Palbociclib combined with endocrine therapy in heavily pretreated HR(+)/HER2(-) advanced breast cancer patients: Results from the compassionate use program in Spain (PALBOCOMP)
Manso, Luis; Hernando, Cristina; Galán, María; Oliveira, Mafalda; Cabrera, Miguel A; Bratos, Raquel; Rodríguez, César A; Ruiz-Borrego, Manuel; Blanch, Salvador; Llombart-Cussac, Antonio; Delgado-Mingorance, Juan I; Álvarez-Busto, Iñaki; Gallegos, Isabel; González-Cortijo, Lucía; Morales, Serafín; Aguirre, Elena; Hernando, Blanca A; Ballesteros, Ana; Alés-Martínez, José E; REBOREDO RENDO, CRISTINA; Oltra, Amparo; González-Cao, María; Santisteban, Marta; Malón, Diego; Echeverría, Isabel; García-Garre, Elisa; Vega, Estela; Servitja, Sònia; Andrés, Raquel; Robles, Carlos E; López López, Rafael; Galve, Elena; Echarri, María J; Legeren, Marta; Moreno, Fernando
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Identificadores
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Fecha de publicación
2020Título de revista
BREAST
Tipo de contenido
Journal Article
Resumen
BACKGROUND: 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. 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.