Palbociclib Rechallenge for Hormone Receptor–Positive/HER-Negative Advanced Breast Cancer: Findings from the Phase II BioPER Trial

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 multice...

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Autores: 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 Bertrán, Ana, Mina, Leonardo, Bellosillo Paricio, Beatriz, Rojo, Federico, Menéndez, Silvia, Sampayo Cordero, Miguel, Popa, Crina, Malfettone, Andrea, Cortés, Javier, Llombart Cussac, Antonio
Tipo de recurso: artículo
Estado:Versión publicada
Fecha de publicación:2022
País:España
Institución:Universidad de Barcelona
Repositorio:Dipòsit Digital de la UB
OAI Identifier:oai:diposit.ub.edu:2445/193148
Acceso en línea:https://hdl.handle.net/2445/193148
Access Level:acceso abierto
Palabra clave:Càncer de mama
Assaigs clínics
Marcadors bioquímics
Breast cancer
Clinical trials
Biochemical markers
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spelling Palbociclib Rechallenge for Hormone Receptor–Positive/HER-Negative Advanced Breast Cancer: Findings from the Phase II BioPER TrialAlbanell Mestres, JoanPérez García, José ManuelGil Gil, MiguelCurigliano, GiuseppeRuíz Borrego, ManuelComerma, LauraGibert, JoanBellet Ezquerra, MeritxellBermejo, BegoñaCalvo, LourdesHaba, Juan de laEspinosa, EnriqueMinisini, Alessandro MarcoQuiroga Garcia, VanesaSantaballa Bertrán, AnaMina, LeonardoBellosillo Paricio, BeatrizRojo, FedericoMenéndez, SilviaSampayo Cordero, MiguelPopa, CrinaMalfettone, AndreaCortés, JavierLlombart Cussac, AntonioCàncer de mamaAssaigs clínicsMarcadors bioquímicsBreast cancerClinical trialsBiochemical markersPurpose: 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.American Association for Cancer Research (AACR)2022info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionapplication/pdfhttps://hdl.handle.net/2445/193148Articles publicats en revistes (Institut d'lnvestigació Biomèdica de Bellvitge (IDIBELL))reponame:Dipòsit Digital de la UBinstname:Universidad de BarcelonaInglésReproducció del document publicat a: https://doi.org/10.1158/1078-0432.CCR-22-1281Clinical Cancer Research, 2022, vol. 29, num. 1, p. 67-80https://doi.org/10.1158/1078-0432.CCR-22-1281cc by-nc-nd (c) Albanell Mestres, Joan et al., 2022http://creativecommons.org/licenses/by-nc-nd/3.0/es/info:eu-repo/semantics/openAccessoai:diposit.ub.edu:2445/1931482026-05-27T06:46:51Z
dc.title.none.fl_str_mv Palbociclib Rechallenge for Hormone Receptor–Positive/HER-Negative Advanced Breast Cancer: Findings from the Phase II BioPER Trial
title Palbociclib Rechallenge for Hormone Receptor–Positive/HER-Negative Advanced Breast Cancer: Findings from the Phase II BioPER Trial
spellingShingle Palbociclib Rechallenge for Hormone Receptor–Positive/HER-Negative Advanced Breast Cancer: Findings from the Phase II BioPER Trial
Albanell Mestres, Joan
Càncer de mama
Assaigs clínics
Marcadors bioquímics
Breast cancer
Clinical trials
Biochemical markers
title_short Palbociclib Rechallenge for Hormone Receptor–Positive/HER-Negative Advanced Breast Cancer: Findings from the Phase II BioPER Trial
title_full Palbociclib Rechallenge for Hormone Receptor–Positive/HER-Negative Advanced Breast Cancer: Findings from the Phase II BioPER Trial
title_fullStr Palbociclib Rechallenge for Hormone Receptor–Positive/HER-Negative Advanced Breast Cancer: Findings from the Phase II BioPER Trial
title_full_unstemmed Palbociclib Rechallenge for Hormone Receptor–Positive/HER-Negative Advanced Breast Cancer: Findings from the Phase II BioPER Trial
title_sort Palbociclib Rechallenge for Hormone Receptor–Positive/HER-Negative Advanced Breast Cancer: Findings from the Phase II BioPER Trial
dc.creator.none.fl_str_mv 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 Bertrán, Ana
Mina, Leonardo
Bellosillo Paricio, Beatriz
Rojo, Federico
Menéndez, Silvia
Sampayo Cordero, Miguel
Popa, Crina
Malfettone, Andrea
Cortés, Javier
Llombart Cussac, Antonio
author Albanell Mestres, Joan
author_facet 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 Bertrán, Ana
Mina, Leonardo
Bellosillo Paricio, Beatriz
Rojo, Federico
Menéndez, Silvia
Sampayo Cordero, Miguel
Popa, Crina
Malfettone, Andrea
Cortés, Javier
Llombart Cussac, Antonio
author_role author
author2 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 Bertrán, Ana
Mina, Leonardo
Bellosillo Paricio, Beatriz
Rojo, Federico
Menéndez, Silvia
Sampayo Cordero, Miguel
Popa, Crina
Malfettone, Andrea
Cortés, Javier
Llombart Cussac, Antonio
author2_role author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
dc.subject.none.fl_str_mv Càncer de mama
Assaigs clínics
Marcadors bioquímics
Breast cancer
Clinical trials
Biochemical markers
topic Càncer de mama
Assaigs clínics
Marcadors bioquímics
Breast cancer
Clinical trials
Biochemical markers
description 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.
publishDate 2022
dc.date.none.fl_str_mv 2022
dc.type.none.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
format article
status_str publishedVersion
dc.identifier.none.fl_str_mv https://hdl.handle.net/2445/193148
url https://hdl.handle.net/2445/193148
dc.language.none.fl_str_mv Inglés
language_invalid_str_mv Inglés
dc.relation.none.fl_str_mv Reproducció del document publicat a: https://doi.org/10.1158/1078-0432.CCR-22-1281
Clinical Cancer Research, 2022, vol. 29, num. 1, p. 67-80
https://doi.org/10.1158/1078-0432.CCR-22-1281
dc.rights.none.fl_str_mv cc by-nc-nd (c) Albanell Mestres, Joan et al., 2022
http://creativecommons.org/licenses/by-nc-nd/3.0/es/
info:eu-repo/semantics/openAccess
rights_invalid_str_mv cc by-nc-nd (c) Albanell Mestres, Joan et al., 2022
http://creativecommons.org/licenses/by-nc-nd/3.0/es/
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv application/pdf
dc.publisher.none.fl_str_mv American Association for Cancer Research (AACR)
publisher.none.fl_str_mv American Association for Cancer Research (AACR)
dc.source.none.fl_str_mv Articles publicats en revistes (Institut d'lnvestigació Biomèdica de Bellvitge (IDIBELL))
reponame:Dipòsit Digital de la UB
instname:Universidad de Barcelona
instname_str Universidad de Barcelona
reponame_str Dipòsit Digital de la UB
collection Dipòsit Digital de la UB
repository.name.fl_str_mv
repository.mail.fl_str_mv
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score 15,300719

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