Hormone-receptor positive (HR+), Human-Epidermal-growth Factor negative (HER2-) breast cancer, including the Luminal A and the Luminal B subtypes, is the most common in women diagnosed with ...early-stage BC. Despite the advances in screening, surgery and therapies, recurrence still occurs. Therefore, it is important to identify early those factors that significantly impact the recurrence risk. Based on current evidence and their professional expertise, a Panel of oncologists discussed the definition of high risk of recurrence in early breast cancer. Histological grade, nodal involvement, genomic score, histological grade, tumor size, and Ki-67 proliferation index were rated as the most important factors to define the high risk in patients with early breast cancer. All these factors should be considered comprehensively to tailor the choice of treatment to the peculiar characteristics of each patient.
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•Recurrence still occurs in early HR+ HER2- breast cancer.•Determination of recurrence risk is required to optimize the therapeutic approach.•Histological grade and nodal involvement are the most important factors.•Genomic score, Ki-67, and tumor size are also relevant to define the risk.
Purpose
The VICTOR-1 study demonstrated that the all-oral metronomic combination of vinorelbine and capecitabine is highly active and well tolerated in hormone receptor-positive/HER2-negative ...patients. The VICTOR-2 study was designed to confirm these results.
Methods
Patients received mVNR 40 mg three times a week and mCAPE 500 mg three times a day, continuously. The primary endpoint was the clinical benefit rate (CBR); secondary endpoints were toxicity, objective response rate (ORR), and progression-free survival (PFS).
Results
Eighty patients were evaluable for the primary efficacy analysis. Median age was 65.3 years; most patients had HR-positive tumors (65 %). The CBR was 45.7 % (95 % CI 28.8–63.4) and 51.1 % (95 % CI 35.8–66.3) in first- and ≥ second-line therapy, respectively. The ORR was 35.5 % in first-line (95 % CI 19.2–54.6) and 25.6 % in ≥second-line (95 % CI 13.5–41.2). The median duration of response was 11.3 and 6.4 months and PFS rates at 1 year were 24.3 and 22.2 %, respectively. In triple-negative breast cancer patients (
N
= 28, 35 %) a lower, but clinically relevant CBR (35.7, 95 % CI 18.6–55.9) was observed. The main toxicities per cycle were non-febrile neutropenia (1.1 %), hand-foot syndrome (1.0 %), nausea and vomiting (1.0 %), leucopenia (0.8 %), fatigue (0.7 %), and diarrhea (0.4 %).
Conclusion
The VICTOR-2 study confirms the clinical activity of mVNR and mCAPE in HER2-negative breast cancer patients, suggesting that the easy schedule of administration, which requires monthly blood tests and limits patients’ dependence on hospitals, and the low cost of the drugs are valuable elements, even for countries with limited access to innovative or expensive drugs.
Background: The incidence of breast cancer increases with age, and the disease affects many older women; however, attitudes about prevention and treatment of breast cancer vary based on the patient's ...age. Older women have less access to clinical trials and fewer opportunities for treatment with innovative therapies. The National Oncological Research observatory on Adjuvant therapy in breast cancer (NORA) study was a cohort study designed to obtain information about adjuvant strategies for treatment of breast cancer after surgery, patterns of recurrence, and possible correlations between cancer-related events and biological factors. Patients and methods: This report describes patient characteristics, disease status, and local and systemic adjuvant treatments in a population of breast cancer patients aged ≥65 years. The NORA study consecutively enrolled >3500 patients from 2000 through 2002 at 77 Italian hospitals; of these, 1085 were aged ≥65 years. Data on patient characteristics, cancer presentation, and treatments were analyzed to identify possible relationships between these factors and age. Results: The findings indicate that age is significantly related to later diagnosis and different patterns of treatment. Choice of adjuvant systemic treatment was primarily related to hormone receptor status and tumor stage but was strongly influenced by the patient's age; there was a proportional relationship between endocrine treatment and increasing age. Cyclophosphamide, methotrexate, and 5-fluorouracil as well as anthracyclines were widely used, but the use of taxanes was limited to a very small percentage of patients. Conclusions: The findings of the NORA study may help to change attitudes that currently exclude a significant proportion of breast cancer patients from secondary prevention policies, more active treatment strategies, and clinical research trials based on age.
The prognosis for patients with locally advanced or metastatic breast cancer (mBC) remains poor, with a median survival of 2-4 years. About 10% of newly diagnosed breast cancer patients present with ...metastatic disease, and 30%-50% of those diagnosed at earlier stages will subsequently progress to mBC. In terms of ongoing management for advanced/metastatic breast cancer after failure of hormonal therapy, there is a high medical need for new treatment options that prolong the interval to the start of intensive cytotoxic therapy, which is often associated with potentially serious side effects and reduced quality of life. Oral chemotherapeutic agents such as capecitabine and vinorelbine have demonstrated efficacy in patients with mBC, with prolonged disease control and good tolerability. Use of oral chemotherapy reduces the time and cost associated with treatment and is often more acceptable to patients than intravenous drug delivery. Metronomic administration of oral chemotherapy is therefore a promising treatment strategy for some patients with mBC and inhibits tumor progression via multiple mechanisms of action. Ongoing clinical trials are investigating metronomic chemotherapy regimens as a strategy to prolong disease control with favorable tolerability. This article provides an overview of metronomic chemotherapy treatment options in mBC, with perspectives on this therapy from a panel of experts.
The severe acute respiratory syndrome coronavirus 2 pandemic has dominated the global health scenario from the beginning of 2020 and still represents a major health emergency. Cytokine inhibitors as ...tocilizumab have been used to treat COVID-19 severe pneumonia with conflicting results. We performed a retrospective study whose results can contribute to the general overview regarding the role of these agents in severe COVID-19 pneumonia, suggesting an interesting, even not statistically significant evidence of the effectiveness of tocilizumab treatment in this disease and sow a seed of reflection about their use in future waves of pandemic. We compared two cohorts of patients treated with local standard of care and with tocilizumab in the experimental one. With a median follow-up of 92 days, deaths were 6 and 16 in the tocilizumab and the standard of care group, respectively. With a longer follow-up than previous studies, a trend in difference with regards to mortality of the groups was observed.
Background: Despite recommendations contained in international guidelines, factors such as the type of oncology centre, geographic distribution and the introduction of scientific advances into ...clinical practice can influence the choice of recommended treatment for early breast cancer. The NORA study is a prospective, longitudinal cohort study aimed at investigating tumour characteristics, treatment modalities, and other factors that influence therapeutic choices in early breast cancer patients who have undergone mastectomy or breast-conserving surgery (BCS). Patients and methods: From January 2000 to early 2004, we collected data on methods of cancer diagnosis, type of surgery and adjuvant medical treatment administered to the first 10 consecutive patients treated in 2000–2002 and the first 20 consecutive patients in 2003 and 2004 at 71 oncology centres in Italy, with the approval of the ethical committee at each centre. Results: Approximately one-quarter of the cases (26.5%) were detected through screening programmes. BCS was performed in 63.7% and sentinel node biopsy (SNB) occurred in 11.1% of the patients. Of the 3515 total cases, 56.5% were node-negative. Grade 2 cancers comprised 51.3%, and 66.2% were hormone-receptor positive (ER+/PgR+). Chemotherapy (CHT) followed by hormone therapy (HT) was the most prescribed treatment (48.5%). CHT was mainly anthracycline-based (52.9%) and most patients received tamoxifen alone (77.7%) or after CHT (85.2%). For node-negative patients, HR+ and menopause status are the factors influencing the choice to add HT after CHT; patients with HR+ and pT4 tumours are more likely to receive HT instead of CHT. In node-positive patients, the addition of HT is influenced by HR+ status, the opportunity to have HT instead of CHT, and menopause. Conclusions: NORA is the first large cohort study to describe the factors that influence therapeutic choices in early breast cancer. Understanding these findings can help physicians in daily clinical practice.
Late postoperative arrhythmias and right ventricular dysfunction may occur after classic repair of tetralogy of Fallot.
During a mean follow-up of 8.9 years (range, 5 to 14 years), 24-hour ambulatory ...electrocardiographic studies were done in 107 patients after repair of tetralogy of Fallot. Radionuclide angiography was performed in 97, and 78 patients also underwent postoperative heart catheterization. The patients were divided into two groups: group A consisted of 71 patients aged 2 months to 61 years (mean, 6.8 years) in whom the right ventricular approach was used; group B included 36 patients aged 8 months to 39 years (mean, 7.9 years) whose repair was through the right atrium. A transannular patch was employed in 42 (59.2%) patients in group A and in 23 (63.9%) patients in group B. Eighteen patients were adults (> 18 years old) at the time of surgery: 13 (18.3%) in group A and 5 (13.8%) in group B. During a mean follow-up of 9.7 years, 57 (80.3%) group A patients were in New York Heart Association (NYHA) functional class I. Atrial flutter was present in 3 (4.2%) patients, and 28 (39.4%) had significant ventricular arrhythmias (> or = Lown grade 2). Postoperative heart catheterization showed good hemodynamic results in 36 of 54 group A patients studied (12 of whom had ventricular arrhythmias); moderate-to-severe pulmonary regurgitation was present in 14 (25.9%) patients; only 2 (3.7%) patients had right ventricular hypertension. On electrophysiological study, 8 of 28 (28.6%) patients in group A had inducible sustained ventricular tachycardia. Despite antiarrhythmic therapy, 2 of these patients died suddenly, presumably from ventricular arrhythmias. Two other late deaths in group A were caused by heart failure. During a mean follow-up of 7.2 years, 33 of 36 (91.7%) patients in group B were in NYHA functional class I. Atrial flutter was not found in any patient in this group. Only 1 (2.8%) patient, who had moderate-to-severe pulmonary regurgitation, had significant ventricular arrhythmias (> or = Lown grade 2). Postoperative catheterization showed good hemodynamic results in 20 of 24 patients; 3 (12.5%) had moderate-to-severe pulmonary regurgitation, and 1 (4.2%) patient had right ventricular hypertension. Sustained ventricular tachycardia could not be induced in any of the 5 adult patients who underwent electrophysiological studies. One late death (caused by endocarditis) occurred in group B.
The right atrial approach significantly reduced the risk of life-threatening ventricular arrhythmias after repair of tetralogy of Fallot (P < .001) without increasing the incidence of supraventricular arrhythmias. Right ventricular dysfunction and severe pulmonary regurgitation were also more prevalent (P < .01) when the right ventricular approach was used.
Total correction of tetralogy of Fallot was performed without a ventriculotomy in 39 patients aged 8 months to 39 years (mean age, 9.1 years) between May 1984 and July 1988. A transatrial approach ...was used to resect the obstructed infundibulum and to close the ventricular septal defect. In 14 patients, the pulmonary annulus was not enlarged (group 1). Twenty-five patients required a transannular patch (group 2), placed by extending the pulmonary artery incision 1 cm into the right ventricular infundibulum. Eleven patients had repair of pulmonary artery branch stenosis, and associated intracardiac anomalies were simultaneously corrected in 10 patients. After repair, the right ventricular to left ventricular systolic pressure ratios ranged from 0.36 to 0.59 (mean ratio, 0.45) in group 1 and 0.33 to 0.70 (mean ratio, 0.51) in group 2. There were no hospital or late deaths in group 1. Two patients in group 2 with a small left ventricle died shortly after operation. The 37 survivors were followed for 2 to 51 months. Postoperative catheterization in 7 patients detected no residual ventricular septal defects, mild pulmonary regurgitation in 2 patients (group 2), and right ventricular to left ventricular pressure ratios ranging from 0.25 to 0.42 (mean ratio, 0.34). Only 1 patient with a previous total repair by ventriculotomy is symptomatic and requires antiarrhythmic agents and diuretics. The other 36 patients are asymptomatic. In conclusion, tetralogy of Fallot can be safely repaired at any age without a ventriculotomy. The results indicate a minimal incidence of postoperative arrhythmias and pulmonary regurgitation, as well as improved right ventricular function.
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