Efficacy of fulvestrant in the treatment of postmenopausal women with endocrine-resistant advanced breast cancer in routine clinical practice

Blancas, Isabel; Fontanillas, Montserrat; Conde, V.; Lao, Juan; Martínez, E.; Sotelo, Miguel; Jaén, A.; Bayo, Juan; Carabantes, F.; Illarramendi, J.J.; Gordon, Maria; Cruz, Josefina; García‐Palomo, Andrés; Mendiola, C.; Pérez-Ruiz, Elísabeth; Bofill, Javier Salvador; Baena-Cañada, José Manuel; Jáñez, Noelia Martínez; Esquerdo, G.; Ruíz‐Borrego, Manuel

doi:10.1007/s12094-017-1797-9

Cited by 3 publications

(2 citation statements)

References 31 publications

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“…The available real-world experiences, although not fully comparable for population heterogeneity, treatment line, and clinical context, globally confirm that F500 is an effective and well-tolerated therapy for postmenopausal HR+/HER2− MBC. 30–34 The most recently reported study described a CBR of 61% on 160 patients treated with F500 in different lines, with a PFS of 7 months and an OS of 35 months; as in our experience, visceral involvement had a prognostic value for PFS, whereas endocrine sensitivity and upfront metastatic disease negatively correlated with OS. As expected, patients who had received previous first-line ET for advanced disease exhibited a worse outcome and a lower CBR, while patients with lower body mass index had a PFS advantage.…”

Section: Discussionsupporting

confidence: 71%

Patterns of treatment and outcome with 500-mg fulvestrant in postmenopausal women with hormone receptor-positive/HER2-negative metastatic breast cancer: a real-life multicenter Italian experience

et al. 2019

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Background: Fulvestrant 500 mg (F500) is the most active endocrine single agent in hormone receptor-positive (HR+)/HER2-negative metastatic breast cancer (MBC). Few data are available regarding the effectiveness of the drug in a real-world setting. Patients and methods: This prospective, multicenter cohort study aimed to describe the patterns of treatment and performance of F500 in a large population of unselected women with MBC, focusing on potential prognostic or predictive factors for disease outcome and response. The primary endpoints were progression-free survival (PFS) and clinical benefit rate. Results: From January 2011 to December 2015, 490 consecutive patients treated with F500 were enrolled. Overall, three different cohorts were identified and analyzed: the first received F500 after progression from previous chemotherapy (CT) or endocrine therapy; the second received the drug for de novo metastatic disease; and the third was treated as maintenance following disease stabilization or a response from a previous CT line. Median overall survival (OS) in the whole population was 26.8 months, ranging from 32.4 in first line to 22.0 and 13.7 months in second line and subsequent lines, respectively. Both the presence of liver metastasis and the treatment line were significantly associated with a worse PFS, while only the presence of liver metastasis maintained its predictive role for OS in multivariate analysis. Conclusions: The effectiveness of F500 was detected in patients treated both upon disease progression and as maintenance. The relevant endocrine sensitivity of 80% of patients included in the study could probably explain the good results observed in terms of outcome.

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Section: Discussionsupporting

confidence: 71%

Patterns of treatment and outcome with 500-mg fulvestrant in postmenopausal women with hormone receptor-positive/HER2-negative metastatic breast cancer: a real-life multicenter Italian experience

et al. 2019

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“…In the cohort of patients treated as 1st line in the MonaLEEsa-3 study mPFS in the Fulvestrant/placebo arm was 19 months, while in the control arms of 2nd/3rd line studies with CDK 4/6i and Fulvestrant, mPFS decreased to 9 and 4.6 months, respectively [15][16][17] . Similar data have been reported in patients treated with Fulvestrant in real-world series [18][19][20] .…”

Section: Discussionsupporting

confidence: 86%

Predictors of fulvestrant long-term benefit in hormone receptor-positive/HER2 negative advanced breast cancer

Torrisi

Vaira

Giordano

et al. 2022

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We retrospectively investigated in women treated with fulvestrant for HR+/HER2 negative advanced breast cancer clinical, pathological and molecular features associated with long-term benefit from treatment defined as being progression-free at 18 months. Specifically, we analyzed on formalin-fixed paraffin-embedded tumor samples ESR1 and PI3KCA mutations and miRNAs profiles. 59 patients were evaluable (median age of 67 years, range 32–92). 18-month PFS rate was 27%; the lack of visceral metastases significantly predicted the likelihood of being progression-free at 18 months, while PI3KCA mutations, found in 36% of patients, were not associated with 18-month PFS. As of miRNAs, miR-549a, miR-644a, miR-16-5p were negatively while let-7c-5p was positively associated with 18-month PFS. In addition, miR-520d-3p and miR-548g-3p values were significantly lower while miR-603, miR-181a-5p and miR-199a-miR-199b-3p values were significantly higher in patients achieving 18-month PFS. In silico analysis of targets modulated by these two latter groups of miRNAs show that in patients achieving 18-month PFS the Hippo and Wnt signaling pathways were predicted to be upregulated while endocrine resistance was potentially repressed by miR-603, miR-181a-5p and miR-199a-miR-199b-3p. Our results provide additional clues on the molecular mechanisms involved in fulvestrant activity and resistance. Underlying pathways should be further elucidated and confirmed in larger cohorts.

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The Evolving Complexity of Treating Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor-2 (HER2)-Negative Breast Cancer: Special Considerations in Older Breast Cancer Patients—Part II: Metastatic Disease

et al. 2020

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Efficacy of fulvestrant in the treatment of postmenopausal women with endocrine-resistant advanced breast cancer in routine clinical practice

Abstract: Fulvestrant 500 mg administered in clinical practice was shown to be effective (PFS, 10.6 months; CBR, 56.5%) and well tolerated, in accordance with previous trials.

Cited by 3 publications

References 31 publications

Patterns of treatment and outcome with 500-mg fulvestrant in postmenopausal women with hormone receptor-positive/HER2-negative metastatic breast cancer: a real-life multicenter Italian experience

Patterns of treatment and outcome with 500-mg fulvestrant in postmenopausal women with hormone receptor-positive/HER2-negative metastatic breast cancer: a real-life multicenter Italian experience

Predictors of fulvestrant long-term benefit in hormone receptor-positive/HER2 negative advanced breast cancer

The Evolving Complexity of Treating Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor-2 (HER2)-Negative Breast Cancer: Special Considerations in Older Breast Cancer Patients—Part II: Metastatic Disease

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