Comparative efficacy between real-world and randomized studies of palbociclib+endocrine therapy in HR-positive/HER2-negative metastatic breast cancer: systematic review and meta-analysis.

Background: Cyclin-dependent kinase 4/6 inhibitors (CDK4/6i) combined with endocrine therapy are the standard-of-care for hormone receptor-positive (HR+)/HER2-negative (HER2-) metastatic breast cancer (MBC). Palbociclib, the first approved CDK4/6i, significantly improved progression-free survival (PFS) in randomized controlled trials (RCTs). However, real-world (RW) outcomes may differ due to broader patient populations.

Management of trastuzumab deruxtecan-related adverse events in breast cancer: Italian expert panel recommendations.

Trastuzumab deruxtecan (T-DXd) - antibody - drug conjugate targeting the human epidermal growth factor receptor 2 (HER2) - has demonstrated high efficacy in clinical studies, with high rates of durable responses and improved outcomes in HER2-positive and HER2-low metastatic breast cancer (mBC) patients. T-DXd has demonstrated a generally manageable safety profile across the DESTINY trials, but there is an emerging unmet need for additional real-world clinical practice information. Italian experts conducted a Delphi panel and several roundtables to develop recommendations for the prevention and practical management of T-DXd-related AEs and toxicities, including nausea and vomiting (N/V), neutropenia, anemia, cardiovascular events, interstitial lung disease/pneumonitis (ILD/P), and treatment safety.

Trastuzumab plus lapatinib or chemotherapy in patients with HER2-overexpressed advanced breast cancer: a randomized, phase II trial (GIM12-TYPHER).

Background: Trastuzumab combined with chemotherapy is a standard treatment for human epidermal growth factor receptor 2 (HER2)-positive advanced breast cancer in later lines. Lapatinib and trastuzumab have also demonstrated efficacy. This study assessed the efficacy, toxicity, and quality of life (QoL) of trastuzumab plus lapatinib (with endocrine therapy for hormone receptor-positive cases) versus trastuzumab with physician-selected chemotherapy in patients previously treated with at least 2 anti-HER2 regimens.

The evolving landscape of hormone receptor-positive/HER2-negative metastatic breast cancer (EVOLVE): An Italian Delphi consensus report.

Background: The expanding treatment landscape for patients with hormone receptor-positive, HER2-negative (HR+/HER2-) metastatic breast cancer (mBC) has led to the emergence of new "grey areas" not covered by international guidelines, where treatment decision making is particularly challenging.

Methods: Sixteen relevant statements regarding the management of HR+ /HER2- mBC were formulated by an Executive Board and validated by a Scientific Board, composed by internationally recognized experts in the field of BC. Subsequently, 50 Italian oncologists were surveyed between May 2024 and June 2024 through the modified Delphi method, in order to capture their rate of agreement and disagreement on the proposed statements.

Survival Outcomes of Luminal Metastatic Breast Cancer Patients According to Changes in Molecular Subtype at Re-Biopsy: Insights from the GIM-13-AMBRA Study.

: The treatment of MBC patients is guided by receptor status, with re-biopsy at relapse recommended to reassess hormone receptor (HR) status. Various treatment options are available for HER2-veMBC, including CDK4/6 inhibitors, PARP inhibitors, and checkpoint inhibitors. The study highlights the importance of determining receptor subtype for guiding treatment choices.

Patient preferences for treatments in hormone receptor-positive/HER2-negative metastatic breast cancer in Italy: a discrete choice experiment study.

Hormone receptor (HR) positive (HR +) and human epidermal growth factor receptor 2 (HER2) negative (aka HER2 -) breast cancer (BC) is the most frequently diagnosed subtype. Recent development of next-generation endocrine therapies (e.g.

Delphi consensus on the management of adverse events in patients with metastatic triple-negative breast cancer treated with sacituzumab govitecan.

Background: Metastatic triple-negative breast cancer (BC; mTNBC) is one of the most aggressive cancers, difficult to treat due to the absence of hormone target receptors. Sacituzumab govitecan (SG) is a new therapeutic approach that exploits the combination of an antibody directed against the Trop-2 antigen expressed in solid epithelial tumors and the active metabolite SN-38, to precisely target cancer cells. The development of consensus recommendations requires synthesizing expert opinions, especially when direct evidence is limited.

Cardio-Oncology Challenges in Elderly Patients.

Along with the ageing of the population, cancer and cardiovascular (CV) diseases more frequently coexist, complicating patients' management. Here, we focus on elderly oncologic patients, describing clinical features and comorbidities, discussing therapeutic management CV risk factors and CV complications risen during our CV follow-up, and exploring the different items of the comprehensive geriatric assessment (CGA) and the correlation between cardiac function by means of standard 2D echocardiography and each of the CGA items. A total of 108 consecutive patients (mean age 73.

Multidisciplinary discussion on phenotypical characterization of metastatic breast cancer and patient pathway optimization from an expert panel across South Italian regions.

Breast cancer (BC) might change its receptor status during malignant progression, resulting in challenging clinical care. The project, developed during two residential meetings by expert Italian oncologists and pathologists, was aimed at optimizing metastatic BC management. A 17-point survey was administered to healthcare workers in centers of three regions, essentially to assess the perception of metastasis biopsy on treatment choice in different BC molecular subtypes, the appropriate timing for performing tissue and liquid biopsy in metastatic BC, the selection of target genes and the use of multidisciplinary approaches in tumour management.

Impact of Dietary Supplements on Clinical Outcomes and Quality of Life in Patients with Breast Cancer: A Systematic Review.

This systematic review aimed to evaluate the efficacy and safety of dietary supplements in breast cancer patients, focusing on their impact on clinical outcomes, treatment-related side effects, and therapy adherence. Only RCTs investigating the effects of various orally administered supplements in adult breast cancer patients were included. Well-defined substances like vitamins, minerals, antioxidants, and specific herbal extracts were explored.

Insights on the association of anthropometric and metabolic variables with tumor features and genomic risk in luminal early breast cancer: Results of a multicentric prospective study.

Background: Hormone receptor-positive (HR+)/HER2-negative (HER2-) early-stage breast cancers (EBC) are treated with adjuvant endocrine therapy (ET), with chemotherapy (CT) reserved for high-risk cases. Obesity is linked to increased recurrence risk. The Oncotype DX® assay predicts prognosis and CT benefit.

Prognostic implications of risk definitions from the monarchE and NATALEE trials.

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.

Clinico-pathological predictors of radiologic complete response to first-line anti-HER2 therapy in metastatic breast cancer.

This study aimed to identify the clinico-pathological variables predictive of radiologic complete response (rCR) to first-line anti-HER2 therapy in patients with HER2-positive metastatic breast cancer. Patients were selected from the database of the GIM14 study and classified according to the best radiologic response obtained to first-line anti-HER2 therapy and upon time-to-treatment-discontinuation (TTD). A total of 545 patients were included in the analysis.

Warming-up the immune cell engagers (ICEs) era in breast cancer: state of the art and future directions.

The advent of immune checkpoint inhibitors (ICIs) has deeply reshaped the therapeutic algorithm of triple-negative breast cancer (TNBC). However, there is considerable scope for better engagement of the immune system in other BC subtypes. ICIs have paved the way for investigations into emerging immunotherapeutic strategies, such as immune cell engagers (ICEs) that work by promoting efficient tumor cell killing through the redirection of immune system against cancer cells.

The journey of patients affected by metastatic hormone receptor-positive/HER2-negative breast cancer from CDK 4/6 inhibitors to second-line treatment: A real-world analysis of 701 patients enrolled in the GIM14/BIOMETA study.

Purpose: The aim of this study was to evaluate the effectiveness of CDK 4/6 inhibitors (CDK 4-6i) according to HER2 status (low/zero), and endocrine resistance/sensitivity, as well as the efficacy of second-line treatments, in a large real-world cohort.

Methods: The GIM14/BIOMETA study (NCT02284581) is a retrospective/prospective study of the Gruppo Italiano Mammella evaluating treatment patterns and survival outcomes in patients with metastatic breast cancer (MBC). We retrieved data on patients with hormone receptor-positive/HER2-negative MBC receiving first-line CDK 4/6i.

Measurement of resting energy expenditure and its accuracy in women with breast cancer.

Background & Aims: Breast cancer (BC) is frequently linked with obesity, metabolic syndrome, and sarcopenia. Therefore, measuring or accurately estimating resting energy expenditure (REE) is crucial for tailoring nutritional needs, managing weight and prevent under- or over-nutrition. We aimed to measure and compare REE between women with BC and a matched control group.

Parp-inhibitors in the therapeutic landscape of breast cancer patients with BRCA1 and BRCA2 pathogenic germline variants: An Italian consensus paper and critical review.

The introduction of PARP inhibitors has revolutionized the management and treatment of patients with pathogenic germline variants of BRCA1/2 who have developed breast cancer. The implementation of PARP inhibitors in clinical settings can be challenging due to their overlapping indications with other drugs, including both recently approved medications and those with proven efficacy. This study utilized the Delphi method to present the first Italian consensus regarding genetic testing, the use of PARP inhibitors in both early and metastatic settings, and strategies for managing the potential toxicity of these novel drugs.

Exploring the interplay between Kaposi's sarcoma and SARS-CoV-2 infection: A case series and systematic review.

Kaposi's sarcoma (KS) is an angio-proliferative disease with a viral etiology and a multifactorial pathogenesis that results from immune dysfunction. In patients affected by latent viral infections such as herpesviruses, SARS-CoV-2 infection may result in lytic cycle reactivation in host cells. A robust immune system response is crucial for eliminating pathogens and resolving both latent and non-latent viral infections.

Neoadjuvant Versus Adjuvant Systemic Therapy in Breast Cancer: A Matched Case-control Study.

Background/aim: Neoadjuvant systemic therapy (NAT) in breast cancer can make tumors resectable or reduce the extent of surgery needed for locally advanced cancers. It can also better prevent distant relapse and possibly modulate drug therapy by adjusting adjuvant therapy (AD) based on the response to NAT, either by escalating or de-escalating the treatment. However, clear evidence of improved outcomes is currently missing.

Monitoring changing patterns in HER2 addiction by liquid biopsy in advanced breast cancer patients.

Background: During targeted treatment, HER2-positive breast cancers invariably lose HER2 DNA amplification. In contrast, and interestingly, HER2 proteins may be either lost or gained. To longitudinally and systematically appreciate complex/discordant changes in HER2 DNA/protein stoichiometry, HER2 DNA copy numbers and soluble blood proteins (aHER2/sHER2) were tested in parallel, non-invasively (by liquid biopsy), and in two-dimensions, hence HER2-2D.

Exploring a Novel Approach to Spare Classic Chemotherapy in HER2-Low, ER-Positive Breast Cancer Based on Trastuzumab Deruxtecan Combined with Endocrine Therapy.

Background: Breast cancer presents diverse molecular subtypes affecting treatment strategies. Human epidermal growth factor receptor 2 (HER2)-low, hormone receptor-positive (HR+) breast cancer poses a challenge due to limited targeted therapies. Current neoadjuvant treatment primarily utilizes chemotherapy, with conflicting results regarding efficacy in patients with HER2-low breast cancer.