Adjuvant treatment of premenopausal women with endocrine-responsive early breast cancer: design of the TEXT and SOFT trials

OBJECTIVES In 2003 the International Breast Cancer Study Group (IBCSG) initiated the TEXT and SOFT randomized phase III trials to answer two questions concerning adjuvant treatment for premenopausal women with endocrine-responsive early breast cancer: 1-What is the role of aromatase inhibitors (AI) for women treated with ovarian function suppression (OFS)? 2-What is the role of OFS for women who remain premenopausal and are treated with tamoxifen? METHODS TEXT randomized patients to receive exemestane or tamoxifen with OFS. SOFT randomized patients to receive exemestane with OFS, tamoxifen with OFS, or tamoxifen alone. Treatment was for 5 years from randomization. RESULTS TEXT and SOFT successfully met their enrollment goals in 2011. The 5738 enrolled women had lower-risk disease and lower observed disease-free survival (DFS) event rates than anticipated. Consequently, 7 and 13 additional years of follow-up for TEXT and SOFT, respectively, were required to reach the targeted DFS events (median follow-up about 10.5 and 15 years). To provide timely answers, protocol amendments in 2011 specified analyses based on chronological time and median follow-up. To assess the AI question, exemestane + OFS versus tamoxifen + OFS, a combined analysis of TEXT and SOFT became the primary analysis (n = 4717). The OFS question became the primary analysis from SOFT, assessing the unique comparison of tamoxifen + OFS versus tamoxifen alone (n = 2045). The first reports are anticipated in mid- and late-2014. CONCLUSIONS We present the original designs of TEXT and SOFT and adaptations to ensure timely answers to two questions concerning optimal adjuvant endocrine treatment for premenopausal women with endocrine-responsive breast cancer. Trial Registration TEXT: Clinicaltrials.govNCT00066703 SOFT: Clinicaltrials.govNCT00066690.

Prediction of Cranio-Maxilofacial Surgical Planning using an Inverse Soft Tissue Modelling Approach

In cranio-maxillofacial surgery, the determination of a proper surgical plan is an important step to attain a desired aesthetic facial profile and a complete denture closure. In the present paper, we propose an efficient modeling approach to predict the surgical planning on the basis of the desired facial appearance and optimal occlusion. To evaluate the proposed planning approach, the predicted osteotomy plan of six clinical cases that underwent CMF surgery were compared to the real clinical plan. Thereafter, simulated soft-tissue outcomes were compared using the predicted and real clinical plan. This preliminary retrospective comparison of both osteotomy planning and facial outlook shows a good agreement and thereby demonstrates the potential application of the proposed approach in cranio-maxillofacial surgical planning prediction.

Simultaneous detection and discrimination of virulent and benign Dichelobacter nodosus in sheep of flocks affected by foot rot and in clinically healthy flocks by competitive real-time PCR.

Ovine foot rot caused by Dichelobacter nodosus is affecting sheep worldwide. The current diagnostic methods are difficult and cumbersome. Here, we present a competitive real-time PCR based on allelic discrimination of the protease genes aprV2 and aprB2. This method allows direct detection and differentiation of virulent and benign D. nodosus from interdigital skin swabs in a single test. Clinically affected sheep harbored high loads of only virulent strains, whereas healthy sheep had lower loads of predominantly benign strains.

Interpolation of hard and soft dilepton rates

Strict next-to-leading order (NLO) results for the dilepton production rate from a QCD plasma at temperatures above a few hundred MeV suffer from a breakdown of the loop expansion in the regime of soft invariant masses M 2 ≪ (πT)2. In this regime an LPM resummation is needed for obtaining the correct leading-order result. We show how to construct an interpolation between the hard NLO and the leading-order LPM expression, which is theoretically consistent in both regimes and free from double counting. The final numerical results are presented in a tabulated form, suitable for insertion into hydrodynamical codes.

Three-dimensional imaging methods for quantitative analysis of facial soft tissues and skeletal morphology in patients with orofacial clefts: a systematic review.

BACKGROUND Current guidelines for evaluating cleft palate treatments are mostly based on two-dimensional (2D) evaluation, but three-dimensional (3D) imaging methods to assess treatment outcome are steadily rising. OBJECTIVE To identify 3D imaging methods for quantitative assessment of soft tissue and skeletal morphology in patients with cleft lip and palate. DATA SOURCES Literature was searched using PubMed (1948-2012), EMBASE (1980-2012), Scopus (2004-2012), Web of Science (1945-2012), and the Cochrane Library. The last search was performed September 30, 2012. Reference lists were hand searched for potentially eligible studies. There was no language restriction. STUDY SELECTION We included publications using 3D imaging techniques to assess facial soft tissue or skeletal morphology in patients older than 5 years with a cleft lip with/or without cleft palate. We reviewed studies involving the facial region when at least 10 subjects in the sample size had at least one cleft type. Only primary publications were included. DATA EXTRACTION Independent extraction of data and quality assessments were performed by two observers. RESULTS Five hundred full text publications were retrieved, 144 met the inclusion criteria, with 63 high quality studies. There were differences in study designs, topics studied, patient characteristics, and success measurements; therefore, only a systematic review could be conducted. Main 3D-techniques that are used in cleft lip and palate patients are CT, CBCT, MRI, stereophotogrammetry, and laser surface scanning. These techniques are mainly used for soft tissue analysis, evaluation of bone grafting, and changes in the craniofacial skeleton. Digital dental casts are used to evaluate treatment and changes over time. CONCLUSION Available evidence implies that 3D imaging methods can be used for documentation of CLP patients. No data are available yet showing that 3D methods are more informative than conventional 2D methods. Further research is warranted to elucidate it.

Indication and timing of soft tissue augmentation at maxillary and mandibular incisors in orthodontic patients. A systematic review.

OBJECTIVE To assess the indication and timing of soft tissue augmentation for prevention or treatment of gingival recession when a change in the inclination of the incisors is planned during orthodontic treatment. MATERIALS AND METHODS Electronic database searches of literature were performed. The following electronic databases with no restrictions were searched: MEDLINE, EMBASE, Cochrane, and CENTRAL. Two authors performed data extraction independently using data collection forms. RESULTS No randomized controlled trial was identified. Two studies of low-to-moderate level of evidence were included: one of prospective and retrospective data collection and one retrospective study. Both implemented a periodontal intervention before orthodontics. Thus, best timing of soft tissue augmentation could not be assessed. The limited available data from these studies appear to suggest that soft tissue augmentation of bucco-lingual gingival dimensions before orthodontics may yield satisfactory results with respect to the development or progression of gingival recessions. However, the strength of the available evidence is not adequate in order to change or suggest a possible treatment approach in the daily practice based on solid scientific evidence. CONCLUSIONS Despite the clinical experience that soft tissue augmentation of bucco-lingual gingival dimensions before orthodontic treatment may be a clinically viable treatment option in patients considered at risk, this treatment approach is not based on solid scientific evidence. Moreover, the present data do not allow to draw conclusions on the best timing of soft tissue augmentation when a change in the inclination of the incisors is planned during orthodontic treatment and thus, there is a stringent need for randomized controlled trials to clarify these open issues.

"Rot und glühend ist das Auge des Juden" : Gedichte zu 8 Radierungen von Jacob Steinhardt

Arno Nadel

Soft tissue wound healing around teeth and dental implants.

AIM To provide an overview on the biology and soft tissue wound healing around teeth and dental implants. MATERIAL AND METHODS This narrative review focuses on cell biology and histology of soft tissue wounds around natural teeth and dental implants. RESULTS AND CONCLUSIONS The available data indicate that: (a) Oral wounds follow a similar pattern. (b) The tissue specificities of the gingival, alveolar and palatal mucosa appear to be innately and not necessarily functionally determined. (c) The granulation tissue originating from the periodontal ligament or from connective tissue originally covered by keratinized epithelium has the potential to induce keratinization. However, it also appears that deep palatal connective tissue may not have the same potential to induce keratinization as the palatal connective tissue originating from an immediately subepithelial area. (d) Epithelial healing following non-surgical and surgical periodontal therapy appears to be completed after a period of 7–14 days. Structural integrity of a maturing wound between a denuded root surface and a soft tissue flap is achieved at approximately 14-days post-surgery. (e) The formation of the biological width and maturation of the barrier function around transmucosal implants requires 6–8 weeks of healing. (f) The established peri-implant soft connective tissue resembles a scar tissue in composition, fibre orientation, and vasculature. (g) The peri-implant junctional epithelium may reach a greater final length under certain conditions such as implants placed into fresh extraction sockets versus conventional implant procedures in healed sites.