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In females, salivary secretion was significantly lower in patients with severe reflux esophagitis than in healthy controls. 在女性中,严重反流性食管炎患者的唾液分泌量明显低于健康对照组。
IF 2.2 4区 医学 Q3 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2024-07-01 Epub Date: 2024-03-27 DOI: 10.1007/s10388-024-01052-0
Shintaro Hoshino, Eri Momma, Mai Koeda, Yoshimasa Hoshikawa, Tomohide Tanabe, Noriyuki Kawami, Yuichi Kitasako, Katsuhiko Iwakiri

Background: The salivary secretion in patients with mild reflux esophagitis (RE) and non-erosive reflux disease is significantly lower in females, but not in males. However, sex differences in salivary secretion in patients with severe RE remain unknown. Therefore, the present study investigated sex differences in saliva secretion in patients with severe RE.

Methods: Subjects consisted of 23 male patients with severe RE, 24 male healthy controls (HCs), 26 female patients with severe RE, and 25 female HCs. Saliva secretion was assessed as follows: each patient chewed sugarless gum for 3 min prior to endoscopy, and the amount and pH of saliva secreted before and after acid loading as an index of the acid-buffering capacity were measured.

Results: In males, no significant differences were observed in the amount of saliva secretion, salivary pH, or the acid-buffering capacity between severe RE patients and HCs. In females, the amount of saliva secretion (severe RE: 2.4 [1.8-4.1], HCs: 5.3 [3.4-7.5], p = 0.0017), salivary pH (severe RE: 7.0 [6.7-7.3], HCs: 7.2 [7.1-7.3], p = 0.0455), and the acid-buffering capacity (severe RE: 5.9 [5.3-6.2], HCs: 6.2 [6.1-6.5], p = 0.0024) were significantly lower in severe RE patients than in HCs.

Conclusion: Among females, the salivary secretion was significantly lower in severe RE patients than in HCs. This reduction in salivary secretion may contribute to the pathophysiology of severe RE in females.

背景:轻度反流性食管炎(RE)和非反流性食管炎患者的唾液分泌量女性明显低于男性。然而,重度反流性食管炎患者唾液分泌的性别差异仍然未知。因此,本研究调查了严重RE患者唾液分泌的性别差异:受试者包括 23 名男性重度 RE 患者、24 名男性健康对照者(HCs)、26 名女性重度 RE 患者和 25 名女性健康对照者。唾液分泌情况的评估方法如下:每位患者在接受内窥镜检查前咀嚼无糖口香糖3分钟,测量酸负荷前后唾液分泌量和pH值,作为酸缓冲能力的指标:结果:在男性中,严重RE患者和HCs患者的唾液分泌量、唾液pH值和酸缓冲能力均无明显差异。在女性中,唾液分泌量(重度 RE:2.4 [1.8-4.1],HCs:5.3 [3.4-7.5],p = 0.0017)、唾液 pH 值(重度 RE:7.0 [6.7-7.3],HCs:7.2 [7.1-7.3],p = 0.严重RE患者的唾液pH值(严重RE:7.0 [6.7-7.3],HCs:7.2 [7.1-7.3],p = 0.0455)和酸缓冲能力(严重RE:5.9 [5.3-6.2],HCs:6.2 [6.1-6.5],p = 0.0024)显著低于HCs:结论:在女性中,重度RE患者的唾液分泌量明显低于HCs。结论:女性重度RE患者的唾液分泌量明显低于HCs,唾液分泌量的减少可能是女性重度RE的病理生理学原因之一。
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引用次数: 0
Impact of quality of life on mortality risk in patients with esophageal cancer: a systematic review and meta-analysis. 生活质量对食管癌患者死亡风险的影响:系统回顾和荟萃分析。
IF 2.2 4区 医学 Q3 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2024-07-01 Epub Date: 2024-05-21 DOI: 10.1007/s10388-024-01064-w
Junichiro Inoue, Shinichiro Morishita, Taro Okayama, Katsuyoshi Suzuki, Takashi Tanaka, Jiro Nakano, Takuya Fukushima

This systematic review and meta-analysis investigated the impact of quality of life (QoL) on mortality risk in patients with esophageal cancer. A literature search was conducted using the CINAHL, PubMed/MEDLINE, and Scopus databases for articles published from inception to December 2022. Observational studies that examined the association between QoL and mortality risk in patients with esophageal cancer were included. Subgroup analyses were performed for time points of QoL assessment and for types of treatment. Seven studies were included in the final analysis. Overall, global QoL was significantly associated with mortality risk (hazard ratio 1.02, 95% confidence interval 1.01-1.04; p < 0.00004). Among the QoL subscales of QoL, physical, emotional, role, cognitive, and social QoL were significantly associated with mortality risk. A subgroup analysis by timepoints of QoL assessment demonstrated that pre- and posttreatment global and physical, pretreatment role, and posttreatment cognitive QoL were significantly associated with mortality risk. Moreover, another subgroup analysis by types of treatment demonstrated that the role QoL in patients with surgery, and the global, physical, role, and social QoL in those with other treatments were significantly associated with mortality risk. These findings indicate that the assessment of QoL in patients with esophageal cancer before and after treatment not only provides information on patients' condition at the time of treatment but may also serve as an outcome for predicting life expectancy. Therefore, it is important to conduct regular QoL assessments and take a proactive approach to improve QoL based on the results of these assessments.

本系统综述和荟萃分析调查了生活质量(QoL)对食管癌患者死亡风险的影响。我们使用 CINAHL、PubMed/MEDLINE 和 Scopus 数据库对从开始到 2022 年 12 月发表的文章进行了文献检索。纳入了研究食管癌患者 QoL 与死亡风险之间关系的观察性研究。根据 QoL 评估的时间点和治疗类型进行了分组分析。最终分析纳入了七项研究。总体而言,总体 QoL 与死亡风险显著相关(危险比 1.02,95% 置信区间 1.01-1.04;P
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引用次数: 0
Reply to: The use of drugs to prevent postoperative delirium in elderly patients with radical esophagectomy. 回复:使用药物预防老年食管根治术患者术后谵妄。
IF 2.2 4区 医学 Q3 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2024-07-01 Epub Date: 2024-03-08 DOI: 10.1007/s10388-024-01051-1
Shuhei Mayanagi, Yasuhiro Tsubosa
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引用次数: 0
Efficacy and survival of nivolumab treatment for recurrent/unresectable esophageal squamous-cell carcinoma: real-world clinical data from a large multi-institutional cohort. nivolumab治疗复发性/不可切除食管鳞状细胞癌的疗效和生存率:来自大型多机构队列的真实世界临床数据。
IF 2.2 4区 医学 Q3 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2024-07-01 Epub Date: 2024-05-08 DOI: 10.1007/s10388-024-01056-w
Tomoki Makino, Shigeto Nakai, Kota Momose, Kotaro Yamashita, Koji Tanaka, Hiroshi Miyata, Sachiko Yamamoto, Masaaki Motoori, Yutaka Kimura, Yuki Ushimaru, Motohiro Hirao, Jin Matsuyama, Yusuke Akamaru, Yukinori Kurokawa, Hidetoshi Eguchi, Yuichiro Doki

Background: Real-world clinical outcomes of and prognostic factors for nivolumab treatment for esophageal squamous-cell carcinoma (ESCC) remain unclear. This study aimed to evaluate real-world outcomes of nivolumab monotherapy in association with relevant clinical parameters in recurrent/unresectable advanced ESCC patients.

Methods: This population-based multicenter cohort study included a total of 282 patients from 15 institutions with recurrent/unresectable advanced ESCC who received nivolumab as a second-line or later therapy between 2014 and 2022. Data, including the best overall response, progression-free survival (PFS), and overall survival (OS), were retrospectively collected from these patients.

Results: Objective response and disease control rates were 17.0% and 47.9%, respectively. The clinical response to nivolumab treatment significantly correlated with development of overall immune-related adverse events (P < .0001), including rash (P < .0001), hypothyroidism (P = .03), and interstitial pneumonia (P = .004). Organ-specific best response rates were 20.6% in lymph nodes, 17.4% in lungs, 15.4% in pleural dissemination, and 13.6% in primary lesions. In terms of patient survival, the median OS and PFS was 10.9 and 2.4 months, respectively. Univariate analysis of OS revealed that performance status (PS; P < .0001), number of metastatic organs (P = .019), C-reactive protein-to-albumin ratio (CAR; P < .0001), neutrophil-lymphocyte ratio (P = .001), and PMI (P = .024) were significant. Multivariate analysis further identified CAR [hazard ratio (HR) = 1.61, 95% confidence interval (CI) 1.15-2.25, P = .0053)] in addition to PS (HR = 1.65, 95% CI 1.23-2.22, P = .0008) as independent prognostic parameters.

Conclusions: CAR and PS before nivolumab treatment are useful in predicting long-term survival in recurrent/unresectable advanced ESCC patients with second-line or later nivolumab treatment.

Trial registration: UMIN000040462.

背景:nivolumab治疗食管鳞状细胞癌(ESCC)的实际临床结果和预后因素仍不清楚。本研究旨在评估nivolumab单药治疗复发/不可切除的晚期ESCC患者的实际疗效与相关临床参数的关系:这项基于人群的多中心队列研究共纳入了来自15家机构的282例复发性/不可切除晚期ESCC患者,这些患者在2014年至2022年期间接受了nivolumab作为二线或以后的疗法。研究人员回顾性地收集了这些患者的数据,包括最佳总体反应、无进展生存期(PFS)和总生存期(OS):客观反应率和疾病控制率分别为17.0%和47.9%。nivolumab治疗的临床反应与总体免疫相关不良事件的发生有显著相关性(P 结论:nivolumab治疗的临床反应与免疫相关不良事件的发生有显著相关性:nivolumab治疗前的CAR和PS有助于预测接受二线或以后nivolumab治疗的复发性/不可切除晚期ESCC患者的长期生存率:UMIN000040462.
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引用次数: 0
Eosinophilic esophagitis and risk of incident major adverse cardiovascular events: a nationwide matched cohort study. 嗜酸性粒细胞食管炎与重大不良心血管事件的发生风险:一项全国范围的匹配队列研究。
IF 2.2 4区 医学 Q3 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2024-07-01 Epub Date: 2024-05-29 DOI: 10.1007/s10388-024-01066-8
Anders Forss, Amiko M Uchida, Bjorn Roelstraete, Fahim Ebrahimi, John J Garber, Johan Sundström, Jonas F Ludvigsson

Background: Inflammatory diseases have been associated with an increased cardiovascular risk. However, data on incident major adverse cardiovascular events (MACE) from large population-based cohorts of patients with eosinophilic esophagitis (EoE) is lacking.

Methods: This study included all Swedish adults with EoE without a record of previous cardiovascular disease (CVD) (1990-2017, N = 1546) with follow-up until 2019. Individuals with EoE were identified from prospectively recorded histopathology reports from all Swedish pathology departments (n = 28). EoE patients were matched at index date for age, sex, calendar year and county with up to five general population reference individuals (N = 7281) without EoE or CVD. Multivariable-adjusted hazard ratios (aHRs) for MACE (ischemic heart disease, congestive heart failure, stroke and cardiovascular mortality) were calculated using Cox proportional hazards models. Full sibling comparisons and adjustment for cardiovascular medication were performed.

Results: During a median follow-up of 6.0 years, we observed 65 incident MACE in patients with EoE (6.4/1000 person-years (PY)) and 225 in reference individuals (4.7/1000 PY). EoE was not associated with a higher risk of MACE (aHR = 1.14, 95% CI = 0.86-1.51) or any of its components. No differences between age, sex and follow-up time were observed. The results remained stable in sensitivity analyses, including when adjusting for relevant cardiovascular medications and a full sibling comparison.

Conclusions: In this large population-based cohort study, patients with EoE had no increased risk of MACE compared to reference individuals and full siblings. The results are reassuring for patients with EoE.

背景:炎症性疾病与心血管风险增加有关。然而,目前还缺乏嗜酸性粒细胞性食管炎(EoE)患者大型人群队列中关于重大不良心血管事件(MACE)的数据:这项研究纳入了瑞典所有既往无心血管疾病(CVD)记录的成人食管炎患者(1990-2017 年,N = 1546),随访至 2019 年。从瑞典所有病理部门的前瞻性记录组织病理学报告中确定了咽喉炎患者(N = 28)。咽喉炎患者在指数日期与多达五名无咽喉炎或心血管疾病的普通人群参照个体(N = 7281)进行年龄、性别、日历年和郡县匹配。使用 Cox 比例危险模型计算经多变量调整的 MACE(缺血性心脏病、充血性心力衰竭、中风和心血管疾病死亡率)危险比 (aHRs)。进行了同胞比较,并对心血管药物进行了调整:在中位随访 6.0 年期间,我们观察到 65 例咽喉炎患者(6.4/1000 人-年)和 225 例参照个体(4.7/1000 人-年)发生 MACE。肠易激综合征与较高的 MACE 风险(aHR = 1.14,95% CI = 0.86-1.51)或其任何组成部分无关。未观察到年龄、性别和随访时间之间的差异。在进行敏感性分析时,包括调整相关心血管药物和进行同胞比较时,结果保持稳定:在这项大型人群队列研究中,与参照个体和同胞兄弟姐妹相比,咽喉炎患者的MACE风险并没有增加。这些结果让咽喉炎患者感到放心。
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引用次数: 0
Effectiveness of prehabilitation during neoadjuvant therapy for patients with esophageal or gastroesophageal junction cancer: a systematic review. 食管癌或胃食管交界癌患者在新辅助治疗期间进行康复训练的效果:系统性综述。
IF 2.2 4区 医学 Q3 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2024-07-01 Epub Date: 2024-02-27 DOI: 10.1007/s10388-024-01049-9
Tomohiro Ikeda, Shusuke Toyama, Tsuyoshi Harada, Kazuhiro Noma, Masanori Hamada, Takashi Kitagawa

Progression of the physical weakness during neoadjuvant therapy (NAT) in patients with esophageal or gastroesophageal junction cancer is a serious problem; however, prehabilitation during NAT has the potential to overcome the unmet need. Nevertheless, systematic reviews on this topic have not been summarized. Therefore, this systematic review aimed to determine prehabilitation's effectiveness, acceptability, and safety during NAT for patients with esophageal or gastroesophageal junction cancer. An electronic search was performed in the MEDLINE, Web of Science, CENTRAL, CINAHL, and PEDro databases. A meta-analysis was conducted to assess the effectiveness of prehabilitation during NAT, along with a descriptive analysis of acceptance and safety. This study analyzed data from three randomized controlled trials (RCTs) and nine non-RCTs involving 664 patients. The meta-analysis of two RCTs demonstrated that prehabilitation during NAT may be more effective than usual care in enhancing tolerance to NAT and grip strength; moreover, one RCT and three non-RCTs revealed that prehabilitation may reduce the risk of postoperative complications. The adherence rates for exercise programs in two RCTs and seven non-RCTs were 55-76%. Additionally, two studies reported a 76% adherence rate for multimodal prehabilitation programs, including exercise, dietary, and psychological care. Six studies reported no serious prehabilitation-related adverse events during NAT. Prehabilitation during NAT may be a safe and beneficial intervention strategy for patients with esophageal or gastroesophageal junction cancer. However, the investigation of strategies to enhance adherence is essential. Furthermore, additional high-quality RCTs are needed to examine the effect of prehabilitation during NAT.

食管癌或胃食管交界处癌患者在接受新辅助治疗(NAT)期间体力下降是一个严重问题。然而,有关这一主题的系统性综述尚未总结。因此,本系统性综述旨在确定食管癌或胃食管交界处癌患者在 NAT 期间进行康复训练的有效性、可接受性和安全性。我们在 MEDLINE、Web of Science、CENTRAL、CINAHL 和 PEDro 数据库中进行了电子检索。研究人员进行了一项荟萃分析,以评估 NAT 期间预康复的有效性,并对接受度和安全性进行了描述性分析。该研究分析了三项随机对照试验(RCT)和九项非 RCT 的数据,涉及 664 名患者。对两项随机对照试验的荟萃分析表明,在提高对 NAT 的耐受性和握力方面,NAT 期间的预康复训练可能比常规护理更有效;此外,一项随机对照试验和三项非随机对照试验显示,预康复训练可降低术后并发症的风险。两项研究和七项非研究表明,运动计划的坚持率为 55%-76%。此外,有两项研究报告称,包括运动、饮食和心理护理在内的多模式康复计划的坚持率为 76%。六项研究报告称,在 NAT 期间没有发生与康复前相关的严重不良事件。对于食管癌或胃食管交界处癌患者来说,NAT 期间的预康复可能是一种安全有益的干预策略。然而,研究提高依从性的策略至关重要。此外,还需要更多高质量的 RCT 研究来考察 NAT 期间预康复的效果。
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引用次数: 0
Changes in and clinical utility of maximum phonation time and repetitive saliva swallowing test scores after esophagectomy. 食管切除术后最大发音时间和重复唾液吞咽测试评分的变化和临床实用性。
IF 2.2 4区 医学 Q3 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2024-07-01 Epub Date: 2024-05-24 DOI: 10.1007/s10388-024-01065-9
Suguru Maruyama, Yoshihiko Kawaguchi, Kyoko Nitta, Hidenori Akaike, Katsutoshi Shoda, Yudai Higuchi, Takashi Nakayama, Ryo Saito, Wataru Izumo, Koichi Takiguchi, Kensuke Shiraishi, Shinji Furuya, Yuki Nakata, Hidetake Amemiya, Hiromichi Kawaida, Daisuke Ichikawa

Background: Postoperative pneumonia in patients with esophageal cancer occurs due to swallowing dysfunction and aspiration. Recently, maximum phonation time (MPT) assessment and repetitive saliva swallowing test (RSST) have been focused on as swallowing function assessment methods that can identify patients as high risk for pneumonia. We aimed to evaluate the clinical utility of MPT assessment and RSST in patients undergoing oncological esophagectomy.

Methods: In total, 47 consecutive patients who underwent esophagectomy for esophageal cancer between August 2020 and July 2023 were eligible. The perioperative changes in MPTs and RSST scores were examined. In addition, univariate and multivariate analyses were performed to identify the predictive factors of postoperative pneumonia.

Results: The median MPTs before surgery and on postoperative days (PODs) 3, 6, and 10 were 18.4, 7.2, 10.6, and 12.4 s, respectively; postoperative MPTs were significantly lower than preoperative MPT. In addition, the MPT of POD 6 was significantly longer than that of POD 3 (P < 0.05). Meanwhile, there were no significant changes in perioperative RSST scores. Overall, 8 of 47 patients (17.0%) developed pneumonia postoperatively. A short MPT on POD 6 was one of the independent predictive factors for the incidence of postoperative pneumonia (odds ratio: 12.6, 95% confidence interval: 1.29-123, P = 0.03) in the multivariate analysis.

Conclusions: The MPT significantly decreased after esophagectomy. However, the RSST score did not. The MPT on POD6 can be a predictor of postoperative pneumonia.

背景:食管癌患者术后肺炎的发生是由于吞咽功能障碍和误吸。最近,最大发音时间(MPT)评估和重复唾液吞咽试验(RSST)作为吞咽功能评估方法受到关注,它们可以识别肺炎高危患者。我们的目的是评估最大发音时间评估和重复唾液吞咽试验在肿瘤食管切除术患者中的临床实用性:2020年8月至2023年7月期间,共有47名连续接受食管癌食管切除术的患者符合条件。研究了围手术期 MPTs 和 RSST 评分的变化。此外,还进行了单变量和多变量分析,以确定术后肺炎的预测因素:术前和术后第 3、6 和 10 天 (POD) 的中位 MPT 分别为 18.4、7.2、10.6 和 12.4 秒;术后 MPT 显著低于术前 MPT。此外,POD 6 的 MPT 明显长于 POD 3(P 结论:术后 MPT 明显降低:食管切除术后 MPT 明显下降。但是,RSST 评分却没有下降。POD6 的 MPT 可以预测术后肺炎。
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引用次数: 0
Manometric esophagogastric junction barrier metrics as predictors of gastroesophageal reflux 作为胃食管反流预测指标的压力测量食管胃交界处屏障指标
IF 2.4 4区 医学 Q3 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2024-05-01 DOI: 10.1007/s10388-024-01057-9
Shaili Babbar, Matthew Omara, Abraham Khan, Rita Knotts

Background

High-resolution manometry (HRM) tools, like esophagogastric junction contractile integral (EGJ-CI), assess EGJ barrier function.

Goals

This study aimed to evaluate the relationships between manometric EGJ metrics with esophageal acid exposure.

Study

We conducted a retrospective review of 284 patients who underwent HRM and ambulatory reflux testing between 11/2017–1/2020. EGJ-CI and total-EGJ-CI were manually calculated. Pathologic acid exposure was defined as pH < 4 with esophageal acid exposure time (EAET) exceeding 6.0%. Pearson’s correlation, univariable and multivariable regression models were utilized to assess the relationships between pathologic acid exposure and EGJ parameters. Sensitivity and specificity thresholds for EGJ-CI and total EGJ-CI were optimized with ROC analyses.

Results

On univariable analysis, patients with pathologic acid exposure had increased odds of having lower mean basal LES pressures, EGJ-CI, and total EGJ-CI than patients without pathologic acid exposure. On multivariable analysis, age, EGJ-CI and mean DCI were significant predictors of pathologic acid exposure. There were significant, though weak, correlations between EAET and EGJ-CI and total EGJ-CI (r = − 0.18, − 0.19, p < 0.01, respectively). An EGJ-CI cutoff of 44.16 as a predictor for pathologic acid exposure had a sensitivity of 46% and specificity of 42% (AUC 0.60). Total EGJ-CI cutoff of 11,461.3 for pathologic acid exposure had a sensitivity of 44% and a specificity of 43% (AUC 0.62).

Conclusion

EGJ-CI can independently predict pathologic acid exposure. However, the poor correlation between EGJ-CI and acid exposure, as well as the low sensitivity and specificity of calculated thresholds, indicate that mechanisms other than EGJ barrier function may impact acid exposure.

背景高分辨率测压(HRM)工具,如食管胃交界处收缩积分(EGJ-CI),可评估食管胃交界处屏障功能。研究我们对2017年11月至2020年1月期间接受HRM和流动反流检测的284名患者进行了回顾性研究。手动计算了EGJ-CI和总EGJ-CI。病理性酸暴露定义为 pH <4,食管酸暴露时间(EAET)超过 6.0%。利用皮尔逊相关性、单变量和多变量回归模型来评估病理性酸暴露与 EGJ 参数之间的关系。结果在单变量分析中,与无病理性酸暴露的患者相比,有病理性酸暴露的患者具有较低平均基础 LES 压力、EGJ-CI 和总 EGJ-CI 的几率更高。在多变量分析中,年龄、EGJ-CI 和平均 DCI 是病理性酸暴露的重要预测因素。EAET与EGJ-CI和总EGJ-CI之间存在明显的相关性(r = - 0.18, - 0.19, p < 0.01),但相关性较弱。作为病理性酸暴露的预测指标,EGJ-CI 临界值为 44.16,灵敏度为 46%,特异度为 42%(AUC 0.60)。结论EGJ-CI 可独立预测病理性酸暴露。然而,EGJ-CI 与酸暴露之间的相关性较差,计算阈值的灵敏度和特异性也较低,这表明除 EGJ 屏障功能外,其他机制也可能影响酸暴露。
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引用次数: 0
Systemic inflammation score as a predictor of death within one year after esophagectomy 预测食管切除术后一年内死亡的全身炎症评分
IF 2.4 4区 医学 Q3 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2024-04-16 DOI: 10.1007/s10388-024-01059-7
Shinsuke Sato, Eiji Nakatani, Philip Hawke, Erina Nagai, Yusuke Taki, Masato Nishida, Masaya Watanabe, Ko Ohata, Hideyuki Kanemoto, Noriyuki Oba

Background

After radical resection for esophageal cancer, death within 1 year of surgery can occur due both to recurrence and to other diseases, even after postoperative complications have been overcome. This study identified risk factors for early death within 1 year of esophagectomy for reasons other than death in hospital in patients undergoing esophagectomy for esophageal cancer or esophagogastric junction cancer.

Methods

We reviewed 366 patients who underwent esophagectomy without adjuvant treatment between January 2009 and July 2022 for thoracic esophageal cancer or esophagogastric junction cancer. Patients who died within 1 year excluding in-hospital death were compared with those who did not. Multivariable logistic regression analysis was used to identify predictors of death within 1 year after surgery.

Results

Death within 1 year occurred in 32 of 366 patients, 24 from primary disease and 8 from other diseases. Deaths within 1 year were significantly older than the other cases, had significantly lower % vital capacity (%VC), and occurred significantly more often in cases in advanced stages of disease. In a multivariable analysis, a systemic inflammation score (SIS) based on serum albumin level and lymphocyte-to-monocyte ratio was identified as an independent predictor of death within 1 year. As SIS increased, %VC decreased significantly, and CRP level and neutrophil–lymphocyte ratio increased significantly. There was no relationship between SIS and pN. Death within 1 year increased as SIS increased (p = 0.001 for trend).

Conclusion

SIS assessment undertaken before beginning esophageal cancer treatment is a useful predictor of death within 1 year of surgery.

背景食管癌根治性切除术后,即使术后并发症已被克服,术后 1 年内仍有可能因复发或其他疾病而死亡。本研究确定了因食管癌或食管胃交界处癌接受食管切除术的患者在术后1年内因住院死亡以外的原因而提前死亡的风险因素。方法我们回顾了2009年1月至2022年7月期间因胸腔食管癌或食管胃交界处癌接受食管切除术且未进行辅助治疗的366例患者。将 1 年内死亡(不包括院内死亡)的患者与未死亡的患者进行比较。结果366名患者中有32人在1年内死亡,其中24人死于原发性疾病,8人死于其他疾病。1年内死亡的患者年龄明显大于其他病例,生命容量百分比(%VC)明显低于其他病例,且晚期病例明显多于其他病例。在一项多变量分析中,基于血清白蛋白水平和淋巴细胞与单核细胞比值的全身炎症评分(SIS)被确定为一年内死亡的独立预测因子。随着 SIS 的增加,%VC 显著下降,CRP 水平和中性粒细胞-淋巴细胞比值显著增加。SIS 和 pN 之间没有关系。结论在开始食管癌治疗前进行 SIS 评估是预测术后 1 年内死亡的有效指标。
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引用次数: 0
First-line pembrolizumab plus chemotherapy for advanced/metastatic esophageal cancer: 1-year extended follow-up in the Japanese subgroup of the phase 3 KEYNOTE-590 study 晚期/转移性食管癌的一线pembrolizumab联合化疗:3期KEYNOTE-590研究日本亚组的1年延长随访
IF 2.4 4区 医学 Q3 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2024-04-12 DOI: 10.1007/s10388-024-01053-z
Ken Kato, Takashi Kojima, Hiroki Hara, Akihito Tsuji, Hisateru Yasui, Kei Muro, Taroh Satoh, Takashi Ogata, Ryu Ishihara, Masahiro Goto, Hideo Baba, Tomohiro Nishina, ShiRong Han, Keiichi Iwakami, Naoyoshi Yatsuzuka, Toshihiko Doi

Background

First-line pembrolizumab plus chemotherapy (pembrolizumab–chemotherapy) demonstrated improved efficacy and a manageable safety profile versus placebo plus chemotherapy (placebo–chemotherapy) in the subgroup analysis of Japanese patients with advanced/metastatic esophageal cancer in KEYNOTE-590 at a median follow-up of 24.4 months. Longer-term data from the Japanese subgroup analysis of KEYNOTE-590 are reported.

Methods

Patients were randomly assigned 1:1 to pembrolizumab 200 mg or placebo every 3 weeks for ≤ 35 cycles plus chemotherapy (cisplatin 80 mg/m2 and 5-fluorouracil 800 mg/m2/day). Endpoints included overall survival (OS) and progression-free survival (PFS; investigator-assessed per RECIST v1.1; dual primary) and safety (secondary). Early tumor shrinkage (ETS) and depth of response (DpR) were assessed post hoc.

Results

Overall, 141 patients were enrolled in Japan. As of July 9, 2021, median follow-up was 36.6 months (range, 29.8–45.7). Pembrolizumab–chemotherapy showed a trend toward favorable OS (hazard ratio [HR], 0.70; 95% confidence interval [CI] 0.47–1.03) and PFS (0.57; 0.39–0.83) versus placebo–chemotherapy. In the pembrolizumab–chemotherapy group, patients with ETS ≥ 20% (55/74; 74.3%) versus < 20% (19/74; 25.7%) had favorable OS (HR, 0.23; 95% CI 0.12–0.42) and PFS (0.24; 0.13–0.43). Patients with DpR ≥ 60% (31/74; 41.9%) versus < 60% (43/74; 58.1%) had favorable OS (HR, 0.37; 95% CI 0.20–0.68) and PFS (0.24; 0.13–0.43). Grade 3–5 treatment-related adverse events occurred in 55/74 patients (74.3%) with pembrolizumab–chemotherapy and 41/67 patients (61.2%) with placebo–chemotherapy.

Conclusions

With longer-term follow-up of Japanese patients with advanced/metastatic esophageal cancer, efficacy continued to favor pembrolizumab–chemotherapy compared with placebo–chemotherapy, with no new safety signals observed.

Clinical trial registration: ClinicalTrials.gov, NCT03189719.

背景在KEYNOTE-590日本晚期/转移性食管癌患者亚组分析中,一线pembrolizumab联合化疗(pembrolizumab-化疗)与安慰剂联合化疗(安慰剂-化疗)相比,在中位随访24.4个月时显示出更好的疗效和可控的安全性。本文报告了KEYNOTE-590日本亚组分析中的长期数据。方法将患者按1:1随机分配至pembrolizumab 200 mg或安慰剂,每3周一次,持续≤35个周期,同时进行化疗(顺铂80 mg/m2和5-氟尿嘧啶800 mg/m2/天)。终点包括总生存期(OS)和无进展生存期(PFS;根据 RECIST v1.1 由研究者评估;双重主要终点)和安全性(次要终点)。对早期肿瘤缩小(ETS)和反应深度(DpR)进行了事后评估。截至 2021 年 7 月 9 日,中位随访时间为 36.6 个月(29.8-45.7 个月)。与安慰剂-化疗相比,Pembrolizumab-化疗显示出良好的OS(危险比[HR],0.70;95%置信区间[CI]0.47-1.03)和PFS(0.57;0.39-0.83)趋势。在pembrolizumab-化疗组中,ETS≥20%(55/74;74.3%)的患者与< 20%(19/74;25.7%)的患者相比,具有良好的OS(HR,0.23;95% CI 0.12-0.42)和PFS(0.24;0.13-0.43)。DpR≥60%(31/74;41.9%)与< 60%(43/74;58.1%)的患者具有良好的OS(HR,0.37;95% CI 0.20-0.68)和PFS(0.24;0.13-0.43)。结论通过对日本晚期/转移性食管癌患者的长期随访发现,与安慰剂化疗相比,pembrolizumab化疗的疗效仍然更佳,且未观察到新的安全性信号:临床试验注册:ClinicalTrials.gov,NCT03189719。
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