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Palbociclib combined with endocrine therapy in heavily pretreated HR+/HER2(-) advanced breast cancer patients: Results from the compassionate use program in Spain (PALBOCOMP)

Autores: Manso, L.; Hernando, C.; Galan, M.; Oliveira, M.; Cabrera, M. A.; Bratos, R.; Rodríguez, C. A.; Ruiz-Borrego, M.; Blanch, S.; Llombart-Cussac, A.; Delgado-Mingorance, J. I.; Alvarez-Busto, I.; Gallegos, I.; Gonzalez-Cortijo, L.; Morales, S.; Aguirre, E.; Hernando, B. A,; Ballesteros, A,; Ales-Martinez, J. E.; Reboredo, C.; Oltra, A.; Gonzalez-Cao, M.; Santisteban Eslava, Marta; Malon, D.; Echeverria, I.; Garcia-Garre, E.; Vega, E.; Servitja, S.; Andres, R.; Robles, C. E.; Lopez, R.; Galve, E.; Echarri, M. J.; Legeren, M.; Moreno, F. (Autor de correspondencia)
Título de la revista: BREAST
ISSN: 0960-9776
Volumen: 54
Páginas: 286 - 292
Fecha de publicación: 2020
Background: This study evaluated efficacy and safety of palbociclib, a CDK4/6 inhibitor, in heavilypretreated 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. Patients and methods: 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. Results: 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 < 0.001). The most frequently reported toxicities were neutropenia, asthenia, thrombopenia and anemia. Conclusions: 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. (C) 2020 The Author(s). Published by Elsevier Ltd.