Portal de investigación
Palbociclib Rechallenge for Hormone Receptor- Positive/HER-Negative Advanced Breast Cancer: Findings from the Phase II BioPER Trial
Fecha de publicación:
Autores de FISABIO
Autores ajenos a FISABIO
- Albanell J
- Pérez-García JM
- Gil-Gil M
- Curigliano G
- Ruíz-Borrego M
- Comerma L
- Gibert J
- Bellet M
- Bermejo B
- Calvo L
- de la Haba J
- Espinosa E
- Minisini AM
- Quiroga V
- Santaballa Bertran A
- Mina L
- Bellosillo B
- Rojo F
- Menéndez S
- Sampayo-Cordero M
- Popa C
- Malfettone A
- Cortés J
Grupos de Investigación
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.
Datos de la publicación
- ISSN/ISSNe:
- 1078-0432, 1557-3265
- Tipo:
- Article
- Páginas:
- 67-80
- PubMed:
- 36165912
CLINICAL CANCER RESEARCH AMER ASSOC CANCER RESEARCH
Citas Recibidas en Web of Science: 34
Documentos
- No hay documentos