Trastuzumab is the standard treatment in Canada for patients with breast cancer positive for her2 (human epidermal growth factor receptor 2), dramatically improving outcomes in that patient group. However, its current intravenous (iv) administration is associated with long infusion times that place a significant burden on health care resources and patient quality of life. In an effort to provide a faster and easier administration method, a subcutaneous (sc) formulation of trastuzumab has been developed. Data from comparative trials demonstrate that the two formulations are comparable with respect to pharmacokinetics and efficacy. They also have similar safety profiles, with the exception of mild local and administration reactions with the sc formulation. Furthermore, the sc formulation is preferred by patients and health care professionals, and greatly reduces administration and chair time. Additional advantages include easier preparation and dosing, reduced drug wastage, and reduced discomfort at the injection site. By using well-thought-out administration procedures, the sc formulation can be given safely and effectively, potentially reducing the burden on health care resources and improving quality of life for patients.
Background Recently, the COMPASS trial demonstrated that dual therapy reduced cardiovascular outcomes compared with aspirin alone in patients with stable atherosclerotic disease. Methods and Results We sought to assess the proportion of patients eligible for the COMPASS trial and to compare the epidemiology and outcome of these patients with those without COMPASS inclusion or with any exclusion criteria in a contemporary, nationwide cohort of patients with stable coronary artery disease (CAD). Among the 4068 patients with detailed information allowing evaluation of eligibility, 1416 (34.8%) did not fulfill the inclusion criteria (COMPASS-Not-Included), 841 (20.7%) had exclusion criteria (COMPASS-Excluded) and the remaining 1811 (44.5%) were classified as COMPASS-Like. At 1 year, the incidence of major adverse cardiovascular event (MACE), a composite of cardiovascular death, myocardial infarction and stroke, was 0.9% in the COMPASS-Not-Included and 2.0% in the COMPASS-Like (p = 0.01), and 5.0% in the COMPASS-Excluded group (p < 0.0001 for all comparisons). Among the COMPASS-Like population, patients with multiple COMPASS enrichment criteria presented a significant increase in the risk of MACE (from 1.0% to 3.3% in those with 1 and ≥3 criteria, respectively; p = 0.012), and a modest absolute increase in major bleeding risk (from 0.2% to 0.4%, respectively; p = 0.46). Conclusions In a contemporary real-world cohort registry of stable CAD, most patients resulted as eligible for the COMPASS. These patients presented a considerable annual risk of MACE that consistently increases in the presence of multiple risk factors.
In February 2021 a 28 years old woman presented with effort dyspnea. She refers a history of post caesarean section sepsis treated with antibiotic therapy. At TTE and following TEE: thickening of the interatrial septum, protruding neoformation in the left atrium as well as mitral valve steno–insufficency related to infiltration of the neoformation. The patient was then referred for cardiac surgery in Vicenza. The resection of the neoformation infiltrating the left atrium, interatrial septum, leaflet, annulus and papillary muscles of the mitral valve was performed (minithoracotomy). Finally valve replacement with Hanckock bioprosthesis no. 27 was performed. Extemporaneous histological examination showed a possible intimal sarcoma, which was subsequently confirmed (G3, IV stadium, MDM2+). At CT angiography evidence of vascular involvement (VCI and pulmonary vein) and possible secondary sites. The patient was referred to the regional reference centre (C.R.O. Aviano) where she was treated with six cycles of chemotherapy with EpiADM and Ifofosfamide, resulting in excellent remission of the tumour. At control PET/CT with FDG (01/22) substantial absence of disease. Intimal sarcoma (ISA) is an exceedingly rare undifferentiated sarcoma that arises in the pulmonary artery and less frequently in the aorta or its branches. ISAs behave highly aggressive with a mean patients’ survival ranging from 5 to 18 months. Patients with ISA are mostly of middle age at diagnosis and typically present with non–specific symptoms, which sometimes masquerades as thromboembolic disease. Thus, patients are often diagnosed in an advanced disease stage. Furthermore, ISAs are often reported to be resistant to conventional chemotherapy.
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