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1.
JAMA Surg ; 158(10): 1013-1021, 2023 10 01.
Artículo en Inglés | MEDLINE | ID: mdl-37466971

RESUMEN

Importance: The role of axillary lymph node dissection (ALND) to determine nodal burden to inform systemic therapy recommendations in patients with clinically node (cN)-positive breast cancer (BC) is currently unknown. Objective: To address the association of ALND with systemic therapy in cN-positive BC in the upfront surgery setting and after neoadjuvant chemotherapy (NACT). Design, Setting, and Participants: This was a prospective, observational, cohort study conducted from August 2018 to June 2022. This was a preplanned study within the phase 3 randomized clinical OPBC-03/TAXIS trial. Included were patients with confirmed cN-positive BC from 44 private, public, and academic breast centers in 6 European countries. After NACT, residual nodal disease was mandatory, and a minimum follow-up of 2 months was required. Exposures: All patients underwent tailored axillary surgery (TAS) followed by ALND or axillary radiotherapy (ART) according to TAXIS randomization. TAS removed suspicious palpable and sentinel nodes, whereas imaging-guidance was optional. Systemic therapy recommendations were at the discretion of the local investigators. Results: A total of 500 patients (median [IQR] age, 57 [48-69] years; 487 female [97.4%]) were included in the study. In the upfront surgery setting, 296 of 335 patients (88.4%) had hormone receptor (HR)-positive and Erb-B2 receptor tyrosine kinase 2 (ERBB2; formerly HER2 or HER2/neu)-negative disease: 145 (49.0%) underwent ART, and 151 (51.0%) underwent ALND. The median (IQR) number of removed positive lymph nodes without ALND was 3 (1-4) nodes compared with 4 (2-9) nodes with ALND. There was no association of ALND with the proportion of patients undergoing adjuvant chemotherapy (81 of 145 [55.9%] vs 91 of 151 [60.3%]; adjusted odds ratio [aOR], 0.72; 95% CI, 0.19-2.67) and type of systemic therapy. Of 151 patients with NACT, 74 (51.0%) underwent ART, and 77 (49.0%) underwent ALND. The ratio of removed to positive nodes was a median (IQR) of 4 (3-7) nodes to 2 (1-3) nodes and 15 (12-19) nodes to 2 (1-5) nodes in the ART and ALND groups, respectively. There was no observed association of ALND with the proportion of patients undergoing postneoadjuvant systemic therapy (57 of 74 [77.0%] vs 55 of 77 [71.4%]; aOR, 0.86; 95% CI, 0.43-1.70), type of postneoadjuvant chemotherapy (eg, capecitabine: 10 of 74 [13.5%] vs 10 of 77 [13.0%]; trastuzumab emtansine-DM1: 9 of 74 [12.2%] vs 11 of 77 [14.3%]), or endocrine therapy (eg, aromatase inhibitors: 41 of 74 [55.4%] vs 36 of 77 [46.8%]; tamoxifen: 8 of 74 [10.8%] vs 6 of 77 [7.8%]). Conclusion: Results of this cohort study suggest that patients without ALND were significantly understaged. However, ALND did not inform systemic therapy recommendations.


Asunto(s)
Neoplasias de la Mama , Humanos , Femenino , Persona de Mediana Edad , Neoplasias de la Mama/tratamiento farmacológico , Neoplasias de la Mama/cirugía , Biopsia del Ganglio Linfático Centinela , Metástasis Linfática/patología , Estudios de Cohortes , Estudios Prospectivos , Escisión del Ganglio Linfático , Ganglios Linfáticos/patología , Terapia Neoadyuvante , Axila
2.
Breast Cancer Res Treat ; 201(2): 215-225, 2023 Sep.
Artículo en Inglés | MEDLINE | ID: mdl-37355526

RESUMEN

PURPOSE: The aim of this study was to evaluate clinical practice heterogeneity in use of neoadjuvant systemic therapy (NST) for patients with clinically node-positive breast cancer in Europe. METHODS: The study was preplanned in the international multicenter phase-III OPBC-03/TAXIS trial (ClinicalTrials.gov Identifier: NCT03513614) to include the first 500 randomized patients with confirmed nodal disease at the time of surgery. The TAXIS study's pragmatic design allowed both the neoadjuvant and adjuvant setting according to the preferences of the local investigators who were encouraged to register eligible patients consecutively. RESULTS: A total of 500 patients were included at 44 breast centers in six European countries from August 2018 to June 2022, 165 (33%) of whom underwent NST. Median age was 57 years (interquartile range [IQR], 48-69). Most patients were postmenopausal (68.4%) with grade 2 and 3 hormonal receptor-positive and human epidermal growth factor receptor 2-negative breast cancer with a median tumor size of 28 mm (IQR 20-40). The use of NST varied significantly across the countries (p < 0.001). Austria (55.2%) and Switzerland (35.8%) had the highest percentage of patients undergoing NST and Hungary (18.2%) the lowest. The administration of NST increased significantly over the years (OR 1.42; p < 0.001) and more than doubled from 20 to 46.7% between 2018 and 2022. CONCLUSION: Substantial heterogeneity in the use of NST with HR+/HER2-breast cancer exists in Europe. While stringent guidelines are available for its use in triple-negative and HER2+ breast cancer, there is a need for the development of and adherence to well-defined recommendations for HR+/HER2-breast cancer.


Asunto(s)
Neoplasias de la Mama , Humanos , Persona de Mediana Edad , Femenino , Neoplasias de la Mama/tratamiento farmacológico , Neoplasias de la Mama/epidemiología , Neoplasias de la Mama/metabolismo , Terapia Neoadyuvante , Estudios Prospectivos , Mama/patología , Europa (Continente)/epidemiología , Receptor ErbB-2/metabolismo
3.
Breast ; 60: 98-110, 2021 Dec.
Artículo en Inglés | MEDLINE | ID: mdl-34555676

RESUMEN

AIM: We developed tailored axillary surgery (TAS) to reduce the axillary tumor volume in patients with clinically node-positive breast cancer to the point where radiotherapy can control it. The aim of this study was to quantify the extent of tumor load reduction achieved by TAS. METHODS: International multicenter prospective study embedded in a randomized trial. TAS is a novel pragmatic concept for axillary surgery de-escalation that combines palpation-guided removal of suspicious nodes with the sentinel procedure and, optionally, imaging-guided localization. Pre-specified study endpoints quantified surgical extent and reduction of tumor load. RESULTS: A total of 296 patients were included at 28 sites in four European countries, 125 (42.2%) of whom underwent neoadjuvant chemotherapy (NACT) and 71 (24.0%) achieved nodal pathologic complete response. Axillary metastases were detectable only by imaging in 145 (49.0%) patients. They were palpable in 151 (51.0%) patients, of whom 63 underwent NACT and 21 had residual palpable disease after NACT. TAS removed the biopsied and clipped node in 279 (94.3%) patients. In 225 patients with nodal disease at the time of surgery, TAS removed a median of five (IQR 3-7) nodes, two (IQR 1-4) of which were positive. Of these 225 patients, 100 underwent ALND after TAS, which removed a median of 14 (IQR 10-17) additional nodes and revealed additional positive nodes in 70/100 (70%) of patients. False-negative rate of TAS in patients who underwent subsequent ALND was 2.6%. CONCLUSIONS: TAS selectively reduced the tumor load in the axilla and remained much less radical than ALND.


Asunto(s)
Neoplasias de la Mama , Axila/patología , Neoplasias de la Mama/tratamiento farmacológico , Neoplasias de la Mama/patología , Neoplasias de la Mama/cirugía , Estudios de Factibilidad , Femenino , Humanos , Escisión del Ganglio Linfático , Ganglios Linfáticos/patología , Ganglios Linfáticos/cirugía , Estadificación de Neoplasias , Estudios Prospectivos , Biopsia del Ganglio Linfático Centinela
4.
Geburtshilfe Frauenheilkd ; 81(4): 422-446, 2021 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-33867562

RESUMEN

Aims The aim of this official guideline published and coordinated by the German Society of Gynaecology and Obstetrics (DGGG) in cooperation with the Austrian Society for Gynaecology and Obstetrics (OEGGG) and the Swiss Society for Gynaecology and Obstetrics (SGGG) was to provide consensus-based recommendations for the diagnosis and treatment of endometriosis based on an evaluation of the relevant literature. Methods This S2k guideline represents the structured consensus of a representative panel of experts with different professional backgrounds commissioned by the Guideline Committee of the DGGG, OEGGG and SGGG. Recommendations Recommendations on the epidemiology, aetiology, classification, symptomatology, diagnosis and treatment of endometriosis are given and special situations are discussed.

5.
Ann Surg Oncol ; 25(9): 2632-2640, 2018 Sep.
Artículo en Inglés | MEDLINE | ID: mdl-29948418

RESUMEN

BACKGROUND: Several studies and a meta-analysis showed that fibrin sealant patches reduced lymphatic drainage after various lymphadenectomy procedures. Our goal was to investigate the impact of these patches on drainage after axillary dissection for breast cancer. METHODS: In a phase III superiority trial, we randomized patients undergoing breast-conserving surgery at 14 Swiss sites to receive versus not receive three large TachoSil® patches in the dissected axilla. Axillary drains were inserted in all patients. Patients and investigators assessing outcomes were blinded to group assignment. The primary endpoint was total volume of drainage. RESULTS: Between March 2015 and December 2016, 142 patients were randomized (72 with TachoSil® and 70 without). Mean total volume of drainage in the control group was 703 ml [95% confidence interval (CI) 512-895 ml]. Application of TachoSil® did not significantly reduce the total volume of axillary drainage [mean difference (MD) -110 ml, 95% CI -316 to 94, p = 0.30]. A total of eight secondary endpoints related to drainage, morbidity, and quality of life were not improved by use of TachoSil®. The mean total cost per patient did not differ significantly between the groups [34,253 Swiss Francs (95% CI 32,625-35,880) with TachoSil® and 33,365 Swiss Francs (95% CI 31,771-34,961) without, p = 0.584]. In the TachoSil® group, length of stay was longer (MD 1 day, 95% CI 0.3-1.7, p = 0.009), and improvement of pain was faster, although the latter difference was not significant [2 days (95% CI 1-4) vs. 5.5 days (95% CI 2-11); p = 0.2]. CONCLUSIONS: TachoSil® reduced drainage after axillary dissection for breast cancer neither significantly nor relevantly.


Asunto(s)
Neoplasias de la Mama/patología , Neoplasias de la Mama/cirugía , Drenaje , Fibrinógeno/uso terapéutico , Escisión del Ganglio Linfático , Trombina/uso terapéutico , Técnicas de Cierre de Heridas/instrumentación , Anciano , Axila , Combinación de Medicamentos , Femenino , Fibrinógeno/economía , Costos de la Atención en Salud , Humanos , Tiempo de Internación , Escisión del Ganglio Linfático/efectos adversos , Escisión del Ganglio Linfático/economía , Mastectomía Segmentaria , Persona de Mediana Edad , Dolor Postoperatorio/etiología , Trombina/economía , Técnicas de Cierre de Heridas/economía
6.
Swiss Med Wkly ; 145: w14087, 2015.
Artículo en Inglés | MEDLINE | ID: mdl-25668217

RESUMEN

QUESTIONS UNDER STUDY: The impact of assisted reproductive technology (ART) on Swiss demography was quantified. From 1993 to 2012 the number of deliveries, including multiples, generated by ART was compared with overall delivery numbers. Swiss experts in ART collaborated in a consensus to increase successful outcomes, to reduce the incidence of complications of ART and to validate recommendations through statistical review of available data. METHODS: Data generated between 1993 and 2012 and published by the Federal Office of Statistics (BfS) were compared with the Swiss database on ART (FIVNAT-CH) as organised by the Swiss Society of Reproductive Medicine (SGRM). From these analyses a panel of Swiss experts in ART extracted recommendations to improve current practice, to prevent complications related to ART and to recommend changes in current Swiss legislation dealing with ART. RESULTS: Since 1993 the age of women giving birth rose together with the number of women asking for ART. This demographic trend was reflected in a rise in the number of deliveries generated by ART (in 2012: 2.2%) and the proportion of multiple births (in 2012: 17.6%). The outcome of ART was most negatively influenced by the age of the treated patient. The number of retrieved oocytes decisively impacted the likelihood of delivery, the risk of multiple births and the incidence of ovarian hyperstimulation syndrome. CONCLUSIONS: Optimal ovarian stimulation should be designed for the retrieval of 10 to 15 oocytes per treatment. Swiss legislation should enable and stimulate a policy of elective single embryo transfer to avoid multiple births.


Asunto(s)
Técnicas Reproductivas Asistidas/tendencias , Adulto , Factores de Edad , Censos , Parto Obstétrico/estadística & datos numéricos , Femenino , Humanos , Persona de Mediana Edad , Progenie de Nacimiento Múltiple/estadística & datos numéricos , Recuperación del Oocito/estadística & datos numéricos , Síndrome de Hiperestimulación Ovárica/epidemiología , Vigilancia de la Población , Embarazo , Resultado del Embarazo , Sistema de Registros , Técnicas Reproductivas Asistidas/normas , Sociedades Médicas , Suiza/epidemiología
7.
Ther Umsch ; 66(12): 825-9, 2009 Dec.
Artículo en Alemán | MEDLINE | ID: mdl-19950062

RESUMEN

Currently, there is a rising trend to consider a multiple delivery as a genuine complication of assisted reproduction, which can be prevented by the replacement of one single, selected embryo. Particularly previously infertile women due to their poor reproductive function are at risk of complications during gestation leading to premature delivery. Cerebral palsy is the most common consequence of multiple gestation and a significant cause of disabling among the offspring. Particularly Swedish specialists in reproductive medicine have been at the forefront of the development of single embryo transfer (denominated SET), which has become the main therapeutic strategy in IVF since 2004. In Sweden, approximately 70 % of all treatment cycles with assisted reproduction are now being performed with SET. Despite the transfer of fewer embryos per cycle, acceptable pregnancy rates are being achieved thereby reducing the multiple delivery rate to approximately 5 %. In Switzerland, however, legal restrictions ban the selection of embryos, so that all available embryos (not more than three) are still being transferred.


Asunto(s)
Transferencia de Embrión/métodos , Adulto , Criopreservación/ética , Criopreservación/métodos , Transferencia de Embrión/ética , Ética Médica , Femenino , Humanos , Recién Nacido , Masculino , Complicaciones del Trabajo de Parto/etiología , Complicaciones del Trabajo de Parto/prevención & control , Evaluación de Procesos y Resultados en Atención de Salud/ética , Evaluación de Procesos y Resultados en Atención de Salud/legislación & jurisprudencia , Embarazo , Complicaciones del Embarazo/etiología , Complicaciones del Embarazo/prevención & control , Reducción de Embarazo Multifetal/ética , Reducción de Embarazo Multifetal/legislación & jurisprudencia , Embarazo Múltiple , Transferencia de un Solo Embrión/ética , Transferencia de un Solo Embrión/métodos , Suiza , Resultado del Tratamiento
8.
J Assist Reprod Genet ; 23(3): 129-36, 2006 Mar.
Artículo en Inglés | MEDLINE | ID: mdl-16622803

RESUMEN

PURPOSE: To assess the clinical and biological effect of the preincubation of oocytes in follicular fluid prior to IVF and ICSI cycles. METHODS: A series of patients were treated by the preincubation of oocytes in the patients' follicular fluid for 3 h after oocyte retrieval followed by processing with standard protocols. Control oocytes were preincubated in normal IVF culture medium. Fluorescence techniques were used to examine oocyte mitochondrial membrane potential. RESULTS: Fertilisation, pregnancy, and implantation rates were all significantly improved after the preincubation of oocytes in follicular fluid. Further tests suggested that differences in pH between follicular fluid and artificial culture medium may be critical to these differences. CONCLUSIONS: Preincubation of human oocytes in follicular fluid improves the results after IVF. This may be partly due to the use of a non-"physiological" pH in artificial culture media during in vitro fertilisation procedures.


Asunto(s)
Fertilización In Vitro/métodos , Oocitos/citología , Folículo Ovárico/citología , Ovario/citología , Adulto , Femenino , Humanos , Concentración de Iones de Hidrógeno , Membranas Intracelulares/metabolismo , Potenciales de la Membrana , Mitocondrias/metabolismo , Oocitos/metabolismo , Embarazo , Índice de Embarazo , Estudios Prospectivos , Manejo de Especímenes , Factores de Tiempo , Resultado del Tratamiento
9.
J Assist Reprod Genet ; 19(10): 456-61, 2002 Oct.
Artículo en Inglés | MEDLINE | ID: mdl-12416649

RESUMEN

PURPOSE: To determine the efficiency of transferring human zygotes as opposed to human day 2 or 3 embryos. METHODS: A prospective, randomized, Multicenter trial. Patients were randomized into zygote or embryo transfer. Patients were prepared for oocyte retrieval using standardized protocols. Oocyte retrieval was performed under general anesthesia. Oocytes and spermatozoa were treated using standard laboratory techniques. All protocols were coordinated by the coordinating center. RESULTS: A total of 386 patients were included in the trial. Pregnancy rates were 36.5% after zygote transfer and 42% after embryo transfer. Implantation rates were equivalent (17%) in both groups. CONCLUSIONS: No general difference was observed for zygote or embryo transfer. The results suggest that zygote transfer is a valid alternative to embryo transfer.


Asunto(s)
Implantación del Embrión , Transferencia de Embrión , Fertilización In Vitro , Transferencia Intrafalopiana del Cigoto , Adulto , Femenino , Humanos , Infertilidad Femenina/terapia , Embarazo , Resultado del Embarazo , Estudios Prospectivos
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