prostate-specific antigen (PSA)

前列腺特异性抗原 (PSA)
  • 文章类型: Journal Article
    目的前列腺癌(PC)是全球重大的健康问题,早期发现对于有效治疗至关重要。本研究旨在探讨血红蛋白-白蛋白-淋巴细胞-血小板(HALP)评分在经尿道前列腺电切术(TURP)患者前列腺癌检测中的作用。此外,我们进行了一项综合分析,以探讨TURP术后与偶然诊断前列腺癌相关的临床参数.方法131例经TURP治疗的症状性膀胱出口梗阻患者纳入研究。患者分为两组:良性前列腺增生(BPH)和偶发前列腺癌(IPC)。IPC组由Gleason评分确定的低级别和高级别IPC患者组成。人口统计数据,包括年龄,种族,病史,身体质量指数,吸烟和酒精状况,前列腺癌家族史,进行了评估。还分析了术后标本重量和前列腺特异性抗原(PSA)水平的测量。结果结果显示,大约50%的患者患有BPH,而剩下的50%有IPC。IPC患者,特别是高级IPC,与BPH患者相比,PSA水平明显较高,切除的标本重量较低。HALP得分,其中包含血红蛋白(Hb),白蛋白,淋巴细胞,和血小板水平,显示出作为区分BPH和IPC的歧视性工具的希望,以及高级IPC和BPH/低级IPC之间。Logistic回归分析发现PSA水平升高(p=0.02),HALP评分降低(p≤0.001),和较小的标本重量(p=0.007)作为TURP后IPC的独立预测因素。值得注意的是,HALP评分是与高级别IPC相关的唯一有意义的独立预测因素(p=0.004).结论这些发现有助于了解膀胱出口梗阻患者行TURP时偶然发现的前列腺癌的危险因素和诊断工具。HALP得分,以及PSA水平和样本重量,可以帮助前列腺癌的早期发现和管理。需要进一步的研究来验证这些发现,并探索HALP评分在预测前列腺癌预后中的临床实用性。
    Aims Prostate cancer (PC) is a significant health concern worldwide, and early detection is crucial for effective treatment. This study aimed to investigate the role of the hemoglobin-albumin-lymphocyte-platelet (HALP) score in detecting prostate cancer in patients undergoing transurethral resection of the prostate (TURP). Additionally, a comprehensive analysis was performed to explore clinical parameters associated with incidentally diagnosed prostate cancer post TURP. Methods A total of 131 patients with symptomatic bladder outlet obstruction who underwent TURP were included in the study. The patients were divided into two groups: those with benign prostatic hyperplasia (BPH) and those with incidental prostate cancer (IPC). The IPC group consisted of patients with both low-grade and high-grade IPC determined by the Gleason score. Demographic data, including age, race, medical history, body mass index, smoking and alcohol status, and family history of prostate cancer, were evaluated. The postoperative measurement of specimen weight and prostate-specific antigen (PSA) levels were also analyzed. Result Results revealed that approximately 50% of the patients had BPH, while the remaining 50% had IPC. Patients with IPC, particularly high-grade IPC, had significantly higher PSA levels and lower resected specimen weight compared to those with BPH. The HALP score, which incorporates hemoglobin (Hb), albumin, lymphocyte, and platelet levels, showed promise as a discriminatory tool for distinguishing between BPH and IPC, as well as between high-grade IPC and BPH/low-grade IPC. Logistic regression analysis identified increased PSA levels (p=0.02), decreased HALP score (p≤0.001), and smaller specimen weight (p=0.007) as independent predictive factors for IPC after TURP. Notably, the HALP score was the only significant independent predictive factor associated with high-grade IPC (p=0.004). Conclusion These findings contribute to the understanding of risk factors and diagnostic tools for incidentally detected prostate cancer in patients with bladder outlet obstruction undergoing TURP. The HALP score, along with PSA levels and specimen weight, can aid in the early detection and management of prostate cancer. Further research is warranted to validate these findings and explore the clinical utility of the HALP score in predicting prostate cancer outcomes.
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  • 文章类型: Journal Article
    目前针对转移性激素敏感性前列腺癌(mHSPC)的治疗策略是雄激素受体信号抑制剂(ARSI)药物与雄激素剥夺疗法(ADT)的组合。然而,缺乏比较不同ARSI药物疗效的真实数据。因此,这项研究的目的是比较比卡鲁胺的有效性和安全性,阿比特龙,恩扎鲁他胺,阿帕鲁胺联合ADT治疗mHSPC患者。
    我们回顾性分析了82例诊断为mHSPC的患者,包括18例醋酸阿比特龙和泼尼松治疗,21例恩杂鲁胺患者,阿帕鲁胺20例,和23例比卡鲁胺患者。我们评估了PSA无进展生存期(PSA-PFS),影像学无进展生存期(rPFS),去势抵抗无进展生存期(CRPC-PFS),和总生存期(OS)使用Kaplan-Meier生存分析。此外,我们通过单变量和多变量Cox风险比例模型探讨了影响预后的相关因素.3、6和12个月时的PSA反应率,最低PSA水平(nPSA),记录治疗后不同药物亚组的最低点时间(TTN),我们使用单因素方差分析来确定这些指标对患者预后的影响.
    与比卡鲁胺相比,在mHSPC患者中,恩杂鲁胺和阿帕鲁胺在延缓疾病进展方面均显示出显著优势.具体来说,恩杂鲁胺可显著延长PSA-PFS(HR2.244;95%CI1.366-3.685,p=0.001),rPFS(HR2.539;95%CI1.181-5.461;p=0.007),CRPC-PFS(HR2.131;95%CI1.295-3.506;p=0.003),和OS(HR2.06;95%CI1.183-3.585;P=0.005)。同样,阿帕鲁胺显著延长患者PSA-PFS(HR5.071;95%CI1.711-15.032;P=0.003)和CRPC-PFS(HR6.724;95%CI1.976-22.878;P=0.002)。另一方面,在mHSPC患者中,与其他3种药物相比,阿比曲酮联合ADT在延缓疾病进展方面没有显著优势.就安全性而言,四种药物之间的总体不良事件发生率没有显着差异。此外,对PSA动力学的观察表明,恩杂鲁胺,阿帕鲁胺,与比卡鲁胺相比,醋酸阿比特龙在实现深PSA反应(PSA≤0.2ng/ml)方面具有显著优势(12个月时p=0.007).恩扎鲁胺和阿帕鲁胺表现出卓越的疗效,两种药物之间没有实质性差异。
    阿比特龙,恩扎鲁他胺,发现阿帕鲁胺比比卡鲁胺更快,更彻底地降低和稳定mHSPC患者的PSA水平。此外,与比卡鲁胺相比,恩杂鲁胺和阿帕鲁胺可显着延长mHSPC患者的生存期并延迟疾病进展。应当指出,与恩杂鲁胺和阿帕鲁胺相比,阿比曲酮在延缓疾病方面没有显着优势。在进行药物毒性分析后,确定四种药物之间没有显着差异。
    UNASSIGNED: The current treatment strategy for metastatic Hormone-Sensitive Prostate Cancer (mHSPC) is the combination of Androgen Receptor Signaling Inhibitors (ARSIs) medicines with androgen deprivation therapy (ADT). However, there is a lack of real-world data comparing the efficacy of different ARSI pharmaceuticals. Therefore, the objective of this study was to compare the effectiveness and safety of bicalutamide, abiraterone, enzalutamide, and apalutamide in combination with ADT for patients with mHSPC.
    UNASSIGNED: We retrospectively analyzed 82 patients diagnosed with mHSPC, including 18 patients treated with abiraterone acetate with prednisone, 21 patients with enzalutamide, 20 patients with apalutamide, and 23 patients with bicalutamide. We evaluated PSA progression-free survival (PSA-PFS), imaging progression-free survival (r PFS), castration resistance progression-free survival (CRPC-PFS), and overall survival (OS) using Kaplan-Meier survival analyses. Additionally, we explored relevant factors affecting prognosis through univariate and multivariate Cox risk-proportionality models. PSA response rates at 3, 6, and 12 months, nadir PSA levels (nPSA), and time to nadir (TTN) in different medication subgroups after treatment were documented, and we used one-way ANOVA to determine the effect of these measures on patient prognosis.
    UNASSIGNED: In comparison with bicalutamide, both enzalutamide and apalutamide have shown significant advantages in delaying disease progression among mHSPC patients. Specifically, enzalutamide has been found to significantly prolong PSA-PFS (HR 2.244; 95% CI 1.366-3.685, p=0.001), rPFS (HR 2.539; 95% CI 1.181-5.461; p= 0.007), CRPC-PFS (HR 2.131; 95% CI 1.295-3.506; p= 0.003), and OS (HR 2.06; 95% CI 1.183-3.585; P=0.005). Similarly, apalutamide has significantly extended PSA-PFS (HR 5.071; 95% CI 1.711-15.032; P= 0.003) and CRPC-PFS (HR 6.724; 95% CI 1.976-22.878; P=0.002) among patients. On the other hand, the use of abiraterone in combination with ADT did not demonstrate a significant advantage in delaying diseases progression when compared with the other three agents in mHSPC patients. There were no significant differences in overall adverse event rates among the four pharmaceuticals in terms of safety. Additionally, the observation of PSA kinetics revealed that enzalutamide, apalutamide, and abiraterone acetate had a significant advantage in achieving deep PSA response (PSA ≤ 0.2 ng/ml) compared with bicalutamide (p=0.007 at 12 months). Enzalutamide and apalutamide exhibited preeminence efficacy, with no substantial difference observed between the two medications.
    UNASSIGNED: Abiraterone, enzalutamide, and apalutamide were found to significantly reduce and stabilize PSA levels in mHSPC patients more quickly and thoroughly than bicalutamide. Furthermore, enzalutamide and apalutamide were found to significantly prolong survival and delay disease progression in mHSPC patients compared with bicalutamide. It should be noted that abiraterone did not demonstrate a significant advantage in delaying disease compared with enzalutamide and apalutamide. After conducting drug toxicity analyses, it was determined that there were no significant differences among the four drugs.
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  • 文章类型: Editorial
    暂无摘要。
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  • 文章类型: Journal Article
    直肠指检术(DRE)是一个简单的,成本效益高,实用,和历史悠久的体检方法,在前列腺癌(PCa)的检测中起着有价值的作用。然而,随着前列腺特异性抗原(PSA)时代的到来,进行DRE的必要性已成为辩论的主题。我们的目的是调查DRE在人群中的诊断功效和辅助作用(前列腺成像报告和数据系统(PI-RADS),PI-RADS≥3或PSA≥4ng/mL)怀疑PCa。
    从2020年2月至2021年5月连续前瞻性招募了597例疑似PCa需要转诊活检的患者。所有患者在活检前均接受了泌尿科医生的DRE和相应的临床诊断。根据收集的临床和病理资料,DRE在不同PSA分层中的诊断性能,并对其与肿瘤部位及Gleason评分(GS)的相关性进行统计学分析。
    在疑似癌症患者中,DRE的诊断准确率为63.45%.与中央区或过渡区肿瘤相比,DRE阳性结果的外周区PCa召回率较高(65.50%vs.34.55%)。DRE阳性结果与GS≥7PCa显著相关(P<0.001),DRE阳性PCa患者的平均GS明显高于DRE阴性患者(7.92vs.7.11,P<0.001)。
    DRE可以帮助医生进一步判断PSA升高患者活检的必要性,并初步估计肿瘤的位置和侵袭性。然而,仍有必要探讨DRE在正常PSA人群中的价值。
    UNASSIGNED: Digital rectal examination (DRE) is a straightforward, cost-effective, practical, and time-honored physical examination method that plays a valuable role in the detection of prostate cancer (PCa). Nevertheless, with the advent of the prostate-specific antigen (PSA) era, the necessity of performing DRE has become a subject of debate. Our aim was to investigate the diagnostic efficacy and adjunctive role of DRE in a population (Prostate Imaging Reporting and Data System (PI-RADS), PI-RADS ≥3 or PSA ≥4 ng/mL) suspected of PCa.
    UNASSIGNED: Five hundred and ninety-seven patients with suspected PCa requiring referral for biopsy were prospectively enrolled consecutively from February 2020 to May 2021. All patients received DRE and corresponding clinical diagnosis by a urologist before biopsy. According to the collected clinical and pathological information, the diagnostic performance of DRE in different PSA stratifications, and its association with tumor location and Gleason score (GS) were statistically analyzed.
    UNASSIGNED: Among patients with suspected cancer, the diagnostic accuracy of DRE was 63.45%. Compared with central zone or transition zone tumors, the recall rate of peripheral zone PCa with DRE-positive results was higher (65.50% vs. 34.55%). DRE-positive results were significantly correlated with GS ≥7 PCa (P<0.001), and the average GS of DRE-positive PCa patients was significantly higher than that of DRE-negative (7.92 vs. 7.11, P<0.001).
    UNASSIGNED: DRE may help physicians further judge the necessity of biopsy in patients with elevated PSA, and preliminarily estimate the location and invasiveness of the tumor. However, it is still necessary to explore the value of DRE in a normal PSA population.
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  • 文章类型: Journal Article
    背景:已经报道了关于硒对减少前列腺癌的影响的结果。目前的分析旨在了解是否存在影响硒与前列腺癌关系的潜在因素。
    目的:阐明膳食硒摄入与前列腺癌的关系,我们基于国家健康与营养调查(NHANES)数据库评估了膳食硒摄入量与前列腺特异性抗原(PSA)之间的相关性.
    方法:在筛选了2005年至2010年的NHANES调查数据后,31,034名参与者中的3,614名数据被认为适合纳入我们的研究。膳食硒摄入量是我们研究的独立变量,而PSA是因变量。我们将参与者分层为当前,前者,和从不吸烟者,并使用多变量逻辑回归对每个吸烟状态亚组的硒摄入量和PSA之间的关系进行了交互作用检验。
    结果:对于我们的亚组分析,我们根据吸烟状况对参与者进行分组,并调查了膳食硒摄入量与PSA水平之间的关系.在PSA水平为4或更高的242名参与者中,平均年龄为58.5岁(±12.1).在调整协变量后,我们没有发现膳食硒与PSA水平高的可能性之间存在显著关联.然而,我们观察到吸烟状况和日粮硒与PSA水平之间存在显著的交互作用(P=.007).具体来说,吸烟者PSA水平高的几率较低,而不吸烟者的几率更高。这表明吸烟状况可能会改变饮食硒对PSA水平的影响。
    结论:我们的研究结果表明,吸烟状况会影响膳食硒摄入量与PSA之间的关系,并且吸烟者的PSA水平较高的几率较低。
    Conflicting results regarding the impact of selenium on reducing prostate cancer have been reported. The current analysis aimed to understand whether there are potential factors affecting the relationship between selenium and prostate cancer.
    To clarify the relationship between dietary selenium intake and prostate cancer, we evaluated the correlation between dietary selenium intake and prostate-specific antigen (PSA) based on the National Health and Nutrition Examination Survey (NHANES) database.
    After screening the NHANES survey data from 2005 to 2010, data for 3,614 of 31,034 participants were considered suitable to include in our study. Dietary selenium intake was the independent variable of our study, while PSA was the dependent variable. We stratified participants into current, former, and never smokers and performed an interaction test on the relationship between selenium intake and PSA using multivariable logistic regression for each smoking-status subgroup.
    For our subgroup analysis, we grouped participants based on smoking status and investigated the association between dietary selenium intake and PSA levels. Among the 242 participants with a PSA level of 4 or higher, the mean age was 58.5 years (±12.1). After adjusting for covariates, we did not find a significant association between dietary selenium and the odds of having a high PSA level. However, we observed a significant interaction between smoking status and dietary selenium in relation to PSA levels (P = .007). Specifically, smokers had lower odds of having high PSA levels, while nonsmokers had higher odds. This suggests that smoking status may modify the effect of dietary selenium on PSA levels.
    Our findings suggest that smoking status affects the relationship between dietary selenium intake and PSA and that smokers are at lower odds of having a high PSA level.
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  • 文章类型: Journal Article
    癌症前体的早期诊断可改善治疗结果。有组织的前列腺癌筛查在尼日利亚仍然很少见,如果将其添加到国家卫生预算中,它可能需要额外的联合融资替代方案。
    该研究旨在评估一组尼日利亚男性中基于人群的前列腺癌筛查的最大支付意愿和可接受性。
    该研究是一项基于横断面调查的研究,在来自该州不同地区的男性中进行。支付卡引出格式用于估计平均最大WTP金额。采用多因素Logistic回归分析评价WTP的相关性。
    共有439名(81.9%)参与者愿意支付筛查费用,而只有97名(18.1%)参与者拒绝筛查。平均WTP金额为6.01美元(平均值±中位数±SD6.01±4.12±5.75)。居住地和对疾病的了解是主要的预测因素。
    研究结果表明,尼日利亚阿南布拉州的男性愿意为基于人口的筛查平均支付6.01美元。尽管与传统的机会主义筛查成本(21美元之间)相比,规定的WTP金额似乎较低,439名愿意支付筛查费用的参与者(81.9%)中的大多数应在寻找该计划的替代融资方案时加以利用.
    UNASSIGNED: Early diagnosis of cancer precursors improves treatment outcomes. Organized screening for prostate cancer is still uncommon in Nigeria, and if it is added to the national health budget, it may necessitate additional co-financing alternatives.
    UNASSIGNED: The study aims to evaluate the maximum willingness- to- pay amount and acceptability of a Population-based screening for prostate cancer among a group of Nigerian men.
    UNASSIGNED: The study was a cross-sectional survey-based study conducted among men drawn from different districts of the state. The payment card elicitation format was used to estimate the average maximum WTP amount. Multivariate Logistic regression was used to evaluate the correlates of WTP.
    UNASSIGNED: A total of 439(81.9%) participants were willing to pay for the screening while only 97(18.1%) of the participants rejected the screening. The average WTP amount was US$6.01(mean ± median ± SD 6.01±4.12±5.75). Residence and knowledge of the disease were the major predictors.
    UNASSIGNED: The findings showed that men in Anambra state Nigerian were willing to pay an average of US$6.01 for the Population-based screening. Even though the stated WTP amount seems low compared to the conventional cost of opportunistic screening (between USD 21), the majority of the participants 439(81.9%) willing to pay for the screening should be capitalized upon in finding alternative financing options for the program.
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  • 文章类型: Clinical Trial, Phase III
    背景:CHHiP试验评估了局部前列腺癌的中度小分割放疗。我们利用随时间收集的纵向前列腺特异性抗原(PSA)测量值来评估和表征患者的预后。
    方法:我们开发了一种临床动态预测联合模型来预测生化或临床复发的风险。建模包括重复的PSA值,并根据年龄的基线预后风险因素进行校正,肿瘤特征和接受治疗。我们包括3,071名试验参与者,使用纵向PSA的混合效应子模型进行模型开发,和预测前列腺癌复发的时间至事件危险子模型。我们评估了基线预后因素亚组如何随时间对非线性PSA水平的影响,并量化了PSA与复发时间的关联。我们评估了自举乐观调整后的校准和辨别预测性能。此外,我们对具有不同预后因素的患者进行了动态比较预测,并调查了各标志时间内PSA阈值与预后的相关性.
    结果:发生复发的患者在随访期间的基线和总体PSA值普遍较高,并且在复发前两年内PSA呈指数上升。此外,在混合效应和相对风险子模型中,大多数基线风险因素是显著的.PSA值和变化率可预测复发。该模型在8年内的不同预测时间内的预测性能良好,总体平均AUC为0.70,平均Brier评分为0.10,平均综合校正指数为0.048;在进行5年累积的纵向治疗后PSA评估后,这些结果在预测方面得到了进一步改善.3年后低于0.23ng/mL的PSA阈值表明8年后复发的风险最小。
    结论:我们成功开发了一个联合统计模型来预测前列腺癌的复发,评估预后因素和纵向PSA。我们展示了动态更新的PSA信息可以改善预后,可用于指导后续和治疗管理选择。
    The CHHiP trial assessed moderately hypofractionated radiation therapy in localized prostate cancer. We utilized longitudinal prostate-specific antigen (PSA) measurements collected over time to evaluate and characterize patient prognosis.
    We developed a clinical dynamic prediction joint model to predict the risk of biochemical or clinical recurrence. Modeling included repeated PSA values and adjusted for baseline prognostic risk factors of age, tumor characteristics, and treatment received. We included 3071 trial participants for model development using a mixed-effect submodel for the longitudinal PSAs and a time-to-event hazard submodel for predicting recurrence of prostate cancer. We evaluated how baseline prognostic factor subgroups affected the nonlinear PSA levels over time and quantified the association of PSA on time to recurrence. We assessed bootstrapped optimism-adjusted predictive performance on calibration and discrimination. Additionally, we performed comparative dynamic predictions on patients with contrasting prognostic factors and investigated PSA thresholds over landmark times to correlate with prognosis.
    Patients who developed recurrence had generally higher baseline and overall PSA values during follow-up and had an exponentially rising PSA in the 2 years before recurrence. Additionally, most baseline risk factors were significant in the mixed-effect and relative-risk submodels. PSA value and rate of change were predictive of recurrence. Predictive performance of the model was good across different prediction times over an 8-year period, with an overall mean area under the curve of 0.70, mean Brier score of 0.10, and mean integrated calibration index of 0.048; these were further improved for predictions after 5 years of accrued longitudinal posttreatment PSA assessments. PSA thresholds <0.23 ng/mL after 3 years were indicative of a minimal risk of recurrence by 8 years.
    We successfully developed a joint statistical model to predict prostate cancer recurrence, evaluating prognostic factors and longitudinal PSA. We showed dynamically updated PSA information can improve prognostication, which can be used to guide follow-up and treatment management options.
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  • 文章类型: Clinical Trial, Phase I
    ADXS31-142是一种减毒的基于单核细胞增生李斯特菌的免疫疗法,靶向前列腺特异性抗原(PSA),正在评估作为单一疗法,并与派姆单抗联合治疗转移性去势耐药前列腺癌(mCRPC)。
    2部分I/II期KEYNOTE-046研究招募了患有mCRPC的男性,他们在转移背景下经过2个或更少的先前全身治疗方案后进展。在A部分,每3周(q3w)给予静脉内ADXS31-142单药治疗至3个剂量递增队列.在B部分,将ADXS31-142(1×109集落形成单位)加派姆单抗(200mg)q3w静脉内施用3个剂量,在3周后(12周周期)静脉内施用第四个派姆单抗剂量长达24个月或直至进展/毒性。终点包括安全性,总反应率,无进展生存期(PFS),总生存期(OS),和免疫原性。
    50例患者单独接受ADXS31-142(n=13)或使用派姆单抗(n=37)。在37名RECIST可评估患者中(n=8个A部分;n=29个B部分),没有客观的反应。单药治疗的中位PFS为2.2个月(95%CI:0.8-7.4),联合治疗的中位PFS为5.4个月(95%CI:2.3-7.9);中位OS为7.8个月(95%CI:4.4-18.5)和33.7个月(95%CI:15.4-不可评估),分别。在先前接受多西他赛的联合治疗患者中观察到有希望的OS获益(16.0个月,95%CI:6.4-34.6;n=20)和有内脏转移的患者(16.4个月,95%CI4.0-不可评估;n=11)。所有患者均有≥1次治疗相关不良事件,主要是1/2级可管理的事件。用组合处理没有观察到附加毒性。
    将ADXS31-142与派姆单抗联合使用是安全且耐受性良好的。mCRPC中观察到的OS保证了对该组合的进一步测试。
    NCT02325557。
    ADXS31-142 is an attenuated Listeria monocytogenes-based immunotherapy targeting prostate-specific antigen (PSA), being evaluated as monotherapy and combined with pembrolizumab for metastatic castration-resistant prostate cancer (mCRPC).
    The 2-part phase I/II KEYNOTE-046 study enrolled men with mCRPC who have progressed after 2 or fewer prior systemic treatment regimens in the metastatic setting. In Part A, intravenous ADXS31-142 monotherapy was given every 3 weeks (q3w) to 3 dose-escalation cohorts. In Part B, ADXS31-142 (1 × 109 colony-forming units) plus pembrolizumab (200 mg) was administered intravenously q3w for 3 doses with a fourth pembrolizumab dose 3 weeks later (12-week cycles) for up to 24 months or until progression/toxicity. Endpoints included safety, overall response rate, progression-free survival (PFS), overall survival (OS), and immunogenicity.
    Fifty patients received ADXS31-142 alone (n = 13) or with pembrolizumab (n = 37). Among the 37 RECIST-evaluable patients (n = 8 Part A; n = 29 Part B), there were no objective responses. Median PFS was 2.2 months (95% CI: 0.8-7.4) with monotherapy and 5.4 months (95% CI: 2.3-7.9) with the combination; median OS was 7.8 months (95% CI: 4.4-18.5) and 33.7 months (95% CI: 15.4-not evaluable), respectively. Promising OS benefit was observed in combination-treated patients who had received prior docetaxel (16.0 months, 95% CI: 6.4-34.6; n = 20) and those with visceral metastasis (16.4 months, 95% CI 4.0-not evaluable; n = 11). All patients had ≥1 treatment-related adverse event, mostly grade 1/2 manageable events. No additive toxicity was observed with combination treatment.
    Combining ADXS31-142 with pembrolizumab was safe and well tolerated. The observed OS in mCRPC warrants further testing of this combination.
    NCT02325557.
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  • 文章类型: Journal Article
    UNASSIGNED:亚洲男性前列腺癌的发病率和死亡率一直在上升。ELIGARD®是醋酸亮丙瑞林的制剂,其安全性和有效性已在西部地区得到确认。然而,亚洲人群的安全性数据有限.
    未经批准:精英(ELIGardAsiaNsTudy)是第4阶段,多中心,prospective,单臂,介入研究。患有局部晚期或转移性前列腺癌的男性,没有伴随化疗,或另一种雄激素受体途径抑制剂,在整个亚洲注册,每3个月接受ELIGARD®(22.5mg皮下储库注射),持续15个月,18个月后进行随访。主要目的是确定ELIGARD®在患有激素依赖性前列腺癌的亚洲男性中的安全性。次要目标是评估疗效,通过前列腺特异性抗原(PSA)进展和睾酮水平,和健康相关生活质量(HRQoL)。
    未经批准:总共,106名患者被纳入安全性分析集(SAF)。最常见的治疗引起的不良事件(TEAE)包括PSA升高,咳嗽,背痛,热冲洗,贫血,上呼吸道感染.在13.2%的患者中报告了与ELIGARD®相关的TEAE(n=14),其中两个是严重的。在完整分析集(FAS)(n=105)中,81.2%(n=56)和68.5%(n=61)的患者在12个月和18个月时从基线降低PSA≥90%,分别。18个月时,睾酮水平<20、20-50和>50ng/dL的患者人数为65(61.9%),17(16.2%),和两个(1.9%),分别为20%的睾酮测量缺失。HRQoL在整个研究中保持稳定,在研究完成时与基线的变化最小。
    未经批准:总而言之,在患有激素依赖性前列腺癌的亚洲男性患者中,ELIGARD®(22.5mg)的安全性与之前在西方地区的研究相当.
    UNASSIGNED:临床试验登记号NCT03035032。
    UNASSIGNED: The incidence and mortality rate of men with prostate cancer have been increasing in Asia. ELIGARD® is a formulation of leuprorelin acetate whose safety and efficacy have been well-established in Western regions. However, limited safety data are available for Asian populations.
    UNASSIGNED: ELIGANT (ELIGard AsiaN sTudy) was a Phase 4, multicenter, prospective, single-arm, interventional study. Men with locally advanced or metastatic prostate cancer without concomitant chemotherapy, or another androgen receptor pathway inhibitor, were enrolled across Asia to receive ELIGARD® (22.5 mg subcutaneous depot injection) every 3 months for 15 months, with a follow-up visit at 18 months. The primary objective was to establish the safety of ELIGARD® in Asian men with hormone-dependent prostate cancer. The secondary objectives were to assess efficacy, via prostate-specific antigen (PSA) progression and testosterone levels, and health-related quality of life (HRQoL).
    UNASSIGNED: In total, 106 patients were included in the safety analysis set (SAF). The most common treatment-emergent adverse events (TEAEs) included PSA increase, cough, back pain, hot flush, anemia, and upper respiratory tract infection. TEAEs considered related to ELIGARD® were reported in 13.2% of patients (n=14), two of which were serious. In the full analysis set (FAS) (n=105), 81.2% (n=56) and 68.5% (n=61) of patients achieved a PSA reduction of ≥90% from baseline at 12 and 18 months, respectively. At 18 months, the numbers of patients with testosterone levels <20, 20-50, and >50 ng/dL were 65 (61.9%), 17 (16.2%), and two (1.9%), respectively; 20% had missing testosterone measurements. HRQoL remained stable throughout the study with minimal change from baseline at study completion.
    UNASSIGNED: In conclusion, the safety profile of ELIGARD® (22.5 mg) in Asian men with hormone-dependent prostate cancer is comparable to previous studies in Western regions.
    UNASSIGNED: Clinical trial registration number NCT03035032.
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  • 文章类型: Journal Article
    Many clinical biomarkers in cancer are glycoproteins, but the majority of them only consider the protein levels. Indeed, only alfa-fetoprotein (AFP) in hepatocarcinoma and CA15-3 in breast cancer are clinically monitored for their glycoforms. Aberrant glycosylation occurs frequently in many of the glycoproteins synthesized by tumor cells and often produce changes in protein glycoforms that could be exploited as potential biomarkers for improving diagnosis, prognosis or to study the response to treatment. Ideally, the screening of potential biomarkers should be performed from noninvasive samples like serum or plasma, therefore these glycoproteins with tumor associated-glycoforms should be shed from the tumor cell membrane or secreted into the blood to be detectable. Glycosylation changes that are commonly associated with cancer transformation include fucosylation, sialylation, branching, and polylactosaminylation.Lectins are glycan-binding proteins that bind with great specificity to different glycan moieties. Lectin-based strategies to enrich or fractionate glycoproteins are being extensively used and hold promise in targeted analysis for cancer biomarker discovery. Here we describe the use of lectin chromatography to separate prostate specific antigen (PSA) glycoforms based on their sialic acid linkage from sera of patients with prostate cancer (with PSA levels in the range of 2-20 ng/mL). In particular, agarose-bound Sambucus nigra agglutinin (SNA) lectin which has affinity for terminal α2,6-sialic acids on glycoproteins was used. The protocol included first a previous immunoaffinity step to enrich PSA and to avoid interferences of the most abundant serum glycoproteins. Then, the immunopurified PSA was loaded on the SNA chromatography and two fractions were obtained, the first one (unbound fraction) containing the PSA glycoforms without α2,6-sialic acid (basically α2,3-sialylated PSA glycoforms) and the second one (bound fraction) the α2,6-sialylated PSA glycoforms. The quantification of the PSA eluted in the two fractions allows for the determination of the relative content of both groups of PSA glycoforms. The percentage of the α2,6-sialylated PSA glycoforms is significantly decreased in aggressive prostate cancer compared to indolent prostate cancer and benign prostate hyperplasia, being a promising new glycobiomarker for prostate cancer risk stratification.
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