Randomized phase II study of fulvestrant plus palbociclib or placebo in endocrine-sensitive, hormone receptor- positive/HER2-advanced breast cancer: GEICAM/2014-12 (FLIPPER)
Background: The potential benefit of adding palbociclib to fulvestrant as first-line treatment in hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative endocrine-sensitive advanced breast cancer (ABC) patients remains uncharacterized.& nbsp;Patients and methods...
| Autores: | , , , , , , , , , , , , , , , , , , , |
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| Tipo de recurso: | artículo |
| Fecha de publicación: | 2022 |
| País: | España |
| Institución: | Conselleria de Salut i Consum del Govern de les Illes Balears |
| Repositorio: | Docusalut |
| Idioma: | inglés |
| OAI Identifier: | oai:docusalut.com:20.500.13003/19787 |
| Acceso en línea: | https://hdl.handle.net/20.500.13003/19787 |
| Access Level: | acceso abierto |
| Palabra clave: | Breast Neoplasms Aged, 80 and over Aged Adult Female Piperazines Pyridines Humans Fulvestrant Middle Aged Double-Blind Method Método Doble Ciego Piperazinas Piridinas Humanos Persona de Mediana Edad Anciano Anciano de 80 o más Años Femenino Neoplasias de la Mama Adulto Breast cancer Metastatic First-line Endocrine-sensitive Palbociclib CDK 4/6 |
| Sumario: | Background: The potential benefit of adding palbociclib to fulvestrant as first-line treatment in hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative endocrine-sensitive advanced breast cancer (ABC) patients remains uncharacterized.& nbsp;Patients and methods: In this randomized (1:1), double-blind, phase II study, postmenopausal women with HR-positive, HER2-negative ABC with de novo metastatic disease or those who relapsed after > 12 months of adjuvant endocrine therapy received palbociclib/fulvestrant or placebo/fulvestrant. Stratification was based on recurrent versus de novo metastatic disease and visceral involvement. The primary objective was one-year progression-free survival (PFS-1y) rate. The sample size was 190 patients. The two-sided alpha of 0.2, 80% of power to detect a difference between the arms, assuming PFS rates of 0.695 and 0.545 for palbociclib/fulvestrant and placebo/fulvestrant, respectively.& nbsp;Results: In total, 189 patients were randomized to palbociclib/fulvestrant ([n = 94] or placebo/ fulvestrant [n = 95]). 45.5% and 60.3% of patients had de novo metastatic disease and visceral involvement, respectively. PFS-1y rates were 83.5% and 71.9% in the palbociclib/fulvestrant and placebo/fulvestrant arms, (HR 0.55, 80% CI 0.36-0.83, P = 0.064). The median PFS were 31.8 and 22.0 months for the palbociclib/fulvestrant and placebo/fulvestrant arms (aHR 0.48, 80% CI 0.37-0.64, P = 0.001).& nbsp;The most frequent grade 3-4 adverse events were neutropenia (68.1% vs. 0%), leucopenia (26.6% vs. 0%), anemia (3.2% vs. 0%), and lymphopenia (14.9% vs. 2.1%) for the palbociclib/fulvestrant and placebo/fulvestrant, respectively.The most frequent non-hematologic grade 3-4 adverse event was fatigue (4.3% vs. 0%).& nbsp;Conclusions: Palbociclib/fulvestrant demonstrated better PFS-1y rates and median PFS than placebo/fulvestrant in HR-positive/HER2-negative endocrine-sensitive ABC patients. (C) 2021 The Author(s). Published by Elsevier Ltd. |
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