柳叶刀杂志恶性肿瘤手册:奥拉帕尼片状对卵巢疾病保持医治也合理

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柳叶刀杂志恶性肿瘤手册:奥拉帕尼片状对卵巢疾病保持医治也合理 。
奥拉帕尼(利普卓)摘 要:奥拉帕尼实际效果太棒了。柳叶刀杂志恶性肿瘤手册:奥拉帕尼片状对卵巢疾病保持医治也合理奥拉帕尼(Olaparib)是一种革新的、潜在性创新内服多聚ADP核糖核苷酸聚合酶(PARP)缓聚剂,在医学前实体模型中已被证实,可以运用DNA修复方式的缺点,优先选择杀掉肿瘤细胞。这类功效方式,授予奥拉帕尼Olaparib医治具备DNA修复缺点的普遍恶性肿瘤类型的发展潜力。PARP与广泛性的恶性肿瘤类型有关,尤其是乳腺癌和卵巢疾病。《壹篇》按《柳叶刀肿瘤分册》2022年7月25日线上先给http://thelancet.com/journals/lanonc/article/PIIS1470-2045(17)30469-2/fulltext

奥拉帕尼片对BRCA1/2基因突变、铂类比较敏感的重反复性卵巢疾病病患者开展保持医治(SOLO2/ENGOT-Ov21实验):一项双盲实验、随机化、安慰剂对照的3期临床试验

环境奥拉帕尼是一种多聚(ADP-核糖核苷酸)聚合酶(PARP)缓聚剂,在以往的一项2期分析中,对铂类比较敏感、重反复性、高級其他浆体性卵巢疾病病患者避而远之地给与奥拉帕尼胶襄,显出治疗效果。,大家致力于选用奥拉帕尼片状,在BRCA1或BRCA2(BRCA1/2)基因突变的病患者中确认这种結果。方式此项全球性、多核心、双盲实验、随机化、安慰剂对照的3期临床试验,对BRCA1/2基因突变、铂类比较敏感的重反复性卵巢疾病病患者,且这种病患者以往早已接纳过最少两条线之上的有机化学治疗法,点评了奥拉帕尼片保持医治的功效。满足条件的病患者为≥18岁、入组时ECOG身体素质情况得分0-一分、经病理学确认、重反复性、高级别浆体性卵巢疾病或高级别子宫壁样癌,包含继发性腹膜后肿瘤或继发性宫颈腺癌。选用互动式视频语音及互联网回复系统软件,将病患者按2:1的占比随机分组,奥拉帕尼组(2片150mg共300mg,每日2次,)或相符合的安慰剂效应组。对随机化排序依据以往铂类有机化学疗法治疗实际效果(放任不管较为一部分减轻)、无铂医治时间间隔(6-12个月较为≥12个月)开展分层次(分亚组),病患者、医治干涉工作人员、材料收藏者和数据统计分析工作人员对医治排序状况不了解。关键终端为科研工作人员点评的无进度存活時间,大家从此项仍在进行中的分析中汇报了基本研究結果。对意向医治病患者开展治疗效果剖析,安全性特点剖析列入了最少进行过一个科学研究医治使用量的病患者。此项实验在ClinicalTrials.gov注册网站,许可证号NCT01874353,实验仍在开展,但不会再征募病患者。結果2013年9月3日至2014年11月21日,大家入组了295名满足条件的生病柳叶刀杂志恶性肿瘤手册:奥拉帕尼片状对卵巢疾病保持医治也合理者,这种病患者随机分组到奥拉帕尼组(n=196)或信息组(n=99)。奥拉帕尼组里有1名病患者因随机化排序不正确,未接纳探究性医治。科学研究工作人员点评的无进度存活時间中位值,奥拉帕尼组(19.一个月[95%CI,16.3–25.7])显著善于安慰剂效应组(5.5个月[5.2–5.8],风险比[HR],0.30[95%CI,0.22–0.41],p<0.0001)。最普遍的≥3级欠佳(过虑词)为缺铁性贫血(奥拉帕尼组195名病患者中有38名[19%]较为安慰剂效应组99名病患者中有2名[2%])、疲倦或孱弱(8名[4%较为2名[2%])、单核细胞减小症(10名[5%]较为4名[4%])。奥拉帕尼组是35名病患者(18%)经历了比较严重欠佳(过虑词),安慰剂效应组是8名(8%)。奥拉帕尼组最多见者为缺铁性贫血(7名[4%])、腹疼(3名[2%])和肠梗堵(3名[2%]),安慰剂效应组最多见者为严重便秘(2名[2%])和肠梗堵(2名[2%])。奥拉帕尼组里1名病患者有医治相关联性欠佳(过虑词)(亚急性髓性败血症),結果过世。表述在BRCA1/2基因突变、铂类比较敏感、重反复性卵巢疾病病患者中,奥拉帕尼片保持医治促使无进度存活時间显著增加,且对病患者生活品质沒有造成危害性危害。除缺铁性贫血之外,奥拉帕尼的毒副作用低且可控性。《壹篇》南南和晨晨

Olaparib tablets as maintenance therapy in patients with platinum-sensitive, relapsed ovarian cancer and a BRCA1/2 mutation (SOLO2/ENGOT-Ov21): a double-blind, randomised, placebo-controlled, phase 3 trial

BackgroundOlaparib, a poly(ADP-ribose) polymerase (PARP) inhibitor, has previously shown efficacy in a phase 2 study when given in capsule formulation to all-comer patients with platinum-sensitive, relapsed high-grade serous ovarian cancer. We aimed to confirm these findings in patients with a BRCA1 or BRCA2 (BRCA1/2) mutation using a tablet formulation of olaparib.MethodsThis international, multicentre, double-blind, randomised, placebo-controlled, phase 3 trial evaluated olaparib tablet maintenance treatment in platinum-sensitive, relapsed ovarian cancer patients with a BRCA1/2 mutation who had received at least two lines of previous chemotherapy. Eligible patients were aged 18 years or older with an Eastern Cooperative Oncology Group performance status at baseline of 0–1 and histologically confirmed, relapsed, high-grade serous ovarian cancer or high-grade endometrioid cancer, including primary peritoneal or fallopian tube cancer. Patients were randomly assigned 2:1 to olaparib (300 mg in two 150 mg tablets, twice daily) or matching placebo tablets using an interactive voice and web response system. Randomisation was stratified by response to previous platinum chemotherapy (complete vs partial) and length of platinum-free interval (6–12 months vs ≥12 months) and treatment assignment was masked for patients, those giving the interventions, data collectors, and data analysers. The primary endpoint was investigator-assessed progression-free survival and we report the primary analysis from this ongoing study. The efficacy analyses were done on the intention-to-treat population; safety analyses included patients who received at least one dose of study treatment. This trial is registered with ClinicalTrials.gov, number NCT01874353, and is ongoing and no longer recruiting patients.FindingsBetween Sept 3, 2013, and Nov 21, 2014, we enrolled 295 eligible patients who were randomly assigned to receive olaparib (n=196) or placebo (n=99). One patient in the olaparib group was randomised in error and did not receive study treatment. Investigator-assessed median progression-free survival was significantly longer with olaparib (19·1 months [95% CI 16·3–25·7]) than with placebo (5·5 months [5·2–5·8]; hazard ratio [HR] 0·30 [95% CI 0·22–0·41], p<0·0001). The most common adverse events of grade 3 or worse severity were anaemia (38 [19%] of 195 patients in the olaparib group vs two [2%] of 99 patients in the placebo group), fatigue or asthenia (eight [4%] vs two [2%]), and neutropenia (ten [5%] vs four [4%]). Serious adverse events were experienced by 35 (18%) patients in the olaparib group and eight (8%) patients in the placebo group. The most common in the olap柳叶刀杂志恶性肿瘤手册:奥拉帕尼片状对卵巢疾病保持医治也合理arib group were anaemia (seven [4%] patients), abdominal pain (three [2%] patients), and intestinal obstruction (three [2%] patients). The most common in the placebo group were constipation (two [2%] patients) and intestinal obstruction (two [2%] patients). One (1%) patient in the olaparib group had a treatment-related adverse event (acute myeloid leukaemia) with an outcome of death.InterpretationOlaparib tablet maintenance treatment provided a significant progression-free survival improvement with no detrimental effect on quality of life in patients with platinum-sensitive, relapsed ovarian cancer and a BRCA1/2 mutation. Apart from anaemia, toxicities with olaparib were low grade and manageable.FundingAstraZeneca.《壹篇》(与桓兴医讯同歩)系关键朝向医护人员的服务性【微信号码:yaodaoyaofang】,不因盈利为目地,不开展一切有偿服务资询和服务项目,不销售一切商品,与ASCO、CSCO等全部技术专业学好和组织并没有任何的关联和联络,都不意味着一切官方网学好发音。文章照片均来源于互联网,不做商业行为,若有著作权异议请与《壹篇》联络。不断关注点赞——【手机微信:india2080】、称赞和分享——【手机微信:india2080】是一种心态和适用。
孟加拉国珠穆朗玛峰Everest,耀品国际性制药业产奥拉帕尼 利普卓。印度的全世界海淘药店:olaparib价钱。

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