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Title: | Palbociclib Rechallenge for Hormone Receptor–Positive/HER-Negative Advanced Breast Cancer: Findings from the Phase II BioPER Trial |
Author: | Albanell Mestres, Joan Pérez García, José Manuel Gil Gil, Miguel Curigliano, Giuseppe Ruíz Borrego, Manuel Comerma, Laura Gibert, Joan Bellet Ezquerra, Meritxell Bermejo, Begoña Calvo, Lourdes Haba, Juan de la Espinosa, Enrique Minisini, Alessandro Marco Quiroga Garcia, Vanesa Santaballa Bertran, Ana Mina, Leonardo Bellosillo Paricio, Beatriz Rojo, Federico Menéndez, Silvia Sampayo Cordero, Miguel Popa, Crina Malfettone, Andrea Cortés, Javier Llombart Cussac, Antonio |
Keywords: | Càncer de mama Assaigs clínics Marcadors bioquímics Breast cancer Clinical trials Biochemical markers |
Issue Date: | 27-Sep-2022 |
Publisher: | American Association for Cancer Research (AACR) |
Abstract: | Purpose: To assess the efficacy and exploratory biomarkers of continuing palbociclib plus endocrine therapy (ET) beyond pro-gression on prior palbociclib-based regimen in patients with hor-mone receptor-positive/HER2-negative (HR+/HER2-) advanced breast cancer (ABC).Patients and Methods: The multicenter, open-label, phase II BioPER trial included women who had experienced a progressive disease (PD) after having achieved clinical benefit on the immedi-ately prior palbociclib plus ET regimen. Palbociclib (125 mg, 100 mg, or 75 mg daily orally for 3 weeks and 1 week off as per prior palbociclib-based regimen) plus ET of physician's choice were administered in 4-week cycles until PD or unacceptable toxicity. Coprimary endpoints were clinical benefit rate (CBR) and percent-age of tumors with baseline loss of retinoblastoma (Rb) protein expression. Additional endpoints included safety and biomarker analysis.Results: Among 33 patients enrolled, CBR was 34.4% [95% confidence interval (CI), 18.6-53.2; P < 0.001] and 13.0% of tumors (95% CI, 5.2-27.5) showed loss of Rb protein expression, meeting both coprimary endpoints. Median progression-free survival was 2.6 months (95% CI, 1.8-6.7). No new safety signals were reported. A signature that included baseline mediators of therapeutic resistance to palbociclib and ET (low Rb score, high cyclin E1 score, ESR1 mutation) was independently associated with shorter median progression-free survival (HR, 22.0; 95% CI, 1.71-282.9; P = 0.018). Conclusions: Maintaining palbociclib after progression on prior palbociclib-based regimen seems to be a reasonable, investigational approach for selected patients. A composite biomarker signature predicts a subset of patients who may not derive a greater benefit from palbociclib rechallenge, warranting further validation in larger randomized controlled trials. |
Note: | Reproducció del document publicat a: https://doi.org/10.1158/1078-0432.CCR-22-1281 |
It is part of: | Clinical Cancer Research, 2022, vol. 29, num. 1, p. 67-80 |
URI: | http://hdl.handle.net/2445/193148 |
Related resource: | https://doi.org/10.1158/1078-0432.CCR-22-1281 |
ISSN: | 1078-0432 |
Appears in Collections: | Articles publicats en revistes (Institut d'lnvestigació Biomèdica de Bellvitge (IDIBELL)) |
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