Prospective, Multicenter, Randomized Phase III Trial Evaluating the Impact of Lymphoscintigraphy as Part of Sentinel Node Biopsy in Early Breast Cancer: SenSzi (GBG80) Trial.

PURPOSE: The aim of the current work was to clarify whether a preoperative lymphoscintigraphy (LSG) enhances staging accuracy of sentinel lymph node biopsy (SLNB). PATIENTS AND METHODS: In a prospective, multicenter, randomized phase III trial, patients with cN0 early breast cancer or extensive/high-grade ductal carcinoma in situ planned for standard radioactive-labeled colloid LSG with subsequent SLNB were randomly assigned 1:1 to receive SLNB either with knowledge of the LSG findings or without. As the false-negative rate of SLNB correlates with the number of resected sentinel lymph nodes (SLNs), our primary end point was the mean number of histologically detected SLNs per patient. One thousand one hundred two evaluable patients were necessary to demonstrate noninferiority of SLNB without LSG. Stratified one-sided 95% CI for the difference (without LSG - with LSG) in the mean number of histologically detected SLNs had to be greater than -0.27 (10% noninferiority margin). Stratification was performed according to tumor focality and trial site. Additional predefined secondary end points (rates of node-positive patients and of completion axillary lymph node dissection) were analyzed to rule out differences in the reliable detection of nodal metastases. RESULTS: Between May 2014 and October 2015, 1,198 patients were randomly assigned in 23 German and Swiss breast centers. Modified intention-to-treat analysis (n = 1,163) showed a mean number of histologically detected SLNs of 2.21 with LSG and 2.26 without LSG (difference 0.05; stratified 95% CI, -0.18 to infinity), thus establishing noninferiority of omitting preoperative LSG. Secondary end points displayed no statistically significant differences. CONCLUSION: We show that SLNB is equally effective irrespective of the surgeon's knowledge of preoperative LSG results. SLNB without LSG will speed up the preoperative workflow and reduce cost.

Breast cancer therapy planning - a novel support concept for a sequential decision making problem.

Breast cancer is the most common carcinosis with the largest number of mortalities in women. Its therapy comprises a wide spectrum of different treatment modalities a breast oncologist decides about for the individual patient case. These decisions happen according to medical guide lines, current scientific publications and experiences acquired in former cases. Clinical decision making therefore involves the time-consuming search for possible therapy options and their thorough testing for applicability to the current patient case.This research work addresses breast cancer therapy planning as a multi-criteria sequential decision making problem. The approach is based on a data model for patient cases with therapy descriptions and a mathematical notion for therapeutic relevance of medical information. This formulation allows for a novel decision support concept, which targets at eliminating observed weaknesses in clinical routine of breast cancer therapy planning.

Integrative oncology for breast cancer patients: introduction of an expert-based model.

BACKGROUND: Malignant breast neoplasms are among the most frequent forms of cancer in the Western world. Conventional treatment of breast cancer may include surgery, hormonal therapy, chemotherapy, radiation and/or immunotherapy, all of which are often accompanied by severe side effects. Complementary and alternative medicine (CAM) treatments have been shown to be effective in alleviating those symptoms. Furthermore, with patient survival rates increasing, oncologists, psychologists and other therapists have to become more sensitive to the needs of cancer survivors that go beyond than the mere alleviation of symptoms. Many CAM methods are geared to treat the patient in a holistic manner and thus are also concerned with the patient's psychological and spiritual needs. DISCUSSION: The use of certain CAM methods may become problematic when, as frequently occurs, patients use them indiscriminately and without informing their oncologists. Herbal medicines and dietary supplements, especially, may interfere with primary cancer treatments or have other detrimental effects. Thus, expertise in this highly specialized field of integrative medicine should be available to patients so that they can be advised about the benefits and negative effects of such preparations and practices.Being a beneficial combination of conventional and CAM care, integrative oncology makes possible the holistic approach to cancer care. The concept of integrative oncology for breast cancer is jointly practiced by the Department of Internal and Integrative Medicine, Kliniken Essen-Mitte, academic teaching hospital of the University of Duisburg-Essen, and the Breast Center at Kliniken Essen-Mitte in Germany. This model is introduced here; its scope is reviewed, and its possible implications for the practice of integrative medicine are discussed. SUMMARY: Evidence-based integrative care is crucial to the field of oncology in establishing state-of-the-art care for breast cancer patients.

In vitro vascular tube formation testing as a tool for treatment individualisation in patients with cervical cancer.

BACKGROUND/AIM: Targeted tumour therapies are promising, but their results in unselected patient populations are modest and tumour growth and metastasis may be promoted rather than suppressed in some cases. The present study investigates the suitability of vascular in vitro tube formation as a tool for the identification of cervical neoplasms that will respond to bevacizumab therapy. PATIENTS AND METHODS: Fifteen patients with recurrent cervical cancer selected from the ongoing cervical cancer monitoring database of the Charité University Hospital Berlin, Germany, were included. Information obtained from the database included tumour stage, malignancy grade, presence of nodal metastases, lymph vessel invasion, patient age and menopausal status and serum concentrations of vascular endothelial growth factor (VEGF), basic fibroblast growth factor (bFGF), endostatin and vascular endothelial growth factor receptor 1 (VEGF-R1). Vascular tube formation was assessed with cultured human umbilical vein epithelial cells. RESULTS: Five patients showed a positive, 5 an inverse and 5 no in vitro response to bevacizumab. Tube length showed a marked and significant dependency on bevacizumab response. Besides tube length, VEGF-R1 concentration was the only variable with some correlation to bevacizumab response, with high levels especially for inverse responders. CONCLUSION: The identification of patients with a likely benefit from targeted therapies is crucial. Tube formation shows substantial potential, but its utility needs to be confirmed in studies on the clinical rather than in vitro response to bevacizumab.

Prognostic significance of the angiogenic factors angiogenin, endoglin and endostatin in cervical cancer.

BACKGROUND/AIM: Angiogenesis plays a key role in tumour growth and metastasis. Expression of angiogenic factors has been suggested as a marker for tumour malignity, and it may help to identify those patients with a poorer prognosis, aiding patient stratification for more aggressive and/or angiogenesis-targeted therapy. The present study examines the relationship between concentration of circulating angiogenic factors and clinical tumour criteria as well as patient survival. PATIENTS AND METHODS: A total of 125 patients with cervical cancer who underwent follow-up examinations between October 2002 and June 2005 were enrolled, and serum samples were examined for angiogenin, endoglin and endostatin by means of an ELISA. Concentrations were statistically correlated with clinical and outcome parameters. RESULTS: Concentrations of all examined angiogenic factors were on average within the manufacturer-provided normal range. Both angiogenin and endostatin increased from non-invasive tumours through invasive lesions to recurrent disease, and endoglin showed an equally steady inverse trend; differences between non-invasive, invasive and recurrent stages of the disease were statistically significant. However it was not possible to determine a sufficiently selective cut-off point for either factor by receiver operating characteristic analysis, and there was no significant correlation with survival. CONCLUSION: Angiogenic factors angiogenin, endoglin and endostatin show a definite relationship with disease stage in uterine cervical cancer, but are presently not suitable for use in risk stratification.