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

Cristofanilli, Massimo and Rugo, Hope S. and Im, Seock-Ah and Slamon, Dennis J. and Harbeck, Nadia and Bondarenko, Igor and Masuda, Norikazu and Colleoni, Marco and DeMichele, Angela and Loi, Sherene and Iwata, Hiroji and O’Leary, Ben and André, Fabrice and Loibl, Sibylle and Bananis, Eustratios and Yuan Liu, Yuan Liu and Huang, Xin and Kim, Sindy and Frean, Maria Jose Lechuga and Turner, Nicholas C. (2022) 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. Clinical Cancer Research, 28 (16). pp. 3433-3442. ISSN 1078-0432 (print), 1557-3265 ( online)

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Official URL: https://aacrjournals.org/clincancerres


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 (HRþ/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 HRþ/HER2 ABC, supporting palbociclib plus fulvestrant as a standard of care in these patients.

Item Type: Article
Additional Information: Cristofanilli M, Rugo HS, Im S-, Slamon DJ, Harbeck N, Bondarenko I, Masuda N, Colleoni M, DeMichele A, Loi S, Iwata H, O’Leary B, André F, Loibl S, Bananis E, Liu Y, Huang X, Kim S, Frean MJL, Turner NC. Overall survival with palbociclib and fulvestrant in women with HRþ/HER2¯ ABC: Updated exploratory analyses of PALOMA-3, a double-blind, phase III randomized study. Clin Cancer Res [Internet]. 2022;28(16):3433-42. https://doi.org/10.1158/1078-0432.CCR-22-0305 Available from: www.scopus.com http://surl.li/dapwh
Subjects: Oncology
Divisions: Departments > Department of Oncology and Medical Radiology
Depositing User: Елена Шрамко
Date Deposited: 16 Sep 2022 10:02
Last Modified: 16 Sep 2022 10:14
URI: http://repo.dma.dp.ua/id/eprint/7841

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