Palbociclib with adjuvant endocrine therapy in early breast cancer: 5-year follow-up analysis of the global multicenter, open-label, randomized phase III PALLAS trial (ABCSG-42/AFT-05/PrE0109/BIG-14-13)

Background: In the phase III PALLAS trial, the addition of 2 years of palbociclib to adjuvant endocrine therapy (ET) did not improve short-term invasive disease-free survival (iDFS) compared with ET alone in high-risk early-stage hormone receptor (HR)-positive/human epidermal growth factor receptor...

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Detalles Bibliográficos
Autores: Mayer, Erika L., Hlauschek, D., Gnant, Michael F. X., O'Brien, Peter J., Bellet Ezquerra, Meritxell, Goetz, Matthew P., Ruiz Borrego, Manuel, Chan, Andrew T., Clifton, K., Egle, D., Lake, D., Cabrera, P., Mamounas, T., Pristauz Telsnigg, G., Dayao, Z., Gil Gil, Miguel, Cameron, David A., Traina, Tiffany A., Morris, Patrick Glyn, Sabanathan, D., Rinnerthaler, Gabriel, Meisel, Jane Lowe, Prat Aparicio, Aleix, Wolff, A. C., Tseng, Lingming, Isaacs, Claudine, Singer, Christian F., Rubovszky, Gábor, Foukakis, Theodoros, Jassem, Jacek, Winer, Eric P., Vetter, Marcus, Federmann, J., Metzger Filho, Otto
Tipo de recurso: artículo
Estado:Versión publicada
Fecha de publicación:2026
País:España
Institución:Universidad de Barcelona
Repositorio:Dipòsit Digital de la UB
OAI Identifier:oai:dnet:ubarcelona__::6d0c3a16d1d2661c5da52d71df7ee298
Acceso en línea:https://hdl.handle.net/2445/229566
Access Level:acceso abierto
Palabra clave:Càncer de mama
Tractament adjuvant del càncer
Breast cancer
Adjuvant treatment of cancer
Descripción
Sumario:Background: In the phase III PALLAS trial, the addition of 2 years of palbociclib to adjuvant endocrine therapy (ET) did not improve short-term invasive disease-free survival (iDFS) compared with ET alone in high-risk early-stage hormone receptor (HR)-positive/human epidermal growth factor receptor 2 (HER2)-negative breast cancer. In this article, we report 5-year efficacy outcomes, including updated iDFS and overall survival (OS). Patients and methods: PALLAS is an international, open-label, randomized phase III trial evaluating the addition of 2 years of palbociclib to adjuvant ET in patients with stage II-III HR-positive/HER2-negative breast cancer. The primary endpoint was iDFS. Results: The trial enrolled 5753 patients, with 2883 randomized to receive palbociclib plus ET and 2870 to receive ET alone. With a median follow-up of 59.8 months, the 5-year iDFS was 84.2% [95% confidence interval (CI) 82.7% to 85.6%] in the palbociclib plus ET arm and 82.4% (95% CI 80.8% to 83.9%) in the ET-alone arm [hazard ratio (HR) 0.88, 95% CI 0.77-1.01, log-rank P = 0.0614]. No significant iDFS benefit of palbociclib was observed in any subgroup, including analyses by anatomic stage, T-stage, N-stage, tumor grade, prior (neo)adjuvant chemotherapy, age, or clinical risk. The 5-year OS was 92.6% (95% CI 91.5% to 93.6%) in the palbociclib plus ET arm and 93.2% (95% CI 92.1% to 94.1%) in the ET-alone arm (HR 1.09, 95% CI 0.89-1.33, log-rank P = 0.4051). More patients in the ET-alone arm (65.7%) than in the palbociclib plus ET arm (33.0%) received cyclin-dependent kinase 4/6 inhibitors after recurrence. Conversely, more patients in the palbociclib plus ET arm (52.5%) than in the ET-alone arm (41.0%) received chemotherapy after recurrence. Conclusions: In conclusion, 5-year follow-up from the PALLAS trial confirms initially reported results. These long-term findings will provide investigators with important benchmarks for clinical outcomes in the contemporary management of HR-positive/HER2-negative breast cancer, and may be further used to guide adjuvant therapy for patients with high-risk early-stage HR-positive/HER2-negative breast cancer.

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