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Tie Zhou Shengfei Qin Weidong Xu Shouyan Tang Guanghua Chen Song Li Jianguo Hou Xu Gao Guowei Shi Zhongquan Sun Jie Jin Lijun Chen Weibing Sun Ben Liu Jingen Wang Qinggui Meng Dongwen Wang Zhiquan Hu Dalin He Yong Yang Xishuang Song Cheng Fu Yinhuai Wang Dingwei Ye Wei Zhang 《International journal of cancer. Journal international du cancer》2023,153(4):792-802
We aim to assess the safety and efficacy of proxalutamide, a novel androgen receptor antagonist, for men with metastatic castration-resistant prostate cancer (mCRPC) in a multicenter, randomized, open-label, phase 2 trial. In our study, the enrolled mCRPC patients were randomized to 100, 200 and 300 mg dose groups at 1:1:1. The primary efficacy endpoint was prostate-specific antigen (PSA) response rate. The secondary endpoints included objective response rate (ORR), disease control rate (DCR) and time to PSA and radiographic progression. Safety and pharmacokinetics were also assessed. Finally, there were 108 patients from 17 centers being enrolled. By week 16, there were 13 (35.1%), 12 (36.4%) and 15 (42.9%) patients with confirmed 50% or greater PSA decline in 100 mg (n = 37), 200 mg (n = 33) and 300 mg (n = 35) groups, respectively. Among the 19 patients with target lesions at study entry, three (15.8%) had a partial response and 12 (63.2%) had stable disease. The ORRs of 20.0%, 22.2%, 0% and DCRs of 80.0%, 88.9%, 60.0% were, respectively, achieved in 100, 200 and 300 mg groups. By the maximum follow-up time of 24 weeks, there were 42.6% and 10.2% of cases experiencing PSA progression and radiographic progression, respectively. Overall, adverse events (AEs) were experienced by 94.4% of patients, most of which were mild or moderate. There were 28 patients experiencing ≥grade 3 AEs. The most common AEs were fatigue (17.6%), anemia (14.8%), elevated AST (14.8%) and ALT (13.0%), decreased appetite (13.0%). These findings preliminarily showed the promising antitumor activity of proxalutamide in patients with mCRPC with a manageable safety profile. The proxalutamide dose of 200 mg daily is recommended for future phase 3 trial (Clinical trial registration no. CTR20170177). 相似文献
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Shengxiang Ren Jifeng Feng Shenglin Ma HuaJun Chen Zhiyong Ma Cheng Huang Li Zhang Jianxing He Changli Wang Jianying Zhou Pongwut Danchaivijitr Chin-Chou Wang Ihor Vynnychenko Kai Wang Francisco Orlandi Virote Sriuranpong Ben Li Jun Ge Thao Dang Caicun Zhou 《International journal of cancer. Journal international du cancer》2023,153(3):623-634
KEYNOTE-033 (NCT02864394) was a multicountry, open-label, phase 3 study that compared pembrolizumab vs docetaxel in previously treated, programmed death-ligand 1 (PD-L1)-positive, advanced non-small cell lung cancer (NSCLC), with most patients enrolled in mainland China. Eligible patients were randomized (1:1) to pembrolizumab 2 mg/kg or docetaxel 75 mg/m2 every 3 weeks. Primary endpoints were overall survival (OS) and progression-free survival and were evaluated sequentially using stratified log-rank tests, first in patients with PD-L1 tumor proportion score (TPS) ≥50% and then in patients with PD-L1 TPS ≥1% (significance threshold: P < .025, one-sided). A total of 425 patients were randomized to pembrolizumab (N = 213) or docetaxel (N = 212) between 8 September 2016 and 17 October 2018. In patients with a PD-L1 TPS ≥50% (n = 227), median OS was 12.3 months with pembrolizumab and 10.9 months with docetaxel; the hazard ratio (HR) was 0.83 (95% confidence interval [CI]: 0.61-1.14; P = .1276). Because the significance threshold was not met, sequential testing of OS and PFS was ceased. In patients with a PD-L1 TPS ≥1%, the HR for OS for pembrolizumab vs docetaxel was 0.75 (95% CI: 0.60-0.95). In patients from mainland China (n = 311) with a PD-L1 TPS ≥1%, HR for OS was 0.68 (95% CI: 0.51-0.89). Incidence of grade 3 to 5 treatment-related AEs was 11.3% with pembrolizumab vs 47.5% with docetaxel. In summary, pembrolizumab improved OS vs docetaxel in previously treated, PD-L1-positive NSCLC without unexpected safety signals; although the statistical significance threshold was not reached, the numerical improvement is consistent with that previously observed for pembrolizumab in previously treated, advanced NSCLC. 相似文献
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Qiangsheng He Chongfei Huang Xiwen Qin Yuanyuan Yu Di Tang Junjie Huang Zi Chong Kuo Yuyao Ling Deli Mao Bin Xia Wenjing Li Kuiqing Lu Man Yang Yulong He Wenbo Meng Jinqiu Yuan Yihang Pan 《International journal of cancer. Journal international du cancer》2023,153(5):942-949
Recent epidemiological studies suggested that proton pump inhibitor (PPI) use was associated with an increased risk of biliary tract cancer (BTC), however, confounders were not adequately controlled. Our study aimed to evaluate PPI use and subsequent risk of BTC and its subtypes in three well-established cohorts. We conducted a pooled analysis of the subjects free of cancers in UK Biobank (n = 463 643), Nurses' Health Study (NHS, n = 80 235) and NHS II (n = 95 869). Propensity score weighted Cox models were used to estimate marginal HRs of PPIs use on BTC risk, accounting for potential confounders. We documented 284 BTC cases in UK Biobank (median follow-up: 7.6 years), and 91 cases in NHS and NHS II cohorts (median follow-up: 15.8 years). In UK biobank, PPI users had a 96% higher risk of BTC compared to nonusers in crude model (HR 1.96, 95% CI 1.44-2.66), but the effect was attenuated to null after adjusting for potential confounders (HR 0.95, 95% CI 0.60-1.49). PPI use was not associated with risk of BTC in the pooled analysis of three cohorts (HR 0.93, 95% CI 0.60-1.43). We also observed no associations between PPI use with risk of intrahepatic (HR 1.00, 95% CI 0.49-2.04), extrahepatic bile duct (HR 1.09, 95% CI 0.52-2.27) and gallbladder cancers (HR 0.66, 95% CI 0.26-1.66) in UK Biobank. In summary, regular use of PPIs was not associated with the risk of BTC and its subtypes. 相似文献
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目的研究医联体背景下射血分数中间值的中老年急性失代偿心力衰竭(心衰)住院患者临床特征及1年内发生主要心血管事件的风险。方法回顾性队列研究, 连续收集天津市胸科医院心内科和天津河西医院诊区急性失代偿心衰住院患者180例, 根据入院后左心室射血分数(LVEF)将心衰患者分为射血分数低(HFrEF, LVEF< 40%)组70例(38.9%)、射血分数中间值(HFmEF, LVEF 40%~49%)组50例(27.8%)和射血分数保留(HFpEF, LVEF≥50%)组60例(33.3%), 比较3组患者临床特征及1年预后差异。结果 1年全因死亡和心血管死亡单因素Cox回归分析, HFrEF组与HFmEF组、HFpEF组与HFmEF组患者比较, 差异无统计学意义(均P>0.05);1年心衰再入院分析, HFrEF组47.1%(33例)较HFmEF组48.3%(29例)高、HFpEF组24.0%(12例)较HFmEF组高(HR分别为2.307、2.368, 95%CI:0.187~4.480、1.207~4.644, 均P<0.05);1年主要心血管事件HFrEF组57.1%... 相似文献
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目的:探究应用B细胞成熟抗原(BCMA)靶向的嵌合抗原受体(CAR)T细胞治疗的复发/难治多发性骨髓瘤(MM)患者发生肿瘤溶解综合征(TLS)的危险因素。方法:收集浙江大学医学院附属第一医院2018年7月至2021年12月共99例接受BCMA靶向的CAR-T细胞治疗MM患者的临床资料,通过单因素分析及多因素logistic回归分析患者接受BCMA靶向的CAR-T细胞治疗后发生TLS的危险因素。结果:99例患者中,17例发生TLS(TLS组),发生率为17.2%,发生时间为BCMA靶向的CAR-T细胞输注后(8.9±3.0)d。TLS组均出现TLS相关临床表现,其中出现肾功能不全17例,心律失常8例。TLS组均发生细胞因子释放综合征(CRS),发生时间为BCMA靶向CAR-T细胞输注后1.0(1.0,6.5)d,其中3~4级CRS 13例。TLS组治疗前血肌酐、血尿酸较非TLS组高,3~4级CRS患者的比例也高于非TLS组(P<0.01或P<0.05)。Logistic回归分析结果显示,高血肌酐水平(OR=1.015,P<0.01)和严重CRS(OR=9.371,P<0.01)是TLS发生的独立危险因素。结论:接受BCMA靶向的CAR-T细胞治疗的复发/难治MM患者具有较高的TLS发生率,高血肌酐水平和严重CRS是TLS的主要危险因素,临床可通过降低血肌酐、控制CRS严重程度预防TLS的发生。 相似文献
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尽管嵌合抗原受体(CAR)T细胞治疗在血液系统恶性肿瘤患者中取得了显著的临床疗效,但需要进一步优化。脂质纳米粒(LNP)-信使核糖核酸(mRNA)递送系统作为一种非病毒性基因载体运用于CAR-T细胞治疗研究中,一方面通过LNP将密封蛋白-6 mRNA靶向递送至抗原提呈细胞,从而实现抗原提呈细胞辅助性增强密封蛋白-6靶向的CAR-T细胞的功能,以进一步诱导对实体瘤的清除;另一方面,通过LNP将成纤维细胞激活蛋白(FAP)CARmRNA靶向递送至T细胞,实现体内FAP靶向的CAR-T细胞的制备,以通过阻断心脏纤维化过程达到治疗急性心肌损伤的目的。在CAR-T细胞研究和治疗中,LNP-mRNA递送系统具有不与细胞基因组整合、价格便宜、毒副作用小及可修饰等优点,亦存在蛋白瞬时表达导致调控细胞功能的持久性不足及制备等方面的技术局限性。本文综述了LNP-mRNA递送系统及其在CAR-T细胞治疗中的应用研究。 相似文献
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目的:评价嵌合抗原受体(CAR)T细胞治疗复发/难治B细胞非霍奇金淋巴瘤(B-NHL)的长期疗效。方法:收集2016年6月至2020年6月在浙江大学医学院附属第一医院骨髓移植中心应用CAR-T细胞治疗的27例复发/难治B-NHL患者的资料,随访日期截至2022年2月1日。运用Kaplan-Meier生存分析评估患者总存活率和无进展存活率,并统计相关不良反应。结果:27例患者中位随访时间为32(1,56)个月,CAR-T细胞治疗总反应率为85.2%(23/27),完全缓解率为63.0%(17/27),部分缓解率为22.2%(6/27)。患者3年总存活率为(50.0±10.1)%,无进展存活率为(44.4±9.6)%。CAR-T细胞治疗后获完全缓解患者的总存活率和无进展存活率均优于未获完全缓解患者[总存活率分别为(66.9±12.7)%和(20.0±12.6)%,P=0.01;无进展存活率分别为(64.7±11.6)%和(10.0±9.5)%,P<0.01]。CD19单靶点和CD19/CD22双靶点的CAR-T细胞治疗患者总存活率和无进展存活率差异无统计学意义(均P>0.05)。92.6%(25/27)的患者发生细胞因子释放综合征;88.9%(24/27)的患者治疗期间发生Ⅲ~Ⅳ级骨髓抑制;其他不良反应包括免疫效应细胞相关神经毒性综合征、乙型肝炎病毒激活以及肺部或胃肠道感染等。未观察到远期不良反应发生。结论:CAR-T细胞治疗是复发/难治B-NHL患者的有效治疗方案,不良反应可控。CAR-T细胞治疗后获得完全缓解及随访至1年时处于存活状态的患者可能有更好的长期存活率。 相似文献
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目的探讨儿童肺炎支原体肺炎外周血T淋巴细胞亚群、细胞因子以及免疫球蛋白的动态变化。方法选取2018年12月至2020年5月本院收治的儿童支原体肺炎患儿50例作为观察组,按病情的发展进程分为急性期组和恢复期组,各25例;另选取同期健康儿童50名作为对照组。3组均进行样本采集,比较3组外周血T淋巴细胞亚群、细胞因子以及免疫球蛋白的动态效果。结果检测后,急性期组CD3+、CD4+、CD4+/CD8+均低于恢复期组和对照组(P<0.05),NK细胞的比例高于恢复期组和对照组(P<0.05),恢复期组CD8+与B细胞的占比与对照组比较差异无统计学意义。检测后,急性期组IFN-γ、IL-4、Th1/Th2含量均高于恢复期组和对照组(P<0.05),恢复期组IFN-γ、IL-4、Th1/Th2与对照组比较差异无统计学意义。检测后,恢复期组血清IgG水平高于急性期组和对照组(P<0.05),急性期组血清IgG水平与对照组比较差异无统计学意义,急性期组和恢复期组血清IgA水平均低于对照组(P<0.05),急性期组血清IgA水平与恢复期组比较差异无统计学意义,急性期组血清IgM水平高于对照组和恢复期组(P<0.05),对照组血清IgM水平与恢复期组比较差异无统计学意义。结论患儿感染支原体肺炎时,机体内免疫功能发生紊乱,随病情的发展,免疫状态发生变化,临床上对幼儿采取免疫监测,可对疾病的诊断以及后期治疗提供依据。 相似文献