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...
| Authors: | ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; |
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| 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 |
| _version_ | 1878729722603503616 |
|---|---|
| author | Martínez-Jáñez, Noelia |
| author2 | 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 |
| author2_role | author author author author author author author author author author author author author author author author author author author |
| author_browse | Andrés, Raquel Antón, Antonio Ayala de la Peña, Francisco Bellet, Meritxell Boronat Ruiz, Laia Calvo Martínez, Lourdes Chacón, José Ignacio Galve Calvo, Elena Henao Carrasco, Fernando Hernando Fernandez de Aranguiz, Blanca Ascensión López Tarruella, Sara López, Rafael Manso Sánchez, Luis Manuel Martos Cardenas, Tamara Martínez-Jáñez, Noelia Morales, Serafín Moreno Antón, Fernando Obadia Gil, Verónica Luisa Sampedro, Teresa Tolosa Ortega, Pablo |
| author_facet | 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 |
| author_role | author |
| collection | Repositorio Digital de la UPF |
| description | 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. |
| eu_rights_str_mv | openAccess |
| format | article |
| id | ES_0dacae64bf4dd2ba55df237b05f4e23d |
| institution | Universitat Pompeu Fabra |
| instname_str | Universitat Pompeu Fabra |
| network_acronym_str | ES |
| network_name_str | España |
| oai_identifier_str | oai:repositori.upf.edu:10230/69849 |
| publishDate | 2024 |
| publishDateSort | 2024 |
| publisher | Springer |
| publisherStr | Springer |
| reponame_str | Repositorio Digital de la UPF |
| spelling | First-line therapy with palbociclib in patients with advanced HR+/HER2- breast cancer: The real-life study PALBOSPAIN 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 Advanced breast cancer First-line treatment HR+/HER2− Overall survival Palbociclib Progression-free survival 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. Springer http://hdl.handle.net/10230/69849 http://dx.doi.org/10.1007/s10549-024-07287-w |
| spellingShingle | First-line therapy with palbociclib in patients with advanced HR+/HER2- breast cancer: The real-life study PALBOSPAIN Martínez-Jáñez, Noelia Advanced breast cancer First-line treatment HR+/HER2− Overall survival Palbociclib Progression-free survival |
| status_str | publishedVersion |
| title | First-line therapy with palbociclib in patients with advanced HR+/HER2- breast cancer: The real-life study PALBOSPAIN |
| title_full | First-line therapy with palbociclib in patients with advanced HR+/HER2- breast cancer: The real-life study PALBOSPAIN |
| title_fullStr | First-line therapy with palbociclib in patients with advanced HR+/HER2- breast cancer: The real-life study PALBOSPAIN |
| title_full_unstemmed | First-line therapy with palbociclib in patients with advanced HR+/HER2- breast cancer: The real-life study PALBOSPAIN |
| title_short | First-line therapy with palbociclib in patients with advanced HR+/HER2- breast cancer: The real-life study PALBOSPAIN |
| title_sort | First-line therapy with palbociclib in patients with advanced HR+/HER2- breast cancer: The real-life study PALBOSPAIN |
| topic | Advanced breast cancer First-line treatment HR+/HER2− Overall survival Palbociclib Progression-free survival |
| topic_facet | Advanced breast cancer First-line treatment HR+/HER2− Overall survival Palbociclib Progression-free survival |
| url | http://hdl.handle.net/10230/69849 http://dx.doi.org/10.1007/s10549-024-07287-w |