Breast Cancer 2013 - Interpretation of New and Known Data

Lux, Michael P.; Maass, Nicolaì; Schütz, Florian; Schwidde, Ilka; Fasching, Peter A.; Fehm, Tanja; Janni, Wolfgang; Kümmel, Sherko; Kolberg, Hans Christian; Lüftner, Diana

doi:10.1055/s-0032-1328691

Cited by 20 publications

(22 citation statements)

References 72 publications

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“…For subgroup analysis according to molecular tumor subtypes, patients were categorized into four groups: luminal A like (hormone receptor positive, human epidermal growth factor receptor 2 (HER2) negative, G1/G2), luminal B like (hormone receptor positive, HER2 negative, G3), HER2 positive (all HER2-positive tumors) and triple negative (hormone receptor negative, HER2 negative) [ 10 , 11 ]. Due to missing values for hormone receptor and/or HER2 status, molecular subtypes could be determined for only 3670 of the 3754 randomized patients (Table 1 ).…”

Section: Methodsmentioning

confidence: 99%

The influence of obesity on survival in early, high-risk breast cancer: results from the randomized SUCCESS A trial

et al. 2015

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IntroductionObese breast cancer patients have worse prognosis than normal weight patients, but the level at which obesity is prognostically unfavorable is unclear.MethodsThis retrospective analysis was performed using data from the SUCCESS A trial, in which 3754 patients with high-risk early breast cancer were randomized to anthracycline- and taxane-based chemotherapy with or without gemcitabine. Patients were classified as underweight/normal weight (body mass index (BMI) < 25.0), overweight (BMI 25.0–29.9), slightly obese (BMI 30.0–34.9), moderately obese (BMI 35.0–39.9) and severely obese (BMI ≥ 40.0), and the effect of BMI on disease-free survival (DFS) and overall survival (OS) was evaluated (median follow-up 65 months). In addition, subgroup analyses were conducted to assess the effect of BMI in luminal A-like, luminal B-like, HER2 (human epidermal growth factor 2)-positive and triple-negative tumors.ResultsMultivariate analyses revealed an independent prognostic effect of BMI on DFS (p = 0.001) and OS (p = 0.005). Compared with underweight/normal weight patients, severely obese patients had worse DFS (hazard ratio (HR) 2.70, 95 % confidence interval (CI) 1.71–4.28, p < 0.001) and OS (HR 2.79, 95 % CI 1.63–4.77, p < 0.001), while moderately obese, slightly obese and overweight patients did not differ from underweight/normal weight patients with regard to DFS or OS. Subgroup analyses showed a similar significant effect of BMI on DFS and OS in patients with triple-negative breast cancer (TNBC), but not in patients with other tumor subtypes.ConclusionsSevere obesity (BMI ≥ 40) significantly worsens prognosis in early breast cancer patients, particularly for triple-negative tumors.Trial registrationClinicaltrials.gov NCT02181101. Registered September 2005.

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Section: Methodsmentioning

confidence: 99%

The influence of obesity on survival in early, high-risk breast cancer: results from the randomized SUCCESS A trial

et al. 2015

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“…The paper-based methods currently used for recording PROs require costly staff resources, and they may lead to the patients' point of view being underrepresented. With the growing demand for better information provision and communication with patients, on the one hand, and the increasing use of information technology by health-care providers on the other, the potential for developing "eHealth" solutions in health-care research is becoming increasingly clear [10].…”

Section: Introductionmentioning

confidence: 99%

Implementation and Feasibility of Electronic Patient-Reported Outcome (ePRO) Data Entry in the PRAEGNANT Real-Time Advanced and Metastatic Breast Cancer Registry

Wallwiener

Heindl

Brucker

et al. 2017

Senologie - Zeitschrift für Mammadiagnostik und -therapie

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Purpose Patient-reported outcomes (PROs) have been incorporated into clinical trials for many symptoms and medical conditions. A transition from paper-based capture of PROs to electronic PROs (ePROs) has recently started. This study reports on the feasibility of ePRO assessment in a prospective registry including molecular data for patients with advanced breast cancer. Methods As part of the PRAEGNANT network, patients were invited by clinical trial staff, physicians, and nurses to complete three standardized Internet-based questionnaires (EQ-5D-5L, CES-D and IPAQ). Feasibility was assessed by the staff members who assigned the user accounts by the patients. The completeness of the questionnaires was also assessed. Results Fifteen of 17 patients who were asked agreed to participate to complete the PRO questionnaires (EQ-5D-5L and CES-D). However, the IPAQ (physical activity) questionnaire was only validly completed by 9 patients. Feasibility was ranked better by the physicians and dedicated clinical trial staff than by the nursing staff. Conclusions Incorporating ePRO questionnaires into an advanced breast cancer registry is feasible, and no major hurdles were reported. Involving stakeholders from the start, the application is tailored to the capacities and abilities of both patients and clinical staff. The patients’ compliance was better with some questionnaires, butothers may present difficulties.

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“…They therefore have great potential benefits for patients who participate in them, and thanks to strict standards and regulations they have very high safety requirements. Treatment in the context of a clinical study is claimed to be equivalent to or better than the standard treatment and implies increasingly new therapeutic options, particularly in the field of oncology [ 1 ]. In addition, the results of further studies suggest that patients treated in research studies have an improved quality of life [ 2 ].…”

Section: Introductionmentioning

confidence: 99%

Knowledge and attitudes regarding medical research studies among patients with breast cancer and gynecological diseases

et al. 2015

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BackgroundMedical research studies are becoming increasingly important for optimizing the prevention, diagnosis and treatment of illnesses. Participation in research studies can have many benefits for patients. In randomized and controlled clinical studies, they can receive the best possible medical care currently available. However, only a small proportion of patients nowadays are treated within the framework of medical research. The primary endpoint of this study was to discover what level of knowledge patients have about clinical studies and how they currently perceive them, in order to identify ways of optimizing the information provided about studies from the patients’ point of view.MethodsThe study included 2546 patients (breast cancer 21.6 %, gynecological cancer 8.3 %, obstetrics 32.7 %, endometriosis 7.8 %, fertility treatment 3.2 %, other benign gynecological illnesses 19.2 %, no information for 7.2 %) in the outpatient clinic (45.2 %) and in the in-patient sector (54.8 %) at the Department of Gynecology at Erlangen University Hospital and associated centers. In the single-center study, conducted between January 2011 and January 2012, the patients were asked about their level of knowledge regarding the background to medical research studies and the ways in which they are carried out and used. The patients were also asked how they perceived medical studies and how they thought study conditions might be optimized. The three-page questionnaire was included in the feedback sheet received by patients as part of the hospital’s quality management system.ResultsAs a whole, the group only had moderate knowledge about clinical studies. A majority of the respondents considered that studies were valuable (91.6 %), but only a few were also willing to take part in them (58.4 %). Knowledge and willingness to participate strongly depended on age (P < 0.001), educational level (P < 0.001) and patient group (P < 0.001). Most patients would prefer to decide about participating in studies through a discussion with their outpatient physicians.ConclusionsThe information that patients have about clinical studies affects whether they participate in them. It is therefore extremely important for patients to be well informed, for their anxieties about participation to be relieved, and for the benefits of participation to be explained to them.

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Breast Cancer 2013 - Interpretation of New and Known Data

Cited by 20 publications

References 72 publications

The influence of obesity on survival in early, high-risk breast cancer: results from the randomized SUCCESS A trial

The influence of obesity on survival in early, high-risk breast cancer: results from the randomized SUCCESS A trial

Implementation and Feasibility of Electronic Patient-Reported Outcome (ePRO) Data Entry in the PRAEGNANT Real-Time Advanced and Metastatic Breast Cancer Registry

Knowledge and attitudes regarding medical research studies among patients with breast cancer and gynecological diseases

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