This video demonstrates the use of a microsurgical temporary vascular clip system to facilitate laparoscopic enucleation of uterine fibroids. Throughout the course of the last three decades, the laparoscopic route has been established as the approach of choice in the surgical treatment of uterine fibroids. Laparoscopic fibroid enucleation is characterized by a low morbidity rate and a high patient satisfaction level. Especially when treating a large fibroid or multiple fibroids, the well-vascularized myometrium can constitute a technical challenge in endoscopic fibroid enucleation. Diffuse bleeding may lead to significant intraoperative hemorrhage. The extensive use of bipolar or monopolar diathermy, in order to achieve hemostasis, might lead to post-operative uterine wall necrosis with a potential risk of uterine rupture during subsequent pregnancies. To address this clinical challenge, we developed a technique with temporary interruption of the uterine blood supply by applying a microsurgical vascular clip (Yasargil vascular clip system, Aesculap, Tuttlingen, Germany) to the uterine artery and the utero-ovarian vessel arcade to minimize bleeding during endoscopic fibroid enucleation.
Objectives The goal of this study was to examine the safety, feasibility, and effectiveness of the use of a microsurgical temporary vascular clip system to facilitate the laparoscopic enucleation of very large intramural uterine fibroids. Methods In this retrospective study, the surgical outcomes of 26 patients who underwent laparoscopic myomectomy with temporary uterine vessel clipping for very large (the largest measured diameter ≥ 9 cm) symptomatic intramural uterine fibroids in two tertiary referral hospitals between September 2017 and March 2020 were examined. Titan-made vascular clips (YASARGIL® Aneurysm Clip System) were used to temporarily occlude the bilateral uterine arteries and utero-ovarian vessels. Main outcomes included operating time, blood loss, number of leiomyomas and weight, conversion rate, intra- and postoperative complication rates, and length of hospital stay. Results Twenty six patients were included. Dominant intramural uterine fibroid diameters were 9–22 cm. The general characteristics of the patients were similar. The mean surgery duration and intraoperative blood loss were 175.3 ± 32.7 (range 120–250) min and 241.1 ± 103 (range 100–450) ml, respectively. The median postoperative drop in hemoglobin was 0.89 ± 0.75 g/dL. No patient required blood transfusion. No procedure was converted to laparotomy. No major intra- or postoperative complication occurred. Conclusions Laparoscopic myomectomy for very large intramural uterine fibroids can be performed safely and effectively, with less intraoperative blood loss, using vascular clips for temporary clamping of the bilateral uterine vessels.
Background:Metastatic breast cancer (MBC) is usually an incurable disease and maintenance of quality of life (QoL) is one of the main aims of therapy. In patients with HER2-positive MBC taxane-based chemotherapy in combination with dual HER2 targeted therapy with trastuzumab and pertuzumab, has shown significantly increased progression free survival and overall survival. Adverse events are well-known side effects of any cytostatic treatment and can seriously impact the patients' QoL. The synergistic combination of dual HER2-targeted therapy with trastuzumab and pertuzumab plus endocrine therapy might offer a better treatment option for these patients. Preclinical data and first clinical trial results suggest an additional benefit when a CDK4/6 inhibitor is added to the combination of endocrine therapy and anti HER2 treatment. DETECT V is a randomized phase III study comparing the safety and efficacy of trastuzumab plus pertuzumab in combination with either endocrine therapy or chemotherapy. In both treatment arms the CDK4/6 inhibitor ribociclib will be added. Trial design and eligibility criteria: Patients are 1:1 randomized to receive dual HER2-targeted therapy with trastuzumab and pertuzumab combined with endocrine therapy and ribociclib or to chemotherapy with trastuzumab and pertuzumab followed by maintenance therapy with trastuzumab, pertuzumab, endocrine therapy and ribociclib when chemotherapy has stopped. The sample size calculations are based on the assumption that the probability of having an adverse event as defined by the modified adverse event score for patients with HER2 positive metastatic breast cancer in the chemotherapy arm is 86.3%. Based on this assumption, a minimum of 121 patients per treatment arm is required to detect a 25% decreased risk of having an adverse event as defined by the modified adverse event score (i.e. a relative risk ratio of 0.75) for patients treated with dual HER2-targeted plus endocrine therapy and ribociclib as compared to patients treated with dual HER2-targeted plus chemotherapy with the combination of endocrine therapy and ribociclib as maintenance treatment (90% power, two-sided test, α = 0.05). Specific aims: The primary objective of this study is to assess the tolerability of both treatment strategies, as assessed by the occurrence of AEs during the treatment period. Modified adverse event score was developed in order to better reflect the clinical, physiological and psychological impact of AEs on patients' QoL. Key secondary endpoint, besides the efficacy endpoints progression free survival (PFS) and overall survival, is to compare quality-adjusted survival (QAS), as measured using the quality-adjusted time without symptoms and toxicity (Q-TWiST) method, between both treatment arms. The DETECT V trial comes along with a comprehensive translational program focusing on detection and phenotyping of circulating tumor cell (CTC)-and the assessment of marker expression on CTCs in order to calculate an endocrine responsiveness score. Citation Format: Romashova T, Polasik A, Friedl TWP, Rack B, Tzschaschel M, Fasching PA, Taran F-A, Hartkopf A, Schneeweiss A, Mueller V, Bahriye A, Pantel K, Meier-Stiegen F, Wimberger P, Janni W, Fehm T, Huober J. The DETECT V-Study – Comparison of dual HER2-targeted therapy with trastuzumab plus pertuzumab in combination with chemo- or endocrine therapy in addition with CDK4/6 inhibition in patients with HER2-positive and hormone-receptor positive metastatic breast cancer [abstract]. In: Proceedings of the 2017 San Antonio Breast Cancer Symposium; 2017 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2018;78(4 Suppl):Abstract nr OT1-03-05.
e12565 Background: Therapeutic decisions for the primary treatment of breast cancer is commonly based on the expression profiles of estrogen (ER), progesterone (PR) and the human epidermal growth factor 2 (HER2) receptors. However, breast cancer is a very heterogeneous disease, and receptor changes were manifold reported during progression. Little is known about receptor discordance in the primary setting. Here, we compared receptor expression profiles between core needle biopsy (CNB) of the breast tumor tissue and synchronous axillary lymph node metastases (LNM) not at recurrence, but at the primary treatment. Methods: In a German single center study, we retrospectively analyzed 175 breast cancer patients with axillary synchronous LNM. 69,7% of our patients were without any upfront therapy. Profiles of ER, PR and HER2 were immunohistochemically analyzed using the common cut-off at 10% positive tumor cells vs. the controversially discussed low-positive cut-off at 1%. Receptor status was compared between CNB specimens of the primary tumor tissue and axillary LNM. Further, clinicopathological characteristics were correlated to receptor changes. Results: The discordance rates between CNB and axillary LNM were 12.7% for HER2, 6.9% for ER and 22.6% for PR using the ≥1% cut-off, respective 7.5% for ER and 25.6% for PR when using the ≥10% cut-off-level. The most frequently occurring change was a PR loss. Analysis of clinical parameters revealed a significant association of ER change between CNB and LNM in younger patients (p < 0.01) with increased proliferation marker Ki-67 (p = 0.04). Conclusions: Receptor discordance between CNB and synchronous axillary LNM appears to exist at the primary setting already. Hence, receptor profiles of the tumor tissue and the synchronous axillary LNM should be considered for treatment decision.
e18090 Background: The standard therapy of patients with ovarian cancer consists of primary surgery followed by chemotherapy. Initial response rates are very high, but recurrence occurs in 85% of the cases. Personalized ex vivo analyses of various anti-tumor compounds in a standardized tissue slice culture system (1) might be a very promising approach for individualized therapeutic decisions. In comparison to cell culture, tumor slice cultures maintain the direct tumor microenvironment which plays a role in resistance mechanisms and thus therapy response. Methods: Patient derived tumor cultures (1) are grown under standardized conditions and are analyzed semi-automated. Patient’s tumor samples were collected during surgery, cut into standardized slices and were cultivated in triplicates for 2, 4, 7 and 14 days and treated with standard therapy for 7 days. A baseline control was prepared at day 0. The cultured tissue is PFA-fixated and paraffin embedded. Hematoxylin eosin staining was performed for microscopic evaluation of morphologic structures. Subsequently, immunohistochemical staining against CD3 was applied to examine the immune setting of the tumor and its environment. Results: Ovarian tumor tissues remained their morphological properties over a period of 14 days. Parameters like cellular formation, proliferation and heterogeneity were adequately represented in the cultures.. Staining against CD3 revealed T-cells in ovarian tumor tissue slices up to 14 days ex vivo and individual response to treatment was observable. Conclusions: Correlation to clinical data is ongoing to analyze the tissue culture model of ovarian cancer for clinical usage. Different approaches, concerning mutational burden, immunological signature and histology are considered for decision of response and non-response.
e12559 Background: Lately large clinical trials have provided new treatment options for patients with metastatic HER2-low breast cancer. Studies have shown that there may be change in the expression of HER2 during disease progression. Yet, it is rarely considered that there can be already differences between primary tumor and synchronous lymph node metastases (LMN) in the primary setting. The aim of the present study was to analyze different HER2 expression profiles between primary tumor and synchronous LNM. Methods: We included 205 patients with primary breast cancer and LNM who underwent oncologic surgery between 2008 and 2021. Formalin-fixed and paraffin-embedded (FFPE) material were routinely examined immunohistochemically according to the ASCO guidelines. Membranous HER2-staining was scored as follows: zero = 0, low = 1+, equivocal = 2+ and positive = 3+. Results: 205 patients were either HER2 low or HER2 zero in CNB. When comparing CNB and LNM 5 (2,4%) patients were HER2 zero in CNB and HER2 low in LNM. 161 (78.5%) patients were HER2 zero in both CNB and LNM. 21 (10.2%) patients had a shift from HER2 low to HER2 zero in LNM. 18 (8,8%) patients had a HER2 low expression in CNB and HER2 zero expression in LNM. Conclusions: There seems to be a high frequency of HER2 heterogeneity between primary tumor and LNM in the primary setting. Different HER2 expression profiles should be considered for an optimal and individual treatment.
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