | Bondarenko, I | |
dc.contributor.author | Masuda, N | |
dc.contributor.author | Colleoni, M | |
dc.contributor.author | DeMichele, A | |
dc.contributor.author | Loi, S | |
dc.contributor.author | Iwata, H | |
dc.contributor.author | O'Leary, B | |
dc.contributor.author | André, F | |
dc.contributor.author | Loibl, S | |
dc.contributor.author | Bananis, E | |
dc.contributor.author | Liu, Y | |
dc.contributor.author | Huang, X | |
dc.contributor.author | Kim, S | |
dc.contributor.author | Lechuga Frean, MJ | |
dc.contributor.author | Turner, NC | |
dc.date.accessioned | 2022-06-08T09:36:39Z | |
dc.date.available | 2022-06-08T09:36:39Z | |
dc.date.issued | 2022-08-15 | |
dc.identifier.citation | Clinical cancer research : an official journal of the American Association for Cancer Research, 2022, pp. clincanres.0305.2022 - ? | |
dc.identifier.issn | 1078-0432 | |
dc.identifier.uri | https://repository.icr.ac.uk/handle/internal/5173 | |
dc.identifier.eissn | 1557-3265 | |
dc.identifier.eissn | 1557-3265 | |
dc.identifier.doi | 10.1158/1078-0432.ccr-22-0305 | |
dc.identifier.doi | 10.1158/1078-0432.ccr-22-0305 | |
dc.description.abstract | PURPOSE: To conduct an updated exploratory analysis of overall survival (OS) with a longer median follow-up of 73.3 months and evaluate the prognostic value of molecular analysis by circulating tumor DNA (ctDNA). PATIENTS AND METHODS: Patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) advanced breast cancer (ABC) were randomized 2:1 to receive palbociclib (125 mg orally/day; 3/1 week schedule) and fulvestrant (500 mg intramuscularly) or placebo and fulvestrant. This OS analysis was performed when 75% of enrolled patients died (393 events in 521 randomized patients). ctDNA analysis was performed among patients who provided consent. RESULTS: At the data cutoff (August 17, 2020), 258 and 135 deaths occurred in the palbociclib and placebo groups, respectively. The median OS [95% confidence interval (CI)] was 34.8 months (28.8-39.9) in the palbociclib group and 28.0 months (23.5-33.8) in the placebo group (stratified hazard ratio, 0.81; 95% CI, 0.65-0.99). The 6-year OS rate (95% CI) was 19.1% (14.9-23.7) and 12.9% (8.0-19.1) in the palbociclib and placebo groups, respectively. Favorable OS with palbociclib plus fulvestrant compared with placebo plus fulvestrant was observed in most subgroups, particularly in patients with endocrine-sensitive disease, no prior chemotherapy for ABC and low circulating tumor fraction and regardless of ESR1, PIK3CA, or TP53 mutation status. No new safety signals were identified. CONCLUSIONS: The clinically meaningful improvement in OS associated with palbociclib plus fulvestrant was maintained with >6 years of follow-up in patients with HR+/HER2- ABC, supporting palbociclib plus fulvestrant as a standard of care in these patients. | |
dc.format | Print-Electronic | |
dc.format.extent | clincanres.0305.2022 - ? | |
dc.language | eng | |
dc.language.iso | eng | |
dc.publisher | AMER ASSOC CANCER RESEARCH | |
dc.rights.uri | http://creativecommons.org/licenses/by/4.0/ | |
dc.title | Overall Survival with Palbociclib and Fulvestrant in Women with HR+/HER2- ABC: Updated Exploratory Analyses of PALOMA-3, a Double-blind, Phase III Randomized Study. | |
dc.type | Journal Article | |
dcterms.dateAccepted | 2022-05-09 | |
rioxxterms.version | VoR | |
rioxxterms.versionofrecord | 10.1158/1078-0432.ccr-22-0305 | |
rioxxterms.licenseref.startdate | 2022-05-12 | |
dc.relation.isPartOf | Clinical cancer research : an official journal of the American Association for Cancer Research | |
pubs.notes | Not known | |
pubs.organisational-group | /ICR | |
pubs.organisational-group | /ICR/ImmNet | |
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/Students | |
pubs.organisational-group | /ICR/Students/PhD and MPhil | |
pubs.organisational-group | /ICR/Students/PhD and MPhil/15/16 Starting Cohort | |
pubs.publication-status | Published | |
pubs.embargo.terms | Not known | |
icr.researchteam | Molecular Oncology | |
dc.contributor.icrauthor | O'Leary, Benjamin | |
dc.contributor.icrauthor | Turner, Nicholas | |