maintenance treatment

维持治疗
  • 文章类型: Journal Article
    即使取得了重大进展,多发性骨髓瘤(MM)的治疗仍然困难。目前,主要治疗方法包括干细胞移植联合治疗,药物治疗,等。随着MM分子生物学机制的阐明,以及对骨髓瘤细胞内部信号和MM患者微环境的深入研究,越来越多的针对骨髓瘤和微环境的新药逐渐用于临床维持治疗,如抑制蛋白体:ixazomib,硼替佐米和卡非佐米,免疫调节剂:沙利度胺和来那度胺,单克隆抗体,等。在MM保养处理方面取得了很大的进步。随着蛋白酶体抑制剂维持治疗在MM中的不断发展,该疾病的预后得到了明显改善。我们的目的是评估蛋白酶体抑制剂在多发性骨髓瘤维持治疗中的有效性和不良反应。为临床用药提供新思路。
    计算机检索了四个数据库,其中包含有关蛋白酶体抑制剂在多发性骨髓瘤维持治疗中的有效性和安全性的随机对照研究。一旦对文献质量进行了全面评估,通过RevMan5.3软件运行数据。
    最终,本系统综述增加了8项研究。与安慰剂组相比,蛋白酶体抑制剂在多发性骨髓瘤患者的维持治疗中具有延长的生存期而无进展和整体存在。5项研究报道了治疗组与安慰剂组相比多发性骨髓瘤的周围神经病变,显著高于安慰剂组(OR:1.98;95%Cl:1.35,2.92;P<0.001),严重不良事件(OR:1.60;95%Cl:1.19,2.14;P<0.01),皮疹(OR:2.23;95%Cl:1.62,3.05;P<0.001)和呕吐(OR:5.12;95%Cl:3.36,7.80;P<0.001)。治疗组的严重不良事件明显高于未治疗组(OR:1.60;95%Cl:1.19,2.14;P<0.01)。
    研究结果表明,与安慰剂组相比,蛋白酶体抑制剂在多发性骨髓瘤维持治疗中有效。硼替佐米在延长PFS方面具有一定的优势,在疗效方面依次为艾沙佐米和卡非佐米。硼替佐姆在扩展OS方面可能优于卡菲佐姆。然而,蛋白酶体抑制剂引起的不良反应,如周围神经病变,严重不良事件,皮疹,呕吐,等。,应该给予足够的重视。
    UNASSIGNED: Even with significant advancements, treating multiple myeloma (MM) remains difficult. At present, the main treatment methods include combined treatment of stem cell transplantation, drug treatment, etc. With the clarification of the molecular biological mechanism of MM, as well as the in-depth study of the internal signal of myeloma cells and the microenvironment of MM patients, more and more new drugs targeting myeloma and microenvironment are gradually used in clinical maintenance treatment, such as inhibit the proteosome: ixazomib, bortezomib and carfilzomib, immune - modulators: thalidomide and lenalidomide, monoclonal antibodies, etc. have made great progress in MM maintenance treatment. With the continuous development of proteasome inhibitor maintenance treatment in MM, the prognosis of the disease has been significantly improved. Our aim is to evaluate the effectiveness and adverse reactions of proteasome inhibitors in maintenance therapy for multiple myeloma, providing new ideas for clinical medication.
    UNASSIGNED: Four databases containing randomized controlled studies on the effectiveness and safety of proteasome inhibitors in the maintenance therapy of multiple myeloma are retrieved by the computer. Once the quality of the literature has been thoroughly evaluated, run the data via the RevMan 5.3 software.
    UNASSIGNED: Eventually 8 studies were added in this systematic review. Compared with the placebo group, proteasome inhibitor in maintenance treatment of multiple myeloma patients with prolonged the survival without progression and overall existence. 5 studies reported the peripheral neuropathy of multiple myeloma in the treatment group compared to placebo group, which was remarkably greater (OR: 1.98; 95 % Cl: 1.35, 2.92; P < 0.001) compared to placebo group, Serious adverse events (OR: 1.60; 95 % Cl: 1.19, 2.14; P < 0.01), Rash (OR: 2.23; 95 % Cl: 1.62, 3.05; P < 0.001) and Vomiting (OR: 5.12; 95 % Cl: 3.36, 7.80; P < 0.001). The Serious adverse events of the treatment group were remarkably greater compared with the untreated group (OR: 1.60; 95 % Cl: 1.19, 2.14; P < 0.01).
    UNASSIGNED: The study results proposed that proteasome inhibitors are effective in the multiple myeloma maintenance treatment compared with the placebo group. Bortezomib has certain advantages in prolonging PFS, followed by ixazomib and carfilzomib in terms of efficacy. Bortezombib may be superior to carfilzombib in extending OS. However, the adverse reactions caused by proteasome inhibitors, such as Peripheral neuropathy, Serious adverse events, Rash, Vomiting, etc., should be paid enough attention.
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  • 文章类型: Journal Article
    HSCT前疾病控制,长期预后欠佳,高复发率(RI)继续对幼年型粒单核细胞白血病(JMML)患者的造血干细胞移植(HSCT)构成重大挑战.
    这项回顾性队列研究评估了基于地西他滨(DAC)的方案在接受HSCT的JMML患者中的有效性。HSCT前治疗包括初始治疗和桥接治疗。比较DAC单药治疗与DAC联合细胞毒性化疗(C-DAC)作为初始治疗的疗效,其次是DAC加FLAG(氟达拉滨,阿糖胞苷,和GCSF)作为桥接治疗。HSCT方案基于DAC,氟达拉滨,还有白消安.HSCT后,使用低剂量DAC作为维持治疗。研究终点集中在移植前简化的临床反应和HSCT后存活。
    有109名患者,包括45例接受DAC单一疗法和64例接受C-DAC治疗。106例患者完成桥接治疗。所有患者均接受计划的HSCT方案和HSCT后治疗。初始治疗导致88.1%的患者达到临床缓解,DAC和C-DAC组之间没有显着差异(p=0.769)。桥接治疗后临床缓解率显着提高(p=0.019)。5年总生存率,无白血病生存,RI为92.2%,88.4%,和8.0%,分别。对HSCT前治疗的不良临床反应是OS的危险因素(风险比:9.8,95%CI:2.3-41.1,p=0.002)。
    在整个HSCT前期实施基于DAC的管理策略,在HSCT方案中,在JMML患者中,在HSCT后维持治疗中显着减少了复发并改善了生存率。DAC单一疗法和DAC加FLAG方案均被证明是HSCT前治疗有效。
    UNASSIGNED: Pre-HSCT disease control, suboptimal long-term prognosis, and a high recurrence incidence (RI) continue to pose significant challenges for hematopoietic stem cell transplantation (HSCT) in juvenile myelomonocytic leukemia (JMML) patients.
    UNASSIGNED: This retrospective cohort study assessed the effectiveness of a decitabine (DAC)-based protocol in JMML patients undergoing HSCT. The pre-HSCT treatment includes initial and bridging treatment. The efficacy of DAC monotherapy versus DAC combined with cytotoxic chemotherapy(C-DAC) as initial treatment was compared, followed by DAC plus FLAG (fludarabine, cytarabine, and GCSF) as bridging treatment. The HSCT regimens were based on DAC, fludarabine, and busulfan. Post-HSCT, low-dose DAC was used as maintenance therapy. The study endpoints focused on pretransplantation simplified clinical response and post-HSCT survival.
    UNASSIGNED: There were 109 patients, including 45 receiving DAC monotherapy and 64 undergoing C-DAC treatment. 106 patients completed bridging treatment. All patients were administered planned HSCT regimens and post-HSCT treatment. The initial treatment resulted in 88.1% of patients achieving clinical remission without a significant difference between the DAC and C-DAC groups (p=0.769). Clinical remission rates significantly improved following bridging treatment (p=0.019). The 5-year overall survival, leukemia-free survival, and RI were 92.2%, 88.4%, and 8.0%, respectively. A poor clinical response to pre-HSCT treatment emerged as a risk factor for OS (hazard ratio: 9.8, 95% CI: 2.3-41.1, p=0.002).
    UNASSIGNED: Implementing a DAC-based administration strategy throughout the pre-HSCT period, during HSCT regimens, and in post-HSCT maintenance significantly reduced relapse and improved survival in JMML patients. Both DAC monotherapy and the DAC plus FLAG protocol proved effective as pre-HSCT treatments.
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  • 文章类型: Journal Article
    背景:溃疡性结肠炎(UC)是一种以非特异性炎症为特征的慢性炎症性肠病。由于UC的慢性性质和高复发率,管理UC面临重大挑战。天然靛蓝已成为临床UC治疗的潜在治疗剂,与其他治疗方法相比,在缓解难治性UC和维持缓解期方面具有优势。
    目的:这篇综述旨在阐明靛蓝在UC治疗中潜在的治疗作用机制,评估其临床疗效,优势,和限制,并提供在UC管理中利用靛蓝的方法和策略的见解。
    方法:从包括PubMed在内的知名在线数据库中收集了有关天然靛蓝的综合数据,GreenMedical,WebofScience,谷歌学者,中国国家知识基础设施数据库,和国家知识产权局。
    结果:临床研究表明,靛蓝,单独或与其他药物联合使用,在UC治疗中产生有利的结果。其作用机制涉及AHR受体的调节,抗炎特性,调节肠道菌群,肠道屏障的恢复,和调节免疫力。尽管它在治疗难治性UC和延长缓解期方面有效,天然靛蓝治疗与不良反应有关,质量变化,药代动力学研究不足。
    结论:靛蓝在UC治疗中的疗效与其调节AHR受体的能力密切相关,发挥抗炎作用,mcodulate肠道菌群,恢复肠道屏障,调节免疫力。针对目前的不足,包括不良反应,质量控制问题,药代动力学数据不足,对于优化靛蓝在UC管理中的临床应用至关重要。通过完善以患者为中心的治疗策略,天然靛蓝有望在UC治疗中得到更广泛的应用,从而减轻UC患者的痛苦。
    BACKGROUND: Ulcerative colitis (UC) is a chronic inflammatory bowel disease characterized by non-specific inflammation. Managing UC presents significant challenges due to its chronic nature and high recurrence rates. Indigo naturalis has emerged as a potential therapeutic agent in clinical UC treatment, demonstrating advantages in alleviating refractory UC and maintaining remission periods compared to other therapeutic approaches.
    OBJECTIVE: This review aims to elucidate the potential mechanisms underlying the therapeutic effects of indigo naturalis in UC treatment, assess its clinical efficacy, advantages, and limitations, and provide insights into methods and strategies for utilizing indigo naturalis in UC management.
    METHODS: Comprehensive data on indigo naturalis were collected from reputable online databases including PubMed, GreenMedical, Web of Science, Google Scholar, China National Knowledge Infrastructure Database, and National Intellectual Property Administration.
    RESULTS: Clinical studies have demonstrated that indigo naturalis, either alone or in combination with other drugs, yields favorable outcomes in UC treatment. Its mechanisms of action involve modulation of the AHR receptor, anti-inflammatory properties, regulation of intestinal flora, restoration of the intestinal barrier, and modulation of immunity. Despite its efficacy in managing refractory UC and prolonging remission periods, indigo naturalis treatment is associated with adverse reactions, quality variations, and inadequate pharmacokinetic investigations.
    CONCLUSIONS: The therapeutic effects of indigo naturalis in UC treatment are closely linked to its ability to regulate the AHR receptor, exert anti-inflammatory effects, mcodulate intestinal flora, restore the intestinal barrier, and regulate immunity. Addressing the current shortcomings, including adverse reactions, quality control issues, and insufficient pharmacokinetic data, is crucial for optimizing the clinical utility of indigo naturalis in UC management. By refining patient-centered treatment strategies, indigo naturalis holds promise for broader application in UC treatment, thereby alleviating the suffering of UC patients.
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  • 文章类型: Journal Article
    目的:一线化疗后的维持治疗在诊断为复发或转移性鼻咽癌(NPC)的患者中尤为重要。我们进行了一项荟萃分析,以研究维持治疗(MT)对复发性或转移性NPC患者生存预后的影响。
    方法:数据库Embase,PubMed,对Cochrane图书馆进行了全面搜索。需要对复发性或转移性NPC的MT进行前瞻性研究。研究终点包括无进展生存期(PFS)和总生存期(OS)。
    结果:两项随机对照临床试验,共有294人参加,进行了分析。维持治疗组由140名参与者组成,而其余参与者为非维持治疗(非MT)组。与非MT组相比,MT组PFS显着增强,风险比(HR)为0.44,95%置信区间[CI]为0.34-0.58(p<0.0001)。总生存率也显著提高(HR0.42,95%CI0.30-0.58;p<0.0001)。MT组3级或4级副作用的发生率为白细胞减少症(2.9%),血小板减少症(0.7%),贫血(4.3%),手足综合症(5.8%),和血小板减少(0.7%)。口腔黏膜炎(1.5%),恶心及呕吐(2.2%)。
    结论:一线化疗后使用S-1(替加氟/吉马拉西坦/奥替西坦)或卡培他滨维持治疗可显著提高复发或转移性鼻咽癌患者的OS和PFS,同时表现出最低的3-4级副作用发生率。
    OBJECTIVE: Maintenance therapy following first-line chemotherapy is of particular significance in patients diagnosed with recurrent or metastatic nasopharyngeal carcinoma (NPC). We conducted a meta-analysis to investigate the impact of maintenance therapy (MT) on the survival prognosis of individuals with recurrent or metastatic NPC.
    METHODS: The databases Embase, PubMed, and the Cochrane Library were thoroughly searched in a comprehensive manner. Prospective studies of MT for recurrent or metastatic NPC are required. Study endpoints included progression-free survival (PFS) and overall survival (OS).
    RESULTS: Two randomized controlled clinical trials, with a total of 294 participants, were analyzed. The maintenance therapy group consisted of 140 participants, while the remaining participants were in the non-maintenance therapy (non-MT) group. The MT group showed a notable enhancement in PFS compared to the non-MT group, with a hazard ratio(HR) of 0.44 and a 95% Confidence interval [CI] of 0.34-0.58 (p < 0.0001). Overall survival was also significantly improved (HR0.42, 95% CI 0.30-0.58; p < 0.0001). The incidence of grade 3 or 4 side effects in the MT group was leukopenia (2.9%), thrombocytopenia (0.7%), and anemia (4.3%), hand-foot syndrome (5.8%), and thrombocytopenia (0.7%). oral mucositis (1.5%), and nausea and vomiting (2.2%).
    CONCLUSIONS: Maintenance therapy with S-1 (tegafur/gimeracil/oltiracetam) or capecitabine following first-line chemotherapy significantly enhanced OS and PFS in patients with recurrent or metastatic nasopharyngeal carcinoma, while exhibiting minimal incidence of grade 3-4 side effects.
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  • 文章类型: Journal Article
    背景:比较接受一线或维持治疗的不可切除的结直肠癌肝转移(CRLM)患者不同治疗方法的疗效的证据很少。我们旨在评估这些治疗的疗效和安全性,特别注重分别评估一线和维持治疗。方法:我们进行了贝叶斯网络荟萃分析,从包括PubMed,Embase,Cochrane图书馆,ClinicalTrials.gov,和关键会议记录。包括评估两种或两种以上治疗方案的Ⅱ期或Ⅲ期试验。主要结果是总生存期(OS)。次要结局包括无进展生存期(PFS),客观反应率(ORR),不良事件分级为3级或以上(SAE),和R0肝切除率。使用危害比(HR)和95%置信区间(CI)作为OS和PFS的效应大小,ORR使用赔率(OR)和95%CI,SAEs和R0切除率。进行亚组和敏感性分析以分析模型的不确定性(PROSPERO:CRD42023420498)。结果:纳入56项RCT(一线治疗50项,六个用于维持治疗),共有21,323名患者。关于第一行,对于操作系统,前三个机制是:局部治疗+单药化疗(SingleCT),靶向治疗(TAR)+单CT,TAR+多药化疗(MultiCT)。切除或消融术(R/A)+单CT,S1和西妥昔单抗+基于氟尿嘧啶的强化联合化疗(ICTFU)被确定为最佳治疗。对于PFS,前三种机制是:免疫治疗+TAR+MultiCT,多靶向治疗(MultiTAR),TAR+SingleCT。前三名的治疗方法是:阿替珠单抗+贝伐单抗+氟尿嘧啶联合化疗(CTFU),TAS-102+贝伐单抗,贝伐单抗+ICTFU。西妥昔单抗+CTFU是RAS/RAF野生型患者的最佳选择。关于维护处理,贝伐单抗+SingleCT和Adavosertib是OS和PFS的最佳选择,分别。为了安全,MultiCT是最安全的,其次是局部治疗+MultiCT,TAR+MultiCT引起的SAE最多。发现贝伐单抗加化疗是所有靶向联合疗法中最安全的。结论:在第一线,局部治疗或靶向治疗加化疗是最好的机制。R/A+SingleCT或CTFU在操作系统中表现最好,阿替珠单抗+贝伐单抗+ICTFU是PFS的最佳选择。对于RAS/RAF野生型患者,西妥昔单抗+CTFU是最佳选择。单一疗法可能是维持治疗的首选。与标准化疗相比,联合治疗导致更多的SAE。
    Background: Evidence comparing the efficacy of different treatments for patients with unresectable colorectal liver metastases (CRLM) receiving first-line or maintenance therapy is sparse. We aimed to assess the efficacy and safety of these treatments, with a distinct focus on evaluating first-line and maintenance treatments separately. Methods: We conducted Bayesian network meta-analyses, sourcing English-language randomized controlled trials (RCTs) published through July 2023 from databases including PubMed, Embase, the Cochrane Library, ClinicalTrials.gov, and key conference proceedings. Phase Ⅱ or Ⅲ trials that assessed two or more therapeutic regimens were included. Primary outcome was overall survival (OS). Secondary outcomes included progression-free survival (PFS), objective response rate (ORR), adverse events graded as 3 or above (SAE), and R0 liver resection rate. Hazards Ratios (HRs) and 95% confidence intervals (CI) were used as effect size for OS and PFS, Odds Ratios (ORs) and 95% CI were used for ORR, SAEs and R0 resection rate. Subgroup and sensitive analyses were conducted to analysis the model uncertainty (PROSPERO: CRD42023420498). Results: 56 RCTs were included (50 for first-line treatment, six for maintenance therapies), with a total of 21,323 patients. Regarding first-line, for OS, the top three mechanisms were: local treatment + single-drug chemotherapy (SingleCT), Targeted therapy (TAR)+SingleCT, and TAR + multi-drug chemotherapy (MultiCT). Resection or ablation (R/A)+SingleCT, S1, and Cetuximab + intensified fluorouracil-based combination chemotherapy (ICTFU) were identified as the best treatments. For PFS, the top three mechanisms were: Immune therapy + TAR + MultiCT, multi-targeted therapy (MultiTAR), TAR + SingleCT. The top three treatments were: Atezolizumab + Bevacizumab + fluorouracil-based combination chemotherapy (CTFU), TAS-102+bevacizumab, Bevacizumab + ICTFU. Cetuximab + CTFU was the best choice for RAS/RAF wild-type patients. Regarding maintenance treatment, Bevacizumab + SingleCT and Adavosertib were the best options for OS and PFS, respectively. For safety, MultiCT was the safest, followed by local treatment + MultiCT, TAR + MultiCT caused the most SAEs. Bevacizumab plus chemotherapy was found to be the safest among all targeted combination therapies. Conclusion: In first-line, local treatment or targeted therapsy plus chemotherapy are the best mechanisms. R/A + SingleCT or CTFU performed the best for OS, Atezolizumab + Bevacizumab + ICTFU was the best option regarding PFS. For RAS/RAF wild-type patients, Cetuximab + CTFU was the optimal option. Monotherapy may be preferred choice for maintenance treatment. Combination therapy resulted in more SAEs when compared to standard chemotherapy.
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  • 文章类型: Journal Article
    一些患有视神经脊髓炎谱系障碍(NMOSD)的患者在利妥昔单抗(RTX)治疗后经历复发。在这项回顾性研究中,我们分析了复发相关的临床特征,实验室调查结果,30例女性复发性NMOSD患者使用针对水通道蛋白-4的免疫球蛋白G自身抗体,并在重复0.5gRTX输注作为维持治疗期间复发。中位随访期为6.62年。观察到35次发作,脊髓炎是最常见的。中位扩展残疾状况量表变化评分为0.50分。RTX输注后复发率降低了44.23%/年。约85.71%的患者在10个月内出现无RTX输注的复发。总的来说,RTX可能对复发性NMOSD病例有效。
    Some patients with neuromyelitis optica spectrum disorder (NMOSD) experience relapse after rituximab (RTX) treatment. In this retrospective study, we analyzed the recurrence-related clinical features, laboratory investigation results, and dosing protocol of 30 female patients with relapsing NMOSD with immunoglobulin G autoantibodies against aquaporin-4 and relapses during repeated 0.5 g RTX infusions as maintenance treatment. The median follow-up period was 6.62 years. Thirty-five episodes were observed, with myelitis being the most frequent. The median expanded disability status scale change score was 0.50. The recurrence rate decreased by 44.23%/year with RTX infusion. Approximately 85.71% of the patients showed relapse without RTX infusion within 10 months. Overall, RTX may be effective for relapsing NMOSD cases.
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  • 文章类型: Journal Article
    对于化疗后的晚期胃癌患者,维持治疗的最佳模式尚不清楚.本研究旨在比较一线联合化疗后无疾病进展的晚期胃癌患者采用S-1维持治疗及随访观察的疗效和不良反应。这项研究回顾性分析了2018年1月至2021年12月的106例患者。主要终点是总生存期和无进展生存期,次要终点是化疗相关毒性,分析患者的疗效和基线特征。S-1维持治疗组的无进展生存期和总生存期均优于随访观察组(p<0.001)。亚组无进展生存期和总生存期无明显差异(p>0.05)。在维持治疗组中,血小板减少症和手足综合征的发生率显著增加(p<0.001).没有发生与毒性相关的死亡。纳入的一线联合化疗后无疾病进展的患者可以通过接受S-1维持治疗获得显著的生存益处。患者对S-1维持治疗的耐受性良好。
    For patients with advanced gastric cancer after chemotherapy, the optimal mode of maintenance therapy is not yet clear. This research aimed to compare the efficacy and adverse effects of S-1 maintenance therapy and follow-up observation in patients with advanced gastric cancer without disease progression after first-line combined chemotherapy. This study retrospectively analyzed 106 patients from January 2018 to December 2021. The primary endpoints were overall survival and progression-free survival, the secondary endpoint was chemotherapy-related toxicity, and the curative effects and baseline characteristics of the patients were analyzed. Longer progression-free survival and overall survival were observed in the S-1 maintenance treatment group than in the follow-up observation group (p < 0.001). No obvious differences existed in the subgroup results regarding progression-free survival or overall survival (p > 0.05). In the maintenance treatment group, the occurrence of thrombocytopenia and hand-foot syndrome was significantly increased (p < 0.001). No toxicity-related deaths occurred. The included patients without disease progression after first-line combined chemotherapy can achieve significant survival benefits by receiving S-1 maintenance therapy. The patient\'s tolerance to S-1 maintenance therapy was good.
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  • 文章类型: Randomized Controlled Trial
    背景:Durvalumab是一种针对程序性死亡配体-1(PD-L1)的检查点抑制剂,安洛替尼是一种新型口服多靶点酪氨酸激酶抑制剂(TKI)。两家代理商均已在中国获得批准。临床前和临床试验表明,抗血管生成疗法有可能缓解免疫抑制,并在与ICI联合使用时显示出协同作用。然而,目前尚不清楚这种联合治疗在ES-SCLC患者中作为维持治疗开始时是否有效.
    方法:这是一个多中心,随机化,第二阶段研究。共有64名符合条件的患者在四个周期后未出现疾病进展铂类化疗联合durvalumab将被随机分配至durvalumab联合安洛替尼或durvalumab,直至疾病进展。撤回同意,或不可接受的毒性。主要终点是PFS(来自随机化);次要终点是OS和PFS(来自诊断),客观反应率(ORR);疾病控制率(DCR)和反应持续时间(DOR),安全性和耐受性由美国国家癌症研究所不良事件通用术语标准(CTCAE)5.0版评估.
    结论:我们进行了一项II期研究,以研究杜瓦单抗联合安洛替尼作为ES-SCLC患者维持治疗的安全性和有效性。
    BACKGROUND: Durvalumab is a check-point inhibitor against programmed death ligand-1 (PD-L1), and anlotinib is a new orally administered multitarget tyrosine kinase inhibitor (TKI). Both agents have been approved in China. Preclinical and clinical trials have suggested that antiangiogenic therapy has the potential to alleviate immunosuppression and showed synergetic effect when combined with ICIs. However, it is unclear that whether this combination is effective when initiated as maintenance treatment in ES-SCLC patients.
    METHODS: This is a multicenter, randomized, phase II study. A total of 64 eligible patients who do not experience disease progression after four cycles platinum-based chemotherapy combined with durvalumab will be randomized to durvalumab with anlotinib or durvalumab alone until disease progression, withdrawal of consent, or unacceptable toxicity. The primary endpoint is PFS (from randomization); secondary endpoint was OS and PFS (from diagnosis), objective response rate (ORR); disease control rate (DCR) and duration of response (DOR), safety and tolerability assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
    CONCLUSIONS: We conduct a phase II study to investigate the safety and efficacy of durvalumab combined with anlotinib as maintenance treatment in ES-SCLC patients.
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  • 文章类型: Journal Article
    尚未获得标准的维持治疗以延长一线化疗后软组织肉瘤(STS)的反应持续时间。在这项研究中,我们旨在评估STS化疗后安洛替尼作为维持治疗的疗效和安全性.
    在这个多中心,开放标签,单臂第二阶段试验,纳入了2019年4月至2022年1月接受以蒽环类药物为基础的一线化疗后部分缓解或疾病稳定的晚期STS患者.所有患者均接受安洛替尼作为维持治疗。主要终点是安洛替尼维持治疗的无进展生存期(PFS)。其他终点包括总生存期(OS),客观反应率(ORR),疾病控制率(DCR)和安全性。这项研究在ClinicalTrials.gov注册,NCT03890068。
    在数据截止日期(2022年8月8日),49名患者入选,包括17例脂肪肉瘤(35%)和15例平滑肌肉瘤(31%)。在中位随访17.1个月(IQR9.0-27.2)后,维持治疗开始时的中位PFS为9.1个月(95%CI5.7-12.5),未达到OS中位数,安洛替尼维持治疗的1年OS率为98.0%.最佳ORR和DCR分别为16%(8/49,95%CI7-30)和94%(46/49,95%CI83-99),分别。大多数治疗相关的不良事件为1-2级。在3-4级不良事件中,最常见的是高血压(10%)和手足综合征反应(6%).
    在晚期STS患者中,使用安洛替尼进行化疗后维持治疗具有良好的疗效和可耐受的毒性。
    正大天庆药业集团有限公司Ltd.,国家重点研究发展计划,和国家自然科学基金。
    UNASSIGNED: No standard maintenance treatment has been obtained to prolong the response duration of soft tissue sarcoma (STS) after first-line chemotherapy. In this study, we aimed to evaluate the efficacy and safety of anlotinib as a maintenance treatment after chemotherapy in STS.
    UNASSIGNED: In this multicentre, open-label, single-arm phase 2 trial, patients with advanced STS who achieved partial response or stable disease after first-line anthracycline-based chemotherapy were enrolled between April 2019 and January 2022. All patients received anlotinib as a maintenance treatment. The primary endpoint was progression-free survival (PFS) of anlotinib maintenance treatment. Other endpoints included overall survival (OS), objective response rate (ORR), disease control rate (DCR) and safety. This study is registered with ClinicalTrials.gov, NCT03890068.
    UNASSIGNED: At the data cut-off date (August 8, 2022), 49 patients were enrolled, including 17 with liposarcoma (35%) and 15 with leiomyosarcoma (31%). After a median follow-up of 17.1 months (IQR 9.0-27.2), the median PFS from the beginning of maintenance treatment was 9.1 months (95% CI 5.7-12.5), and the median OS was not reached, and the 1-year OS rate for anlotinib maintenance treatment was 98.0%. The best ORR and DCR were 16% (8/49, 95% CI 7-30) and 94% (46/49, 95% CI 83-99), respectively. Most of the treatment-related adverse events were grade 1-2. Of the grade 3-4 adverse events, the most common were hypertension (10%) and hand-foot syndrome reaction (6%).
    UNASSIGNED: Postchemotherapy maintenance treatment with anlotinib exhibits promising efficacy and tolerable toxicity in patients with advanced STS.
    UNASSIGNED: Chia Tai Tianqing Pharmaceutical Group Co., Ltd., the National Key Research and Development Program of China, and the National Natural Science Foundation of China.
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  • 文章类型: Journal Article
    抗精神病药(disis)的延续问题一直是一个长期存在的临床难题。虽然抗精神病药的常规使用与副作用和污名有关,短期证据表明,抗精神病药物停药后复发风险增加.因此,临床指南建议在首发精神病(FEP)缓解后维持治疗一到两年,但除此之外的指导仍不清楚。只有两项对照研究解决了抗精神病药物停药的长期后果。而Wunderink等人。得出结论,剂量减少与较高的恢复率有关,Hui等人。发现停药与更好的临床结局相关。数据来自Hui等人。这项研究进一步表明,治疗应在FEP缓解后至少维持前三年,以降低复发风险,以及随后糟糕的长期结果。值得注意的是,这两项研究不仅在结果衡量标准上有所不同,而且在他们的“抗精神病药物停药”策略中。考虑到停药对大多数患者来说是更有吸引力的选择,因此,它可能更具临床相关性。需要更多的长期随访停药研究,为FEP治疗指南的制定提供进一步的证据。
    The issue of antipsychotic (dis)continuation has been a long-standing clinical dilemma. While the routine usage of antipsychotic is associated with side effects and stigma, short-term evidence suggest that the risk of relapse is heightened following antipsychotics withdrawal. Clinical guidelines therefore propose a one to two years duration of maintenance treatment upon remission in first episode psychosis (FEP), but guidance beyond which remains unclear. Only two controlled studies have addressed the long-term consequences of antipsychotic discontinuation. While Wunderink et al. concluded that dose reduction is associated with a higher rate of recovery, Hui et al. found discontinuation to be associated with better clinical outcomes. Data from Hui et al.\'s study further suggests that treatment should be maintained for at least the first three years upon remission in FEP in order reduce the risk of relapse, as well as subsequent poor long-term outcome. It is noted that the two studies not only differ in outcome measures, but also in their strategies of \"antipsychotic discontinuation\". Considering that discontinuation is a more compelling option to most patients, it may therefore be more clinically relevant. More long-term follow-up discontinuation studies are needed to provide further evidence in the development of treatment guidelines for FEP.
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