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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 Field | Value | Language |
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dc.contributor.author | Cristofanilli, Massimo | - |
dc.contributor.author | Rugo, Hope S. | - |
dc.contributor.author | Im, Seock-Ah | - |
dc.contributor.author | Slamon, Dennis J. | - |
dc.contributor.author | Harbeck, Nadia | - |
dc.contributor.author | Bondarenko, Igor | - |
dc.contributor.author | Masuda, Norikazu | - |
dc.contributor.author | Colleoni, Marco | - |
dc.contributor.author | DeMichele, Angela | - |
dc.contributor.author | Loi, Sherene | - |
dc.contributor.author | Iwata, Hiroji | - |
dc.contributor.author | O'Leary, Ben | - |
dc.contributor.author | Andre, Fabrice | - |
dc.contributor.author | Loibl, Sibylle | - |
dc.contributor.author | Bananis, Eustratios | - |
dc.contributor.author | Liu, Yuan | - |
dc.contributor.author | Huang, Xin | - |
dc.contributor.author | Kim, Sindy | - |
dc.contributor.author | Frean, Maria Jose Lechuga | - |
dc.contributor.author | Turner, Nicholas C. | - |
dc.date.accessioned | 2022-10-11T01:16:06Z | - |
dc.date.available | 2022-10-11T01:16:06Z | - |
dc.date.created | 2022-09-08 | - |
dc.date.created | 2022-09-08 | - |
dc.date.created | 2022-09-08 | - |
dc.date.created | 2022-09-08 | - |
dc.date.created | 2022-09-08 | - |
dc.date.created | 2022-09-08 | - |
dc.date.created | 2022-09-08 | - |
dc.date.created | 2022-09-08 | - |
dc.date.created | 2022-09-08 | - |
dc.date.created | 2022-09-08 | - |
dc.date.issued | 2022-08 | - |
dc.identifier.citation | Clinical Cancer Research, Vol.28 No.16, pp.3433-3422 | - |
dc.identifier.issn | 1078-0432 | - |
dc.identifier.uri | https://hdl.handle.net/10371/185725 | - |
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, support-ing palbociclib plus fulvestrant as a standard of care in these patients. | - |
dc.language | 영어 | - |
dc.publisher | American Association for Cancer Research | - |
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 | Article | - |
dc.identifier.doi | 10.1158/1078-0432.CCR-22-0305 | - |
dc.citation.journaltitle | Clinical Cancer Research | - |
dc.identifier.wosid | 000843625200001 | - |
dc.identifier.scopusid | 2-s2.0-85136342162 | - |
dc.citation.endpage | 3422 | - |
dc.citation.number | 16 | - |
dc.citation.startpage | 3433 | - |
dc.citation.volume | 28 | - |
dc.description.isOpenAccess | Y | - |
dc.contributor.affiliatedAuthor | Im, Seock-Ah | - |
dc.type.docType | Article | - |
dc.description.journalClass | 1 | - |
dc.subject.keywordPlus | METASTATIC BREAST-CANCER | - |
dc.subject.keywordPlus | PLUS FULVESTRANT | - |
dc.subject.keywordPlus | BENEFIT | - |
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