Publications by authors named "Elisa Agostinetto"

Background: Routine brain imaging screening (BIS) in patients with metastatic breast cancer (BC) without neurological symptoms is currently not recommended, as no survival/quality-of-life improvements have been demonstrated. We aimed to examine physicians and patients' attitudes and perceptions toward BIS.

Methods: International cross-sectional online survey for patients and physicians, distributed from May 2023 to February 2024.

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Background: Disparities in breast cancer (BC) prevention, screening, treatment access, and survival based on ethnicity have been described. Data in Arab population are limited. We aimed to dissect differences in BC characteristics and outcomes among patients of Maghreb versus non-Maghreb origin.

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Background: We investigated safety of breastfeeding after breast cancer in patients carrying germline BRCA pathogenic or likely pathogenic variants.

Methods: This was an international, multicentre, hospital-based, retrospective cohort study including BRCA carriers diagnosed with stage I-III invasive breast cancer at age 40 years or younger between January 2000 and December 2020 (NCT03673306). Locoregional recurrences and/or contralateral breast cancers, disease-free survival (DFS) and overall survival (OS) were compared between patients who breastfed after delivery and those who did not.

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Background: An anthracycline-free regimen of adjuvant paclitaxel and trastuzumab is the standard-of-care for patients with HER2-positive (HER2+) early breast cancer (eBC) with tumors ≤20 mm, node-negative tumors, based on the results of a single-arm phase II trial. We investigated the outcomes of this regimen in a real-world (RW) setting.

Methods: This retrospective, international RW study included patients with stage I HER2+ eBC treated with the APT regimen (tumors of 5-20 mm, node-negative (N0 or Nmi) and no previous history of BC).

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Background: Body mass index (BMI) may affect prognosis in patients with breast cancer (BC). We assessed the association of BMI and weight changes with outcomes of patients with HER2-positive early BC included in the APHINITY trial.

Methods: This is an exploratory analysis of APHINITY (NCT01358877), randomized trial testing adjuvant dual vs.

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Background: Little evidence exists on the effect of risk-reducing surgeries in young BRCA carriers with a previous history of breast cancer. We investigated the association between risk-reducing mastectomy (RRM) or risk-reducing salpingo-oophorectomy (RRSO), or both procedures, with survival outcomes in a large global cohort of young BRCA carriers with previous breast cancer.

Methods: The BRCA BCY Collaboration is an international, hospital-based, retrospective cohort study, conducted at 109 centres in five continents, including women harbouring germline BRCA1, BRCA2, or both, pathogenic or likely pathogenic variants and diagnosed with stage I-III invasive breast cancer at the age of 40 years or younger between Jan 1, 2000, and Dec 31, 2020.

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Introduction: Very limited data exist on assisted reproductive technology (ART) use in BRCA1/2 carriers conceiving after breast cancer. This study aimed to investigate the safety of ART to achieve a pregnancy after breast cancer in BRCA1/2 carriers.

Methods: This is an international, hospital-based, retrospective cohort study including BRCA1/2 carriers with a pregnancy after prior breast cancer diagnosis at ≤ 40 years of age between 2000 and 2020.

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Purpose: There is evidence that statins might improve the outcome of patients with breast cancer. The role of statins in patients with early HER2-positive breast cancer is unknown. Therefore, we explored the association between statin use and survival outcomes in early HER2-positive breast cancer patients in the phase III APHINITY trial (adjuvant pertuzumab/trastuzumab).

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Background: Leptomeningeal metastases (LM) in patients with breast cancer (BC) are associated with a dismal prognosis. We explored clinical characteristics and prognostic factors in patients with BC and LM in the German Brain Metastases in Breast Cancer Registry.

Methods: All patients with histologically confirmed BC and diagnosis of LM (defined as the presence of tumor cells in the cerebrospinal fluid, or presence of typical clinical symptoms in combination with typical magnetic resonance imaging findings) were included.

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Purpose: To investigate the clinical behavior of breast cancer in young carriers according to the specific gene () and the association of the timing of genetic testing (before at diagnosis) with prognosis.

Methods: This was an international, multicenter, hospital-based, retrospective cohort study that included 4,752 patients harboring germline pathogenic/likely pathogenic variants (PVs) in or , who were diagnosed with stage I-III invasive breast cancer at 40 years or younger between January 2000 and December 2020 in 78 centers worldwide (ClinicalTrials.gov identifier: NCT03673306).

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Background: The monarchE and NATALEE trials employed different high-risk inclusion criteria. The main objective is to assess prognostic differences based on their inclusion criteria.

Methods: Patients with hormone receptor-positive/HER2-negative early breast cancer enrolled in the phase III Mammella InterGruppo (MIG) 1, Gruppo Italiano Mammella (GIM) 2, and GIM3 trials were categorized as high-risk cohort (HRC) and low-risk cohort (LRC) according to the inclusion criteria of monarchE and NATALEE trials.

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Patients with human epidermal receptor 2 (HER2)-positive breast cancer are experiencing a consistent shift toward better survival across the years, thanks to tremendous advancements in treatment strategies. The consistent improvements of outcomes set a high bar for new drug development and the need to explore new ways to overcome resistance mechanisms. Emerging treatments in HER2-positive breast cancer aim to tackle the disease by acting on different targets, including not only HER2 (both at the extra- and intracellular level), but also HER3, PD-(L)1, CTLA4, NKG2A, AKT, PI3K, and, in triple-positive tumors, the estrogen receptors and the cyclin-dependent kinases 4/6.

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Article Synopsis
  • Breast cancer (BC) is rare in women aged ≤40 years with BRCA1/2 variants, but it often presents aggressive features; recent studies show HER2-low expression as a potential treatment target in this subset.
  • A study analyzed data from 3,547 young women with newly diagnosed HER2-negative BC, finding that 32.3% exhibited HER2-low status, which was more common in hormone receptor-positive and BRCA2 variant cases.
  • Results indicated that HER2-low BC had better disease-free survival (DFS) and overall survival (OS) compared to HER2-0, particularly in triple-negative tumors, with lower grades and more favorable outcomes linked to BRCA2 variants.
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Introduction: The CLEOPATRA trial (NCT00567190) established a dual anti-HER2 blockade in combination with docetaxel as the first-line standard of care for patients with metastatic HER2-positive breast cancer. While this treatment is overall associated with significant improvement in progression-free survival (PFS) and overall survival (OS), not all patients respond equally. We hypothesized that a radiological complete response (CR) at week 9 (i.

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Background: Cyclin-Dependent Kinase 4/6 inhibitors (CDK4/6i) combined with Endocrine Therapy (ET) are the standard treatment for patients with Hormone Receptor-positive/HER2-negative advanced breast cancer (HR+/HER2- aBC).

Objectives: While CDK4/6i are known to reduce several peripheral blood cells, such as neutrophils, lymphocytes and platelets, the impact of these modulations on clinical outcomes is unknown.

Design: A multicenter, retrospective-prospective Italian study.

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Introduction: In randomized clinical trials (RCTs), blinded independent central review (BICR) is used to minimize heterogeneity and bias associated with radiological response evaluation by local investigators. However, BICR adds costs and complexity to the trial management. We assessed the discrepancy index between progression-free survival (PFS) assessment by local investigators and by BICR in RCTs conducted in patients with metastatic breast cancer (MBC).

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Importance: Young women with breast cancer who have germline pathogenic variants in BRCA1 or BRCA2 face unique challenges regarding fertility. Previous studies demonstrating the feasibility and safety of pregnancy in breast cancer survivors included limited data regarding BRCA carriers.

Objective: To investigate cumulative incidence of pregnancy and disease-free survival in young women who are BRCA carriers.

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Article Synopsis
  • Luminal B breast cancer has a poorer prognosis and lower sensitivity to chemotherapy compared to Luminal A, leading to a clinical trial (Neo-CheckRay) that explores combining stereotactic body radiation therapy (SBRT) with the drug oleclumab to enhance treatment effectiveness.
  • The safety run-in of the trial involved six patients receiving a neo-adjuvant treatment regimen, including chemotherapy and immunotherapy, followed by SBRT directed at the primary tumor before surgery.
  • Results showed that the treatment was generally well-tolerated with only one minor adverse event reported, and all patients successfully completed their treatments with surgery occurring 2-4 weeks afterward.
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Chemo-immunotherapy is the first-line standard of care for patients with PD-L1 positive metastatic triple-negative breast cancer (mTNBC). SYNERGY (NCT03616886) is a dose-finding phase I and a randomized phase II, open-label trial evaluating if targeting the immunosuppressive adenosine pathway can enhance the antitumor activity of chemo-immunotherapy. The phase I part included 6 patients with untreated locally-advanced or mTNBC to determine the safety and recommended phase II dose of the anti-CD73 antibody oleclumab in combination with the anti-PD-L1 durvalumab and 12 cycles of weekly carboplatin and paclitaxel.

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Article Synopsis
  • - The HER2-enriched intrinsic subtype accounts for around 75% of HER2-positive, hormone receptor-negative breast cancer, and optimizing therapy in this group may reduce the need for toxic anthracycline chemotherapy
  • - The DECRESCENDO trial (NCT04675827) is a major phase II study focusing on early HER2-positive, HR-negative breast cancer, testing a combination of pertuzumab and trastuzumab with chemotherapy before proceeding to adjuvant treatment
  • - The main goal of the trial is to assess the 3-year recurrence-free survival rate and offers a unique care model allowing some patients to receive their post-surgery treatment outside the hospital setting
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Up to 20% of breast cancer overexpress HER2 protein, making it a reliable target for antibody-based treatments. In early HER2-positive breast cancer avoiding anthracycline-based chemotherapy is a challenge. Based on the single-arm phase II APT trial results, adjuvant paclitaxel/trastuzumab is an accepted regimen for patients with stage I HER2-positive disease.

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