First-line therapy with palbociclib in patients with advanced HR+/HER2- breast cancer: The real-life study PALBOSPAIN

Purpose: To evaluate the efficacy and safety of first-line therapy with palbociclib in a Spanish cohort treated after palbociclib approval. Methods: PALBOSPAIN is an observational, retrospective, multicenter study evaluating real-world patterns and outcomes with 1 L palbociclib in men and women (any...

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Detalles Bibliográficos
Autores: Martínez-Jáñez, Noelia, Bellet, Meritxell, Manso Sánchez, Luis Manuel, Henao Carrasco, Fernando, Antón, Antonio, Morales, Serafín, Tolosa Ortega, Pablo, Obadia Gil, Verónica Luisa, Sampedro, Teresa, Andrés, Raquel, Calvo Martínez, Lourdes, Galve Calvo, Elena, López, Rafael, Ayala de la Peña, Francisco, López Tarruella, Sara, Hernando Fernandez de Aranguiz, Blanca Ascensión, Boronat Ruiz, Laia, Martos Cardenas, Tamara, Chacón, José Ignacio, Moreno Antón, Fernando
Tipo de recurso: artículo
Estado:Versión publicada
Fecha de publicación:2024
País:España
Institución:Varias* (Consorci de Biblioteques Universitáries de Catalunya, Centre de Serveis Científics i Acadèmics de Catalunya)
Repositorio:Recercat. Dipósit de la Recerca de Catalunya
OAI Identifier:oai:recercat.cat:10230/69849
Acceso en línea:http://hdl.handle.net/10230/69849
http://dx.doi.org/10.1007/s10549-024-07287-w
Access Level:acceso abierto
Palabra clave:Advanced breast cancer
First-line treatment
HR+/HER2−
Overall survival
Palbociclib
Progression-free survival
Descripción
Sumario:Purpose: To evaluate the efficacy and safety of first-line therapy with palbociclib in a Spanish cohort treated after palbociclib approval. Methods: PALBOSPAIN is an observational, retrospective, multicenter study evaluating real-world patterns and outcomes with 1 L palbociclib in men and women (any menopausal status) with advanced HR+/HER2- BC diagnosed between November 2017 and November 2019. The primary endpoint was real-world progression-free survival (rw-PFS). Secondary endpoints included overall survival (OS), the real-world response rate (rw-RR), the clinical benefit rate, palbociclib dose reduction, and safety. Results: A total of 762 patients were included. The median rw-PFS and OS were 24 months (95% CI 21-27) and 42 months (40-not estimable [NE]) in the whole population, respectively. By cohort, the median rw-PFS and OS were as follows: 28 (95% CI 23-39) and 44 (95% CI 38-NE) months in patients with de novo metastatic disease, 13 (95% CI 11-17) and 36 months (95% CI 31-41) in patients who experienced relapse < 12 months after the end of ET, and 31 months (95% CI 26-37) and not reached (NR) in patients who experienced relapse > 12 months after the end of ET. rw-PFS and OS were longer in patients with oligometastasis and only one metastatic site and those with non-visceral disease. The most frequent hematologic toxicity was neutropenia (72%; grade ≥ 3: 52.5%), and the most common non-hematologic adverse event was asthenia (38%). Conclusion: These findings, consistent with those from clinical trials, support use of palbociclib plus ET as 1 L for advanced BC in the real-world setting, including pre-menopausal women and men. Trial registration number: NCT04874025 (PALBOSPAIN). Date of registration: 04/30/2021 retrospectively registered.

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