bleomycin

博来霉素
  • 文章类型: Journal Article
    背景:硬化疗法在治疗指状黏液囊肿(DMC)的非手术选择中显示出优异的疗效。值得注意的是,先前的研究表明,博来霉素具有更有利的副作用,并且与常规硬化剂具有相似的疗效.
    目的:本研究旨在通过皮质类固醇ILI和手术切除的比较分析,评估博来霉素病灶内注射(ILI)治疗DMC的疗效和安全性。
    方法:我们回顾了电子病历和临床照片。进行电话访谈以进一步调查长期治疗效果,安全,总体治疗满意度。
    结果:10例患者接受了手术切除,13和15例患者接受博来霉素和皮质类固醇ILI,分别。与皮质类固醇ILI相比,手术切除和博来霉素ILI均显示出更好的治疗效果。手术切除和博来霉素ILI之间的治疗效果没有统计学上的显着差异。没有观察到明显的不良反应。在调查中,博来霉素ILI的满意度最高,其次是手术切除和皮质类固醇ILI。
    结论:这项研究表明,博来霉素ILI的治疗效果高于皮质类固醇ILI,略低于手术切除,没有任何副作用。因此,博来霉素ILI是治疗DMC的安全有效的治疗选择。
    BACKGROUND: Sclerotherapy has shown superior efficacy among the nonsurgical options for managing digital mucous cysts (DMC). Notably, previous research has indicated that bleomycin offers a more favorable side-effect profile and similar efficacy to conventional sclerosing agents.
    OBJECTIVE: This study aimed to assess the efficacy and safety of bleomycin intralesional injection (ILI) for treating DMC through a comparative analysis of corticosteroid ILI and surgical excision.
    METHODS: We retrospectively reviewed electronic medical records and clinical photographs. Telephone interviews were conducted to further investigate long-term treatment efficacy, safety, and overall treatment satisfaction.
    RESULTS: Ten patients underwent surgical excision, and 13 and 15 patients received bleomycin and corticosteroid ILI, respectively. Both surgical excision and bleomycin ILI demonstrated superior treatment efficacy compared to corticosteroid ILI. No statistically significant difference in the treatment effectiveness between surgical excision and bleomycin ILI was observed. No significant adverse effects were observed. In the survey, the level of satisfaction was the highest for bleomycin ILI, followed by surgical excision and corticosteroid ILI.
    CONCLUSIONS: This study revealed that bleomycin ILI exhibits a treatment efficacy higher than that of corticosteroid ILI and slightly lower than that of surgical excision, without any side effects. Therefore, bleomycin ILI is a safe and effective therapeutic option for the treatment of DMC.
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  • 文章类型: Journal Article
    特发性肺纤维化(IPF)是一种来源不明的进行性肺部疾病,治疗选择有限,预后不良。来自利用间充质干细胞(MSCs)的临床前研究的令人鼓舞的发现表明,它们可以作为管理慢性肺部疾病的有希望的治疗替代方案。比如IPF。这项研究的目的是比较骨髓来源的MSCs(BM-MSCs)与泼尼松龙的效率,标准的抗炎药,在博来霉素(BLM)诱导的肺纤维化大鼠中。创建了四组:对照组,BLM组,泼尼松龙治疗组,和BM-MSC处理组。诱导肺纤维化,气管内施用5mg/kg的BLM。BLM显著增加促炎细胞因子和氧化应激标志物的血清水平。光和透射电子显微镜研究也揭示了受干扰的肺结构。α-平滑肌肌动蛋白免疫表达上调,转化生长因子β-1和Bax得到证实。有趣的是,所有发现在使用泼尼松龙和BM-MSCs治疗时显著回归。然而,用BM-MSCs治疗的结果优于泼尼松龙。总之,BM-MSC可能是管理肺纤维化的有希望的方法。
    Idiopathic pulmonary fibrosis (IPF) is a progressive lung disease of unknown origin with limited treatment options and poor prognosis. The encouraging findings from preclinical investigations utilizing mesenchymal stem cells (MSCs) indicated that they could serve as a promising therapeutic alternative for managing chronic lung conditions, such as IPF. The objective of this study was to compare the efficiency of bone marrow-derived MSCs (BM-MSCs) versus prednisolone, the standard anti-inflammatory medication, in rats with bleomycin (BLM)-induced lung fibrosis. Four groups were created: a control group, a BLM group, a prednisolone-treated group, and a BM-MSCs-treated group. To induce lung fibrosis, 5 mg/kg of BLM was administered intratracheally. BLM significantly increased serum levels of pro-inflammatory cytokines and oxidative stress markers. The disturbed lung structure was also revealed by light and transmission electron microscopic studies. Upregulation in the immune expression of alpha-smooth muscle actin, transforming growth factor beta-1, and Bax was demonstrated. Interestingly, all findings significantly regressed on treatment with prednisolone and BM-MSCs. However, treatment with BM-MSCs showed better results than with prednisolone. In conclusion, BM-MSCs could be a promising approach for managing lung fibrosis.
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  • 文章类型: Journal Article
    晚期毒性可能会影响经典霍奇金淋巴瘤(cHL)患者的生存,在含博来霉素的化疗后具有肺毒性。在这项基于丹麦人群的研究中检查了肺部疾病的发病率。共有1474例成人cHL患者接受ABVD治疗(阿霉素,博来霉素,长春碱和达卡巴嗪)或BEACOPP(博来霉素,长春新碱,依托泊苷,阿霉素,环磷酰胺,包括2000年至2018年的丙卡巴嗪和泼尼松)以及来自背景人群的7370个年龄和性别匹配的比较者。患者的中位随访时间为8.6年。cHL患者发生肺部疾病的风险增加(HR2.91[95%CI2.30-3.68]),10年累积风险为7.4%,而比较者为2.9%。观察到间质性肺病(HR15.84[95%CI9.35-26.84])和慢性阻塞性肺病(HR1.99[95%CI1.43-2.76])的风险过高,患者的10年累积风险分别为4.1%和3.5%。没有观察到哮喘的额外风险(HR0.82[95%CI0.43-1.56])。间质性肺病的危险因素为年龄≥60岁,B症状和低白蛋白的存在。这些发现记录了cHL患者肺部疾病的重大负担,并强调了肺部症状诊断工作的重要性。
    Late toxicities can impact survivorship in patients with classical Hodgkin lymphoma (cHL) with pulmonary toxicity after bleomycin-containing chemotherapy being a concern. The incidence of pulmonary diseases was examined in this Danish population-based study. A total of 1474 adult patients with cHL treated with ABVD (doxorubicin, bleomycin, vinblastine and dacarbazine) or BEACOPP (bleomycin, vincristine, etoposide, doxorubicin, cyclophosphamide, procarbazine and prednisone) between 2000 and 2018 were included along with 7370 age- and sex-matched comparators from the background population. Median follow-up was 8.6 years for the patients. Patients with cHL had increased risk of incident pulmonary diseases (HR 2.91 [95% CI 2.30-3.68]), with a 10-year cumulative risk of 7.4% versus 2.9% for comparators. Excess risks were observed for interstitial lung diseases (HR 15.84 [95% CI 9.35-26.84]) and chronic obstructive pulmonary disease (HR 1.99 [95% CI 1.43-2.76]), with a 10-year cumulative risk of 4.1% and 3.5% respectively for patients. No excess risk was observed for asthma (HR 0.82 [95% CI 0.43-1.56]). Risk factors for interstitial lung diseases were age ≥60 years, the presence of B-symptoms and low albumin. These findings document a significant burden of pulmonary diseases among patients with cHL and emphasize the importance of diagnostic work-up of pulmonary symptoms.
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  • 文章类型: Journal Article
    关于在常规临床实践中治疗初治经典霍奇金淋巴瘤(cHL)的前两个化疗周期(iPET2)后使用临时正电子发射断层扫描(iPET)的数据很少。以及iPET阳性患者强化策略的现实生活采用。我们对cHL进行了一项多中心回顾性研究,以调查iPET在现实生活中的使用情况。其预后作用和患者预后早期转向强化。招募了六百四十一名患者(62%的晚期)。iPET2阳性89例(14%),包括8.7%和17%的早期和晚期患者,分别(p=0.003)。在iPET2阳性病例中,有19例立即修改了治疗方法;在14例中,在额外的iPET4阳性后修改了治疗方法。共有56例iPET2阳性患者从未接受过强化治疗。最常用的强化治疗是自体干细胞移植,然后是BEACOPP。经过72个月的中位随访,与iPET2阴性病例相比,iPET2阳性患者的5年无进展生存期(PFS)为82%,PFS较差:31%对85%.针对iPET2阳性的晚期患者,在任何时间点转向强化治疗的患者的5年PFS为59%,而从未接受强化治疗的患者为61%。我们的研究证实了在现实世界中,幼稚的cHL患者的可固化性更高,以及iPET2在这种情况下的预后作用。对反应适应性策略的依从性较差,但并未转化为患者预后的差异。
    Few data are known regarding the use of interim positron emission tomography (iPET) after the first two cycles (iPET2) of chemotherapy in treatment-naïve classical Hodgkin lymphoma (cHL) in routine clinical practice, and about the real-life adoption of intensification strategies for iPET positive patients. We conducted a multicenter retrospective study on cHL to investigate the use of iPET in the real-life setting, its prognostic role and outcomes of patients early shifted to intensification. Six hundreds and forty-one patients were enrolled (62% had advanced stage). iPET2 was positive in 89 patients (14%) including 8.7% and 17% early and advanced stage patients, respectively (p = 0.003). Among iPET 2 positive cases treatment was immediately modified in 19 cases; in 14 cases treatment was modified after an additional positive iPET4. Overall 56 iPET2 positive patients never received intensified therapies. Most frequently used intensified therapy was autologous stem cell transplantation followed by BEACOPP. After a median follow-up of 72 months, the 5-year progression-free survival (PFS) was 82% with iPET2 positive patients showing a worse PFS compared with iPET2 negative cases: 31% versus 85%. Focusing on advanced stage patients with a positive iPET2, the 5-year PFS was 59% for patients shifted to intensified therapy at any time point versus 61% for patients who never received intensified therapy. Our study confirmed the higher curability of naïve cHL patients in a real-world setting, and the prognostic role of iPET2 in this setting. A poor adherence to response-adapted strategy which however did not translate into a difference in patient outcomes.
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  • 文章类型: Journal Article
    目的:霍奇金淋巴瘤目前使用由阿霉素组成的化疗方案进行治疗,博来霉素,长春碱,还有达卡巴嗪.由于巴西在2017年面临博莱霉素短缺,而且这种药物的高毒性,这项回顾性研究评估了不使用博来霉素对霍奇金淋巴瘤患者治疗反应和总生存期的影响.
    方法:回顾了2007年至2021年间治疗的126例HL患者的病历,并收集了他们的数据,然后根据博来霉素的使用分为ABVD和AVD组。有关患者特征的数据,癌症类型,并通过比例测试分析治疗方案,卡普兰-迈耶曲线。单变量Cox回归,和χ2检验。
    结果:在这项研究中,与没有博来霉素治疗的患者相比,在总体生存率和复发率之间没有发现明显的差异。此外,在完整的ABVD方案的每个后续化疗周期中,死亡风险增加,证明有毒性的风险。在分析的变量中,高血压和B症状的存在也与死亡风险增加有关,而放疗的使用显著提高了生存率。
    结论:本研究结果提示博来霉素对霍奇金淋巴瘤治疗结果无影响。此外,在每个治疗周期中,其毒性导致死亡风险增加,这引发了人们对其作为霍奇金淋巴瘤治疗金标准的重要组成部分的担忧.因此,需要进一步的研究和考虑重新评估博莱霉素在霍奇金淋巴瘤治疗方案中的应用.
    Hodgkin\'s lymphoma is currently treated with a chemotherapy protocol consisting of doxorubicin, bleomycin, vinblastine, and dacarbazine. Due to Brazil facing a bleomycin shortage in 2017, and this drug\'s high toxicity, this retrospective study evaluates the effect that the absence of bleomycin had on treatment response and overall survival of Hodgkin\'s lymphoma patients.
    The medical records of 126 HL patients treated between 2007 and 2021 were reviewed and their data collected, followed by grouping into ABVD and AVD groups according to bleomycin use. Data concerning the patient\'s characteristics, cancer type, and treatment plan were analyzed with proportion tests, Kaplan-Meier curves. univariate Cox regression, and χ2 tests.
    No discernible differences were found in this study between the overall survival and recurrence rate of patients treated with bleomycin compared to those without. Additionally, there was an increased risk of death in each subsequent cycle of chemotherapy of the complete ABVD protocol, demonstrating a risk of toxicity. Among the variables analyzed, hypertension and the presence of B symptoms were also associated with an increased risk of death, while the use of radiotherapy significantly improved survival.
    The results of this study suggest that bleomycin did not impact the outcome of Hodgkin\'s lymphoma treatment. Moreover, the increased risk of death associated with its toxicity during each cycle of treatment raises concerns about its role as an essential component of the gold standard for Hodgkin\'s lymphoma treatment. Therefore, further research and consideration are needed to reassess the use of bleomycin in Hodgkin\'s lymphoma treatment protocols.
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  • 文章类型: Clinical Trial Protocol
    背景:博来霉素是恶性卵巢生殖细胞肿瘤(MOGCT)的重要且不可替代的化疗方案,但其毒性尤其是肺纤维化限制了治疗效果的剂量,并降低了患者的生活质量(QoL)。Nintedanib已被批准用于治疗进行性纤维化间质性肺疾病,并已显示出潜在的抗肿瘤作用。本研究旨在评估尼达尼布预防MOGCT患者博莱霉素诱导的肺纤维化的有效性和安全性。
    方法:这是一个多中心,随机化,双盲,安慰剂对照临床试验。我们将招募总共128名患者,他们将以1:1的比例随机分配到尼达尼布组和安慰剂组。标准博来霉素,每位MOGCT患者将给予依托泊苷和顺铂化疗。此外,分配给尼达尼布和对照组的患者将每天两次口服尼达尼布150毫克,每天两次,安慰剂一片,每天两次,直到最后一个周期的博来霉素治疗后1个月,分别。主要结果是用力肺活量(FVC)下降。次要结果是其他肺功能指标的下降(1s的用力呼气量;FVCpred%,一氧化碳扩散能力)和患者的生活质量,肿瘤和生育结果。我们将使用电子案例报告表记录所有参与者\'数据和SPSSV.27.0/STATAV.16.0/GraphpadPrismV.8.0进行统计分析。
    背景:北京协和医院伦理委员会批准了这项研究(I-23PJ400)。将获得所有参与者/监护人的书面知情同意书。研究结果将提交给同行评审的医学期刊发表,并在学术会议上发表。
    背景:ChiCTR2300070492。
    Bleomycin is a crucial and irreplaceable chemotherapy regimen for malignant ovarian germ cell tumours (MOGCTs) but its toxicities especially pulmonary fibrosis have limited the dose of treatment efficacy and decreased the patients\' quality of life (QoL). Nintedanib has been approved for treating progressive fibrosing interstitial lung diseases and has shown potential anti-tumour effects. This study aims to evaluate the effectiveness and safety of nintedanib in the prevention of pulmonary fibrosis induced by bleomycin in MOGCTs patients.
    This is a multicentre, randomised, double-blinded, placebo-controlled clinical trial. We will enrol a total of 128 patients who will be randomly assigned to the nintedanib group and placebo group in a 1:1 ratio. Standard bleomycin, etoposide and cisplatin chemotherapy will be given to each MOGCT patient. In addition, patients assigned to nintedanib and the control group will be given oral nintedanib 150 mg two times per day and placebo one tablet two times per day until 1 month after the last cycle of bleomycin therapy, respectively. The primary outcome is the decline of forced vital capacity (FVC). The secondary outcomes are the decline of other pulmonary function indices (forced expiratory volume in 1 s; FVC pred%, carbon monoxide diffusion capacity) and the patients\' QoL, oncological and fertility outcomes. We will use electronic case report forms to record all the participants\' data and SPSS V.27.0/STATA V.16.0/Graphpad Prism V.8.0 to conduct statistical analysis.
    The Ethics Committee of Peking Union Medical College Hospital has approved the study (I-23PJ400). Written informed consent will be obtained from all participants/guardians. Study results will be submitted to peer-reviewed medical journals for publication and presented at academic conferences.
    ChiCTR2300070492.
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  • 文章类型: Journal Article
    关于血管老化的动物研究存在一些局限性。最重要的原因之一是缺乏快速有效的血管组织衰老模型。在这项研究中,将离体主动脉培养和Matrigel皮下植入相结合,以开发一种研究血管细胞衰老的新模型。使用8周龄的C57BL/6J小鼠获得主动脉。博来霉素用于体外诱导主动脉衰老。然后,用Matrigel将主动脉移植到受体小鼠。使用蛋白质印迹评估衰老,定量聚合酶链反应,和衰老相关的β-半乳糖苷酶活性。使用Luminex液体悬浮芯片检测炎性细胞因子。通过转录组测序分析RNA水平。结果表明,博来霉素组的血管比对照组的血管表现出明显的衰老,可以通过剥离血管外膜来增强衰老。细胞因子的水平,如白细胞介素(IL-2,IL-1β,和IL-6在离体模型中显著增加。此外,转录组测序显示,与自然老化的主动脉相比,离体模型血管中有56个显着差异表达的基因(DEG)。总之,本研究为血管细胞衰老引入了一种经济有效且节省时间的血管衰老模型。
    Animal studies on vascular aging pose a few limitations. One of the most important reasons for this is the absence of a fast and efficient model of vascular tissue aging. In this study, ex vivo aortic culture and Matrigel subcutaneous implantation are combined to develop a new model for studying vascular cellular senescence. Eight-week-old C57BL/6J mice are used to obtain aortas. Bleomycin is used to induce aortas senescence in vitro. Then, aortas are transplanted to the acceptor mice with Matrigel. Senescence is evaluated using western blotting, quantitative polymerase chain reaction, and senescence-associated beta-galactosidase activity. Inflammatory cytokines are detected using Luminex Liquid Suspension Chip. RNA levels are analyzed by transcriptome sequencing. The results revealed that vessels in the bleomycin group exhibited significant senescence than those in the control group that can be enhanced by stripping vessel adventitia. The levels of cytokines such as interleukin (IL-2, IL-1β, and IL-6 increased significantly in the ex vivo model. Furthermore, transcriptome sequencing revealed 56 significantly differentially expressed genes (DEGs) in ex vivo model vessels compared with those in naturally aging aortas. In conclusion, this study introduces a cost-effective and time-saving vessel senescence model for vascular cellular senescence.
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  • 文章类型: Journal Article
    系统性硬化症(SSc)是一种以血管病变为特征的自身免疫性疾病,免疫失调,和多器官纤维化。间质性肺病(ILD)是SSc的并发症,也是SSc死亡的主要原因。小鼠皮内施用次氯酸(HOCl)(HOCl-SSc)据称显示出SSc的几种典型特征。我们通过每天皮内注射HOCl对BALB/c小鼠进行6周的研究,据报道,暴露诱导肺纤维化。在第42天,HOCl组的皮褶厚度和真皮厚度分别比对照组大两倍和三倍。HOCl治疗不会导致肺纤维化的组织学特征,也不会导致肺顺应性的显着变化。HOCl小鼠肺的自动化图像分析用picrosirius红染色未显示胶原蛋白沉积增加。HOCl注射不会增加促纤维化基因的肺mRNA表达,也不会诱导血清高级氧化蛋白产物和抗拓扑异构酶1抗体的产生。在HOCl处理的动物中,支气管肺泡灌洗液(BALF)和全肺消化物中的免疫细胞没有增加。由于肺纤维化被认为是由氧化应激引发的,我们向Nrf2-/-小鼠注射HOCl,缺乏许多抗氧化蛋白的小鼠。肺顺应性,组织学,Nrf2-/-小鼠和野生型对照之间的BALF白细胞数量相当。我们得出的结论是HOCl-SSc模型没有表现出SSc-肺病。
    Systemic sclerosis (SSc) is an autoimmune disease characterized by vasculopathy, immune dysregulation, and multi-organ fibrosis. Interstitial lung disease (ILD) is a complication of SSc and a leading cause of SSc-death. The administration of hypochlorous acid (HOCl) intradermally in the mouse (HOCl-SSc) purportedly shows several features typical of SSc. We studied the model by injecting BALB/c mice daily intradermally with HOCl for 6-weeks, an exposure reported to induce lung fibrosis. On day 42, the skinfold thickness and the dermal thickness were two and three times larger respectively in the HOCl group compared to controls. HOCl treatment did not result in histological features of pulmonary fibrosis nor significant changes in lung compliance. Automated image analysis of HOCl mice lungs stained with picrosirius red did not show increased collagen deposition. HOCl injections did not increase pulmonary mRNA expression of pro-fibrotic genes nor induced the production of serum advanced oxidation protein products and anti-topoisomerase 1 antibodies. Immune cells in bronchoalveolar lavage fluid (BALF) and whole lung digests were not increased in HOCl-treated animals. Since lung fibrosis is proposed to be triggered by oxidative stress, we injected HOCl to Nrf2-/- mice, a mouse deficient in many antioxidant proteins. Lung compliance, histology, and BALF leukocyte numbers were comparable between Nrf2-/- mice and wild-type controls. We conclude that the HOCl-SSc model does not manifest SSc-lung disease.
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  • 文章类型: Journal Article
    临床试验通常包括在不同时间成熟的多个终点。初次报告,通常基于主要终点,当尚未获得关键计划的共同主要或次要分析时,可能会发布。临床试验更新提供了传播其他研究结果的机会,发表在JCO或其他地方,已经报告了主要终点。对局部霍奇金淋巴瘤H10试验的早期正电子发射断层扫描(ePET)反应适应治疗的主要分析表明,在ePET阴性患者中,当忽略淋巴结放疗(INRT)时,复发风险增加,而在ePET阳性患者中,从阿霉素转换,博来霉素,长春碱,和达卡巴嗪(ABVD)到博来霉素,依托泊苷,阿霉素,环磷酰胺,长春新碱,丙卡巴嗪,和泼尼松(BEACOPPesc)显着改善了5年无进展生存期(PFS)。这里,我们在为期10年的随访中报告了预先计划的分析的最终结果.在有利的(F)ePET-阴性基团中,10年PFS率为98.8%对85.4%(风险比[HR],13.2;95%CI,3.1至55.8;非劣效性的P值=.9735;差异检验P<.0001)有利于ABVDINRT;在不利(U)ePET阴性组中,10年PFS率分别为91.4%和86.5%(HR,1.52;95%CI,0.84至2.75;非劣效性P值=.8577;差异检验P=.1628)。在ePET阳性患者中,标准ABVD和强化BEACOPPesc之间的PFS差异不再具有统计学意义(HR,0.67;95%CI,0.37至1.20;P=.1777)。总之,目前的长期分析证实,在ePET阴性的患者中,INRT的遗漏与较低的10年PFS相关。相反,在ePET阳性患者中,尽管BEACOPPesc强化是安全的,但标准臂和实验臂之间没有显着差异,晚期不良事件没有增加,即,第二恶性肿瘤。
    Clinical trials frequently include multiple end points that mature at different times. The initial report, typically based on the primary end point, may be published when key planned co-primary or secondary analyses are not yet available. Clinical Trial Updates provide an opportunity to disseminate additional results from studies, published in JCO or elsewhere, for which the primary end point has already been reported.The primary analysis of the Early positron emission tomography (ePET) Response-Adapted Treatment in localized Hodgkin Lymphoma H10 Trial demonstrated that in ePET-negative patients, the risk of relapse increased when involved-node radiotherapy (INRT) was omitted and that in ePET-positive patients, switching from doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD) to bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine, and prednisone (BEACOPPesc) significantly improved 5-year progression-free survival (PFS). Here, we report the final results of a preplanned analysis at a 10-year follow-up. In the favorable (F) ePET-negative group, the 10-year PFS rates were 98.8% versus 85.4% (hazard ratio [HR], 13.2; 95% CI, 3.1 to 55.8; P value for noninferiority = .9735; difference test P < .0001) in favor of ABVD + INRT; in the unfavorable (U) ePET-negative group, the 10-year PFS rates were 91.4% and 86.5% (HR, 1.52; 95% CI, 0.84 to 2.75; P value for noninferiority = .8577; difference test P = .1628). In ePET-positive patients, the difference in terms of PFS between standard ABVD and intensified BEACOPPesc was no longer statistically significant (HR, 0.67; 95% CI, 0.37 to 1.20; P = .1777). In conclusion, the present long-term analysis confirms that in ePET-negative patients, the omission of INRT is associated with lower 10-year PFS. Instead, in ePET-positive patients, no significant difference between standard and experimental arms emerged although intensification with BEACOPPesc was safe, with no increase in late adverse events, namely, second malignancies.
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  • 文章类型: Journal Article
    据报道,抗PD-1抗体在复发性和难治性(R/R)经典霍奇金淋巴瘤(cHL)中显示出惊人的效果。然而,评估抗PD-1抗体单一疗法在早期cHL中的作用的实际数据仍然有限.在这个回顾性分析中,我们报道了tisleizumab单药在早期cHL一线治疗中的有效性和安全性.包括23例先前未经治疗的IA-IIBcHL连续患者(10例男性和13例女性)。在2剂tislelizumab单药治疗后的中期评估,23例患者中有11例(47.8%)达到完全缓解(CR)。在tislelizumab单一疗法(EOTM)结束时,23例患者中有22例(95.7%)观察到客观反应,16例患者CR(69.6%)。在6例PR-EOTM患者中,2例患者接受了4个周期的ABVD化疗,1例患者接受了4个周期的tislelizumab联合AVD化疗.一名在4剂tislelizumab后发展为进行性疾病(PD)的患者随后接受了4个周期的ABVD化疗。除4例CR-EOTM患者外,19例患者接受了巩固性放疗。所有患者在所有治疗结束时获得CR。中位随访时间为21.3个月(范围,6.9-32.7个月),估计2年PFS率和2年OS率分别为95.65%和100%,分别。除3级淋巴细胞计数下降外,未观察到其他3/4级TRAE。此外,没有严重的AE报告。我们的初步数据观察到tislelizumab单药治疗在先前未治疗的早期cHL中是安全且高度有效的。
    The anti-PD-1 antibodies have been reported to show a striking effect in relapsed and refractory(R/R) classical Hodgkin lymphoma (cHL), however, there is still limited real-world data assessing the role of anti-PD-1 antibody monotherapy in early-stage cHL. In this retrospective analysis, we reported the effectiveness and safety of tislelizumab monotherapy in the first-line therapy of early-stage cHL. Twenty-three consecutive patients (10 males and 13 females) with previously untreated stage I A-II B cHL were included. At interim evaluation after 2 doses of tislelizumab monotherapy, 11 of 23 patients (47.8%) achieved complete response (CR). At the end of tislelizumab monotherapy (EOTM), objective response was observed in 22 of 23 patients (95.7%), with CR in 16 patients (69.6%). Among six patients with PR-EOTM, two patients underwent 4 cycles of ABVD chemotherapy and one patient underwent 4 cycles of tislelizumab plus AVD. One patient who developed progressive disease (PD) after 4 doses of tislelizumab subsequently underwent 4 cycles of ABVD chemotherapy. Except for four patients with CR-EOTM, consolidative radiotherapy was given to 19 patients. All patients obtained CR at the end of all treatments. With a median follow-up time of 21.3 months (range, 6.9-32.7 months), the estimated 2-year PFS rate and 2-year OS rate were 95.65% and 100%, respectively. Except for grade 3 lymphocyte count decreased, no other grade 3/4 TRAE was observed. In addition, no serious AE was reported. Our preliminary data observed that tislelizumab monotherapy was safe and highly effective in previously untreated early-stage cHL.
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