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BACKGROUND: Vaginal brachytherapy is currently recommended as adjuvant treatment in patients with high-intermediate risk endometrial cancer to maximize local control and has only mild side effects and no or limited impact on quality of life. However, there is still considerable overtreatment and also some undertreatment, which may be reduced by tailoring adjuvant treatment to the patients' risk of recurrence based on molecular tumor characteristics. PRIMARY OBJECTIVES: To compare the rates of vaginal recurrence in women with high-intermediate risk endometrial cancer, treated after surgery with molecular-integrated risk profile-based recommendations for either observation, vaginal brachytherapy or external pelvic beam radiotherapy or with standard adjuvant vaginal brachytherapy STUDY HYPOTHESIS: Adjuvant treatment based on a molecular-integrated risk profile provides similar local control and recurrence-free survival as current standard adjuvant brachytherapy in patients with high-intermediate risk endometrial cancer, while sparing many patients the morbidity of adjuvant treatment and reducing healthcare costs. TRIAL DESIGN: A multicenter, international phase III randomized trial (2:1) of molecular-integrated risk profile-based adjuvant treatment (experimental arm) or adjuvant vaginal brachytherapy (standard arm). MAJOR INCLUSION/EXCLUSION CRITERIA: Women aged 18 years and over with a histological diagnosis of high-intermediate risk endometrioid endometrial cancer after total abdominal or laparoscopic hysterectomy and bilateral salpingo-oophorectomy. High-intermediate risk factors are defined as: (i) International Federation of Gynecology and Obstetrics stage IA (with invasion) and grade 3; (ii) stage IB grade 1 or 2 with age ≥60 and/or lymph-vascular space invasion; (iii) stage IB, grade 3 without lymph-vascular space invasion; or (iv) stage II (microscopic and grade 1). ENDPOINTS: The primary endpoint is vaginal recurrence. Secondary endpoints are recurrence-free and overall survival; pelvic and distant recurrence; 5-year vaginal control (including treatment for relapse); adverse events and patient-reported symptoms and quality of life; and endometrial cancer-related healthcare costs. SAMPLE SIZE: 500 eligible and evaluable patients. ESTIMATED DATES FOR COMPLETING ACCRUAL AND PRESENTING RESULTS: Estimated date for completing accrual will be late 2021. Estimated date for presentation of (first) results is expected in 2023. TRIAL REGISTRATION: The trial is registered at clinicaltrials.gov (NCT03469674) and ISRCTN (11659025).
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Carcinoma Endometrioide/genética , Carcinoma Endometrioide/terapia , Neoplasias Endometriales/genética , Neoplasias Endometriales/terapia , Braquiterapia , Carcinoma Endometrioide/radioterapia , Ensayos Clínicos Fase III como Asunto , Proteínas de Unión al ADN/genética , Proteínas de Unión al ADN/metabolismo , Neoplasias Endometriales/radioterapia , Femenino , Humanos , Endonucleasa PMS2 de Reparación del Emparejamiento Incorrecto/genética , Endonucleasa PMS2 de Reparación del Emparejamiento Incorrecto/metabolismo , Estudios Multicéntricos como Asunto , Homólogo 1 de la Proteína MutL/genética , Homólogo 1 de la Proteína MutL/metabolismo , Proteína 2 Homóloga a MutS/genética , Proteína 2 Homóloga a MutS/metabolismo , Radioterapia Adyuvante , Ensayos Clínicos Controlados Aleatorios como AsuntoRESUMEN
OBJECTIVES: The purpose of this study was to analyze the effects of prior radiotherapy (RT) as well as postmastectomy radiotherapy (PMRT) on patient-reported quality of life (QoL) and on surgical/aesthetic outcomes in patients with expander-/implant-based delayed immediate reconstruction (EIBR) compared to patients that underwent EIBR without any RT. MATERIAL AND METHODS: QoL was assessed by BREAST-Q, the surgical/aesthetic outcome by a structured examination and a picture analysis (BCCT.CORE software) and subsequently compared between the three cohorts. RESULTS: Of 161 eligible patients, 97 followed the invitation (no RT n = 54, 9 of them with bilateral EIBR; PMRT n = 26; history of RT n = 15). The surgical/aesthetic results were better in the RT-naive cohort than in the PMRT cohort, but satisfaction with outcome and psychosocial well-being were better in the PMRT cohort. The RT-naive cohort showed (significantly) higher scores in satisfaction with breast, satisfaction with implant and sexual well-being compared to the history of RT cohort, although satisfaction with outcome was comparable. The PMRT cohort reached significantly more points in almost all categories and better BCCT.CORE and examination results than the history of RT cohort. Of all patients, 92.7%, 84.6% and 78.6% (RT naive, PMRT, history of RT) would agree to undergo EIBR again. CONCLUSION: EIBR results in acceptable QoL and surgical results. In patients with a prior RT, QoL is significantly lower and surgical results are significantly worse. However, high acceptance rates suggest EIBR being a justifiable option even for this group. Prospective studies and long-term follow-up are required for definitive conclusions.
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Implantación de Mama/métodos , Neoplasias de la Mama/cirugía , Mastectomía/métodos , Calidad de Vida/psicología , Neoplasias de la Mama/radioterapia , Estudios de Cohortes , Femenino , Humanos , Persona de Mediana Edad , Estudios ProspectivosRESUMEN
BACKGROUND: Sentinel lymph node dissection (SLND) may reduce morbidity in patients with endometrial cancer. The objective of this study is to estimate how many systematic lymph node dissections (LND) can be spared with an implementation of a SLN-procedure. METHODS: Retrospective, single-center study, SLND according to NCCN-Guidelines. RESULTS: In 109 patients of 154 consecutive patients, SLND was performed. The detection rate was 61% on both sides and 86% on at least one side. Classification of uterine risk factors is as follows: low risk 53, intermediate risk 25, high-intermediate risk 13, and high-risk 18. Stage IIIC: 0, 3, 7, 11, respectively. Under the assumption that 56 patients with "higher than low risk" factors would be treated by systematic LND, we spared 26 pelvic and paraaortic LND. After failures of SLN detection, unilateral pelvic LND was performed in 15 patients. Patients with "higher than low risk" factors and node-negative SLN are candidates for a randomized study to prove safety and efficacy. Only every third patient in our study met these criteria. CONCLUSIONS: In a cohort of patients with "higher than low risk" endometrial cancer, the implementation of SLND nearly divided the number of radical lymph node dissections in half. Further studies are required to define the best modalities for SLND.
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Adenocarcinoma de Células Claras/cirugía , Carcinosarcoma/cirugía , Cistadenocarcinoma Seroso/cirugía , Neoplasias Endometriales/cirugía , Escisión del Ganglio Linfático/métodos , Ganglio Linfático Centinela/patología , Ganglio Linfático Centinela/cirugía , Adenocarcinoma de Células Claras/patología , Adulto , Anciano , Anciano de 80 o más Años , Carcinosarcoma/patología , Cistadenocarcinoma Seroso/patología , Neoplasias Endometriales/patología , Femenino , Estudios de Seguimiento , Humanos , Persona de Mediana Edad , Pronóstico , Estudios Retrospectivos , Biopsia del Ganglio Linfático Centinela/métodosRESUMEN
BACKGROUND: To assess the efficacy and safety of intradetrusor onabotulinumtoxinA (OnabotA) injection treatment in patients with neurogenic lower urinary tract dysfunction (NLUTD), especially for patients with Parkinson disease (PD). METHODS: PD patients refractory to oral antimuscarinic participated in an off-label use study and were evaluated prior and after 200 IU OnabotA injection into detrusor muscle, including trigone. Changes due to treatment were evaluated using bladder diaries, urodynamics, and questionnaires. Statistical analysis comprised Wilcoxon rank-sum test. Values are presented as mean ± standard deviation. RESULTS: Ten PD patients (4 female and 6 male, mean age: 67.9 ± 5.36 years) with LUTD were enrolled. All patients tolerated the treatment. Bladder diary variables decreased significantly (p ≤ 0.011) after OnabotA injection compared to variables prior injection. Desire to void and maximum bladder capacity increased significantly in urodynamics (p ≤ 0.05). Maximum detrusor pressure during voiding phase normalised from 56.2 to 18.75 cm/H20. Detrusor overactivity was less often detectable. All patients voided spontaneously. Mean post void residual (PVR) volume was 77.0 ± 119.78 mL postoperatively. No urinary retention or side effects have been observed during/after treatment. Mean follow-up time was 4 months (range of 1-12). 4 patients requested repeated injection after a mean period of 10 months between first and second injection. CONCLUSIONS: Our data confirm the efficacy and safety of 200 IU OnabotA injection in patients with neurogenic LUTD due to PD. The risk of urinary retention or high post-urinary residual volumes seems to be minor after OnabotA-injection. More research is needed with larger sample size to confirm the significance of these findings. TRIAL NUMBER: ISRCTN 11857462 , Registration Date 2016/10/08.
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Inhibidores de la Liberación de Acetilcolina/administración & dosificación , Toxinas Botulínicas Tipo A/administración & dosificación , Vejiga Urinaria Neurogénica/tratamiento farmacológico , Vejiga Urinaria Neurogénica/fisiopatología , Micción , Administración Intravesical , Anciano , Femenino , Humanos , Masculino , Enfermedad de Parkinson/complicaciones , Vejiga Urinaria Neurogénica/etiologíaRESUMEN
BACKGROUND: The aim was to evaluate cancer-specific survival (CSS) and overall survival (OS) in patients with prostate cancer (PCa) recurrence who underwent salvage extended pelvic lymph node dissection (ePLND), taking into consideration pre- and postoperative androgen deprivation therapy (ADT). METHODS: Salvage ePLND was performed in a cohort of 54 patients with PCa recurrence, and data from 45 patients were analyzed. The indications for salvage ePLND were biochemical recurrence (BCR) of PCa and suspect findings on (11)C-choline PET/CT. PSA-level, biochemical response (BR), duration of biochemical recurrence freedom (BCRF), number of metastases, OS and CSS were analyzed retrospectively. RESULTS: The average follow-up was 42.7 ± 20.8 months. Thirty-three patients (73.3 %, 95 % CI: 60.5-83.6 %) achieved BCRF during follow-up. The mean BCRF-period was 31.4 ± 19.7 months. CSS and OS were both 91.7 % ± 4.8 % (3-year survival) and 80.6 ± 8.6 % (5-year survival). Twenty-four patients (53.3 %, 95 % CI: 40.0-66.3 %) with castration-resistant PCa (CRPC) responded again to ADT after salvage ePLND. CONCLUSIONS: Salvage ePLND for selected patients with BCR and clinically recurrent nodal disease can achieve an immediate complete PSA response (i. e. BCRF) in nearly half of the patients. Patients with CRPC responded again to ADT after ePLND. Multicenter prospective studies with a control group are needed.
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Escisión del Ganglio Linfático , Recurrencia Local de Neoplasia/mortalidad , Recurrencia Local de Neoplasia/cirugía , Neoplasias de la Próstata/mortalidad , Neoplasias de la Próstata/cirugía , Terapia Recuperativa , Anciano , Humanos , Metástasis Linfática , Masculino , Neoplasias de la Próstata/patología , Estudios Retrospectivos , Tasa de SupervivenciaRESUMEN
PURPOSE: We present the 1-year results of the GOLIATH prospective randomized controlled trial comparing transurethral resection of the prostate to GreenLight XPS for the treatment of men with nonneurogenic lower urinary tract symptoms due to prostate enlargement. The updated results at 1 year show that transurethral resection of the prostate and GreenLight XPS remain equivalent, and confirm the therapeutic durability of both procedures. We also report 1-year followup data from several functional questionnaires (OABq-SF, ICIQ-SF and IIEF-5) and objective assessments. MATERIALS AND METHODS: A total of 291 patients were enrolled at 29 sites in 9 European countries. Patients were randomized 1:1 to undergo GreenLight XPS or transurethral resection of the prostate. The trial was designed to evaluate the hypothesis that GreenLight XPS is noninferior to transurethral resection of the prostate on the International Prostate Symptom Score at 6 months. Several objective parameters were assessed, including maximum urinary flow rate, post-void residual urine volume, prostate volume and prostate specific antigen, in addition to functional questionnaires and adverse events at each followup. RESULTS: Of the 291 enrolled patients 281 were randomized and 269 received treatment. Noninferiority of GreenLight XPS was maintained at 12 months. Maximum urinary flow rate, post-void residual urine volume, prostate volume and prostate specific antigen were not statistically different between the treatment arms at 12 months. The complication-free rate at 1 year was 84.6% after GreenLight XPS vs 80.5% after transurethral resection of the prostate. At 12 months 4 patients treated with GreenLight XPS and 4 who underwent transurethral resection of the prostate had unresolved urinary incontinence. CONCLUSIONS: Followup at 1 year demonstrated that photoselective vaporization of the prostate produced efficacy outcomes similar to those of transurethral resection of the prostate. The complication-free rates and overall reintervention rates were comparable between the treatment groups.
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Síntomas del Sistema Urinario Inferior/cirugía , Hiperplasia Prostática/cirugía , Resección Transuretral de la Próstata/métodos , Obstrucción del Cuello de la Vejiga Urinaria/cirugía , Humanos , Síntomas del Sistema Urinario Inferior/etiología , Masculino , Estudios Prospectivos , Hiperplasia Prostática/complicaciones , Factores de Tiempo , Resultado del Tratamiento , Obstrucción del Cuello de la Vejiga Urinaria/etiologíaRESUMEN
BACKGROUND: An imaging tool providing reliable prostate cancer (PCa) detection and localization is necessary to improve common diagnostic pathway with ultrasound targeted biopsies. To determine the performance of transrectal ultrasound (TRUS) augmented by prostate HistoScanning(TM) analysis (PHS) we investigated the detection of prostate cancer (PCa) foci in repeat prostate biopsies (Bx). METHODS: 97 men with a mean age of 66.2 (44-82) years underwent PHS augmented TRUS analysis prior to a repeat Bx. Three PHS positive foci were defined in accordance with 6 bilateral prostatic sectors. Targeted Bx (tBx) limited to PHS positive foci and a systematic 14-core backup Bx (sBx) were taken. Results were correlated to biopsy outcome. Sensitivity, specificity, predictive accuracy, negative predictive value (NPV) and positive predictive value (PPV) were calculated. RESULTS: PCa was found in 31 of 97 (32%) patients. Detection rate in tBx was significantly higher (p < .001). Detection rate in tBx and sBx did not differ on patient level (p ≥ 0.7). PHS sensitivity, specificity, predictive accuracy, PPV and NPV were 45%, 83%, 80%, 19% and 95%, respectively. CONCLUSIONS: PHS augmented TRUS identifies abnormal prostatic tissue. Although sensitivity and PPV for PCa are low, PHS information facilitates Bx targeting to vulnerable foci and results in a higher cancer detection rate. PHS targeted Bx should be considered in patients at persistent risk of PCa.
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Biopsia por Aspiración con Aguja Fina Guiada por Ultrasonido Endoscópico/métodos , Interpretación de Imagen Asistida por Computador/métodos , Neoplasias de la Próstata/diagnóstico por imagen , Neoplasias de la Próstata/patología , Ultrasonografía/métodos , Adulto , Anciano , Anciano de 80 o más Años , Humanos , Aumento de la Imagen/métodos , Masculino , Persona de Mediana Edad , Reproducibilidad de los Resultados , Sensibilidad y EspecificidadRESUMEN
PURPOSE: We established cell lines from penile squamous cell carcinoma and its lymph node metastasis, and investigated the role of chemokines, chemokine receptors and podoplanin in cancer progression. MATERIALS AND METHODS: Tumor specimen of primary tumors, and lymph node and distant metastases were cultured in vitro and xenotransplanted in SCID beige mice. Specimens were analyzed by hematoxylin and eosin staining, and immunohistochemistry. Comparative screening for chemokines, chemokine receptors and podoplanin was done by polymerase chain reaction, fluorescence activated cell sorting and enzyme-linked immunosorbent assay. RESULTS: We established 2 cell lines from a primary tumor and its corresponding lymph node metastasis, respectively. Heterotopic xenotransplantation revealed reliable tumor growth in vivo. Morphological and immunohistological analysis showed comparable features for human tumors, cell lines in vitro and xenotransplanted tumors in mice regarding the primary tumor and metastasis. Comprehensive analysis of chemokines and chemokine receptors in the metastasis derived cell line and in the cell line originating from the primary tumor revealed the most pronounced changes for CXCL14. This pattern was confirmed on the protein level. Comparative analysis of podoplanin showed marked down-regulation in the metastatic variant on the mRNA and protein levels. CONCLUSIONS: To our knowledge we established the first pair of cell lines of a human primary penile tumor and the corresponding lymph node metastasis. These cell lines offer unique possibilities for further comparative functional investigations in in vitro and in vivo settings. They enable studies of new potential therapeutic agents and other assays to better understand the molecular mechanisms of penile cancer progression.
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Carcinoma de Células Escamosas/fisiopatología , Quimiocinas/metabolismo , Glicoproteínas de Membrana/metabolismo , Neoplasias del Pene/fisiopatología , Receptores de Quimiocina/metabolismo , Células Tumorales Cultivadas , Animales , Carcinoma de Células Escamosas/metabolismo , Progresión de la Enfermedad , Femenino , Humanos , Ganglios Linfáticos/fisiopatología , Metástasis Linfática , Masculino , Ratones , Ratones SCID , Persona de Mediana Edad , Trasplante de Neoplasias , Neoplasias del Pene/metabolismo , Células Tumorales Cultivadas/fisiologíaRESUMEN
Introduction: The aim of the present study was to analyze the performance of Oncotype DX® multigene assay (ODX®) in patients with 0-3 lymph nodes in a high-volume community hospital. Methods: Patients with non-metastatic HR*/HER2- EBC and 0-3 positive lymph nodes, who underwent primary surgery at the Red Cross Hospital Munich, Germany and consecutively had ODX® testing were included in this retrospective study. The distribution of clinicopathologic characteristics, recurrence score (RS) risk, and use of systemic therapy were compared among patients without positive lymph nodes (N0) and patients with micrometastases or 1 to 3 positive lymph nodes (N1). Disease-free survival (DFS) and overall survival (OS) were estimated. Results: From 2012 to 2017 ODX® was consecutively performed in 575 (16.4%) of 3,492 women with HR*/HER- EBC, of which 553 were eligible for this analysis (N0: 60.8%; N1: 39.2%). Among the patients included, 441 (79.7%) had an RS of 0 to 25 and 112 (20.3%) had an RS of 26 or higher. In patients with RS 0 to 25 the rate of chemotherapy use was low, independent from nodal status (N0: 17.1% and N1: 19.1%) and 5-year DFS was 90.5% and 91.7% for N0 and N1 patients, respectively. There was no significant difference in DFS (90.5% vs. 93.3%; p = 0.101) or OS (97.2% vs. 96.0%; p = 0.737) for patients with an RS of 0 to 25 when treated with chemo-endocrine therapy or endocrine therapy alone, independent from nodal status. Conclusions: The results of the study confirm the observations from randomized studies on the use of the ODX® in a real-world population in terms of risk distribution and patient outcome. Adjuvant chemotherapy could be safely omitted in patients with HR*/HER2- breast cancer with 0-3 positive lymph nodes and RS <25.
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BACKGROUND: PITX2 DNA methylation has been shown to predict outcomes in high-risk breast cancer patients after anthracycline-based chemotherapy. To determine its prognostic versus predictive value, the impact of PITX2 DNA methylation on outcomes was studied in an untreated cohort vs. an anthracycline-treated triple-negative breast cancer (TNBC) cohort. MATERIAL AND METHODS: The percent DNA methylation ratio (PMR) of paired-like homeodomain transcription factor 2 (PITX2) was determined by a validated methylation-specific real-time PCR test. Patient samples of routinely collected archived formalin-fixed paraffin-embedded (FFPE) tissue and clinical data from 144 TNBC patients of 2 independent cohorts (i.e., 66 untreated patients and 78 patients treated with anthracycline-based chemotherapy) were analyzed. RESULTS: The risk of 5- and 10-year overall survival (OS) increased continuously with rising PITX2 DNA methylation in the anthracycline-treated population, but it increased only slightly during 10-year follow-up time in the untreated patient population. PITX2 DNA methylation with a PMR cutoff of 2 did not show significance for poor vs. good outcomes (OS) in the untreated patient cohort (HR = 1.55; p = 0.259). In contrast, the PITX2 PMR cutoff of 2 identified patients with poor (PMR >2) vs. good (PMR ≤2) outcomes (OS) with statistical significance in the anthracycline-treated cohort (HR = 3.96; p = 0.011). The results in the subgroup of patients who did receive anthracyclines only (no taxanes) confirmed this finding (HR = 5.71; p = 0.014). CONCLUSION: In this hypothesis-generating study PITX2 DNA methylation demonstrated predominantly predictive value in anthracycline treatment in TNBC patients. The risk of poor outcome (OS) correlates with increasing PITX2 DNA methylation.
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BACKGROUND: Patients with triple-negative primary breast cancer (TNBC) who have residual invasive carcinoma after neoadjuvant chemotherapy have poor prognosis. Proven adjuvant approaches to reduce the risk of recurrence and improve outcome in patients with non-pathological complete response (non-pCR) are limited. METHODS: From our institutional registry, a consecutive case series of patients with operable, unilateral, primary invasive noninflammatory early TNBC of stage I-IIIB and pathologically verified residual cancer cells (no pathological complete response) after neoadjuvant chemotherapy underwent adjuvant treatment with gemcitabine plus cisplatin combined with regional hyperthermia. For quality assurance, we analyzed feasibility, efficacy, and toxicity of all treated patients. Outcome was evaluated for the entire group of patients as well as for the subgroups of patients with or without lymph node involvement at baseline (cN0/ cN+). RESULTS: From August 2012 to January 2019, we offered this treatment to 53 patients at our center as part of routine care. The median follow-up was 38 months. The majority of patients (64.2%) had cT2 tumors at baseline. Twenty-four patients (45%) were clinically node positive as evaluated by sonography. Thirty-nine patients (74%) had grade 3, and 14 patients (26%) had grade 2 tumors. Forty-one patients (76%) showed a regression grade 1 according to Sinn. Patients received a median of six treatment cycles of gemcitabine and cisplatin (range 1-6) combined with 12 applications of regional hyperthermia (median 12, range 2-12). Disease-free survival (DFS) at 3 years was 57.5%. In patients with no lymph node involvement at baseline (cN0), DFS at 3 years was significantly higher than in initially node-positive (cN+) patients (80 vs. 31%; p = 0.001). Overall survival (OS) at 3 years was 81.6%. In patients with no lymph node involvement at baseline (cN0), OS at 3 years was significantly higher than in node-positive (cN+) patients (93 vs. 70.4%; p = 0.02). Overall, grade 3/4 toxicities were leukopenia (38%), thrombocytopenia (4%), and anemia (4%). CONCLUSION: After standard neoadjuvant chemotherapy containing anthracycline plus cyclophosphamide followed by taxanes, addition of adjuvant gemcitabine plus cisplatin in combination with regional hyperthermia was safe and effective in TNBC patients with non-pCR.
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PURPOSE: Loss of appetite is a common complaint in cancer patients. There is still no overall conclusion whether this symptom might be caused by distorted taste/smell function or by tumor byproducts. This knowledge would be important for adequate patient counseling as well as symptom relief. Several studies investigated taste function, but to our knowledge, only one studied olfactory function in cancer patients. MATERIALS AND METHODS: Sixty-nine breast cancer patients were investigated by a validated taste (taste strips) and smell test (Sniffin' Sticks) prior to chemotherapy. RESULTS: Compared to normative data, breast cancer patients showed no significant difference in odor threshold, but better scores for odor identification and odor discrimination. For taste, breast cancer patients showed a significantly lower value for the quality sour compared to healthy controls only on left side of the tongue; there was no difference in the qualities sweet, salty, and bitter. An increase in tumor size was associated with a significant decrease in olfactory function, but not in gustatory function. Different histology or graduation of breast cancer, resection status, or metastasis to the lung and liver had no influence on taste and smell. There was no correlation between taste and smell to estrogen or progesterone receptor status. There was no correlation between smell and human epidermal growth factor receptor 2 (Her2 status), but there was a significant correlation between bitter taste and Her2 status. CONCLUSION: Taste/smell did not seem substantially altered in breast cancer patients compared to normative data. Nevertheless, increasing tumor burden resulted in decreased olfactory function, but not in taste changes.
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Neoplasias de la Mama/complicaciones , Neoplasias de la Mama/patología , Trastornos del Olfato/etiología , Trastornos del Gusto/etiología , Adulto , Anciano , Femenino , Humanos , Metástasis Linfática , Persona de Mediana Edad , Estadificación de Neoplasias , Estudios ProspectivosRESUMEN
OBJECTIVE: To examine interobserver variations in assessing grade and stage of penile squamous cell carcinoma (SCC). PATIENTS AND METHODS: We retrospectively reviewed the pathological features and clinical outcome in 75 patients with SCC of the penis, who were treated in participating urological centres between 1996 and 2005; the assessments of the local pathologists and the review pathologists were compared. RESULTS: There was conformity in tumour grade in 67% and the assessment of tumour stage conformed in 84%; the combination assessment of both grade and stage conformed in 56%. CONCLUSION: Accurate histological subtyping by the surgical pathologist demands standardized guidelines, in particular for histological grading, which is crucial for clinical treatment, but shows significant interobserver variation.
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Carcinoma de Células Escamosas/patología , Neoplasias del Pene/patología , Pene/patología , Adulto , Anciano , Anciano de 80 o más Años , Carcinoma de Células Escamosas/epidemiología , Humanos , Incidencia , Masculino , Persona de Mediana Edad , Estadificación de Neoplasias , Variaciones Dependientes del Observador , Neoplasias del Pene/epidemiología , Pronóstico , Estudios Retrospectivos , Factores de RiesgoRESUMEN
OBJECTIVE: To assess the satisfaction profiles following penile prosthesis surgery in patients with erectile dysfunction (ED) in their seventh decade of life. PATIENTS AND METHODS: In all, 174 patients received, for the first time, a penile prosthesis between 1990 and 2007 in our department. Among these, 35 patients were aged > or =70 years at prosthesis implantation. Of these, 18 patients were still alive at the time of follow-up. Using a telephone survey, patients were asked to answer the Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) as well as the International Index of Erectile Dysfunction (IIEF). Another question in the survey was developed by the authors based on a comprehensive review of the literature, which assessed the usefulness of the device for the patient and the degree of their usage. This was formulated as follows: How many times per 2 weeks do you have a sexual intercourse? RESULTS: In all, 15 of 18 patients were either very or somewhat satisfied (83%). At follow-up 11 out of 15 (73%) patients were using their prosthesis regularly. The mean IIEF and EDITS scores were 21.80 and 75.20, respectively. CONCLUSION: A penile prosthesis remains a highly promising treatment in older patients with a similar satisfaction rate to those published for younger patients. Thus, the motivation of the patient and not the age of the patient should be the main determinant factor in this surgical procedure.
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Disfunción Eréctil/cirugía , Satisfacción del Paciente , Implantación de Pene , Prótesis de Pene , Factores de Edad , Anciano , Coito , Estudios de Seguimiento , Humanos , Masculino , Implantación de Pene/psicología , Prótesis de Pene/psicología , Encuestas y Cuestionarios , Resultado del TratamientoRESUMEN
INTRODUCTION: The innervation of the membranous urethra (MU) is still under debate. We analysed the functional effects of electrostimulation of the rhabdosphincter branch of the pelvic nerve (RBP) on the MU in a standardized male rabbit model, paying attention both to the efferent and the possible afferent effects of stimulation. MATERIAL AND METHODS: Six male rabbits (chinchilla bastards) were included in this study. Pudendal nerve branches as well as pelvic nerve branches were exposed bilaterally in all animals. Randomized electrostimulation trials of both the pudendal nerve fibres and the RBP were carried out using a biphasic signal (0.3 mA, 200 mus). The stimulation frequency ranged from 10 to 40 Hz in a randomized pattern. Changes in MU pressure were measured urodynamically. The pressure changes occurring as a result of stimulation were compared in both nerve structures. At the end of the stimulation trial, the RBP and the pudendal nerve were dissected at different positions before repeating the stimulation and the MU pressure recording. RESULTS: The mean MU baseline pressure without stimulation was 24 cm H(2)O (range 21-27) in all animals. During unilateral pudendal stimulation, the mean pressure response rose by highly significant values (p < 0.005) compared to baseline. The pressure response was frequency dependent. Stimulation of the RBP resulted in a small but significant change of the MU pressure in the lower frequency range (10 and 20 Hz) (p > 0.05). On performing stimulation at higher frequencies, there was no significant difference from baseline. The pressure response of the MU during stimulation of the intact RBP did not differ significantly from the response after dissection of the RBP. However, after dissecting the pudendal nerve, the MU pressure response to RBP stimulation was diminished. CONCLUSION: Our results confirm the primacy of the pudendal nerve in the innervation of the MU. Stimulation of the RBP, however, may produce an afferent signal which is transmitted to the pudendal nerve, thus resulting in a pressure increase of the MU and contributing towards continence. We showed the importance of the RBP to maintain full urinary continence in rabbits. Our results suggest that substantially higher continence rates can be achieved through a nerve-sparing procedure in radical prostatectomy. Nerve-sparing radical prostatectomy incidentally also protects the RBP from injury.
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Uretra/inervación , Uretra/fisiología , Animales , Estimulación Eléctrica , Masculino , Contracción Muscular , Músculo Liso/fisiología , Perineo/inervación , Presión , Conejos , UrodinámicaRESUMEN
Aim: We assessed the suitability of a biomarker panel to improve early detection and individual risk assessment in breast cancer (BC) patients. Materials & methods: PENK, pro-SP, hGH and CA15-3 of 204 BC patients and 68 healthy controls were measured. Results: PENK and human growth hormone concentrations were significantly lower and pro-SP values higher in BC patients compared with controls. C-index increased from 0.628 for CA15-3 alone to 0.754 when all three biomarkers were added to the model. Conclusion: This biomarker panel may improve early detection of BC and influence the assessment of breast imaging. It might be useful for a risk-adapted cancer surveillance or primary prevention program by a more precise determination of an individualized BC risk.
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Biomarcadores de Tumor/sangre , Neoplasias de la Mama/diagnóstico , Adulto , Anciano , Área Bajo la Curva , Neoplasias de la Mama/patología , Estudios de Casos y Controles , Detección Precoz del Cáncer , Encefalinas/sangre , Femenino , Hormona de Crecimiento Humana/sangre , Humanos , Modelos Logísticos , Mamografía , Persona de Mediana Edad , Mucina-1/sangre , Clasificación del Tumor , Estadificación de Neoplasias , Precursores de Proteínas/sangre , Curva ROC , Sustancia P/sangreRESUMEN
BACKGROUND: Urinary involvement is common in hereditary spastic paraplegias (HSPs), but has rarely been assessed systematically. METHODS: We characterized urinary complaints in 71 German HSP patients (mean age 55.4 ± 13.9 years; mean disease duration 20.7 ± 14.3 years; 48% SPG4-positive) using validated clinical rating scales (SCOPA-AUT, ICIQ-SF, ICIQ-LUTSqol). Treatment history and satisfaction with medical care was also assessed. RESULTS: 74.6% of patients had one or more urological problems, most commonly nocturia and urgency. Incontinence was more severe in women, correlating with SCOPA-AUT. Female gender and SPG4 mutations were associated with higher urinary frequency and severity of urological involvement. QoL was overall reduced, more in women and in SPG4 mutation carriers. Almost 90% consulted a medical specialist; more than half were largely satisfied. 43.4% received oral medication and 5.7% received intravesical botulinum toxin. However, more than one-third of patients remained untreated. CONCLUSION: Urinary complaints are common in HSP and should be addressed and treated.
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Satisfacción del Paciente , Calidad de Vida , Paraplejía Espástica Hereditaria/fisiopatología , Paraplejía Espástica Hereditaria/psicología , Enfermedades Urológicas/fisiopatología , Enfermedades Urológicas/psicología , Femenino , Humanos , Masculino , Persona de Mediana Edad , Paraplejía Espástica Hereditaria/epidemiología , Paraplejía Espástica Hereditaria/terapia , Enfermedades Urológicas/epidemiología , Enfermedades Urológicas/terapiaRESUMEN
Background Various methods of intrapartum analgesia are available these days. Pethidine, meptazinol and epidural analgesia are among the most commonly used techniques. A relatively new one is patient-controlled intravenous analgesia with remifentanil, although the experiences published so far in Germany are limited. Our goal was to study the influence of these analgesic techniques (opioids vs. patient-controlled intravenous analgesia with remifentanil vs. epidural analgesia) on the second stage of labour and on perinatal outcome. Material and Methods We conducted a retrospective study with 254 parturients. The women were divided into 4 groups based on the analgesic technique and matched for parity, maternal age and gestational age (opioids n = 64, patient-controlled intravenous analgesia with remifentanil n = 60, epidural analgesia n = 64, controls without the medicinal products mentioned n = 66). Maternal, fetal and neonatal data were analysed. Results The expulsive stage was prolonged among both primiparas and multiparas with patient-controlled intravenous analgesia with remifentanil (79 [74] vs. 44 [55] min, p = 0.016, and 28 [68] vs. 10 [11] min, p < 0.001, respectively) and epidural analgesia (90 [92] vs. 44 [55] min, p = 0.004, and 22.5 [73] vs. 10 [11] min, p = 0.003, respectively) compared with the controls. The length of the pushing stage was similar among primiparas in all groups but prolonged compared with the controls in multiparas with patient-controlled intravenous analgesia with remifentanil (15 [17] vs. 5 [7] min, p = 0.001) and epidural analgesia (10 [15] vs. 5 [7] min, p = 0.006). The Apgar, umbilical arterial pH and base excess values were similar between the groups, as were the rates of acidosis and neonatal intensive care unit admission. Conclusion Parturients with patient-controlled intravenous analgesia with remifentanil and epidural analgesia showed a prolonged expulsive stage compared with the opioid group and controls. The short-term neonatal outcome was not influenced by the three methods examined.
RESUMEN
PURPOSE: Precise placement of needles is a challenge in a number of clinical applications such as brachytherapy or biopsy. Forces acting at the needle cause tissue deformation and needle deflection which in turn may lead to misplacement or injury. Hence, a number of approaches to estimate the forces at the needle have been proposed. Yet, integrating sensors into the needle tip is challenging and a careful calibration is required to obtain good force estimates. METHODS: We describe a fiber-optic needle tip force sensor design using a single OCT fiber for measurement. The fiber images the deformation of an epoxy layer placed below the needle tip which results in a stream of 1D depth profiles. We study different deep learning approaches to facilitate calibration between this spatio-temporal image data and the related forces. In particular, we propose a novel convGRU-CNN architecture for simultaneous spatial and temporal data processing. RESULTS: The needle can be adapted to different operating ranges by changing the stiffness of the epoxy layer. Likewise, calibration can be adapted by training the deep learning models. Our novel convGRU-CNN architecture results in the lowest mean absolute error of [Formula: see text] and a cross-correlation coefficient of 0.9997 and clearly outperforms the other methods. Ex vivo experiments in human prostate tissue demonstrate the needle's application. CONCLUSIONS: Our OCT-based fiber-optic sensor presents a viable alternative for needle tip force estimation. The results indicate that the rich spatio-temporal information included in the stream of images showing the deformation throughout the epoxy layer can be effectively used by deep learning models. Particularly, we demonstrate that the convGRU-CNN architecture performs favorably, making it a promising approach for other spatio-temporal learning problems.
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Biopsia/instrumentación , Braquiterapia/instrumentación , Aprendizaje Profundo , Agujas , Tomografía de Coherencia Óptica , Algoritmos , Biopsia/métodos , Braquiterapia/métodos , Calibración , Diseño de Equipo , Humanos , Fenómenos MecánicosRESUMEN
BACKGROUND: Sentinel lymph node (SLN) biopsy represents a well-established diagnostic tool for the assessment of lymphatic metastasis. Correct pre- and intraoperative visualization of SLN is of the utmost importance to ensure the safety and feasibility of the procedure. Aim of this study was to evaluate the diagnostic value of preoperative SLN imaging via single photon emission computed tomography/computed tomography (SPECT/CT) and planar scintigraphy in patients with penile carcinoma with nonpalpable inguinal lymph nodes. MATERIALS AND METHODS: After peritumoral intradermal tracer injection (150MBq/4.05mCi Tc-99m nanocolloid), we acquired planar scintigraphies including indirect body contouring using a twin head gamma camera. Subsequently we acquired SPECT/CT images of the abdomen via a hybrid system. Prospective evaluation of 52 groins in 26 examined patients was done for all image files obtained with both techniques by 2 trained experts in consensual assessment. RESULTS: A total of 71 SLNs in 37 groins were identified by means of planar scintigraphy. In these images, no radiolabeled lymph nodes were visualized in 15 out of 52 groins (28.8%). The SPECT/CT images showed a total of 82 SLNs in 42 groins. In 19.2% (10 of the 52 groins), there was no visualization of lymph nodes in SPECT/CT. 8 SLNs in 7 groins that were visualized in the planar technique were found to be false positive by SPECT/CT. In total, 19 SLNs in 16 groins that were overlooked by planar imaging could only be detected by SPECT/CT. In contrast to planar scintigraphy, SPECT/CT imaging enabled clear and precise anatomical localization of SLNs in all 42 groins where radiolabeled SLNs were visible. Even under consideration of all lymphatic drainage regions, statistical evaluation showed a significantly higher number of detected SLNs with SPECT/CT in comparison to the planar technique (P = 0.0022). CONCLUSION: In these patients SPECT/CT is capable of visualizing SLNs that cannot be detected with planar imaging. The SPECT/CT technique reduces the number of false positive findings from planar SLN imaging and is able to show anatomic SLN localization more precisely. If possible, preoperative SLN imaging should be performed by means of the SPECT/CT technique in patients with this tumor entity.