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DOI 10.1016/j.eclinm.2026.104242

Медицинская библиотека · EClinicalMedicine · 2026

Prognostic value of hormone receptor expression in patients with HR+/HER2- advanced BC treated with first-line ET+CDK4/6i: results from the multicentre observational, real-world PALMARES-2 study.

Ligorio Francesca, Provenzano Leonardo, Caputo Roberta, Vigneri Paolo, Giuliano Mario, Curigliano Giuseppe, Toss Angela, Botticelli Andrea, Pedersini Rebecca, Cinieri Saverio, Lambertini Matteo, Rizzo Gianpiero, Tagliaferri Barbara, Sirico Marianna, Giordano Monica, Gerratana Lorenzo, Meattini Icro, Piras Marta, Fabi Alessandra, Zambelli Alberto, Pantano Francesco, Gennari Alessandra, La Verde Nicla, Sartori Donata, Garrone Ornella, De Laurentiis Michelino, Calderaio Claudia, Buono Giuseppe, Luisa d'Aulisio Garigliota Maria, Cirillo Luisa, Guarneri Valentina, Bottosso Michele, Menichetti Alice, Griguolo Gaia, Armani Giovanna, Iacobucci Anthea, Coppola Giulia, Martorana Federica, Conti Chiara, Sanò Maria Vita, Arpino Grazia, Cantile Vincenza, Berton Giachetti Pier Paolo, Marra Antonio, Munzone Elisabetta, Ponzoni Ornella, Zaniboni Silvia, Verrico Monica, Cosentini Deborah, Lobefaro Riccardo, Chiappe Edoardo, Barletta Chiara, Lanzetta Irene, Montanari Daniela, Alaimo Domiziana, Tessitori Martina, Visani Luca, Tinterri Benedetta, Viale Giulia, Paris Ida, Guarino Alessandra, Pruneri Giancarlo, Dieci Maria Vittoria, Vernieri Claudio, PALMARES-2 group

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Аннотация

BACKGROUND

Endocrine therapy (ET) plus Cyclin Dependent Kinase 4/6 inhibitors (CDK4/6i) is the recommended first-line treatment for patients with Hormone Receptor-positive, Human Epidermal growth factor Receptor 2-negative advanced Breast Cancer (HR+/HER2- aBC). The prognostic value of the spectrum of Oestrogen Receptor (ERα) and Progesterone receptor (PgR) expression remains poorly investigated in this setting.

METHODS

We used updated data from the largest annotated dataset from the multicentre, real-world, Italian study PALMARES-2 (NCT06805812) to evaluate the association between ERα expression and real-world Progression-Free Survival (rwPFS), or time-to-chemotherapy (rwTTC), in patients with HR+/HER2- aBC treated with first-line ET plus CDK4/6/i. ERα expression was classified as low-intermediate (LI: 1-49%), high (H: 50-89%) or very-high (VH: 90-100%). We also assessed the prognostic value of combining PgR (<20% vs. ≥20%) and ERα expression. Multivariable Cox regression models were used to adjust associations for clinically relevant covariates.

FINDINGS: Among 4115 patients with available ERα assessment, 157 (3.8%) had ER-LI, 967 (23.5%) had ER-H and 2991 (72.7%) had ER-VH tumours. Median rwPFS and rwTTC increased progressively with increasing ERα expression (ER-LI: 10.6 and 14.3 months; ER-H: 20.5 and 29.9 months; ER-VH: 28.5 and 40.7 months, respectively; p < 0.001). PgR expression provided additional prognostic stratification, with patients with ER-VH/PgR-high tumours showing the longest median rwPFS (32.4 months, 95% CI 30.2-34.9), while those with ER-LI/PgR-low tumours had the shortest (8.3 months; 95% CI 6.9-12).

INTERPRETATION: Effectiveness of first-line ET plus CDK4/6i in patients with HR+/HER2- aBC worsens progressively with decreasing ERα expression, and PgR expression adds further prognostic discrimination, with low ERα and PgR expression identifying a subgroup of patients with particularly poor outcomes. Our findings, if confirmed by future studies, can help clinicians in personalising treatment choices and follow-up strategies in this clinical context.

FUNDING: PALMARES-2 is an academic investigator-initiated study partially supported by AstraZeneca/Daiichi Sankyo.

Для цитирования: Ligorio Francesca, Provenzano Leonardo, Caputo Roberta, Vigneri Paolo, Giuliano Mario, Curigliano Giuseppe, Toss Angela, Botticelli Andrea, Pedersini Rebecca, Cinieri Saverio, Lambertini Matteo, Rizzo Gianpiero, Tagliaferri Barbara, Sirico Marianna, Giordano Monica, Gerratana Lorenzo, Meattini Icro, Piras Marta, Fabi Alessandra, Zambelli Alberto, Pantano Francesco, Gennari Alessandra, La Verde Nicla, Sartori Donata, Garrone Ornella, De Laurentiis Michelino, Calderaio Claudia, Buono Giuseppe, Luisa d'Aulisio Garigliota Maria, Cirillo Luisa, Guarneri Valentina, Bottosso Michele, Menichetti Alice, Griguolo Gaia, Armani Giovanna, Iacobucci Anthea, Coppola Giulia, Martorana Federica, Conti Chiara, Sanò Maria Vita, Arpino Grazia, Cantile Vincenza, Berton Giachetti Pier Paolo, Marra Antonio, Munzone Elisabetta, Ponzoni Ornella, Zaniboni Silvia, Verrico Monica, Cosentini Deborah, Lobefaro Riccardo, Chiappe Edoardo, Barletta Chiara, Lanzetta Irene, Montanari Daniela, Alaimo Domiziana, Tessitori Martina, Visani Luca, Tinterri Benedetta, Viale Giulia, Paris Ida, Guarino Alessandra, Pruneri Giancarlo, Dieci Maria Vittoria, Vernieri Claudio, PALMARES-2 group. Prognostic value of hormone receptor expression in patients with HR+/HER2- advanced BC treated with first-line ET+CDK4/6i: results from the multicentre observational, real-world PALMARES-2 study.. EClinicalMedicine. 2026. DOI: 10.1016/j.eclinm.2026.104242.
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