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Introduction: SB3 is a trastuzumab biosimilar approved in Australia, Brazil, Canada, the European Union, the Republic of Korea, Switzerland, and the USA. This real-world study evaluated safety and effectiveness of SB3 as part of the Korean post approval safety management system. Methods: This post-marketing surveillance in Korea included patients in line with approved indications, i.e., patients with early or metastatic breast cancer or metastatic gastric cancer. Safety outcomes were adverse events (AEs) and adverse drug reactions. Effectiveness outcomes were tumor response and event-free survival. Results: 424 patients were evaluated: 366 patients (86%) with early breast cancer, 53 patients (13%) with metastatic breast cancer, and 5 patients (1%) with metastatic gastric cancer. Among patients with breast cancer, AEs (mostly mild) and adverse drug reactions were reported by 158 (37.7%) and 57 (13.6%) patients, respectively. Most patients with an AE (141, 89.2%) had no change in treatment schedule. Treatment was temporarily suspended in 14 (8.9%) patients with an AE and completely discontinued in 7 (4.4%). Among patients with early and metastatic breast cancer who were evaluated for efficacy, objective response rates were 82.7% and 38.3%, respectively. Pathological complete response was 64.6% in patients with early breast cancer. Discussion/Conclusion: Safety and efficacy of SB3 demonstrated in this real-world study were comparable with previous studies of reference trastuzumab. [ABSTRACT FROM AUTHOR]

Background: We conducted this study to report our novel robotic thyroidectomy using gas-insufflation one-step single-port transaxillary (GOSTA) approach and compare it with a conventional transaxillary (CTA) approach using a retraction method for intraoperative and postoperative outcomes. Methods: We retrospectively analyzed 354 patients who underwent robotic thyroidectomy between January 2019 and April 2023. Of these patients, 143 underwent the procedure through the GOSTA approach, which involves a small incision of 3 cm along the axillary folds with both arms down and a gas-insufflation, from skin flap creation to the completion of thyroidectomy as a one-step single-port procedure without the need for a retractor. The remaining 211 patients underwent the CTA approach. We analyzed the GOSTA approach and compared the surgical outcomes of the GOSTA (n = 100) and CTA (n = 167) approaches in patients with differentiated thyroid cancer who underwent thyroid lobectomy. Results: Out of the 143 patients who underwent the GOSTA approach, 12 underwent total thyroidectomy and 9 underwent lateral neck lymph node dissection with total thyroidectomy. GOSTA-thyroid lobectomy was performed on 122 patients; of these, 100 were diagnosed with differentiated thyroid carcinoma. A comparative study with the CTA approach was only conducted in patients who underwent thyroid lobectomy. No significant differences were found in operative time, hospital stay, or complications between the two groups. Conclusions: Despite proceeding in one-step with a single smaller incision, from skin flap creation to the completion of thyroidectomy, the GOSTA approach is as feasible and safe as the CTA approach. Additionally, the GOSTA approach allows for thyroidectomy without using a retractor and reduces the workload for the surgeon and assistants. [ABSTRACT FROM AUTHOR]

The purpose of this study was to estimate the incidence and clinical significance of thyroid isthmus agenesis based on multi-detector CT imaging in a large-scale study. Data from 1601 patients who underwent neck multi-detector CT at our institution from January 2015 to March 2016 were included in this retrospective study. The morphology of each patient's thyroid gland was evaluated. We classified thyroid isthmus agenesis into two subgroups according to the thickness of the medial margin: clear-cut type (>4 mm) or tapering-edge type (≤4 mm). Associated thyroid pathologies were also evaluated. Thyroid isthmus agenesis was present in 69 patients (41 males, 28 females), and its incidence was 4.77%. Eleven patients (0.76%) had the clear-cut type and 58 patients (4.01%) had the tapering-edge type. Papillary thyroid carcinoma was diagnosed in 4 patients (5.7% of isthmus agenesis patients). A total of 7 patients underwent thyroid function testing during the course of this study; 1 of these patients presented with borderline hyperthyroidism, and the remaining 6 were in a euthyroid state. The clear-cut type showed a statistically significant narrow gap and a high incidence of pyramidal lobes compared to the tapering-edge type. Thyroid isthmus agenesis is not a rare developmental anomaly of the thyroid gland on multi-detector CT. Based on the metastatic pathophysiology of differentiated thyroid cancer, more extended indications for lobectomy are expected in differentiated thyroid cancer patients with thyroid isthmus agenesis. • The incidence of thyroid isthmus agenesis is 4.77%. • Thyroid isthmus agenesis can be classified into clear-cut and tapering-edge types. • The anastomosis of superior and inferior thyroid veins is frequently found in thyroid isthmus agenesis. • Thyroid isthmus agenesis may extend the indication of lobectomy in thyroid cancer. [ABSTRACT FROM AUTHOR]

Radiogenomics investigates the relationship between imaging phenotypes and genetic expression. Breast cancer is a heterogeneous disease that manifests complex genetic changes and various prognosis and treatment response. We investigate the value of machine learning approaches to radiogenomics using low-dose perfusion computed tomography (CT) to predict prognostic biomarkers and molecular subtypes of invasive breast cancer. This prospective study enrolled a total of 723 cases involving 241 patients with invasive breast cancer. The 18 CT parameters of cancers were analyzed using 5 machine learning models to predict lymph node status, tumor grade, tumor size, hormone receptors, HER2, Ki67, and the molecular subtypes. The random forest model was the best model in terms of accuracy and the area under the receiver-operating characteristic curve (AUC). On average, the random forest model had 13% higher accuracy and 0.17 higher AUC than the logistic regression. The most important CT parameters in the random forest model for prediction were peak enhancement intensity (Hounsfield units), time to peak (seconds), blood volume permeability (mL/100 g), and perfusion of tumor (mL/min per 100 mL). Machine learning approaches to radiogenomics using low-dose perfusion breast CT is a useful noninvasive tool for predicting prognostic biomarkers and molecular subtypes of invasive breast cancer. [ABSTRACT FROM AUTHOR]

Background: Insulin receptor substrate 1 (IRS-1) has been known to be an associated factor with breast cancer progression. However, there has been little study with respect to the relationship between the expression of IRS-1 and breast cancer prognosis in clinical practice. In this study, we evaluated the impact of the estrogen receptor (ER) and IRS-1 on the recurrence and survival of breast cancer patients.Methods: We analyzed the pathologic finding of 376 tissue samples from breast cancer patients who received proper treatment between January 1990 and December 2006 using the tissue microarray. We measured the expression of ER and IRS-1 by immunohistochemistry staining and analyzed the difference of recurrence and survival rate in each subgroup of ER and IRS-1.Results: Our results show that there is a significant difference of disease-free survival (DFS) according to ER and IRS-1 subgroups with both univariate and multivariate analyses. Specifically, ER-positive and IRS-1-positive breast cancer samples showed improved DFS compared to ER-positive and IRS-1-negative breast cancer (adjusted hazard ratio: 2.17; 95% confidence interval: 1.15-4.09; P = 0.01). There was a difference of overall survival according to ER and IRS-1 subgroups by univariate analysis (P = 0.01), but not by multivariate analysis (P = 0.36).Conclusion: ER and IRS-1 subgroups appear to be critical factors for the prediction of breast cancer recurrence. In particular, we suggest that the patients who have ER-positive and IRS-1-negative breast cancer undergo more aggressive treatment because they have poorer prognoses. [ABSTRACT FROM AUTHOR]

Skin reaction is major problem during whole breast radiotherapy. To identify factors related to skin reactions during whole breast radiotherapy, various personal, clinical, and radiation dosimetric parameters were evaluated. From January 2012 to December 2013, a total of 125 patients who underwent breast conserving surgery and adjuvant whole breast irradiation were retrospectively reviewed. All patients had both whole breast irradiation and boost to the tumour bed. Skin reaction was measured on the first day of boost therapy based on photography of the radiation field and medical records. For each area of axilla and inferior fold, the intensity score of erythema (score 1 to 5) and extent (score 0 to 1) were summed. The relationship of various parameters to skin reaction was evaluated using chi-square and linear regression tests. The V100 (volume receiving 100% of prescribed radiation dose, p<0.001, both axilla and inferior fold) and age (p=0.039 for axilla and 0.026 for inferior fold) were significant parameters in multivariate analyses. The calculated axilla dose (p=0.003) and breast separation (p=0.036) were also risk factors for axilla and inferior fold, respectively. Young age and large V100 are significant factors for acute skin reaction that can be simply and cost-effectively measured. [ABSTRACT FROM AUTHOR]

The article presents a case study of a 63-year-old woman with a palpable mass at the right breast was treated with breast sparganosis. It also presents a case study of a 67-year-old woman with mastalgia of the left breast. A case study of 63-year-old woman presented with a palpable right breast lump is also presented. It mentions that sera tests from the three patients were conducted to detect levels of anti-sparganum IgG antibody by microenzyme-linked immunosorbent assay (ELISA).

Background Recurrent laryngeal nerve (RLN) palsy is the most common and serious complication of thyroid surgery. The use of energy-based devices (EBDs) has replaced hand-tying methods in many institutions. However, EBD use proximal to the RLN presents risks related to lateral thermal spread and associated nerve damage. THUNDERBEAT (TB) is one of the most widely used EBDs. This study aimed to test the safety of TB during thyroidectomy. Methods Four piglets weighing 30–40 kg experienced thyroidectomy while continuous electrophysiologic monitoring (continuous intraoperative neuromonitoring) occurred, using an electromyography endotracheal tube and NIM 3.0 response system. TB was applied at various distances from the RLN, and we assessed the safety of the protocols. Results Adverse electromyography events did not occur at distances >3 mm from the RLN. Amplitude decreased at 2 mm from the RLN after 8 s. However, immediate loss of signal occurred at 1 mm from the RLN, likely due to immediate shrinkage of surrounding tissue after TB application. Conclusions TB can be used safely at 3 mm from the RLN but must be used for <8 s at more proximal locations. This is the first report assessing the safety of TB, and findings indicate that TB should be used at least 1 mm from the RLN to avoid injury. [ABSTRACT FROM AUTHOR]

Introduction Radiotherapy increases the morbidity of immediate breast reconstruction. To spare the flapped area without an adverse dose distribution of the target volume and organ at risks, various radiation techniques were assessed. Methods Twelve breasts undergoing skin-sparing mastectomy and immediate transverse rectus abdominis myocutaneous flap reconstruction were evaluated. After a delineation of whole breast, the doughnut-like breast target volume ( BTV) including the chest wall and skin and the subtracted central flapped volume ( FV) were defined. The opposed wedge tangential radiotherapy (3-dimensional conformal radiotherapy (3- D CRT) ), field-in-field radiotherapy ( FiF), inverse intensity-modulated radiotherapy ( iIMRT), volumetric modulated arc radiotherapy ( VMRT) and the mixture of FiF and iIMRT ( HYBRID) were tried. Total 50 Gy was prescribed to the BTV. The paired student t-tests were performed. Results The V47.5Gy of the BTV was improved in iIMRT and VMRT compared with 3- D CRT and FiF. The mean FV doses in iIMRT and VMRT were 76.7 ± 3.9% and 85.5 ± 4.0%, respectively. However the mean ipsilateral lung doses were aggravated by iIMRT and VMRT. In terms of HYBRID, the V47.5Gy for the BTV was 97.5 ± 0.7%. The mean FV dose was 89.4 ± 2.1%. While the mean FV dose in HYBRID was 13.7 ± 2.1% ( P < 0.001) lower than FiF, it was 12.8 ± 1.9% ( P < 0.001) higher than iIMRT. The mean ipsilateral lung dose in HYBRID was 2.8 ± 1.9% ( P < 0.001) worse than FiF, and 2.6 ± 1.8% ( P < 0.001) better than iIMRT. Conclusions The HYBRID could minimise the adverse dose distribution of lung and reduce 10% of the mean dose to the flapped area. For patients with adverse factors for the failure of breast reconstruction, the HYBRID could be considered. [ABSTRACT FROM AUTHOR]