Background Adjuvant trastuzumab significantly improves outcomes for patients with HER2-positive early breast cancer. The standard treatment duration is 12 months but shorter treatment could provide similar efficacy while reducing toxicities and cost. We aimed to investigate whether 6-month adjuvant trastuzumab treatment is noninferior to the standard 12-month treatment regarding disease-free survival. Methods This study is an open-label, randomised phase 3 non-inferiority trial. Patients were recruited from 152 centres in the UK. We randomly assigned patients with HER2-positive early breast cancer, aged 18 years or older, and with a clear indication for chemotherapy, by a computerised minimisation process (1:1), to receive either 6-month or 12-month trastuzumab delivered every 3 weeks intravenously (loading dose of 8 mg/kg followed by maintenance doses of 6 mg/kg) or subcutaneously (600 mg), given in combination with chemotherapy (concurrently or sequentially). The primary endpoint was disease-free survival, analysed by intention to treat, with a non-inferiority margin of 3% for 4-year disease-free survival. Safety was analysed in all patients who received trastuzumab. This trial is registered with EudraCT (number 2006-007018-39), ISRCTN (number 52968807), and ClinicalTrials.gov (number NCT00712140).
Introduction: Magseed is an alternative method of localising non-palpable breast lesions that has addressed many of the limitations of wire guided localisation (WGL). It consists of a paramagnetic seed that can be visualised on mammography and ultrasound. Intraoperative localisation of the seed is achieved with the use of the Sentimag probe. The aim of this study was to prospectively compare localisation in patients undergoing wide local excision (WLE) for non-palpable lesions between Magseed and WGL. Methods: We prospectively collected data on all patients undergoing image-guided WLE between October 2017 and September 2018 in two academic breast units with a planned accrual of 100 consecutive patients undergoing Magseed localisation. Data was also collected on a cohort of 100 consecutive patients undergoing WGL in the same time period. Results: Demographic and disease characteristics were well balanced between the two groups. 4/104 patients were converted preoperatively from Magseed to WGL (2 misplaced Magseeds; 2 undetected Magseeds). Intraoperative identification and excision of the localised lesion was successful in all patients as confirmed with specimen radiography. Overall no significant differences were observed in the proportion of patients requiring re-excision between the two groups (Magseed 16% vs. WGL 14% p ¼ 0.692). Specimens size by weight and volume was similar for both groups (Magseed 39.6 g vs. WGL 44.5 g p ¼ 0.206 and 90.1 cm 3 for Magseed vs. 95.6 cm 3 for WGL p ¼ 0.579). Conclusions: In our series Magseed localisation proved to be as reliable and effective as WGL in terms of lesion identification, excision with tumour free margins and specimen weight.
The standard approach to breast-conserving surgery is wide local excision of the tumor and radiotherapy. However, a significant number of patients require further surgery to obtain oncologically clear margins, and may obtain a poor cosmetic result following adjuvant radiotherapy. Oncoplastic techniques may result in improved cosmesis, but few studies have investigated the oncological advantage of this approach. The aim of this retrospective study was to compare tumor clearance and the need for further margin excision following standard wide local excision (group A, 121 patients), and oncoplastic breast-conserving surgery (group B, 37 patients). These techniques included therapeutic mammoplasty, sub-axillary fat pad rotation mammoplasty, thoraco-epigastric flap, and central flap. Compared to standard surgery (group A), oncoplastic techniques (group B) can be employed for significantly larger tumors (17.6 mm versus 23.9 mm, p = 0.002). Oncoplastic breast-conserving surgery results in higher mean specimen weights (58.1 g versus 231.1 g, p < 0.0001), higher specimen volumes (112.3 cm(3) versus 484.5 cm(3) , p < 0.0001), and wider clear margins (6.1 mm versus 14.3 mm, p < 0.0001), resulting in lower rates of further surgery (28.9% versus 5.4%, p = 0.002). There was no statistical increase in complication rates following oncoplastic surgery. Oncoplastic breast-conserving surgery is more successful than standard wide local excision in treating larger tumors and obtaining wider radial margins, thus reducing the need for further margin excision, which delays adjuvant therapy. There was no increase in postoperative complication rate using an oncoplastic approach.
The study findings suggest a skill overlap between the Nintendo Wii and basic laparoscopic tasks. Surgical candidates with advanced Nintendo Wii ability may possess higher baseline laparoscopic ability.
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