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Final Results for Adjuvant Dabrafenib plus Trametinib in Stage III Melanoma. 达拉非尼加曲美替尼辅助治疗 III 期黑色素瘤的最终结果。
IF 96.2 1区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2024-11-07 Epub Date: 2024-06-19 DOI: 10.1056/NEJMoa2404139
Georgina V Long, Axel Hauschild, Mario Santinami, John M Kirkwood, Victoria Atkinson, Mario Mandala, Barbara Merelli, Vanna Chiarion Sileni, Marta Nyakas, Andrew Haydon, Caroline Dutriaux, Caroline Robert, Laurent Mortier, Jacob Schachter, Dirk Schadendorf, Thierry Lesimple, Ruth Plummer, James Larkin, Monique Tan, Sachin Bajirao Adnaik, Paul Burgess, Tarveen Jandoo, Reinhard Dummer

Background: The 5-year results of this trial showed that adjuvant therapy with dabrafenib plus trametinib resulted in longer relapse-free survival and distant metastasis-free survival than placebo among patients with BRAF V600-mutated stage III melanoma. Longer-term data were needed, including data regarding overall survival.

Methods: We randomly assigned 870 patients with resected stage III melanoma with BRAF V600 mutations to receive 12 months of dabrafenib (150 mg twice daily) plus trametinib (2 mg once daily) or two matched placebos. Here, we report the final results of this trial, including results for overall survival, melanoma-specific survival, relapse-free survival, and distant metastasis-free survival.

Results: The median duration of follow-up was 8.33 years for dabrafenib plus trametinib and 6.87 years for placebo. Kaplan-Meier estimates for overall survival favored dabrafenib plus trametinib over placebo, although the benefit was not significant (hazard ratio for death, 0.80; 95% confidence interval [CI], 0.62 to 1.01; P = 0.06 by stratified log-rank test). A consistent survival benefit was seen across several prespecified subgroups, including the 792 patients with melanoma with a BRAF V600E mutation (hazard ratio for death, 0.75; 95% CI, 0.58 to 0.96). Relapse-free survival favored dabrafenib plus trametinib over placebo (hazard ratio for relapse or death, 0.52; 95% CI, 0.43 to 0.63), as did distant metastasis-free survival (hazard ratio for distant metastasis or death, 0.56; 95% CI, 0.44 to 0.71). No new safety signals were reported, a finding consistent with previous trial reports.

Conclusions: After nearly 10 years of follow-up, adjuvant therapy with dabrafenib plus trametinib was associated with better relapse-free survival and distant metastasis-free survival than placebo among patients with resected stage III melanoma. The analysis of overall survival showed that the risk of death was 20% lower with combination therapy than with placebo, but the benefit was not significant. Among patients with melanoma with a BRAF V600E mutation, the results suggest that the risk of death was 25% lower with combination therapy. (Funded by GlaxoSmithKline and Novartis; COMBI-AD ClinicalTrials.gov number, NCT01682083; EudraCT number, 2012-001266-15.).

研究背景这项试验的5年结果显示,在BRAF V600突变的III期黑色素瘤患者中,达拉非尼加曲美替尼的辅助治疗比安慰剂能带来更长的无复发生存期和无远处转移生存期。我们需要更长期的数据,包括总生存期的数据:我们随机分配了870名切除的BRAF V600突变III期黑色素瘤患者,让他们接受为期12个月的达拉菲尼(150毫克,每天两次)加曲美替尼(2毫克,每天一次)或两种匹配的安慰剂治疗。在此,我们报告了这项试验的最终结果,包括总生存期、黑色素瘤特异性生存期、无复发生存期和无远处转移生存期的结果:达拉非尼加曲美替尼的中位随访时间为 8.33 年,安慰剂为 6.87 年。达拉非尼加曲美替尼的总生存期Kaplan-Meier估计值优于安慰剂,但获益并不显著(死亡危险比为0.80;95%置信区间[CI]为0.62至1.01;通过分层对数秩检验,P=0.06)。包括792名BRAF V600E基因突变的黑色素瘤患者在内的多个预设亚组的生存期都一致获益(死亡危险比为0.75;95% CI为0.58至0.96)。达拉非尼加曲美替尼的无复发生存期优于安慰剂(复发或死亡的危险比为0.52;95% CI为0.43至0.63),无远处转移生存期也是如此(远处转移或死亡的危险比为0.56;95% CI为0.44至0.71)。没有报告新的安全信号,这一结果与之前的试验报告一致:经过近10年的随访,在切除的III期黑色素瘤患者中,达拉非尼加曲美替尼辅助治疗的无复发生存期和无远处转移生存期均优于安慰剂。对总生存期的分析表明,联合疗法的死亡风险比安慰剂低20%,但获益并不显著。在BRAF V600E基因突变的黑色素瘤患者中,结果表明联合疗法的死亡风险降低了25%。(由葛兰素史克公司和诺华公司资助;COMBI-AD ClinicalTrials.gov 编号:NCT01682083;EudraCT 编号:2012-001266-15)。
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引用次数: 0
Frailty in Older Adults. 老年人的虚弱。
IF 96.2 1区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2024-11-07 DOI: 10.1056/NEJMc2411327
Ziwei Zheng, Shaoling Yang
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引用次数: 0
Randomized Trial of Very Early Medication Abortion. 极早期药物流产随机试验。
IF 96.2 1区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2024-11-07 DOI: 10.1056/NEJMoa2401646
Karin Brandell, Tagrid Jar-Allah, John Reynolds-Wright, Helena Kopp Kallner, Helena Hognert, Frida Gyllenberg, Janina Kaislasuo, Anand Tamang, Heera Tuladhar, Clare Boerma, Karen Schimanski, Gillian Gibson, Mette Løkeland, Pia Teleman, Marie Bixo, Mette Mandrup Kjaer, Ervin Kallfa, Johan Bring, Oskari Heikinheimo, Sharon Cameron, Kristina Gemzell-Danielsson

Background: Medication abortion, with a combination of mifepristone and misoprostol, is highly effective and safe. However, there is insufficient evidence on efficacy and safety at very early gestations before a pregnancy can be visualized with ultrasonography.

Methods: We conducted a multicenter, noninferiority, randomized, controlled trial involving women requesting medication abortion at up to 42 days of gestation with an unconfirmed intrauterine pregnancy on ultrasound examination (visualized as an empty cavity or a sac-like structure without a yolk sac or embryonic pole). Participants were randomly assigned to either immediate start of abortion (early-start group) or standard-care treatment delayed until intrauterine pregnancy was confirmed (standard group). The primary outcome was complete abortion. The noninferiority margin was set at 3.0 percentage points for the absolute between-group difference.

Results: In total, 1504 women were included at 26 sites in nine countries and were randomly assigned to the early-start group (754 participants) or the standard group (750 participants). In an intention-to-treat analysis, a complete abortion occurred in 676 of 710 participants (95.2%) in the early-start group and in 656 of 688 (95.3%) in the standard group; the absolute between-group difference was -0.1 percentage points (95% confidence interval, -2.4 to 2.1). Ectopic pregnancies occurred in 10 of 741 participants (1.3%) in the early-start group and in 6 of 724 (0.8%) in the standard group, with one rupture before diagnosis (early-start group). Serious adverse events occurred in 12 of 737 participants (1.6%) in the early-start group and in 5 of 718 (0.7%) in the standard group (P = 0.10); the majority were uncomplicated hospitalizations for treatment of ectopic pregnancy or incomplete abortion.

Conclusions: Medication abortion before confirmed intrauterine pregnancy was noninferior to standard, delayed treatment with respect to complete abortion. (Funded by the Swedish Research Council and others; VEMA EudraCT number, 2018-003675-35; ClinicalTrials.gov number, NCT03989869.).

背景:米非司酮和米索前列醇联合应用的药物流产非常有效和安全。然而,目前还没有足够的证据表明,在超声波检查可观察到妊娠之前的早期妊娠中药物流产的有效性和安全性:我们进行了一项多中心、非劣效、随机对照试验,参与试验的女性要求在妊娠 42 天以内进行药物流产,且超声检查未确认宫内妊娠(可视为空腔或无卵黄囊或胚极的囊状结构)。参与者被随机分配到立即开始流产(早期开始组)或标准护理治疗延迟至宫内妊娠确认(标准组)。主要结果是完全流产。组间绝对差异的非劣效差定为 3.0 个百分点:9个国家的26个研究机构共纳入了1504名妇女,她们被随机分配到早期启动组(754名参与者)或标准组(750名参与者)。在意向治疗分析中,早期启动组 710 名参与者中有 676 人(95.2%)完全流产,标准组 688 名参与者中有 656 人(95.3%)完全流产;组间绝对差异为-0.1 个百分点(95% 置信区间,-2.4 至 2.1)。早期启动组的 741 名参与者中有 10 人(1.3%)发生了宫外孕,标准组的 724 名参与者中有 6 人(0.8%)发生了宫外孕,其中一人在确诊前破裂(早期启动组)。早期启动组 737 人中有 12 人(1.6%)发生了严重不良事件,标准组 718 人中有 5 人(0.7%)发生了严重不良事件(P = 0.10);大多数人因治疗宫外孕或不完全流产而住院治疗:结论:就完全流产而言,在确诊宫内妊娠前进行药物流产并不比标准的延迟治疗效果差。(由瑞典研究理事会等机构资助;VEMA EudraCT 编号:2018-003675-35;ClinicalTrials.gov 编号:NCT03989869)。
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引用次数: 0
Long Covid Defined. 长科维定义。
IF 96.2 1区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2024-11-07 Epub Date: 2024-07-31 DOI: 10.1056/NEJMsb2408466
E Wesley Ely, Lisa M Brown, Harvey V Fineberg
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引用次数: 0
Invasive Treatment Strategy for Older Patients with Myocardial Infarction. 老年心肌梗死患者的侵入性治疗策略
IF 96.2 1区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2024-11-07 Epub Date: 2024-09-01 DOI: 10.1056/NEJMoa2407791
Vijay Kunadian, Helen Mossop, Carol Shields, Michelle Bardgett, Philippa Watts, M Dawn Teare, Jonathan Pritchard, Jennifer Adams-Hall, Craig Runnett, David P Ripley, Justin Carter, Julie Quigley, Justin Cooke, David Austin, Jerry Murphy, Damian Kelly, James McGowan, Murugapathy Veerasamy, Dirk Felmeden, Hussain Contractor, Sanjay Mutgi, John Irving, Steven Lindsay, Gavin Galasko, Kelvin Lee, Ayyaz Sultan, Amardeep G Dastidar, Shazia Hussain, Iftikhar Ul Haq, Mark de Belder, Martin Denvir, Marcus Flather, Robert F Storey, David E Newby, Stuart J Pocock, Keith A A Fox

Background: Whether a conservative strategy of medical therapy alone or a strategy of medical therapy plus invasive treatment is more beneficial in older adults with non-ST-segment elevation myocardial infarction (NSTEMI) remains unclear.

Methods: We conducted a prospective, multicenter, randomized trial involving patients 75 years of age or older with NSTEMI at 48 sites in the United Kingdom. The patients were assigned in a 1:1 ratio to a conservative strategy of the best available medical therapy or an invasive strategy of coronary angiography and revascularization plus the best available medical therapy. Patients who were frail or had a high burden of coexisting conditions were eligible. The primary outcome was a composite of death from cardiovascular causes (cardiovascular death) or nonfatal myocardial infarction assessed in a time-to-event analysis.

Results: A total of 1518 patients underwent randomization; 753 patients were assigned to the invasive-strategy group and 765 to the conservative-strategy group. The mean age of the patients was 82 years, 45% were women, and 32% were frail. A primary-outcome event occurred in 193 patients (25.6%) in the invasive-strategy group and 201 patients (26.3%) in the conservative-strategy group (hazard ratio, 0.94; 95% confidence interval [CI], 0.77 to 1.14; P = 0.53) over a median follow-up of 4.1 years. Cardiovascular death occurred in 15.8% of the patients in the invasive-strategy group and 14.2% of the patients in the conservative-strategy group (hazard ratio, 1.11; 95% CI, 0.86 to 1.44). Nonfatal myocardial infarction occurred in 11.7% in the invasive-strategy group and 15.0% in the conservative-strategy group (hazard ratio, 0.75; 95% CI, 0.57 to 0.99). Procedural complications occurred in less than 1% of the patients.

Conclusions: In older adults with NSTEMI, an invasive strategy did not result in a significantly lower risk of cardiovascular death or nonfatal myocardial infarction (the composite primary outcome) than a conservative strategy over a median follow-up of 4.1 years. (Funded by the British Heart Foundation; BHF SENIOR-RITA ISRCTN Registry number, ISRCTN11343602.).

背景:对于患有非 ST 段抬高型心肌梗死(NSTEMI)的老年人来说,单纯的保守药物治疗策略还是药物治疗加侵入性治疗策略更有益,目前仍不清楚:我们开展了一项前瞻性、多中心、随机试验,在英国 48 个地点对 75 岁或以上的 NSTEMI 患者进行了研究。患者按 1:1 的比例被分配到采用现有最佳药物疗法的保守策略或采用冠状动脉造影术和血管再通术加现有最佳药物疗法的侵入性策略。体弱或合并症较多的患者符合条件。主要结果是心血管原因导致的死亡(心血管死亡)或非致死性心肌梗死的复合结果,以时间到事件分析法进行评估:共有1518名患者接受了随机分配,其中753名患者被分配到侵入策略组,765名患者被分配到保守策略组。患者的平均年龄为 82 岁,45% 为女性,32% 为体弱者。在中位 4.1 年的随访期间,侵入策略组有 193 名患者(25.6%)发生了主要结局事件,保守策略组有 201 名患者(26.3%)发生了主要结局事件(危险比为 0.94;95% 置信区间 [CI],0.77 至 1.14;P = 0.53)。有创策略组中有15.8%的患者发生心血管死亡,保守策略组中有14.2%的患者发生心血管死亡(危险比为1.11;95% CI为0.86至1.44)。有创策略组中有 11.7% 的患者发生了非致命性心肌梗死,保守策略组中有 15.0% 的患者发生了非致命性心肌梗死(危险比为 0.75;95% CI 为 0.57 至 0.99)。手术并发症发生率低于1%:结论:对于患有NSTEMI的老年人,在中位随访4.1年的过程中,有创策略并不会导致心血管死亡或非致死性心肌梗死(综合主要结局)的风险显著低于保守策略。(由英国心脏基金会资助;英国心脏基金会SENIOR-RITA ISRCTN注册号:ISRCTN11343602)。
{"title":"Invasive Treatment Strategy for Older Patients with Myocardial Infarction.","authors":"Vijay Kunadian, Helen Mossop, Carol Shields, Michelle Bardgett, Philippa Watts, M Dawn Teare, Jonathan Pritchard, Jennifer Adams-Hall, Craig Runnett, David P Ripley, Justin Carter, Julie Quigley, Justin Cooke, David Austin, Jerry Murphy, Damian Kelly, James McGowan, Murugapathy Veerasamy, Dirk Felmeden, Hussain Contractor, Sanjay Mutgi, John Irving, Steven Lindsay, Gavin Galasko, Kelvin Lee, Ayyaz Sultan, Amardeep G Dastidar, Shazia Hussain, Iftikhar Ul Haq, Mark de Belder, Martin Denvir, Marcus Flather, Robert F Storey, David E Newby, Stuart J Pocock, Keith A A Fox","doi":"10.1056/NEJMoa2407791","DOIUrl":"10.1056/NEJMoa2407791","url":null,"abstract":"<p><strong>Background: </strong>Whether a conservative strategy of medical therapy alone or a strategy of medical therapy plus invasive treatment is more beneficial in older adults with non-ST-segment elevation myocardial infarction (NSTEMI) remains unclear.</p><p><strong>Methods: </strong>We conducted a prospective, multicenter, randomized trial involving patients 75 years of age or older with NSTEMI at 48 sites in the United Kingdom. The patients were assigned in a 1:1 ratio to a conservative strategy of the best available medical therapy or an invasive strategy of coronary angiography and revascularization plus the best available medical therapy. Patients who were frail or had a high burden of coexisting conditions were eligible. The primary outcome was a composite of death from cardiovascular causes (cardiovascular death) or nonfatal myocardial infarction assessed in a time-to-event analysis.</p><p><strong>Results: </strong>A total of 1518 patients underwent randomization; 753 patients were assigned to the invasive-strategy group and 765 to the conservative-strategy group. The mean age of the patients was 82 years, 45% were women, and 32% were frail. A primary-outcome event occurred in 193 patients (25.6%) in the invasive-strategy group and 201 patients (26.3%) in the conservative-strategy group (hazard ratio, 0.94; 95% confidence interval [CI], 0.77 to 1.14; P = 0.53) over a median follow-up of 4.1 years. Cardiovascular death occurred in 15.8% of the patients in the invasive-strategy group and 14.2% of the patients in the conservative-strategy group (hazard ratio, 1.11; 95% CI, 0.86 to 1.44). Nonfatal myocardial infarction occurred in 11.7% in the invasive-strategy group and 15.0% in the conservative-strategy group (hazard ratio, 0.75; 95% CI, 0.57 to 0.99). Procedural complications occurred in less than 1% of the patients.</p><p><strong>Conclusions: </strong>In older adults with NSTEMI, an invasive strategy did not result in a significantly lower risk of cardiovascular death or nonfatal myocardial infarction (the composite primary outcome) than a conservative strategy over a median follow-up of 4.1 years. (Funded by the British Heart Foundation; BHF SENIOR-RITA ISRCTN Registry number, ISRCTN11343602.).</p>","PeriodicalId":54725,"journal":{"name":"New England Journal of Medicine","volume":null,"pages":null},"PeriodicalIF":96.2,"publicationDate":"2024-11-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142121188","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
NEJM at ESC - Invasive versus Conservative Strategy for Older Patients with Myocardial Infarction. NEJM at ESC - 老年心肌梗死患者的侵入性与保守性策略。
IF 96.2 1区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2024-11-07 Epub Date: 2024-09-01 DOI: 10.1056/NEJMe2410900
Eric J Rubin, Jane Leopold, Stephen Morrissey
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引用次数: 0
Two Sides to the Story. 故事的两面性
IF 96.2 1区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2024-11-07 DOI: 10.1056/NEJMcps2400493
Cody E Cotner, Richard M Stone, Amy C Sherman, Katherine H Walker, Joseph Loscalzo
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引用次数: 0
From Evidence to Policy - Finding Authoritative Sources of Information on Health. 从证据到政策--寻找权威的健康信息来源。
IF 96.2 1区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2024-11-07 Epub Date: 2024-07-31 DOI: 10.1056/NEJMe2409293
Eric J Rubin, Victor J Dzau
{"title":"From Evidence to Policy - Finding Authoritative Sources of Information on Health.","authors":"Eric J Rubin, Victor J Dzau","doi":"10.1056/NEJMe2409293","DOIUrl":"10.1056/NEJMe2409293","url":null,"abstract":"","PeriodicalId":54725,"journal":{"name":"New England Journal of Medicine","volume":null,"pages":null},"PeriodicalIF":96.2,"publicationDate":"2024-11-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141861652","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Frailty in Older Adults. 老年人的虚弱。
IF 96.2 1区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2024-11-07 DOI: 10.1056/NEJMc2411327
Nir Y Krakauer, Jesse C Krakauer
{"title":"Frailty in Older Adults.","authors":"Nir Y Krakauer, Jesse C Krakauer","doi":"10.1056/NEJMc2411327","DOIUrl":"10.1056/NEJMc2411327","url":null,"abstract":"","PeriodicalId":54725,"journal":{"name":"New England Journal of Medicine","volume":null,"pages":null},"PeriodicalIF":96.2,"publicationDate":"2024-11-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142592281","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Uterine Fibroids. 子宫肌瘤
IF 96.2 1区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2024-11-07 DOI: 10.1056/NEJMcp2309623
Elizabeth A Stewart, Shannon K Laughlin-Tommaso
{"title":"Uterine Fibroids.","authors":"Elizabeth A Stewart, Shannon K Laughlin-Tommaso","doi":"10.1056/NEJMcp2309623","DOIUrl":"https://doi.org/10.1056/NEJMcp2309623","url":null,"abstract":"","PeriodicalId":54725,"journal":{"name":"New England Journal of Medicine","volume":null,"pages":null},"PeriodicalIF":96.2,"publicationDate":"2024-11-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142592305","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
期刊
New England Journal of Medicine
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