Identifier to cite or link to this item: http://hdl.handle.net/20.500.13003/17402
Palbociclib combined with endocrine therapy in heavily pretreated HR+/HER2(-) advanced breast cancer patients: Results from the compassionate use program in Spain (PALBOCOMP)
WOS ID: 000604437000043
Scopus EID: 2-s2.0-85096711418
Embase PUI: L2010091439
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AuthorManso, Luis; Hernando, Cristina; Galan, Maria; Oliveira, Mafalda; Cabrera, Miguel A.; Bratos, Raquel; Rodriguez, Cesar A.; Ruiz-Borrego, Manuel; Blanch, Salvador; Llombart-Cussac, Antonio; Delgado-Mingorance, Juan I.; Alvarez-Busto, Inaki; Gallegos, Isabel; Gonzalez-Cortijo, Lucia; Morales, Serafin; Aguirre, Elena; Hernando, Blanca A.; Ballesteros, Ana; Ales-Martinez, Jose E.; Reboredo, Cristina; Oltra, Amparo; Gonzalez-Cao, Maria; Santisteban, Marta; Malon, Diego; Echeverria, Isabel; Garcia-Garre, Elisa; Vega, Estela; Servitja, Sonia; Andres, Raquel; Robles, Carlos E.; Lopez, Rafael; Galve, Elena; Echarri, Maria J.; Legeren, Marta; Moreno, Fernando
Document typeresearch article
CitationManso L, Hernando C, Galan M, Oliveira M, Cabrera MA, Bratos R, et al. Palbociclib combined with endocrine therapy in heavily pretreated HR+/HER2(-) advanced breast cancer patients: Results from the compassionate use program in Spain (PALBOCOMP). Breast. 2020 Dec;54:286-92. Epub 2020 Nov 13.
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.
KeywordsAdvanced breast cancer
Compassionate use program