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  • 文章类型: Randomized Controlled Trial
    目的:前列腺癌(PC)是影响全球男性健康的重要疾病。超过60%的65岁以上的患者和超过80%的患者被诊断为局部PC。目前局部PC的治疗方式选择以及过度治疗是否存在争议。因此,我们希望构建一个列线图来预测局部PC老年患者的癌症特异性生存率(CSS)和总生存率(OS)相关危险因素,同时评估局部PC老年患者手术和放疗的生存率差异.
    方法:从监测中获得65岁以上局限性PC患者的数据,流行病学,和结束结果(SEER)数据库。使用单变量和多变量Cox回归模型来确定CSS和OS的独立危险因素。使用多变量Cox回归模型构建预测CSS和OS的列线图。一致性指数(C指数),受试者工作特性曲线下的面积(AUC),和校准曲线用于检验预测模型的准确性和区分度。使用决策曲线分析(DCA)来测试该模型的潜在临床价值。
    结果:从2010年到2018年,共有90,434名65岁以上的患者被诊断为局部PC。将所有患者随机分配到训练集(n=63,328)和验证集(n=27,106)。单因素和多因素Cox回归模型分析表明,种族,婚姻,T级,外科,放射治疗,前列腺特异性抗原(PSA),Gleason评分(GS)是预测老年局限性PC患者CSS的独立危险因素。年龄,种族,婚姻,手术,放射治疗,PSA,GS和GS是预测老年局限性PC患者OS的独立危险因素。预测的CSS的训练和验证集的c指数分别为0.802(95CI:0.788-0.816)和0.798(95CI:0.776-0.820)。用于预测OS的训练和验证集的c指数为0.712(95%:0.704-0.720)和0.724(95%:0.714-0.734)。这表明列线图具有良好的判别能力。AUC和校准曲线也显示出良好的准确性和可辨别性。
    结论:我们开发了新的列线图来预测患有局部PC的老年患者的CSS和OS。经过内部验证和外部时间验证,具有合理的准确性,可靠性和潜在临床价值,该模型可用于临床辅助决策。
    OBJECTIVE: Prostate cancer (PC) is a significant disease affecting men\'s health worldwide. More than 60% of patients over 65 years old and more than 80% are diagnosed with localized PC. The current choice of treatment modalities for localized PC and whether overtreatment is controversial. Therefore, we wanted to construct a nomogram to predict the risk factors associated with cancer-specific survival (CSS) and overall survival (OS) in elderly patients with localized PC while assessing the survival differences in surgery and radiotherapy for elderly patients with localized PC.
    METHODS: Data of patients with localized PC over 65 years were obtained from the Surveillance, Epidemiology, and End Results (SEER) database. Univariate and multivariate Cox regression models were used to determine independent risk factors for CSS and OS. Nomograms predicting CSS and OS were built using multivariate Cox regression models. The consistency index (C-index), the area under the subject operating characteristic curve (AUC), and the calibration curve were used to test the accuracy and discrimination of the prediction model. Decision curve analysis (DCA) was used to test the potential clinical value of this model.
    RESULTS: A total of 90,434 patients over 65 years and diagnosed with localized PC from 2010 to 2018 were included in the study. All patients were randomly assigned to the training set (n = 63,328) and the validation set (n = 27,106). Univariate and multivariate Cox regression model analysis showed that age, race, marriage, T stage, surgical, radiotherapy, prostate-specific antigen (PSA), and Gleason score (GS) were independent risk factors for predicting CSS in elderly patients with localized PC. Age, race, marriage, surgery, radiotherapy, PSA, and GS were independent risk factors for predicting OS in elderly patients with localized PC. The c-index of the training and validation sets for the predicted CSS is 0.802(95%CI:0.788-0.816) and 0.798(95%CI:0.776-0.820, respectively). The c-index of the training and validation sets for predicting OS is 0.712(95%:0.704-0.720) and 0.724(95%:0.714-0.734). It shows that the nomograms have excellent discriminatory ability. The AUC and the calibration curves also show good accuracy and discriminability.
    CONCLUSIONS: We have developed new nomograms to predict CSS and OS in elderly patients with localized PC. After internal validation and external temporal validation with reasonable accuracy, reliability and potential clinical value, the model can be used for clinically assisted decision-making.
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  • 文章类型: Journal Article
    In spite of multiple therapeutic regimens for vitiligo, disease relapse remains a challenge. Most guidelines consider systemic treatments only in rapidly progressive disease with wider surface areas. This delay in halting the immune attack, may give the chance for further disease progression as well as establishment of resident memory T-cell population predisposing to future relapses. To assess the ability of early systemic therapy of localized (<2% BSA), recent onset (<6 months) vitiligo to control disease activity and minimize the possibility of recurrence. Twenty-five patients with recent onset (<6 months), localized (<2% BSA) vitiligo were included. Patients received pulse dexamethasone therapy for 6 months plus topical treatments and NB-UVB sessions. Patients were followed monthly as regards percent of repigmentation and VIDA score. To detect recurrence, biannual assessment was done for 4 years. Eighty-four percent of patients had acrofacial lesions and 44% had facial lesions. Arrest of activity was achieved after 3.65 ± 2.19 months. Complete repigmentation was achieved in a mean duration of 6.88 ± 0.2 months. At the end of the 4-year follow up, recurrence occurred in 32% of patients. In spite of recurrence, localized disease (<2% BSA) was secured. A significantly higher incidence of recurrence was associated with cases with bilateral distribution of lesions. Early systemic immunomodulation for recent localized vitiligo is a successful approach to achieve early control of disease activity and minimize the incidence of recurrence. Such cases should not be overlooked but managed as early as possible; it is a race against time.
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  • 文章类型: Journal Article
    The standard therapy for all localized soft tissue sarcomas is surgical resection of the tumor. For patients with soft tissue sarcomas who are at high risk for recurrence and/or metastasis, perioperative chemotherapy is a potential treatment option. Adriamycin plus ifosfamide is currently the most promising chemotherapy regimen for localized soft tissue sarcomas. Randomized controlled trials and meta-analyses of adjuvant postoperative chemotherapy for soft tissue sarcomas have suggested that adjuvant chemotherapy may provide an advantage, however small, compared with surgery alone. On the other hand, recent randomized trials have demonstrated the efficacy of neoadjuvant preoperative chemotherapy using full-dose anthracycline plus ifosfamide for high-risk soft tissue sarcomas and showed survival benefits in patients with large, deep-seated and high-grade soft tissue sarcomas of the trunk and extremities. In this review, adjuvant and neoadjuvant chemotherapies for soft tissue sarcomas and future perspectives are discussed.
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  • 文章类型: Journal Article
    Background: For localized prostate cancer (PCa) with a low disease burden, whole-gland resection seems like overtreatment, while focal therapy, including cryosurgery, can achieve similar outcomes. We aimed at comparing the long-term survival outcomes of cryotherapy and radical prostatectomy (RP) and further exploring whether RP can be replaced by cryosurgery for those with low-risk PCa. Methods: We conducted analyses from the Surveillance, Epidemiology, and End Results (SEER) database (2004-2015) and performed propensity score matching and used an instrumental variate to reduce the influence of bias and unmeasured confounders to the greatest extent. Results: In the multivariate regression, patients who received cryotherapy had higher risk of overall mortality (OM) (hazard ratio [HR] = 2.52, 95% confidence interval [CI] 1.99-3.20, p < 0.001), but no significant difference was observed in decreasing cancer-specific mortality (CSM) (HR = 1.38, 95% CI 0.63-3.03, p = 0.41) after adjusting the confounders. After propensity score matching, patients who underwent cryotherapy had higher OM and CSM rates (HR = 2.70 [95% CI 1.99-3.66, p < 0.001] and HR = 2.99 [95% CI 1.19-7.48, p = 0.02], respectively). In the IV-adjusted analyses, RP was superior to cryotherapy in decreasing OM (HR = 2.52, 95% CI 1.99-3.20), while no obvious decrease of CSM was observed in the comparison of RP and cryotherapy (HR = 1.38, 95% CI 0.63-3.03). The subgroup analyses showed that RP displayed an obvious benefit in decreasing CSM (HR = 5.02, 95% CI 1.30-19.39, p = 0.02) for those with a prostate-specific antigen (PSA) level higher than 10 ng/ml. Conclusion: RP ranked as the best treatment in regard to tumor control, but the advantages of cryotherapy became evident when taking functional and oncological outcomes into account, especially for low- and intermediate-risk PCa with low PSA levels.
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  • 文章类型: Journal Article
    BACKGROUND: Oxidative damage to melanocytes, resulting from an imbalance between the damaging oxidative pathways and the protective anti-oxidants likely plays a pathogenic role in vitiligo.
    OBJECTIVE: To evaluate three parameters related to the oxidative stress (OS) pathway namely malondialdehyde (MDA), a marker of oxidative damage, and superoxide dismutase (SOD) and reduced glutathione (rGSH) (both antioxidants) in patients with active and stable vitiligo with either localized or generalized disease.
    METHODS: Sixty clinically diagnosed vitiligo patients were categorized into generalized (n = 30) or localized vitiligo (n = 30) and were further sub-grouped according to their disease activity into active and stable groups. Thirty healthy volunteers were included in the control group. ELISA was used for the evaluation of MDA, SOD, and r GSH.
    RESULTS: The patient group demonstrated significantly raised levels of MDA and significantly decreased levels of SOD and rGSH compared with the control group. Further, the OS parameters were significantly more deranged in patients with generalized disease (all three-MDA, rGSH, and SOD) and an active disease (MDA) as compared to those with localized and stable disease, respectively.
    CONCLUSIONS: Our findings suggest an important role of OS in relation to vitiligo activity and severity. Although the OS parameters were deranged in all subsets of patients, with respect to controls, the derangement of oxidative damage marker (MDA) in generalized and active disease groups was most marked. Disease remains active when the oxidative damage becomes higher but is unmatched with the anti-oxidant reserve which does not proportionately increase.
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  • 文章类型: Journal Article
    OBJECTIVE: Definition of the type of appendicitis is based on examination of the peritoneum and appendix. Gomes et al. proposed a laparoscopic grading system of acute appendicitis (grades 1 and 2, noncomplicated appendicitis, grade 3-5 complicated appendicitis). The aim of this study was to evaluate the reproducibility of this score.
    METHODS: All patients managed for acute appendicitis between January 2016 and June 2016 were included in this single-center prospective study. Laparoscopic appendectomy procedures were filmed by analogy to Sugerbaker\'s peritoneal carcinomatosis score (9 quadrants, all of the abdomen was filmed). The videos were then analyzed by seven staff surgeons blinded to each other and the operative report. The primary endpoint was to determine the concordance between staff surgeons for grading of appendicitis using the laparoscopic grading system of acute appendicitis described by Gomes et al.
    RESULTS: A total of 40 patients were included in this study. A concordance was observed between the seven staff surgeons in 85% of cases. For regional peritonitis, the mean ± (SD) number of quadrants in which the staff surgeons reported signs of peritonitis was 1.44 ± 0.63. For diffuse peritonitis, the mean (SD) number of quadrants in which the staff surgeons reported signs of peritonitis was 2.59 ± 0.51. On ROC curve analysis, two quadrants was the best cut-off between grade 4B (local peritonitis) and five (diffuse peritonitis) acute appendicitis (AUC = 0.92, Se = 100%, Sp = 92%, p = 0.005).
    CONCLUSIONS: The classification used to determine the type of appendicitis is reproducible.
    CONCLUSIONS: To give a definition of complicated appendicitis.
    UNASSIGNED: Mariage M, Sabbagh C, et al. Surgeon\'s Definition of Complicated Appendicitis: A Prospective Video Survey Study. Euroasian J Hepatogastroenterol 2019;9(1):1-4.
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  • 文章类型: Journal Article
    OBJECTIVE: To explore the proportion of patients with higher risk localized prostate cancer (PCa) that would become safely biopsy negative 12 months after non-thermal focal therapy with padeliporfin vascular-targeted photodynamic therapy (VTP).
    METHODS: Multicenter study in a scenario of prostate-specific antigen (PSA) ≤20ng/ml and variable PCa target volumes Gleason pattern 3 or low-volume secondary Gleason pattern 4, all patients received VTP, consisting of intravenous 4mg/kg padeliporfin activated by light-diffusing fibers in the prostate. The prostate was biopsied at baseline, months 6 and 12, PSA, patient-reported functional outcomes and quality of life (QoL) questionnaires were recorded at baseline, months 3, 6, and 12 and adverse events (AE) throughout the study.
    RESULTS: In the intention-to-treat population (n=81), the proportion of patients with negative biopsies at month 12 was 74% (60/81 patients; 95% CI: 63.1%,83.2%). In the per-protocol population, the proportion was 79% (58/73 patients; 95% CI: 68.4%,88.0%). Questionnaire results indicated a slight improvement in urinary function and limited deterioration in sexual function. No difference in QoL was observed over time. A total of 42/81 (52%) patients reported mild or moderate and 4 of 81 (4.9%) experienced serious AE, all resolved without sequelae. No phototoxicity, cardiovascular event, fistula or prolonged urinary incontinence, secondary cancer or death was reported.
    CONCLUSIONS: Results support the efficacy, safety, and QoL associated with padeliporfin focal treatment for low/intermediate risk localized PCa.
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  • 文章类型: Journal Article
    Prostate cancer (PCa) incidence is expected to increase in renal transplant recipients (RTR) with no clear nor contemporary data on management and oncological outcome.
    We conducted a retrospective single center study of RTR diagnosed with PCa after transplantation between 2000 and 2013. Demographics, PCa characteristics, and treatment were assessed. For each RTR in radical prostatectomy (RP) subset, we included 4 non-organ transplant patients who underwent RP by the same surgeons, and compared pre-operative and post-operative oncological features, and biochemical recurrence (BCR) rate.
    Twenty-four RTR were included (PCa incidence 1.5%). Mean follow-up was 47 months. PCa was mostly localized (n=21, 87.5%) with treatments including RP (n=16, 76.2%), brachytherapy (n=3, 14.3%), radiation therapy (n=1, 4.7%), and active surveillance (n=1, 4.7%). No graft loss due to PCa treatment was reported. Nineteen RTR with localized PCa (90.5%) were free from BCR. Considering RP subset, no difference in PCa characteristics at diagnosis and BCR rate was found between RTR (n=16) and control patients (n=64).
    Localized PCa following renal transplantation was not associated with adverse features as compared with non-transplant patients. Standard treatments could be proposed to RTR with satisfying results both on oncological outcome and graft function.
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  • 文章类型: Journal Article
    BACKGROUND: Current surgical and ablative treatment options for prostate cancer (PCa) may result in a high incidence of (temporary) incontinence, erectile dysfunction and/or bowel damage. These side effects are due to procedure related effects on adjacent structures including blood vessels, bowel, urethra and/or neurovascular bundle. Ablation with irreversible electroporation (IRE) has shown to be effective and safe in destroying PCa cells and also has the potential advantage of sparing surrounding tissue and vital structures, resulting in less impaired functional outcomes and maintaining men\'s quality of life.
    METHODS: In this randomized controlled trial (RCT) on IRE in localized PCa, 200 patients with organ-confined, unilateral (T1c-T2b) low- to intermediate-risk PCa (Gleason sum score 6 and 7) on transperineal template-mapping biopsies (TTMB) will be included. Patients will be randomized into focal or extended ablation of cancer foci with IRE. Oncological efficacy will be determined by multiparametric Magnetic Resonance Imaging, Contrast-Enhanced Ultrasound imaging if available, TTMP and Prostate Specific Antigen (PSA) follow-up. Patients will be evaluated up to 5 years on functional outcomes and quality of life with the use of standardized questionnaires.
    CONCLUSIONS: There is critical need of larger, standardized RCTs evaluating long-term oncological and functional outcomes before introducing IRE and other focal therapy modalities as an accepted and safe therapeutic option for PCa. This RCT will provide important short- and long-term data and elucidates the differences between focal or extended ablation of localized, unilateral low- to intermediate-risk PCa with IRE.
    BACKGROUND: Clinicaltrials.gov database registration number NCT01835977. The Dutch Central Committee on Research Involving Human Subjects registration number NL50791.018.14.
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  • 文章类型: Journal Article
    OBJECTIVE: To report outcomes of patients with localised prostate cancer (PCa) managed with active surveillance (AS) in a standard clinical setting.
    METHODS: Single-centre, prospective, observational study.
    METHODS: Non-academic, average-size hospital in Switzerland.
    METHODS: Prospective, observational study at a non-academic, average-size hospital in Switzerland. Inclusion and progression criteria meet general recommendations. 157 patients at a median age of 67 (61-70) years were included from December 1999 to March 2012. Follow-up (FU) ended June 2013.
    RESULTS: Median FU was 48 (30-84) months. Overall confirmed reclassification rate was 20% (32/157). 20 men underwent radical prostatectomy with 1 recurrence, 11 had radiation therapy with 2 prostate-specific antigen relapses, and 1 required primary hormone ablation with a fatal outcome. Kaplan-Meier estimates for those remaining in the study showed an overall survival of 92%, cancer-specific survival of 99% and reclassification rate of 41%. Dropout rate was 36% and occurred at a median of 48 (21-81) months after inclusion. 68 (43%) men are still under AS.
    CONCLUSIONS: Careful administration of AS can and will yield excellent results in long-term management of PCa, and also helps physicians and patients alike to balance quality of life and mortality. Our data revealed significant dropout from FU. Patient non-compliance can be a relevant problem in AS.
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