Comparative real-world progression free survival of CDK4/6 inhibitors in HR+/HER2− breast cancer patients with bone metastases

BACKGROUND: The introduction of CDK4/6 inhibitors (CDK4/6i) has improved outcomes in hormone receptor-positive (HR+)/HER2-negative metastatic breast cancer (mBC), including in patients with bone metastases. Assessing their comparative effectiveness in real-world settings is crucial. METHODS: This retrospective, multicenter cohort study (January 2019-December 2023; median follow-up 39 months) evaluated the real-world progression-free survival (rwPFS) of abemaciclib, ribociclib, and palbociclib combined with endocrine therapy (ET) in HR+/HER2- mBC patients with bone metastases. Overall survival (OS) was a secondary exploratory endpoint. A total of 1399 patients with ECOG PS 0-1 and at least 12 months of follow-up were included. Analyses used propensity score matching (PSM) and inverse probability of treatment weighting (IPTW) to adjust for confounding. RESULTS: Palbociclib showed shorter rwPFS (22 months) compared to abemaciclib (32 months; HR = 1.47, p = 0.001) and ribociclib (35 months; HR = 1.49, p < 0.001). No significant difference was observed between abemaciclib and ribociclib. OS was also lower with palbociclib (47 months) versus abemaciclib (60 months; HR = 1.77, p < 0.001) and ribociclib (64 months; HR = 1.69, p = 0.001). Results were consistent after PSM and IPTW adjustment. CONCLUSION: Ribociclib and abemaciclib may provide superior rwPFS and OS compared to palbociclib in HR+/HER2- mBC patients with bone metastases.

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Journal
The Oncologist
Published
2026-04-10
DOI
https://doi.org/10.1093/oncolo/oyag146
Primary Topic
Advanced Breast Cancer Therapies
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article
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article

Comparative real-world progression free survival of CDK4/6 inhibitors in HR+/HER2− breast cancer patients with bone metastases

Elisa Tiberi, Alessandra Chirco, Teresa Arcuri, Ornella Garrone et al.
The Oncologist
Advanced Breast Cancer Therapies
article

Comparative real-world progression free survival of CDK4/6 inhibitors in HR+/HER2− breast cancer patients with bone metastases

Elisa Tiberi, Alessandra Chirco, Teresa Arcuri, Ornella Garrone, Lorena Filomeno, Alessandra Guarino, Elisabetta Cretella, Michele Iuliani, Michelino De Laurentiis, Silvia Cavaliere, Simona Pisegna, Cristina Fiore, M. Mazzotta, Federica Villa, Sara Ramella, Azzurra Irelli, Luca Visani, Maria Grazia Rossino, Niccolò Bertini, Michela Palleschi, Annarita Verrazzo, Caterina Sposetti, Sonia Simonetti, Francesca Sofia Di Lisa, Claudia Piombino, Annalisa La Cesa, Paolo Orsaria, Edy Ippolito, Marianna Sirico, Barbara Tagliaferri, Roberta Scafetta, Luigia Stefania Stucci, Ilaria Bonaparte, Ilaria Portarena, Federica Domati, Matteo Vergati, Simone Foderaro, Maria Vittoria Bonomo, V. Ricozzi, L. Sisca, Federica Riva, Mauro Minelli, Delia De Lisi, Marta Piras, Agnese Fabbri, C. Porta, Sara D'Alessandro, Federica Puce, Antonella Grasso, Francesco Antonio Vilardi, Fabio Venuti, Elena Speziale, Claudio Vernieri, Andrea Botticelli, Vittorio Altomare, Bruno Vincenzi, Giuseppe Tonini, Icro Meattini, Patrizia Vici, Francesco Pantano, Orazio Caffo, Ugo De Giorgi, Roberta Caputo, Giuliana D'Auria, Angela Toss, Simone Scagnoli, Daniele Santini, Carmen Criscitiello, Rossana Berardi, Carla Gullotta, Luigi Rossi, Marco Donato, Stefania Gori, Giuseppe Curigliano, Raffaella Troiano, Alessio Cortellini, Giampaolo Bianchini, Rebecca Pedersini
article en

Abstract

BACKGROUND: The introduction of CDK4/6 inhibitors (CDK4/6i) has improved outcomes in hormone receptor-positive (HR+)/HER2-negative metastatic breast cancer (mBC), including in patients with bone metastases. Assessing their comparative effectiveness in real-world settings is crucial. METHODS: This retrospective, multicenter cohort study (January 2019-December 2023; median follow-up 39 months) evaluated the real-world progression-free survival (rwPFS) of abemaciclib, ribociclib, and palbociclib combined with endocrine therapy (ET) in HR+/HER2- mBC patients with bone metastases. Overall survival (OS) was a secondary exploratory endpoint. A total of 1399 patients with ECOG PS 0-1 and at least 12 months of follow-up were included. Analyses used propensity score matching (PSM) and inverse probability of treatment weighting (IPTW) to adjust for confounding. RESULTS: Palbociclib showed shorter rwPFS (22 months) compared to abemaciclib (32 months; HR = 1.47, p = 0.001) and ribociclib (35 months; HR = 1.49, p < 0.001). No significant difference was observed between abemaciclib and ribociclib. OS was also lower with palbociclib (47 months) versus abemaciclib (60 months; HR = 1.77, p < 0.001) and ribociclib (64 months; HR = 1.69, p = 0.001). Results were consistent after PSM and IPTW adjustment. CONCLUSION: Ribociclib and abemaciclib may provide superior rwPFS and OS compared to palbociclib in HR+/HER2- mBC patients with bone metastases.

The OncologistVol. 31(5)
University of Modena and Reggio Emilia (IT), Marche Polytechnic University (IT), University of Salento (IT), Vita-Salute San Raffaele University (IT), Università Campus Bio-Medico (IT), University of Milan (IT), University of Trento (IT), Leo Pharma (Australia) (AU), Azienda Ospedaliera San Giovanni Addolorata (IT), Policlinico Umberto I (IT), Martin University (US), Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico (IT), Ospedale Santa Chiara (IT), Ospedale di Bolzano (IT), Istituti Clinici Scientifici Maugeri (IT), Azienda Universitaria Ospedaliera Consorziale - Policlinico Bari (IT), Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IT), Ospedale Sacro Cuore Don Calabria (IT), Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (IT), Ospedale Papa Giovanni XXIII (IT), Azienda Ospedaliero-Universitaria di Modena (IT), Azienda Ospedaliero-Universitaria Careggi (IT), Dana-Farber Cancer Institute (US), Azienda Ospedaliera Sant'Andrea (IT), Ospedale di Belcolle (IT), Ospedale Sandro Pertini (IT), Dana-Farber/Harvard Cancer Center (US), Nini Hospital (LB), Policlinico Tor Vergata (IT), Campus Bio Medico University Hospital (IT), Tumori Foundation (US), Istituti di Ricovero e Cura a Carattere Scientifico (IT), Fondazione IRCCS Istituto Nazionale dei Tumori (IT), Maastro Clinic (NL), University of Florence (IT), University of Bari Aldo Moro (IT), European Institute of Oncology (IT), Sapienza University of Rome (IT)
Openalex Percentile: Top 21%
Advanced Breast Cancer Therapies
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