Palbociclib Rechallenge for Hormone Receptor-Positive/HER-Negative Advanced Breast Cancer: Findings from the Phase II BioPER Trial.
Por:
Albanell J, Perez-Garcia J, Gil-Gil M, Curigliano G, Ruiz-Borrego M, Comerma L, Gibert J, Bellet M, Bermejo B, Calvo L, de la Haba J, Espinosa E, Minisini A, Quiroga V, Bertran A, Mina L, Bellosillo B, Rojo F, Menendez S, Sampayo-Cordero M, Popa C, Malfettone A, Cortes J, Llombart-Cussac A
Publicada:
4 ene 2023
Resumen:
PURPOSE: To assess the efficacy and exploratory biomarkers of continuing palbociclib plus endocrine therapy (ET) beyond progression on prior palbociclib-based regimen in patients with hormone 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 immediately 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 percentage 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.
Filiaciones:
Albanell J:
Hosp Mar, Med Oncol Dept, Barcelona, Spain
IMIM Hosp Mar Med Res Inst, Canc Res Program, Barcelona, Spain
Ctr Invest Biomed Red Oncol CIBERONC ISCIII, Madrid, Spain
Univ Pompeu Fabra, Barcelona, Spain
GEICAM, Madrid, Spain
Perez-Garcia J:
Int Breast Canc Ctr IBCC, Quironsalud Grp, Barcelona, Spain
Med Scientia Innovat Res MEDSIR, Barcelona, Spain
Med Scientia Innovat Res MEDSIR, Ridgewood, NJ USA
Gil-Gil M:
GEICAM, Madrid, Spain
IDIBELL, Catalan Inst Oncol, Med Oncol Dept, Breast Canc Unit, Barcelona, Spain
Curigliano G:
IRCCS, Ist Europeo Oncol, Milan, Italy
Univ Milan, Dept Oncol & Hematooncol, Milan, Italy
Ruiz-Borrego M:
GEICAM, Madrid, Spain
Hosp Univ Virgen Rocio, Seville, Spain
Comerma L:
IMIM Hosp Mar Med Res Inst, Canc Res Program, Barcelona, Spain
Hosp Mar, Pathol Dept, Barcelona, Spain
Gibert J:
IMIM Hosp Mar Med Res Inst, Canc Res Program, Barcelona, Spain
Hosp Mar, Pathol Dept, Barcelona, Spain
Bellet M:
Vall dHebron Univ Hosp, Barcelona, Spain
Vall dHebron Inst Oncol VHIO, Barcelona, Spain
Bermejo B:
Ctr Invest Biomed Red Oncol CIBERONC ISCIII, Madrid, Spain
GEICAM, Madrid, Spain
Hosp Clin Univ Valencia, Biomed Res Inst INCLIVA, Med Oncol, Valencia, Spain
Univ Valencia, Med Dept, Valencia, Spain
Calvo L:
GEICAM, Madrid, Spain
Complejo Hosp Univ A Coruna CHUAC, La Coruna, Spain
de la Haba J:
Hosp Univ Reina Sofia, Cordoba, Spain
Espinosa E:
Hosp Univ La Paz, Madrid, Spain
Minisini A:
Azienda Sanitaria Univ Friuli Cent, Dept Oncol, Udine, Italy
Quiroga V:
Catalan Inst Oncol, Badalona Appl Res Grp Oncol B ARGO Grp, Barcelona, Spain
Bertran A:
Hosp Univ & Politecn La Fe, Valencia, Spain
Mina L:
Med Scientia Innovat Res MEDSIR, Barcelona, Spain
Med Scientia Innovat Res MEDSIR, Ridgewood, NJ USA
Bellosillo B:
IMIM Hosp Mar Med Res Inst, Canc Res Program, Barcelona, Spain
Ctr Invest Biomed Red Oncol CIBERONC ISCIII, Madrid, Spain
Univ Pompeu Fabra, Barcelona, Spain
Hosp Mar, Pathol Dept, Barcelona, Spain
Rojo F:
Ctr Invest Biomed Red Oncol CIBERONC ISCIII, Madrid, Spain
GEICAM, Madrid, Spain
IIS Hosp Univ Fdn Jimenez Diaz, Madrid, Spain
Menendez S:
IMIM Hosp Mar Med Res Inst, Canc Res Program, Barcelona, Spain
Sampayo-Cordero M:
Med Scientia Innovat Res MEDSIR, Barcelona, Spain
Med Scientia Innovat Res MEDSIR, Ridgewood, NJ USA
Popa C:
Med Scientia Innovat Res MEDSIR, Barcelona, Spain
Med Scientia Innovat Res MEDSIR, Ridgewood, NJ USA
Malfettone A:
Med Scientia Innovat Res MEDSIR, Barcelona, Spain
Med Scientia Innovat Res MEDSIR, Ridgewood, NJ USA
Cortes J:
Int Breast Canc Ctr IBCC, Quironsalud Grp, Barcelona, Spain
Med Scientia Innovat Res MEDSIR, Barcelona, Spain
Med Scientia Innovat Res MEDSIR, Ridgewood, NJ USA
Univ Europea Madrid, Fac Biomed & Hlth Sci, Dept Med, Madrid, Spain
Llombart-Cussac A:
Med Scientia Innovat Res MEDSIR, Barcelona, Spain
Med Scientia Innovat Res MEDSIR, Ridgewood, NJ USA
Hosp Arnau Vilanova, Calle St Clement 12, Valencia 46015, Spain
Univ Catolica, Valencia, Spain
Green Published, Green Submitted, hybrid
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