RT Journal Article
T1 Palbociclib combined with endocrine therapy in heavily pretreated HR+/HER2- advanced breast cancer patients: Results from the compassionate use program in Spain (PALBOCOMP).
A1 Manso, Luis
A1 Hernando, Cristina
A1 Galán, María
A1 Oliveira, Mafalda
A1 Cabrera, Miguel A
A1 Bratos, Raquel
A1 Rodríguez, César A
A1 Ruiz-Borrego, Manuel
A1 Blanch, Salvador
A1 Llombart-Cussac, Antonio
A1 Delgado-Mingorance, Juan I
A1 Álvarez-Busto, Iñaki
A1 Gallegos, Isabel
A1 González-Cortijo, Lucía
A1 Morales, Serafín
A1 Aguirre, Elena
A1 Hernando, Blanca A
A1 Ballesteros, Ana
A1 Alés-Martínez, José E
A1 Reboredo, Cristina
A1 Oltra, Amparo
A1 González-Cao, María
A1 Santisteban, Marta
A1 Malón, Diego
A1 Echeverría, Isabel
A1 García-Garre, Elisa
A1 Vega, Estela
A1 Servitja, Sònia
A1 Andrés, Raquel
A1 Robles, Carlos E
A1 López, Rafael
A1 Galve, Elena
A1 Echarri, María J
A1 Legeren, Marta
A1 Moreno, Fernando
K1 Advanced breast cancer
K1 CDK4/6 inhibitors
K1 Compassionate use program
K1 Endocrine therapy
K1 Palbociclib
AB This study evaluated efficacy and safety of palbociclib, a CDK4/6 inhibitor, in heavily-pretreated hormone receptor-positive and human epidermal growth factor receptor 2-negative (HR+/HER2-) metastatic breast cancer (mBC) patients during the compassionate use program in Spain from February 2015 to November 2017. Patient data were collected retrospectively from 35 hospitals in Spain. Patients with HR+/HER2- mBC who had progressed on ≥4 treatments for advanced disease were eligible. A total of 219 patients received palbociclib in combination with aromatase inhibitors (110; 50.2%), fulvestrant (87; 39.7%), tamoxifen (8; 3.6%) or as single agent (10; 4.6%). Mean age of the patients was 58 years; 31 patients (16.1%) were premenopausal and 162 (83.9%) were postmenopausal at the beginning of treatment with palbociclib. Patients had received a median of 3 previous lines of endocrine therapy (ET) for advanced disease. Real-world tumor response (rwTR) and clinical benefit rate were 5.9% (n = 13) and 46.2% (n = 101), respectively. The median real world progression-free survival (rwPFS) was 6.0 months (95% CI 5.7-7.0) and the median overall survival was 19.0 months (95% CI 16.4-21.7). Subgroup analysis revealed a significant difference in median rwPFS in patients treated with palbociclib plus fulvestrant depending on the duration of prior treatment with fulvestrant monotherapy (>6 versus ≤6 months; HR 1.93, 95% CI 1.37-2.73, p 6 versus ≤6 months; HR 1.93, 95% CI 1.37-2.73, p  Palbociclib can be an effective and safe treatment option in patients with heavily pretreated endocrine-sensitive mBC, especially in those with longer PFS to previous ET.
YR 2020
FD 2020-11-13
LK http://hdl.handle.net/10668/16671
UL http://hdl.handle.net/10668/16671
LA en
DS RISalud
RD Apr 6, 2025