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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Authors: 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
Format: Article
Status:Published version
Publication date:2024
Country:España
Institution:Universitat Pompeu Fabra
Repository:Repositorio Digital de la UPF
OAI Identifier:oai:repositori.upf.edu:10230/69849
Online Access:http://hdl.handle.net/10230/69849
http://dx.doi.org/10.1007/s10549-024-07287-w
Access Level:Open access
Keyword:Advanced breast cancer
First-line treatment
HR+/HER2−
Overall survival
Palbociclib
Progression-free survival
Summary: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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