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oai:recercat.cat:11351/63722025-10-24T10:37:08Zcom_2072_378070com_2072_378040col_2072_378092

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 Antunes de Melo Oliveira, Ana Mafalda Cabrera, Miguel A. Bratos, Raquel Galán, María Institut Català de la Salut [Manso L] Hospital Universitario 12 de Octubre, Madrid, Spain. [Hernando C] Hospital Clínico Universitario de Valencia, Valencia, Spain. [Galán M] Hospital Universitario Son Llatzer, Palma, Spain. [Oliveira M] Vall d'Hebron Hospital Universitari, Barcelona, Spain. [Cabrera MA] Hospital Universitario Nuestra Senora de Candelaria, Santa Cruz de Tenerife, Spain. [Bratos R] Hospital MD Anderson Cancer Center, Madrid, Spain Vall d'Hebron Barcelona Hospital Campus Mama - Càncer Càncer - Hormonoteràpia Medicaments antineoplàstics - Ús terapèutic CHEMICALS AND DRUGS::Chemical Actions and Uses::Pharmacologic Actions::Therapeutic Uses::Antineoplastic Agents::Antineoplastic Agents, Hormonal Other subheadings::Other subheadings::/therapeutic use DISEASES::Neoplasms::Neoplasms by Site::Breast Neoplasms Other subheadings::Other subheadings::Other subheadings::/drug therapy COMPUESTOS QUÍMICOS Y DROGAS::acciones y usos químicos::acciones farmacológicas::usos terapéuticos::antineoplásicos::antineoplásicos hormonales Otros calificadores::Otros calificadores::/uso terapéutico ENFERMEDADES::neoplasias::neoplasias por localización::neoplasias de la mama Otros calificadores::Otros calificadores::Otros calificadores::/farmacoterapia Càncer de mama avançat; Teràpia endocrina; Palbociclib Cáncer de mama avanzado; Terapia endocrina; Palbociclib Advanced breast cancer; Endocrine therapy; Palbociclib 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. This study was sponsored by Biomedical Research Foundation of the Hospital Clínico San Carlos (Madrid, Spain). The study was funded by an investigator sponsored research grant (WI236789) from Pfizer. 2021-10-01T08:06:13Z 2021-10-01T08:06:13Z 2020-12-01 info:eu-repo/semantics/article info:eu-repo/semantics/publishedVersion Manso L, Hernando C, Galán 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 1;54:286-92. 0960-9776 https://hdl.handle.net/11351/6372 10.1016/j.breast.2020.11.005 33242755 000604437000043 http://hdl.handle.net/11351/6372 eng Breast;54 https://doi.org/10.1016/j.breast.2020.11.005 Attribution-NonCommercial-NoDerivatives 4.0 International http://creativecommons.org/licenses/by-nc-nd/4.0/ info:eu-repo/semantics/openAccess application/pdf Elsevier Scientia