Publications by authors named "Nowecki Zbigniew"

Article Synopsis
  • The SERENA-2 trial investigates the efficacy of camizestrant, a new oral selective estrogen receptor degrader, compared to the traditional injectable SERD, fulvestrant, in treating advanced hormone receptor-positive breast cancer in post-menopausal women.
  • This phase 2 trial includes patients who have experienced disease progression after previous endocrine therapies and assesses different dosages of camizestrant against fulvestrant, focusing on progression-free survival rates as the primary outcome.
  • Conducted across 74 centers worldwide, the study also monitors the safety and side effects of the treatments among all participants who received at least one dose.
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  • * In a phase 3 trial involving 325 patients, those taking inavolisib had a median progression-free survival of 15.0 months, significantly better than the 7.3 months for the placebo group, indicating better disease management.
  • * The treatment with inavolisib showed promising results with a 58.4% objective response rate; however, there were notable side effects, similar between both groups, including high rates of neutropenia
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  • The study explores how low levels of HER2 expression affect breast cancer treatment outcomes and the success of hormone therapy in patients.
  • It analyzes data from a large international study called PALLAS, which included over 5,000 patients to see how HER2 status impacts survival rates and response to the drug palbociclib.
  • The research found that HER2-low levels are common and vary between countries, but HER2 status didn’t significantly change the success rate of hormone therapy in the patients.
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  • The study investigates the presence and burden of coronary artery calcium (CAC) in cancer patients undergoing anthracycline chemotherapy, assessing cardiovascular risks associated with cancer treatment.
  • A total of 80 patients were included, with most being diagnosed with breast cancer and categorized into moderate and high-risk groups for chemotherapy-related cardiovascular toxicity.
  • Results showed that high-risk patients had significantly higher CAC scores, elevated cardiac biomarkers, and more common diastolic dysfunction, despite similar left ventricle ejection fractions compared to moderate-risk patients.
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  • CAPItello-291 is a phase 3 clinical trial studying the effects of capivasertib combined with fulvestrant on progression-free survival in patients with advanced hormone receptor-positive, HER2-negative breast cancer who experienced relapse after aromatase inhibitors.
  • The trial involved a diverse group of participants, including both men and women aged 18 and older, and was conducted across 193 centers in 19 countries, focusing on those with a specific type of breast cancer and previous treatment history.
  • Researchers also assessed the impact of this treatment on quality of life, symptoms, and tolerability, aiming to analyze how the new combination therapy affects overall health and wellbeing beyond just cancer progression.
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<br><b>Introduction:</b> The use of meshes in mastectomies with immediate breast reconstruction (IBR) has become the gold standard.</br> <br><b>Aim:</b> The use of meshes in mastectomies with immediate breast reconstruction (IBR) has become a gold standard. The purpose of the study was to analyze the complications and own experience with the use of Serasynth fully absorbable and SeragynBR partially absorbable synthetic meshes.

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Triple-negative breast cancer (TNBC) poses a serious therapeutic challenge due to the occurrence of frequently aggressive, heterogenic, and metastatic tumours. The absence of therapeutic targets for traditional therapies is a hindrance to establishing a standardised therapy for TNBC. There is limited TNBCs epidemiological and real-world data about TNBC treatment regimens in Poland.

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Purpose: To compare giredestrant and physician's choice of endocrine monotherapy (PCET) for estrogen receptor-positive, HER2-negative, advanced breast cancer (BC) in the phase II acelERA BC study (ClinicalTrials.gov identifier: NCT04576455).

Methods: Post-/pre-/perimenopausal women, or men, age 18 years or older with measurable disease/evaluable bone lesions, whose disease progressed after 1-2 lines of systemic therapy (≤1 targeted, ≤1 chemotherapy regimen, prior fulvestrant allowed) were randomly assigned 1:1 to giredestrant (30 mg oral once daily) or fulvestrant/aromatase inhibitor per local guidelines (+luteinizing hormone-releasing hormone agonist in pre-/perimenopausal women, and men) until disease progression/unacceptable toxicity.

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Background: Ribociclib has been shown to have a significant overall survival benefit in patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer. Whether this benefit in advanced breast cancer extends to early breast cancer is unclear.

Methods: In this international, open-label, randomized, phase 3 trial, we randomly assigned patients with HR-positive, HER2-negative early breast cancer in a 1:1 ratio to receive ribociclib (at a dose of 400 mg per day for 3 weeks, followed by 1 week off, for 3 years) plus a nonsteroidal aromatase inhibitor (NSAI; letrozole at a dose of 2.

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Purpose: To search for new predictive breast cancer biomarkers. We analyzed the serum concentrations of biomarkers involved in carcinogenesis, which can also be targeted by therapy.

Methods: In a single-center prospective study, the serum levels of Aurora A, thymidine kinase 1, and human epidermal growth factor receptor type 3 (HER3) were determined in 119 women with BC before neoadjuvant treatment using ELISA kits.

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Background: Cardiological complications of oncological treatment, including the most serious one, heart failure, constitute a significant and still unsolved clinical problem. A history of dyslipidemia and complications of atherosclerosis, including coronary artery disease, are established risk factors for cardiotoxicity in cancer patients. In recent years, a protective effect of statin treatment on the development of heart failure in cancer patients has been observed.

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Improving the prognosis for patients with metastatic HR+/HER2- breast cancer remains an unmet need. Patients with tumors that have progressed on endocrine therapy and/or are not eligible for endocrine therapy had limited treatment options beyond chemotherapy. Antibody-drug conjugates are a novel and promising treatment class in this setting.

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Neoadjuvant systemic therapy has now become the standard in early breast cancer management. Chemotherapy in combination with trastuzumab +/- pertuzumab targeted therapy can improve the rates of pathologic complete response (pCR) in patients with HER2-positive breast cancer. Achieving a pCR is considered a good prognostic factor, in particular, in patients with more aggressive breast cancer subtypes such as TNBC or HER2-positive cancers.

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Purpose: We aimed to improve efficacy and reduce toxicity of high-risk human epidermal growth factor receptor 2 (HER2)-positive early breast cancer (EBC) treatment by replacing taxanes and trastuzumab with trastuzumab emtansine (T-DM1).

Methods: The phase III KAITLIN study (NCT01966471) included adults with excised HER2-positive EBC (node-positive or node-negative, hormone receptor-negative, and tumor > 2.0 cm).

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Purpose: Palbociclib is a cyclin-dependent kinase 4 and 6 inhibitor approved for advanced breast cancer. In the adjuvant setting, the potential value of adding palbociclib to endocrine therapy for hormone receptor-positive breast cancer has not been confirmed.

Patients And Methods: In the prospective, randomized, phase III PALLAS trial, patients with hormone receptor-positive, human epidermal growth factor receptor 2-negative early breast cancer were randomly assigned to receive 2 years of palbociclib (125 mg orally once daily, days 1-21 of a 28-day cycle) with adjuvant endocrine therapy or adjuvant endocrine therapy alone (for at least 5 years).

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Purpose: PI3K/AKT pathway alterations are frequent in hormone receptor-positive (HR+) breast cancers. IPATunity130 Cohort B investigated ipatasertib-paclitaxel in PI3K pathway-mutant HR+ unresectable locally advanced/metastatic breast cancer (aBC).

Methods: Cohort B of the randomized, double-blind, placebo-controlled, phase 3 IPATunity130 trial enrolled patients with HR+ HER2-negative PIK3CA/AKT1/PTEN-altered measurable aBC who were considered inappropriate for endocrine-based therapy (demonstrated insensitivity to endocrine therapy or visceral crisis) and were candidates for taxane monotherapy.

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Background: Poly(adenosine diphosphate-ribose) polymerase inhibitors target cancers with defects in homologous recombination repair by synthetic lethality. New therapies are needed to reduce recurrence in patients with or germline mutation-associated early breast cancer.

Methods: We conducted a phase 3, double-blind, randomized trial involving patients with human epidermal growth factor receptor 2 (HER2)-negative early breast cancer with or germline pathogenic or likely pathogenic variants and high-risk clinicopathological factors who had received local treatment and neoadjuvant or adjuvant chemotherapy.

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Purpose: Intravenous trastuzumab, pertuzumab, and docetaxel are first-line standard of care for patients with HER2-positive metastatic breast cancer (mBC). MetaPHER is the first study assessing the safety and tolerability of subcutaneous trastuzumab plus intravenous pertuzumab and chemotherapy in a global patient population with HER2-positive mBC.

Methods: In this open-label, single-arm, multicenter, phase 3b study, eligible patients were ≥ 18 years old with histologically/cytologically confirmed previously untreated HER2-positive mBC.

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Background: Palbociclib added to endocrine therapy improves progression-free survival in hormone-receptor-positive, HER2-negative, metastatic breast cancer. The PALLAS trial aimed to investigate whether the addition of 2 years of palbociclib to adjuvant endocrine therapy improves invasive disease-free survival over endocrine therapy alone in patients with hormone-receptor-positive, HER2-negative, early-stage breast cancer.

Methods: PALLAS is an ongoing multicentre, open-label, randomised, phase 3 study that enrolled patients at 406 cancer centres in 21 countries worldwide with stage II-III histologically confirmed hormone-receptor-positive, HER2-negative breast cancer, within 12 months of initial diagnosis.

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Article Synopsis
  • A new subcutaneous formulation combining pertuzumab, trastuzumab, and hyaluronidase was approved by the FDA in June 2020 for treating HER2-positive early breast cancer.
  • The FeDeriCa study tested this formulation against the traditional intravenous method in a large-scale, international trial involving patients with operable breast cancer.
  • The study aimed to evaluate the pharmacokinetics, efficacy, and safety of the new treatment approach in a neoadjuvant-adjuvant setting, offering insights into both methodologies' effectiveness.
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Background: Pembrolizumab monotherapy showed durable antitumour activity and manageable safety in patients with metastatic triple-negative breast cancer. We aimed to examine whether the addition of pembrolizumab would enhance the antitumour activity of chemotherapy in patients with metastatic triple-negative breast cancer.

Methods: In this randomised, placebo-controlled, double-blind, phase 3 trial, done in 209 sites in 29 countries, we randomly assigned patients 2:1 with untreated locally recurrent inoperable or metastatic triple-negative breast cancer using a block method (block size of six) and an interactive voice-response system with integrated web-response to pembrolizumab (200 mg) every 3 weeks plus chemotherapy (nab-paclitaxel; paclitaxel; or gemcitabine plus carboplatin) or placebo plus chemotherapy.

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Germline and mutations confer an increased lifetime risk for breast cancer and ovarian cancer. Several studies have investigated prognosis among mutation carriers and noncarriers, but the prognostic impact on outcomes of breast cancer patients has not been determined. The aim of this study was to determine the prognosis of TNBC patients with and without germline mutation.

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Introduction: Breast cancer is responsible for more than 50% of cutaneous metastases. One of the treatment options is electrochemotherapy (ECT). It is an effective method of local tumor ablation through the application of electroporation.

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Purpose This phase III study compared SB3, a trastuzumab (TRZ) biosimilar, with reference TRZ in patients with human epidermal growth factor receptor 2-positive early breast cancer in the neoadjuvant setting ( ClinicalTrials.gov identifier: NCT02149524). Patients and Methods Patients were randomly assigned to receive neoadjuvant SB3 or TRZ for eight cycles concurrently with chemotherapy (four cycles of docetaxel followed by four cycles of fluorouracil, epirubicin, and cyclophosphamide) followed by surgery, and then 10 cycles of adjuvant SB3 or TRZ.

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