Browsing by Subject "Endocrine therapy"

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    Assessment of estrogen receptor low positive status in breast cancer: Implications for pathologists and oncologists
    (Universidad de Murcia, Departamento de Biologia Celular e Histiologia, 2021) Fusco, Nicola; Ragazzi, Moira; Sajjadi, Elham; Venetis, Konstantinos; Piciotti, Roberto; Morganti, Stefania; Santandrea, Giacomo; Fanelli, Giuseppe Nicolò; Despini, Luca; Invernizzi, Marco; Cerbelli, Bruna; Scatena, Cristian; Criscitiello, Carmen
    Estrogen receptor (ER) status assessment by immunohistochemistry (IHC) is the gold standard test for the identification of patients with breast cancer who may benefit from endocrine therapy (ET). Whilst most ER+ breast cancers have a high IHC score, about 3% of cases display a low positivity, with 1% to 10% of cells being weakly stained. These tumors are generally classified within the luminal-like category; however, their risk profile seems to be more similar to that of ERnegative breast cancers. The decision on ET for patients with a diagnosis of ER-low breast cancer should be carefully considered in light of the risks and possible benefits of the treatment. Potential pitfalls hinder pathologists and oncologists from establishing an appropriate threshold for "low positivity". Furthermore, several pre-analytical and analytical variables might trouble the pathological identification of these clinically challenging cases. In this review, we sought to discuss the adversities that can be accounted for the pathological identification of ER-low breast cancers in real-world clinical practice, and to provide practical suggestions for the perfect ER testing in light of the most updated recommendations and guidelines.
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    Overall survival with palbociclib plus endocrine therapy versus capecitabine in postmenopausal patients with hormone receptor-positive, HER2-negative metastatic breast cancer in the PEARL study
    (Elsevier, 2022-04-13) Martín, Miguel; Zielinski, Christoph; Ruiz-Borrego, Manuel; Carrasco, Eva; Ciruelos, Eva M.; Muñoz, Montserrat; Bermejo, Begoña; Margelí, Mireia; Csöszi, Tibor; Anton, Antonio; Turner, Nicholas; Casas, María I.; Morales, Serafín; Alba, Emilio; Calvo, Lourdes; Haba-Rodríguez, Juan de la; Ramos, Manuel; Murillo, Laura; Corsaro, Massimo; Xin, Huang; Thallinger, Christiane; Kahan, Zsuzsanna; Gil-Gil, Miguel; Medicina
    Background: An earlier analysis of the PEARL phase III study showed that palbociclib plus endocrine therapy (ET) does not improve progression-free survival (PFS) over capecitabine in aromatase inhibitor-resistant, hormone receptor-positive/human epidermal growth factor receptor 2-negative metastatic breast cancer (MBC) patients. Here, we report the final overall survival (OS) analysis. Methods: Postmenopausal patients (N = 601) were randomized 1:1 to capecitabine or palbociclib plus ET (exemestane, Cohort 1; fulvestrant, Cohort 2). OS was analysed in Cohort 2, the wild-type ESR1 population and the overall population. Additionally, we analysed subsequent systemic therapies and explored PFS2 (time from randomization to the end of the first subsequent therapy/death). Results: OS was 31.1 months for palbociclib plus fulvestrant and 32.8 months for capecitabine (adjusted hazard ratio [aHR] 1.10, 95% confidence interval [CI] 0.81–1.50, P = 0.550). In the wild-type ESR1 population, OS was 37.2 months for palbociclib plus ET and 34.8 months for capecitabine (aHR 1.06, 95% CI 0.81–1.37, P = 0.683). In OS analyses, no subgroup showed superiority for palbociclib plus ET over capecitabine. OS in the overall population was 32.6 months for palbociclib plus ET and 30.9 months for capecitabine (P = 0.995). Subsequent systemic therapy was given to 79.8% and 82.9% of patients with palbociclib plus ET and capecitabine, respectively. Median PFS2 was similar between study arms (Cohort 2, P = 0.941; wild-type ESR1 population, P = 0.827). No new safety findings were observed. Conclusions: Palbociclib plus ET did not show a statistically superior OS compared to capecitabine in MBC patients progressing on aromatase inhibitors.