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Frankfurt am Main, Germany

Fischer L.,University of Heidelberg | Wekerle A.-L.,University of Heidelberg | Bruckner T.,University of Heidelberg | Wegener I.,University of Heidelberg | And 14 more authors.
BMC Surgery | Year: 2015

Background: Roux-en-Ygastric bypass (RYGB) and sleeve gastrectomy (SG) rank among the most frequently applied bariatric procedures worldwide due to their positive risk/benefit correlation. A systematic review revealed a similar excess weight loss (EWL) 2 years postoperatively between SG and RYGB. However, there is a lack of randomized controlled multi-centre trials comparing SG and RYGB, not only concerning EWL, but also in terms of remission of obesity-related co-morbidities, gastroesophageal reflux disease (GERD) and quality of life (QoL) in the mid- and long-term. Methods: The BariSurg trial was designed as a multi-centre, randomized controlled patient and observer blind trial. The trial protocol was approved by the corresponding ethics committees of the centres. To demonstrate EWL non-inferiority of SG compared to RYGB, power calculation was performed according to a non-inferiority study design. Morbidity, mortality, remission of obesity-related co-morbidities, GERD course and QoL are major secondary endpoints. 248 patients between 18 and 70 years, with a body mass index (BMI) between 35-60 kg/m2 and indication for bariatric surgery according to the most recent German S3-guidelines will be randomized. The primary and secondary endpoints will be assessed prior to surgery and afterwards at discharge and at the time points 3-6, 12, 24, 36, 48 and 60 months postoperatively. Discussion: With its five year follow-up, the BariSurg-trial will provide further evidence based data concerning the impact of SG and RYGB on EWL, remission of obesity-related co-morbidities, the course of GERD and QoL. Trial registration: The trial protocol has been registered in the German Clinical Trials Register DRKS00004766. © 2015 Fischer et al.

Jackisch C.,Sana Klinikum Offenbach GmbH | Hegg R.,Hospital Perola Byington and FMUSP | Stroyakovskiy D.,City Clinical Oncology Hospital 62 | Ahn J.-S.,Sungkyunkwan University | And 12 more authors.
European Journal of Cancer | Year: 2016

Background In the phase III, open-label, randomised HannaH study, fixed-dose neoadjuvant-adjuvant subcutaneous trastuzumab for human epidermal growth factor receptor 2 (HER2)-positive early breast cancer was non-inferior to standard weight-based intravenous infusion in terms of serum trough concentration and pathological complete response (PCR). Evidence suggests that PCR, particularly total PCR (tPCR), is likely to predict clinical benefit. We report associations between tPCR and event-free survival (EFS) from HannaH (the largest population from a single study of patients presenting with newly diagnosed HER2-positive breast cancer treated with neoadjuvant-adjuvant trastuzumab to date) plus long-term efficacy and safety. Methods Eligible patients received four cycles of neoadjuvant docetaxel followed by four cycles of fluorouracil/epirubicin/cyclophosphamide administered concurrently with 3-weekly subcutaneous (600 mg fixed dose) or intravenous trastuzumab (8 mg/kg loading, 6 mg/kg maintenance doses). Post-surgery, patients received adjuvant trastuzumab as randomised to complete 1 year of standard treatment. In exploratory analyses, we used Cox regression to assess associations between tPCR and EFS. EFS rates per subgroup were estimated using the Kaplan-Meier method. Findings Three-year EFS rates were 76% for subcutaneous and 73% for intravenous trastuzumab (unstratified hazard ratio [HR] 0.95, 95% confidence interval [CI] 0.69-1.30; intention-to-treat population). Three-year overall survival rates were 92% for subcutaneous and 90% for intravenous trastuzumab (unstratified HR 0.76, 95% CI 0.44-1.32). tPCR was associated with a reduced risk of an EFS event: subcutaneous arm HR 0.38 (95% CI 0.22-0.65); intravenous arm HR 0.32 (95% CI 0.18-0.60). Results were similar for subgroups, including oestrogen receptor status. The few additional adverse events occurring during treatment-free follow-up were balanced between arms. Interpretation Long-term efficacy supports the established non-inferiority of subcutaneous trastuzumab, and its safety profile remains consistent with the known intravenous profile. In each of HannaH's treatment arms, tPCR was associated with improved EFS, adding to evidence that tPCR is associated with clinical benefit in HER2-positive early breast cancer. © 2016 The Author(s). Published by Elsevier Ltd.

Jackisch C.,Sana Klinikum Offenbach GmbH | Kim S.-B.,University of Ulsan | Semiglazov V.,Nn Petrov Research Institute Of Oncology | Melichar B.,Palacky` University Medical School and Teaching Hospital | And 7 more authors.
Annals of Oncology | Year: 2015

HannaH revealed consistent overall safety profiles between fixed-dose subcutaneous (s.c.) and weight-based intravenous (i.v.) trastuzumab (median follow-up 20 months). Event-free survival rates were balanced between i.v. and s.c. There was no association between toxicity and exposure or body weight. Similar pathologic complete response rates were observed in higher weight patients in i.v. and s.c. © The Author 2014. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved.

Jackisch C.,Sana Klinikum Offenbach GmbH | Schoenegg W.,Practice | Reichert D.,Practice | Welslau M.,Practice | And 6 more authors.
BMC Cancer | Year: 2014

Background: Trastuzumab was registered in 2000 for the treatment of metastatic breast cancer, both as monotherapy and combination therapy with paclitaxel. In this prospective, non-interventional observation study, the 10-year experience with trastuzumab in the routine management of HER2-positive breast cancer was reviewed. Methods: Between 2000 and 2010, 1843 evaluable patients with advanced HER2-positive breast cancer were recruited in 223 institutions across Germany. Patients were prospectively monitored for about one year. Additional information on long-term outcomes, progression-free survival (PFS), and overall survival (OS) were retrieved at several follow-up points. There were no restrictions with respect to diagnostic or therapeutic procedures. Patients were stratified into three cohorts depending on the treatment regimen, i.e. trastuzumab monotherapy (n =228, 12%), trastuzumab combined with chemotherapy (n =1346, 73%), or trastuzumab combined with endocrine therapy (n =269, 15%). Results: Median age was 59.5 years with a proportion of 28% being older than 65 years. Over a maximum follow-up period of more than 10 years, 1538 PFS events were documented in 83% of patients, resulting in an estimated median PFS of 11.8 months. Median OS, based on recorded death in 64% of patients, amounted to 34.4 months, with 48% (95% confidence intervals 45-50%) still alive after three years. The subgroup selected for a treatment combination with endocrine drugs only had distinctly longer PFS and OS than the other two groups, achieving medians of 23.3 months and 56.3 months, respectively. Median PFS and OS in elderly patients over 65 years of age was 11.4 months and 28.3 months, respectively. Adverse reactions, including cardiac toxicity, of severity grade 3 or 4 were rare. Conclusions: The superior outcome of treatment strategies including trastuzumab in HER2 overexpressing breast cancer, proven in pivotal studies, was confirmed in the management of advanced breast cancer in Germany in the routine setting. Our data suggest a comparable clinical benefit of treatment with trastuzumab in elderly patients (>65 years), who are typically under-represented in randomized clinical studies. © 2014 Jackisch et al.

Khwaja H.,University of Liverpool | Coelho A.J.,Estacio de Sa University | Mazzarella M.,IFSO Executive Secretariat | Miller K.,Bariatric and Metabolic Unit | And 8 more authors.
Obesity Surgery | Year: 2015

The refurbished International Federation for the Surgery of Obesity and Metabolic Disorders (IFSO) website (www.ifso.com) showcases a wealth of high-quality information for bariatric surgery professionals and patients. The website provides free online access to the organisational structure of IFSO and useful information on IFSO-endorsed congresses, symposia and courses. Online access to the journal, Obesity Surgery, and the IFSO Newsletter can also be obtained via the IFSO website. There is also easy-to-understand information on the topics of obesity and the various bariatric/metabolic surgeries for our patients. © 2015, Springer Science+Business Media New York.

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