First-line therapy with palbociclib in patients with advanced HR+/HER2- breast cancer : The real-life study PALBOSPAIN
Martinez-Jañez, Noelia (Hospital Universitario Ramón y Cajal (Madrid))
Bellet Ezquerra, Meritxell (Vall d'Hebron Institut d'Oncologia)
Manso, Luis (Hospital Universitario 12 de Octubre (Madrid))
Carrasco, F.H. (Hospital Universitario Virgen Macarena (Sevilla, Andalusia))
Torres, A.A. (Hospital Universitario Miguel Servet (Saragossa))
Morales, Serafin (Hospital Arnau de Vilanova - Lleida)
Tolosa, Pablo (Hospital Universitario 12 de Octubre (Madrid))
Gil, V.L.O. (ICO - Institut Català d'Oncologia l'Hospitalet)
Sampedro, T. (Hospital Universitario de Cabuenes)
Conejero, R.A. (Hospital Clínico Universitario "Lozano Blesa" de Zaragoza)
Calvo-Martinez, L. (CHUAC - Complexo Hospitalario Universitario A Coruña)
Galve-Calvo, E. (Hospital Universitario de Basurto (Bilbao, Biscaia))
López López, Rafael (Hospital Clínico Universitario e Instituto de Investigación Sanitaria-CIBERONC)
de la Pena, F.A. (Hospital General Universitario Morales Meseguer (Múrcia))
Lopez-Tarruella, S. (Hospital General Universitario Gregorio Marañón. Instituto de Investigación Sanitaria Gregorio Marañón (IiSGM))
de Araguiz, B.A.H.F. (Hospital General Yagüe (Burgos))
Ruiz, L.B. (Hospital de la Santa Creu i Sant Pau (Barcelona, Catalunya))
Cardenas, T.M. (Hospital del Mar (Barcelona, Catalunya))
Chacon, J.I. (Hospital Virgen de la Salud (Toledo))
Antón, F.M. (Hospital Clínico San Carlos (Madrid))
Universitat Autònoma de Barcelona

Fecha:	2024
Resumen:	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.
Derechos:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, fins i tot amb finalitats comercials, sempre i quan es reconegui l'autoria de l'obra original.
Lengua:	Anglès
Documento:	Article ; recerca ; Versió publicada
Materia:	Advanced breast cancer ; First-line treatment ; HR+/HER2- ; Overall survival ; Palbociclib ; Progression-free survival
Publicado en:	Breast Cancer Research and Treatment, Vol. 206 Núm. 2 (july 2024) , p. 317-328, ISSN 1573-7217

DOI: 10.1007/s10549-024-07287-w
PMID: 38561577

12 p, 2.2 MB

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