minimally invasive surgical procedure

微创外科手术
  • 文章类型: Journal Article
    我们调查了韩国结直肠外科医生在微创右半结肠切除术(RHC)中关于体内回结肠吻合术(IIA)的当前做法和看法。
    韩国结肠病学会(KSCP)的成员参加了一项包含人口统计信息的在线调查,手术经验,IIA的方法,和优势,障碍,以及对IIA的看法。我们对调查结果进行了统计分析。
    在联系的1,074名KSCP成员中,178回答了调查。大多数受访者是40-49岁的男性,有超过10年的经验,他们隶属于三级医疗机构。一百五十六位受访者每年进行<100例结直肠癌手术。59名受访者报告了IIA技术在微创RHC中的经验。大多数受访者赞成等周侧(S-S)吻合术和缝合S-S吻合术,用于公共通道的手工缝制闭合件,和脐周区域进行原始标本提取。有IIA经验的受访者强调术后并发症的减少是进行IIA的主要原因。而没有IIA经验的受访者则认为缺乏福利是主要的威慑因素。受访者通常认为吻合口漏和腹腔内污染是不进行IIA的主要原因。与没有IIA经验的受访者相比,有IIA经验的受访者对尝试或过渡到IIA的反应更为积极。具有IIA经验的受访者优先考虑自给自足,而没有IIA经验的受访者则优先考虑代理和对初始案例的讨论。
    必须实施使IIA技术标准化的措施和适当的培训计划,以增强其在微创RHC中的使用。
    UNASSIGNED: We investigated the current practices and perceptions of colorectal surgeons in South Korea regarding intracorporeal ileocolic anastomosis (IIA) in minimally invasive right hemicolectomy (RHC).
    UNASSIGNED: Members of the Korean Society of Coloproctology (KSCP) participated in an online survey encompassing demographic information, surgical experiences, methods for IIA, and advantages, barriers, and perceptions of IIA. We performed a statistical analysis of survey results.
    UNASSIGNED: Among the 1,074 KSCP members contacted, 178 responded to the survey. Most respondents were males aged 40-49 years with >10 years of experience who were affiliated with a tertiary healthcare facility. One hundred fifty-six respondents had performed <100 colorectal cancer surgeries annually. Fifty-nine respondents reported experiences of the IIA technique in minimally invasive RHC. Most respondents favored the isoperistaltic side-to-side (S-S) anastomosis and stapled S-S anastomosis, hand-sewn closure for the common channel, and the periumbilical area for primary specimen extraction. Respondents with IIA experience emphasized the reduction in postoperative complications as the primary reason for performing IIA, whereas respondents without IIA experience cited the lack of benefits as the main deterrent. Respondents commonly cited concerns regarding anastomotic leakage and intraabdominal contamination as the primary reasons for not performing IIA. Respondents with IIA experience demonstrated a more positive response towards attempting or transitioning to IIA than those without. Respondents with IIA experience prioritized self-sufficiency, whereas respondents without IIA experience prioritized proctorship and discussions of the initial cases.
    UNASSIGNED: Measures to standardize the IIA technique and appropriate training programs must be implemented to enhance its use in minimally invasive RHC.
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  • 文章类型: Journal Article
    背景:原发性甲状旁腺功能亢进症(PPH)的治愈性治疗是外科治疗,如今,如果对甲状旁腺组织具有亲和力的放射性药物,则可以通过微创手术(MIS)进行,并且也可以进行放射性引导(RG)注射可以用γ检测器探针或便携式γ相机(PGC)检测。
    目的:目的是评估PGC术中闪烁显像(GGio)是否可以替代术中病理解剖(APio),以确定切除的标本是否为异常甲状旁腺。
    方法:92例患者在给予99mTc-MIBI剂量后接受CMIRG-HPP和PGC。将PGC在分析切除标本时提供的信息与术中病理解剖(AP10)的结果定性比较(捕获是/否)。黄金标准是确定的组织学。
    结果:用GGio和APio评估了120个切块。有110项协议(95TP和15TN)和10项分歧(3FP和7FN)。在120个病灶中,甲状旁腺102例,非甲状旁腺18例。术中闪烁显像(GGio)和PA之间有很好的一致性,根据科恩的Kappa指数,70.1%。GGIO提出了以下灵敏度值,特异性,正预测值,负预测值,正似然比,测试的负似然比和总体值(93.1%,83.3%,96.9%,68.2%,分别为5.59、0.08和0.92)。
    结论:GGio是一种快速有效的手术辅助技术,可用于确认/排除PPH手术中切除的病变可能的甲状旁腺性质,但它不能取代组织学研究。
    BACKGROUND: The curative treatment of primary hyperparathyroidism (PPH) is surgical and today it can be performed by minimally invasive surgery (MIS) and also be radioguided (RG) if a radiopharmaceutical with affinity for the parathyroid tissue that can be detected with gamma-detector probes or with a portable gamma camera (PGC) is injected.
    OBJECTIVE: The objective is to assess whether intraoperative scintigraphy (GGio) with PGC can replace intraoperative pathological anatomy (APio) to determine if the removed specimen is an abnormal parathyroid.
    METHODS: 92 patients underwent CMI RG--HPP with PGC after the administration of a dose of 99 mTc-MIBI. The information provided by the PGC in the analysis of the excised specimens is qualitatively compared (capture yes/no) with the result of the intraoperative pathological anatomy (APio). The Gold standard is the definitive histology.
    RESULTS: 120 excised pieces are evaluated with GGio and APio. There were 110 agreements (95TP and 15TN) and 10 disagreements (3FP and 7FN). Of the 120 lesions, 102 were parathyroid and 18 were non-parathyroid. There was good agreement between intraoperative scintigraphy imaging (GGio) and PA, 70.1% according to Cohen\'s Kappa index. The GGio presented the following values ​​of Sensitivity, Specificity, Positive Predictive Value, Negative Predictive Value, Positive Likelihood Ratio, Negative Likelihood Ratio and Overall Value of the Test (93.1%, 83.3%, 96.9%, 68.2%, 5.59, 0.08 and 0.92 respectively).
    CONCLUSIONS: GGio is a rapid and effective surgical aid technique to confirm/rule out the possible parathyroid nature of the lesions removed in PPH surgery, but it cannot replace histological study.
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  • 文章类型: Journal Article
    背景:长段,IV级造口上气管狭窄罕见且难以治疗(Carpenter等人。,2022年[1])。IV级狭窄患者具有明显的生活质量障碍,因为他们是气管造口术依赖性和调音性的。通常需要进行开放气道手术以改善气管的通畅性,恢复病人的声音,以及在脱管化方面的进展(Abouyared等人。,2017年[2])。然而,并非所有患者都是前期开放手术的候选人(Abouyaredetal.,2017;Shamji,2018[2,3])。因此,重要的是制定和完善内镜干预措施,以改善这些患者的生活质量.
    方法:我们描述了一种逐步的内窥镜方法,用于长段的再管,IV级造口上气管狭窄。简而言之,我们的方法利用狭窄的双重(近端和远端)可视化,然后将25号针头穿过狭窄,以确定合适的再插管轨迹.然后以相同的方式通过16号针,一根线穿过针头进入远端气道。一旦重新气道,最初的精确开口在Savary扩张器的电线上以Seldinger的方式逐渐扩大,然后进行气球扩张。最后,放置了造口上L型支架(改良的MontgomeryT型管)以降低再狭窄的风险(Edwards等人。,2023年[4])。
    方法:一名39岁女性,有既往病史,对I型糖尿病和多物质滥用控制不佳,表现为气管造口术依赖和失音。她被诊断出患有长段,IV级造口上气管狭窄,最初接受了内窥镜再插管。这种干预恢复了她的声音,并允许在开放气道手术之前优化她的医疗条件。
    结论:大多数患者的生活质量得到了显著改善,因为他们的声音通常在此过程后得到恢复。此外,最终需要进行开放气道手术的个人将获得额外的时间进行医疗优化.根据我们的经验,该手术是一种安全有效的方法,可扩展传统内镜下气道介入治疗IV级狭窄患者的实用性.
    BACKGROUND: Long-segment, grade IV suprastomal tracheal stenosis is rare and difficult to treat (Carpenter et al., 2022 [1]). Patients with grade IV stenosis have significant quality of life impairments since they are tracheostomy dependent and aphonic. Open airway surgery is often needed to improve tracheal patency, restore the patient\'s voice, and progress towards decannulation (Abouyared et al., 2017 [2]). However, not all patients are candidates for upfront open surgery (Abouyared et al., 2017; Shamji, 2018 [2,3]). Therefore, it is important to develop and refine endoscopic interventions to improve quality of life for these patients.
    METHODS: We describe a step-by-step endoscopic approach to the recannulation of long-segment, grade IV suprastomal tracheal stenosis. Briefly, our approach utilizes dual (proximal & distal) visualization of the stenosis prior to passing a 25 gauge needle through the stenosis to identify the proper trajectory for recannulation. Then a 16 gauge needle is passed in the same manner, and a wire is placed through the needle and into the distal airway. Once the airway is recannulated, the initial pinpoint opening is gradually widened in Seldinger fashion over the wire with Savary dilators followed by balloon dilation. Finally, a suprastomal L-stent (modified Montgomery T-Tube) is placed to reduce the risk of restenosis (Edwards et al., 2023 [4]).
    METHODS: A 39-year-old woman with a past medical history significant for poorly controlled type I diabetes mellitus and polysubstance abuse presented with tracheostomy dependence and aphonia. She was diagnosed with a long-segment, grade IV suprastomal tracheal stenosis and initially underwent endoscopic recannulation. This intervention restored her voice and allowed for optimization of her medical conditions before open airway surgery.
    CONCLUSIONS: Most patients experience a significant improvement in their quality of life as their voice is typically restored following this procedure. Additionally, individuals who eventually require open airway surgery gain additional time for medical optimization. In our experience, this procedure represents a safe and effective means of extending the utility of traditional endoscopic airway interventions for the management of patients with grade IV stenosis.
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  • 文章类型: Editorial
    暂无摘要。
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  • 文章类型: English Abstract
    BACKGROUND: There are barely any alternative treatment options to the drug treatment of hemodynamically caused cerebral ischemia, as in occlusion of the internal carotid artery.
    OBJECTIVE: For secondary prevention of an ischemic stroke due to carotid occlusion and hemodynamic instability, extracranial-intracranial (EC-IC) bypass surgery can be an important option in selected patients.
    METHODS: The development, study situation, indications and surgical technique for placement of an EC-IC bypass in cases of occlusion of the internal carotid artery are presented.
    RESULTS: With appropriate expertise and strict selection of patients, the placement of an EC-IC bypass enables stabilization of cerebral perfusion with a low rate of complications.
    CONCLUSIONS: The study situation is controversially discussed; nevertheless, surgical treatment in a specialized neurovascular center should at least be considered.
    UNASSIGNED: HINTERGRUND: Für die Prophylaxe hämodynamisch verursachter zerebraler Ischämien, wie bei einem Verschluss der A. carotis interna, steht kaum eine erfolgreiche alternative Behandlungsmethode zur medikamentösen Therapie zur Verfügung.
    UNASSIGNED: Im Rahmen der Sekundärprophylaxe bei Karotisverschluss und hämodynamischer Instabilität kann der extraintrakranielle Bypass bei einem ausgesuchten Patientengut eine wichtige Stellung einnehmen.
    METHODS: Die Entwicklung, die Studienlage, Indikationen und die Operationstechnik zur Anlage eines extraintrakraniellen Bypasses bei Karotisverschluss werden vorgestellt.
    UNASSIGNED: Die Anlage eines extraintrakraniellen Bypasses erlaubt bei entsprechender operativer Expertise und einem streng selektionierten Patientengut eine Stabilisierung der Hirnperfusion bei einer niedrigen Komplikationsrate.
    UNASSIGNED: Die Studienlage wird zwar kontrovers diskutiert. Dennoch sollte eine operative Behandlung in einem spezialisierten neurovaskulären Zentrum zumindest erwogen werden.
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  • 文章类型: Journal Article
    从开放式肝切除术到微创技术的过渡降低了发病率和死亡率。然而,腹腔镜肝切除术(LLR)需要大量的专业知识。机器人肝切除术(RLR)结合最小侵入性和开放手术精度。它可以促进复杂的程序,而无需LLR所需的学习。我们在有限的资源环境中评估了RLR结果,并评估了其有效性和实用性。这项回顾性研究分析了2020年至2023年进行的67例机器人肝切除术。人口统计,围手术期因素,并对手术结果进行分析。接受RLR的46/67(68.7%)患者需要进行大的肝切除术。没有开放的转换,30天死亡率,或再入院发生。7.4%的患者发生并发症;5.9%的患者发生主要并发症。学习曲线分析显示手术顺序与手术时间呈负相关。有效使用机器人技术结合训练有素的外科医生的专业知识,有助于成功执行RLR,并获得可行的手术结果。甚至在较小的中心。
    The transition from open hepatectomy to minimally invasive techniques has reduced morbidity and mortality. However, laparoscopic liver resection (LLR) requires substantial expertise. Robotic liver resection (RLR) combines minimal invasiveness with open surgical precision. It may facilitate complex procedures without the learning required for LLR. We evaluated RLR outcomes in a limited resource setting and assessed its efficacy and practicality. This retrospective study analyzed 67 robotic hepatectomies conducted from 2020 to 2023. Demographic, perioperative factors, and surgical outcomes were analyzed. Major hepatectomies were required in 46/67 (68.7%) patients who underwent RLR. No open conversions, 30-day mortalities, or readmissions occurred. Complications occurred in 7.4% of patients; major complications occurred in 5.9%. Learning curve analysis showed a negative correlation between operation sequence and operative time. Effective use of robotic technology combined with the expertise of well-trained surgeons facilitates successful execution of RLR with feasible surgical outcomes, even at smaller centers.
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  • 文章类型: Journal Article
    目的:本研究旨在评估经直肠超声引导下前列腺穿刺活检(TR活检)后钬激光前列腺摘除术(HoLEP)治疗良性前列腺增生的临床效果和安全性。
    方法:我们回顾性分析了2014年至2021年接受HoLEP的556例患者的数据。患者分为六组:第1-A组(n=45)在TR活检后四个月内接受了HoLEP。1-B组(n=94)在TR活检后四个月以上接受了HoLEP。1-C组(n=120)在一次TR活检后接受了HoLEP。1-D组(n=19)在两次或更多次TR活检后接受HoLEP。第1组(n=139,第1-A组1-B组或第1-C组1-D组)在TR活检后接受了HoLEP。第2组(对照组,n=417)接受了HoLEP,没有进行TR活检。我们检查了围手术期参数,安全,和功能结果。
    结果:年龄,身体质量指数,国际前列腺症状评分(IPSS)尿流仪,第1组和第2组之间的共患疾病具有可比性。然而,第1组-总计显示出显著升高的前列腺特异性抗原水平和更大的前列腺体积(p<0.01)。围手术期因素如摘除时间,摘除重量,第1组的导尿时间明显高于对照组(p<0.01)。所有组均显示IPSS的显着改善,后尿残余尿,术后1年的最大流量(p<0.05)。第1组和第2组的术后并发症发生率相似。
    结论:TR活检组的摘除时间和导管插入时间明显更长。然而,TR活检组和非TR活检组术后并发症无显著差异.
    OBJECTIVE: This study aimed to assess the clinical outcome and safety of holmium laser enucleation of the prostate (HoLEP) following transrectal ultrasound-guided prostate biopsy (TR biopsy) in the treatment of benign prostate hyperplasia.
    METHODS: We retrospectively analyzed data from 556 patients who underwent HoLEP between 2014 and 2021. The patients were categorized into six groups: Group 1-A (n=45) underwent HoLEP within four months post TR biopsy. Group 1-B (n=94) underwent HoLEP more than four months post TR biopsy. Group 1-C (n=120) underwent HoLEP after a single TR biopsy. Group 1-D (n=19) underwent HoLEP after two or more TR biopsies. Group 1-total (n=139, group 1-A+group 1-B or group 1-C+group 1-D) underwent HoLEP post TR biopsy. Group 2 (control group, n=417) underwent HoLEP without prior TR biopsy. We examined perioperative parameters, safety, and functional outcomes.
    RESULTS: The age, body mass index, International Prostate Symptom Score (IPSS), uroflowmetry, and comorbid diseases between group 1-total and group 2 were comparable. However, group 1-total exhibited significantly elevated prostate-specific antigen levels and larger prostate volumes (p<0.01). Perioperative factors like enucleation time, enucleation weight, and catheterization duration were notably higher in group 1-total (p<0.01). All groups showed significant improvements in IPSS, postvoid residual urine, and maximum flow rate during the 1-year postoperative period (p<0.05). The rates of postoperative complications were similar between group 1-total and group 2.
    CONCLUSIONS: Enucleation time and catheterization duration were significantly longer in the TR biopsy group. However, postoperative complications were not significantly different between TR biopsy and non-TR biopsy groups.
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  • 文章类型: Journal Article
    目的:比较围手术期,功能,和使用倾向评分(PS)匹配分析的单一外科医生进行的thulium光纤激光前列腺摘除(ThuFLEP)和双极前列腺摘除之间的安全性结果。
    方法:数据来自675例患者,其中422人由一名经验丰富的外科医生进行ThuFLEP和双极眼球摘除。用FiberlaseU1(IREPolusLtd.)进行ThuFLEP。围手术期参数,安全,和功能结果,如国际前列腺症状评分(IPSS),生活质量(QoL),后空隙残余体积(PVR),和最大尿流率(Qmax)进行评估。要控制选择偏差,使用以下变量作为协变量进行1:1PS匹配分析:总前列腺体积,术前IPSS和早期括约肌释放。
    结果:在422名患者中,370例(87.7%)接受ThuFLEP,52例(12.3%)接受双极摘除。操作,摘除,PS匹配分析前后各组间的分块时间具有可比性(分别为p=0.954,p=0.474,p=0.362).功能参数(IPSS、QoL,PVR,Qmax)在PS匹配之前和之后的每个时间点在组间也是相当的。IPSS的重大改进,QoL评分,Qmax,在24个月的随访期间,ThuFLEP和双极眼球摘除术均观察到PVR,组间无任何显着差异。PS匹配分析前后术后早期和晚期并发症相似。
    结论:ThuFLEP在围手术期特征方面与双极眼球摘除术相当,排泄参数的改进,和并发症发生率。两种方法均被证明在良性前列腺增生的治疗中有效且安全。
    OBJECTIVE: To compare perioperative, functional, and safety outcomes between thulium fiber laser enucleation of the prostate (ThuFLEP) and bipolar enucleation of the prostate performed by a single surgeon with use of propensity score (PS)-matched analysis.
    METHODS: Data were from 675 patients, 422 of whom underwent ThuFLEP and bipolar enucleation by a single highly experienced surgeon. ThuFLEP was performed with Fiberlase U1 (IRE Polus Ltd.). Perioperative parameters, safety, and functional outcomes, such as International Prostate Symptom Score (IPSS), quality of life (QoL), postvoid residual volume (PVR), and maximum urinary flow rate (Qmax) were assessed. To control for selection bias, a 1:1 PS-matched analysis was carried out using the following variables as covariates: total prostate volume, preoperative IPSS and early sphincter release.
    RESULTS: Of 422 patients, 370 (87.7%) underwent ThuFLEP and 52 (12.3%) underwent bipolar enucleation. Operation, enucleation, and morcellation time were comparable between groups before and after PS-matched analysis (p=0.954, p=0.474, p=0.362, respectively). Functional parameters (IPSS, QoL, PVR, Qmax) were also comparable between groups at every time point before and after PS matching. Significant improvements in IPSS, QoL score, Qmax, and PVR were observed during the 24-month follow-up period for both ThuFLEP and bipolar enucleation without any significant differences between groups. Early and late postoperative complications before and after PS-matched analysis were similar.
    CONCLUSIONS: ThuFLEP was comparable to bipolar enucleation in perioperative characteristics, improvement in voiding parameters, and complication rates. Both procedures were shown to be effective and safe in the management of benign prostatic hyperplasia.
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  • 文章类型: Clinical Trial
    目标:磁辅助机器人手术(MARS)平台,由LevitaMagnetics(加利福尼亚,美国),已开发出最大限度地提高微创手术患者的利益,同时增强外科医生的控制和可视化。这项研究的目的是评估MARS平台在腹腔镜肾脏和肾上腺手术中的安全性和有效性。
    方法:前瞻性,单臂,开放标签,进行伦理委员会批准的研究。
    背景:NCT05353777。15例肾或肾上腺病理,纳入了2022年4月至6月期间接受腹腔镜手术的患者.所有患者均随访至术后30天。术前,术中,并记录术后数据.使用多项式回归来确定对接时间的学习曲线。
    结果:干预了10名女性和5名男性;平均年龄55岁,平均BMI29cm/m2。没有病例需要转换为开放手术,所有患者均在术后第一天或第二天出院。在前30天内没有并发症或再次入院的报告。所有肿瘤病例均有阴性切缘。学习曲线是由第四种情况实现的,对接时间从5.22(2.6-11.5;SD2.9)减少到2.68分钟(2.1-3.8;SD0.67)(p=0.002)。对学习曲线进行三次回归拟合,得到R2=0.714。
    结论:这是第一个证明MARS平台在泌尿外科手术中安全性和多功能性的临床研究。机器人对组织收缩特别有用,避免了额外的切口,避免了对手术助手的需要,同时增加外科医生的控制和可视化。学习曲线很快,在第四种情况下实现短对接时间。需要进一步的研究来评估其在这种有前途的新技术的其他手术领域的适用性。
    Introduction and objective: Magnetic-assisted robotic surgery (MARS) has been developed to maximize patient benefits of minimally invasive surgery while enhancing surgeon control and visualization. MARS platform (Levita Magnetics) comprises two robotic arms that provide control to an external magnetic controller and an off-the-shelf laparoscopic camera. Our aim was to evaluate the safety and efficacy of the MARS platform in laparoscopic renal and adrenal procedure for the first time. Methods: This is a prospective, single-arm, open-label study (Clinical Trials Identifier: NCT05353777) including patients with renal or adrenal pathology analysis, submitted to laparoscopic procedure between April and June 2022. Patients were followed up to 30 days postoperatively. Preoperative, intraoperative, and postoperative data were recorded. Polynomial regression was used to determine the learning curve for docking time. Results: Fifteen cases were performed using the MARS platform (three partial nephrectomies, five total nephrectomies for benign pathology analysis, four radical nephrectomies, and three adrenalectomies) corresponding to 10 women and 5 men (mean age, 55 years [18-77]; average body mass index, 29 cm/m2 [22-39]). No cases required conversion to open procedure and all patients were discharged on the first or second postoperative day. No complications or re-admissions were reported within the first 30 days. All oncologic cases had negative margins. Learning curve was achieved by the fourth case, diminishing docking time from 5.22 (2.6-11.5) to 2.68 minutes (2.1-3.8) (p = 0.002). The learning curve was fitted to a cubic regression (R2 = 0.714). Conclusion: This is the first clinical study demonstrating the safety and versatility of the MARS platform in urologic procedures. The robot was especially useful for tissue retraction, avoiding additional incisions and the need for a surgical assistant while increasing surgeon control and visualization. The learning curve was rapid, achieving a short docking time. MARS is a promising new technology that could be successfully evaluated in other surgeries.
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  • 文章类型: Clinical Trial, Phase III
    在开放标签中,III期CheckMate816研究(NCT02998528),在可切除的非小细胞肺癌(NSCLC)患者中,与单纯化疗相比,新辅助纳武单抗联合化疗在无事件生存期(EFS)和病理完全缓解(pCR)方面有统计学显著改善.在这里,我们报告了日本亚群的疗效和安全性结果。IB-IIIA期患者,将可切除的NSCLC以1:1的比例随机分配至nivolumab联合化疗或单独化疗三个周期,然后在完成新辅助治疗后6周内进行确定性手术.在日本16个中心的患者中评估主要终点(EFS和pCR)和安全性。在随机分组的日本患者中,nivolumab加化疗组的93.9%(31/33)和化疗组的82.9%(29/35)接受了手术。最低随访时间为21.5个月,中位EFS为30.6个月(95%置信区间[CI],16.8-未达到[NR])使用nivolumab联合化疗与19.6个月(95%CI,8.5-NR)使用化疗;风险比,0.60(95%CI,0.30-1.24)。pCR率为30.3%(95%CI,15.6-48.7)与5.7%(95%CI,0.7-19.2),分别是;赔率比,7.17(95%CI,1.44-35.85)。3/4级治疗相关的不良事件报告分别为59.4%和42.9%的患者。分别,没有发现新的安全信号。在日本患者中,新辅助纳武单抗加化疗导致更长的EFS和更高的pCR率,与单纯化疗相比,与全球人口的发现一致。这些数据支持nivolumab加化疗作为日本可切除NSCLC患者的新辅助治疗选择。
    In the open-label, phase III CheckMate 816 study (NCT02998528), neoadjuvant nivolumab plus chemotherapy demonstrated statistically significant improvements in event-free survival (EFS) and pathological complete response (pCR) versus chemotherapy alone in patients with resectable non-small-cell lung cancer (NSCLC). Here we report efficacy and safety outcomes in the Japanese subpopulation. Patients with stage IB-IIIA, resectable NSCLC were randomized 1:1 to nivolumab plus chemotherapy or chemotherapy alone for three cycles before undergoing definitive surgery within 6 weeks of completing neoadjuvant treatment. The primary end-points (EFS and pCR) and safety were assessed in patients enrolled at 16 centers in Japan. Of the Japanese patients randomized, 93.9% (31/33) in the nivolumab plus chemotherapy arm and 82.9% (29/35) in the chemotherapy arm underwent surgery. At 21.5 months\' minimum follow-up, median EFS was 30.6 months (95% confidence interval [CI], 16.8-not reached [NR]) with nivolumab plus chemotherapy versus 19.6 months (95% CI, 8.5-NR) with chemotherapy; hazard ratio, 0.60 (95% CI, 0.30-1.24). The pCR rate was 30.3% (95% CI, 15.6-48.7) versus 5.7% (95% CI, 0.7-19.2), respectively; odds ratio, 7.17 (95% CI, 1.44-35.85). Grade 3/4 treatment-related adverse events were reported in 59.4% versus 42.9% of patients, respectively, with no new safety signals identified. Neoadjuvant nivolumab plus chemotherapy resulted in longer EFS and a higher pCR rate versus chemotherapy alone in Japanese patients, consistent with findings in the global population. These data support nivolumab plus chemotherapy as a neoadjuvant treatment option in Japanese patients with resectable NSCLC.
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