205 research outputs found
Spotlight on triptorelin in the treatment of premenopausal women with early-stage breast cancer
No full textMarta Venturelli,1 Giorgia Guaitoli,1 Claudia Omarini,1 Luca Moscetti2 1Division of Medical Oncology, Department of Medical and Surgical Sciences for Children & Adults, University Hospital of Modena, Modena, Italy; 2Division of Medical Oncology, Department of Oncology and Hematology, Azienda Ospedaliero Universitaria Policlinico di Modena, Modena, Italy Abstract: Endocrine treatment represents the cornerstone of endocrine-sensitive premenopausal early breast cancer. The estrogen blockade plays a leading role in the therapeutic management of hormone receptor-positive breast cancer together with surgery, radiotherapy, and selective antiestrogen treatments. For several years, selective estrogen receptor modulators, such as tamoxifen, have represented the mainstay of therapy. The role of amenorrhea has been extensively elucidated in the past year: the benefit observed with chemotherapy-induced amenorrhea has strengthened its therapeutic role. Luteinizing hormone-releasing hormone (LHRH) has been introduced in oncology practice to induce amenorrhea in order to increase the advantage obtained from endocrine treatment. Triptorelin is one of the most widely used LHRH analogs currently available in clinical practice. It was recently investigated in two major clinical trials that studied the role of complete estrogen blockade in the premenopausal setting. Both showed the clinical benefit due to ovarian suppression treatment, primarily in high-risk patients. Furthermore, triptorelin and other LHRH analogs have recently been investigated in the attempt to preserve the ovarian function in young patients. The medical treatment of early breast cancer is always evolving in the effort to search for safe and efficacious treatments. The role of LHRH analogs is actually well recognized as contributing to the improvement of the medical treatment of premenopausal women with early breast cancer. Keywords: adjuvant, hormone therapy, LHRH, amenorrhe
Palbociclib in a patient with HR+/HER2- advanced breast cancer and HIV1 infection: A case report
No full textThe use of drugs that affect the cell cycle represents one of the common strategies for the control of some unrelated pathologies, such as chronic viral HIV infections or cancer. The authors report the case of a patient followed for a hormone receptor-positive (HR+)/HER2 negative (HER2-) advanced breast cancer, treated with hormone therapy and CDK 4/6 inhibitors, and a concomitant HIV infection under antiretroviral treatment. The authors consider the function of the sterile alpha motif and HD domain-containing protein-1 (SAMHD1) enzyme, its implications in the control of viral replication and the correlation between its activity and the mechanism of action of the CDK 4/6 inhibitor palbociclib
Quality of life of therapies for hormone receptor positive advanced/metastatic breast cancer: Regulatory aspects and clinical impact in Europe
No full textIn recent years, the number of trials incorporating health-related quality of life (HRQoL) data has increased. The impact of HRQoL on regulatory decision making in the European context and on clinical practice is not well established. We conducted an analysis of the role of QoL data extracted from the clinical trials of the drugs approved for hormone receptor positive/HER2-negative advanced/metastatic breast cancer (mBC). The results from the HRQoL were collected and a meta-analysis was performed to evaluate the impact of experimental drugs compared to standard treatments. The results showed a non-detrimental effect in HRQoL from the new treatments. As regards the approval process, from an examination of the European Medicine Agency (EMA) documents, HRQoL was reported nonextensively and contained and discussed in the European assessment reports (EPARs) for eleven trials in the approval process and cited in three cases in the EPARs and summary of medicinal product characteristics (SmPC). An effort should be made by all the stakeholders to increase the visibility of the HRQoL results in order to allow increased consideration in the approval process to make QoL data more easily and visibly available for the clinician and the patients. The evaluation should be reflected in the SmPC in order to increase the amount of information provided to the physician
Management of winter cover crop residues under different tillage conditions affects nitrogen utilization efficiency and yield of eggplant (Solanum melanogena L.) in Mediterranean environment
No full textEfficient nitrogen (N) management is required for sustaining crop yield and minimizing environmental impacts. The aims of this study were to evaluate the effects of winter cover crops and their residue management on N-uptake, N use efficiency (NUE) and yield of the following eggplant (Solanum melanogena L.) crop. Two 2-year field experiments (2009/2010 and 2010/2011 growing seasons) were carried out in a Mediterranean environment of Central Italy in a Typic Xerofluvent soil. The treatments
consisted in: (a) three winter cover crops [hairy vetch (Vicia villosa Roth.), oat (Avena sativa L.), and oilseed rape (Brassica napus L.)] and one bare soil; (b) three cover crop residue managements [residues left in strips on soil surface (RS); residues incorporated into the soil at a depth of 10 cm in minimum tillage (MT) and residues incorporated into the soil at a depth of 30 cm in conventional tillage (CT)]. The cover crop
biomass characteristics, soil mineral N, SPAD readings, crop yield and N-uptake of eggplant were determined. At cover crop termination, hairy vetch showed the highest aboveground biomass and nitrogen content (6.18 Mg ha1 of DM and 3.1%, respectively) and the lowest value of C/N ratio (12.7). The mineralization rate of cover crop aboveground biomass was higher in hairy vetch (72%), intermediate in oilseed rape (63%) and lower in oat residues (49%), while it was slower in RS compared to MT and CT
among the residue managements. Yield, fruit and straw N-uptake of eggplant were high following hairy vetch (35.2 Mg ha1 of FM, 93.9 kg N ha1 and 78.3 kg N ha1, respectively) and low following oat (13.2 Mg ha1 of FM, 29.1 kg N ha1 and 33.6 kg N ha1, respectively). Similarly NUE was high in hairy vetch, followed by oilseed rape and oat (48.6, 19.4, 30.8%, respectively), even if RS residue management in hairy vetch and oat and MT residue management in oilseed rape proved to be more effective for
improving the eggplant yield and nitrogen utilization efficiency. The amount of residual N left in the soil, following eggplant cultivation, was higher in the hairy vetch than in oat and oilseed rape treatments. Cover crop species and their residue management strongly influenced NUE and yield of eggplant. Notillage strategy is preferable with legume cover crop residues in order to reduce the risks of N loss
Male mammary myofibroblastoma: Two case reports and brief review of literature
No full textMyofibroblastoma of the breast is a rare benign stromal tumor that occurs in both sexes with a higher prevalence in male breast of older populations. Furthermore, myofibroblastoma can arise in extra mammary sites, along the milk-line. A variety of morphological variants in addition to the classic type have been identified. The differential diagnosis includes both benign and malignant entities that, through the use of clinical and radiological imaging, is difficult to characterize. Histopathological examination and immunohistochemistry are fundamental in the establishment of appropriate management of the disease and avoidance of overtreatment. The present study focuses on two cases of male mammary myofibroblastoma, with a short literature review
Abstract OT1-03-03: Phase II, open label, randomized, biomarker study of immune-mediated mechanism of action of neoadjuvant subcutaneous trastuzumab in patients with operable or locally advanced/Inflammatory HER2-positive breast cancer. ImmunHER trial on behalf of the Gruppo Oncologico Italiano di Ricerca Clinica (GOIRC)
No full textAbstract
Background: Tumor-infiltrating lymphocytes (TILs) have been reported to be associated with increased therapeutic efficacy of trastuzumab in the (neo)adjuvant setting for HER2-positive breast cancer (BC). Subcutaneous (SC) trastuzumab has been observed to act at different immunologic levels than IV trastuzumab. Therefore, by modifying the modality of administration of trastuzumab, it could be possible to interfere with different pathways of the immune system and exert a favorable immunomodulation in HER2-positive BC.
Trial design: In this non-comparative, phase II, neoadjuvant, randomized study, patients will be treated with FEC chemotherapy (fluorouracil 500 mg/m2; epirubicin 75 mg/m2; cyclophosphamide 500 mg/m2) q21 for 3 cycles. Then, they will be randomly assigned in a 1:1 ratio to receive: docetaxel (75 mg/m2) plus pertuzumab (840 mg loading dose, then 420 mg) plus IV trastuzumab (8 mg/kg loading dose, then 6 mg/kg) q21 for 4 cycles (Group A) or, docetaxel plus pertuzumab plus SC trastuzumab (fixed dose of 600 mg) q21 for 4 cycles (Group B). After surgery, study patients will receive trastuzumab q21 x 14 cycles using the same formulation (SC or IV) of the preoperative phase.
Eligibility criteria: Patients must have previously untreated, T2-4d primary HER2-positive BC with no metastatic disease. Other inclusion criteria are: age 18 or older; ECOG performance status 0-1; availability of tumor tissue from diagnostic biopsy; normal left ventricular ejection fraction; normal organ and marrow function.
Specific aims: The main objective of this trial is to evaluate variations of host immune response parameters to either trastuzumab SC or trastuzumab IV given in combination with pertuzumab and chemotherapy as neoadjuvant treatment of patients with HER2-positive BC. Tumor samples obtained at diagnosis and at definitive surgery will be centrally analyzed for TILs. Blood samples will be also collected during study treatment for tumor-specific lymphocyte cell activity (TLA) analysis. Feasibility, efficacy, safety and health-related quality of life will be also evaluated.
Statistical methods: The primary endpoint is post-surgery pathologic TIL rate on residual disease. The threshold for classifying subjects with high TILs, or not, is defined as equal to 15%, according to the median TIL rate observed in primary HER2-positive tumors. Because this is a phase II study with 2 non-comparative arms, Simon's optimal 2-stage design will be used for each of the 2 study groups. For each arm we assume: p1 = 0.4, expected rate of subjects with high TILs on residual disease, p0 = 0.1, lowest limit of the subject rate (alpha= 0.05; beta= 0.20).
Present accrual and target accrual: A total of 60 patients (first stage: 16 patients) will be enrolled from multiple institutions. From November 29, 2016 to June 11, 2017, 34 patients have been recruited.
Contact information:Dr. Antonino Musolino, MD, MSc, PhD; Medical Oncology Unit, University Hospital of Parma; Tel: +390521702316; Fax: +390521995448; e-mail: [email protected]. Clinical Trials.gov: NCT03144947.
Citation Format: Musolino A, Gori S, Cavanna L, Graiff C, Frassoldati A, Bria E, Bisagni G, Zambelli A, Partesotti G, Brandes A, Bonetti A, Moscetti L, Zamagni C, Rocca A, Generali D, Montemurro F, Gianni L, Tognetto M, Maglietta G, Todeschini R. Phase II, open label, randomized, biomarker study of immune-mediated mechanism of action of neoadjuvant subcutaneous trastuzumab in patients with operable or locally advanced/Inflammatory HER2-positive breast cancer. ImmunHER trial on behalf of the Gruppo Oncologico Italiano di Ricerca Clinica (GOIRC) [abstract]. In: Proceedings of the 2017 San Antonio Breast Cancer Symposium; 2017 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2018;78(4 Suppl):Abstract nr OT1-03-03.</jats:p
Ocular Toxicity in Breast Cancer Management: Manual for The Oncologist
No full textOcular adverse events are common to many antineoplastic agents, although often misunderstood. In most cases, they are easily manageable, but sometimes they require instrumental diagnostics and specific treatments. There are currently no international guidelines for the management of these toxicities. In this review we summarized the main ocular adverse events related to the antineoplastic agents used in the treatment of breast cancer, analyzing their clinical presentation and management, trying to provide a useful tool to be used in clinical practice
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