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Characteristics, treatment patterns, and outcomes in patients with high-risk locally advanced cervical cancer 高危局部晚期宫颈癌患者的特征、治疗模式和结果
Q3 Medicine Pub Date : 2024-01-01 DOI: 10.1016/j.ctarc.2024.100800
Francesca Coutinho , Mugdha Gokhale , Charlotte Doran , Matthew Monberg , Karin Yamada , Lei Chen

Objective

To characterize the real-world treatment patterns and outcomes of patients with high-risk locally advanced cervical cancer (HR-LACC).

Methods

This retrospective study identified and randomly selected adults diagnosed between 2010 and 2018 from the ConcertAI Oncology Dataset. For patients initially treated with concurrent chemoradiotherapy (CCRT), we estimated real-world progression-free survival (rwPFS) among those with persistent disease, real-world time on CCRT, and recurrence-free survival (rwRFS) using Kaplan-Meier methods.

Results

The cohort included 300 patients. Median age at diagnosis was 51 years. 53.7 % were White and 30.0 % were Black; 52.0 % were premenopausal; 89.3 % had squamous cell histology; 75.3 % had stage III disease, and 92.7 % had no evidence of performance status impairment. Initial treatment included CCRT (N = 229), surgery (N = 28), antineoplastics only (N = 11), and radiation only (N = 5). Twenty-seven patients were untreated. Baseline characteristics for the CCRT-first patients were similar to the overall cohort; their median real-world time on treatment was 1.6 months; 78.2 % received cisplatin for a median of 1.2 months; 28.4 % received antineoplastics after CCRT, and 11.8 % initiated a second antineoplastic therapy. Of the CCRT-first patients, 27/143 with a complete response had subsequent recurrent disease (median rwRFS not reached). 179 patients had persistent disease, among whom median (95 % confidence interval [CI]) rwPFS was 29.7 (16.9–59.3) months.

Conclusion

In this study of United States-based clinical practices, most HR-LACC patients received CCRT as initial treatment. Many patients developed persistent disease after CCRT indicating a need for improved first treatment and maintenance options.

目的描述高危局部晚期宫颈癌(HR-LACC)患者的真实世界治疗模式和结果。方法这项回顾性研究从ConcertAI肿瘤数据集中识别并随机选择了2010年至2018年间确诊的成人患者。对于最初接受同期化放疗(CCRT)治疗的患者,我们使用 Kaplan-Meier 方法估算了疾病持续存在者的真实世界无进展生存期(rwPFS)、接受 CCRT 的真实世界时间以及无复发生存期(rwRFS)。诊断时的中位年龄为 51 岁。53.7%为白人,30.0%为黑人;52.0%绝经前;89.3%为鳞状细胞组织学;75.3%为III期疾病,92.7%无表现状态受损证据。初始治疗包括CCRT(229例)、手术(28例)、单纯抗肿瘤药物(11例)和单纯放射治疗(5例)。27名患者未经治疗。CCRT首发患者的基线特征与总体队列相似;他们在真实世界中的治疗时间中位数为1.6个月;78.2%的患者接受顺铂治疗,中位数为1.2个月;28.4%的患者在CCRT后接受抗肿瘤治疗,11.8%的患者开始第二次抗肿瘤治疗。在首次接受 CCRT 治疗的患者中,27/143 例获得完全应答,但随后疾病复发(未达到中位 rwRFS)。179例患者病情持续存在,其中中位(95%置信区间[CI])rwPFS为29.7(16.9-59.3)个月。许多患者在接受 CCRT 治疗后出现了顽固性疾病,这表明需要改进首次治疗和维持治疗方案。
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引用次数: 0
Considerations for selecting second-line treatment in patients with progressive small cell lung cancer and the use of Lurbinectedin in this setting 选择二线治疗进展期小细胞肺癌患者的注意事项以及在这种情况下使用鲁比替丁(Lurbinectedin
Q3 Medicine Pub Date : 2024-01-01 DOI: 10.1016/j.ctarc.2024.100803
Firas Badin

Small cell lung cancer (SCLC) is characterized by high initial responses to platinum-based chemotherapy plus immune checkpoint inhibitors; however, most patients quickly relapse and require subsequent treatment. Second-line treatment options in SCLC remain limited, and treatment algorithms are not completely consistent across the available guidelines in this setting. This review highlights key considerations regarding selection of second-line treatment for patients with relapsed SCLC. In particular, the role of lurbinectedin, which was first approved in 2020, representing the first significant addition to treatment algorithms in this setting for decades, is summarized. Future directions, including the identification of SCLC subtypes and the need for predictive biomarkers to guide patient selection and targeted therapy, are also discussed.

小细胞肺癌(SCLC)的特点是对铂类化疗加免疫检查点抑制剂的初始反应较高;然而,大多数患者很快就会复发,需要进行后续治疗。小细胞肺癌的二线治疗方案仍然有限,而且现有指南中的治疗算法也不完全一致。本综述强调了复发 SCLC 患者选择二线治疗的关键注意事项。其中特别总结了鲁比替丁的作用,该药于2020年首次获批,是数十年来该领域治疗算法的首次重要补充。此外,还讨论了未来的发展方向,包括确定SCLC亚型以及对预测性生物标志物的需求,以指导患者的选择和靶向治疗。
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引用次数: 0
Immunoexpression pattern of TLR3 and TLR7 in minor salivary gland adenoid cystic carcinoma and its role in prognosis 小唾液腺腺样囊性癌中 TLR3 和 TLR7 的免疫表达模式及其在预后中的作用
Q3 Medicine Pub Date : 2024-01-01 DOI: 10.1016/j.ctarc.2024.100822
Aleksi Rytkönen , Mine Eray , Auli Suominen , Antti Mäkitie , Caj Haglund , Jaana Hagström , Hanna K. Laine

Objectives

Adenoid cystic carcinoma (ACC) of the salivary glands has poor long-term prognosis and a high metastatic rate. Toll-like receptors (TLRs), first-line immune activators, have been associated with both tumor progression and suppression. We aimed to study TLR3 and TLR7 behavior in ACC.

Materials and methods

We studied TLR3 and TLR7 immunoexpression of 46 minor salivary gland ACCs diagnosed at the Department of Otorhinolaryngology – Head and Neck Surgery, Helsinki University Hospital, Helsinki, Finland over the period 1974–2012. The associations of TLR3 and TLR7 immunoexpression with clinicopathological factors were evaluated by χ2-test and Fisher's exact test.

Results

In the majority of samples, both TLR3 and TLR7 were immunoexpressed in cytoplasm. The immunoexpression was heterogeneous between individual tumors. Stronger TLR7 immunoexpression associated with recurrence rate and poorer disease-specific survival (DSS). TLR3 did not associate significantly with survival although we found an inverse correlation between TLR3 and TLR7 immunopositivity. Hence, when TLR3 immunoexpression was negative or mild, TLR7 immunoexpression was moderate to strong, and vice versa.

Conclusions

TLR3 and TLR7 are immunoexpressed in minor salivary gland ACC. TLR7 is potentially an independent prognostic marker for recurrence rate and DSS.

目的 唾液腺腺样囊性癌(ACC)长期预后不良,转移率高。Toll样受体(TLRs)是一线免疫激活剂,与肿瘤的进展和抑制都有关系。材料与方法我们研究了芬兰赫尔辛基市赫尔辛基大学医院耳鼻咽喉-头颈外科在 1974-2012 年期间诊断出的 46 例小唾液腺 ACC 的 TLR3 和 TLR7 免疫表达。结果在大多数样本中,TLR3和TLR7均在细胞质中免疫表达。不同肿瘤的免疫表达存在差异。较强的TLR7免疫表达与复发率和较差的疾病特异性生存率(DSS)有关。尽管我们发现 TLR3 和 TLR7 免疫阳性之间存在反相关性,但 TLR3 与生存率的关系并不明显。因此,当TLR3免疫表达为阴性或轻度时,TLR7免疫表达为中度到强度,反之亦然。TLR7可能是复发率和DSS的独立预后指标。
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引用次数: 0
Factors associated with delay in diagnosis of oral cancers 与口腔癌诊断延误有关的因素
Q3 Medicine Pub Date : 2024-01-01 DOI: 10.1016/j.ctarc.2024.100831
Deepa Swaminathan, Nebu Abraham George, Shaji Thomas, Elizabeth Mathew Iype

Background

Oral cancer is one of the ten most common malignancies in the world and approximately 90 % of cases are OSCC. Despite the progress in available treatment modalities, the mortality of patients with OSCC has remained steadily high during the last 20 years. Survival data is strongly influenced by the timing of diagnosis: with more than 50 % of patients being diagnosed at an advanced stage, and their 5-year survival rate being less than 50 %. Therefore, early diagnosis plays a crucial role in improving a patient's prognosis, as early stage cancers show a survival rate of over 90 %, whereas it drops to 5–20 % stage III and IV disease. This prospective study has been conducted with an aim of assessing diagnostic delays and looking at the various patient and tumour factors and their association with them.

Methodology

This prospective observational study was conducted from December 2023 to February 2024. The cases for the present study included cases of oral squamous cell carcinoma diagnosed by clinical, radiological and/or histological confirmation. The patient delay was recorded in days as informed by the patients themselves, about the onset of their symptoms to time taken to seek medical attention. This was then associated with various patient and tumour related factors.

Result

A total of 120 (n) patients were interviewed and these patient's case sheets were recruited for the present study. The median primary delay for the entire population was found to be 90 days while the median secondary delay was 11 days. The median total delay was found to be 106 days. The median total delay was higher among females and younger population though this was not statistically significant. However education showed a significant impact with literate patients presenting much earlier. Smoking and alcohol abuse did not show a significant effect on delay. Various tumour factors also did not show any statistically significant effect on delay although, patients with advanced stage and nodal secondaries presented at a much later time.

Conclusion

Both patient and tumour related factors as well as the decisions made during the first contact with health care providers influence delay before specialist consultation. Raising awareness of HNC symptoms among the general population and GPs is the way to get patients to curative treatment without long delay.

背景口腔癌是世界上最常见的十大恶性肿瘤之一,约 90% 的病例为 OSCC。尽管现有的治疗方法取得了进展,但在过去 20 年中,OSCC 患者的死亡率一直居高不下。存活率数据受到诊断时间的很大影响:50%以上的患者被诊断为晚期,其 5 年存活率不到 50%。因此,早期诊断在改善患者预后方面起着至关重要的作用,因为早期癌症的存活率超过 90%,而 III 期和 IV 期癌症的存活率仅为 5%-20%。本前瞻性研究旨在评估诊断延误情况,并研究各种患者和肿瘤因素及其关联。本研究的病例包括经临床、放射学和/或组织学确诊的口腔鳞状细胞癌病例。根据患者自己提供的信息,以天为单位记录了患者从症状出现到就医的延误时间。结果 本研究共访问了 120(n)名患者,并收集了这些患者的病例表。研究发现,全部患者的主要延误时间中位数为 90 天,次要延误时间中位数为 11 天。总延误时间的中位数为 106 天。女性和年轻人的总延误时间中位数较高,但在统计上并不显著。不过,教育程度对识字患者的发病时间有明显影响。吸烟和酗酒对延误没有明显影响。尽管晚期和结节二期患者的就诊时间要晚得多,但各种肿瘤因素对就诊延迟也没有明显的统计学影响。提高普通人群和全科医生对 HNC 症状的认识是让患者尽快接受治疗的途径。
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引用次数: 0
Front-line liquid biopsy for early molecular assessment and treatment of hospitalized lung cancer patients 用于住院肺癌患者早期分子评估和治疗的前沿液体活检技术
Q3 Medicine Pub Date : 2024-01-01 DOI: 10.1016/j.ctarc.2024.100839

Background

Molecular characterization is pivotal for managing non-small cell lung cancer (NSCLC), although this process is often time-consuming and patients’ conditions might worsen while molecular analyses are processed.

Our primary aim was to evaluate the performance of “up-front” next-generation sequencing (NGS) through liquid biopsy (LB) of hospitalized patients with newly detected lung neoplasm in parallel with conventional diagnosis. The secondary aim included longitudinal monitoring through LB of patients with oncogenic alterations at baseline.

Methods

We enrolled 47 consecutive patients immediately after hospitalization and radiological detection of symptomatic lung neoplasm. LB from peripheral blood was performed at baseline, in parallel with conventional biopsy (CB), when feasible. Additionally, LBs were repeated during treatment in patients with actionable gene alterations at baseline. Oncomine™ Lung cfTNA Research Assay panel was employed for processing plasma samples in NGS.

Results

47 hospitalized patients were enrolled. LB identified 28 patients with gene alterations, including mutations of EGFR (n = 7), KRAS (n = 12), ERBB2 (n = 1), TP53 (n = 2), BRAF (n = 1), one ALK rearrangement, and 4 patients with combined mutations involving EGFR, KRAS and PIK3CA.

LB and CB were consistent, except for two patients. Three patients with positive LB for oncogenic drivers did not undergo CB due to contraindications.

Median time to molecular results after LB was significantly lower compared to time to molecular report after CB (11 versus 22 days, p < 0.001).

Conclusions

Despite limited numbers, our study supports the role of front-line LB for improving management of symptomatic patients with lung cancer, potentially leading to early targeted therapy initiation.

背景分子特征描述对于非小细胞肺癌(NSCLC)的治疗至关重要,但这一过程往往耗时较长,而且在分子分析处理过程中患者的病情可能会恶化。我们的主要目的是评估通过液体活检(LB)对新发现肺肿瘤的住院患者进行 "先期 "下一代测序(NGS)与传统诊断的性能。次要目的包括通过液态活检对基线存在致癌基因改变的患者进行纵向监测。方法我们连续招募了 47 名住院并经放射学检测发现无症状肺部肿瘤的患者。在可行的情况下,在常规活检(CB)的同时,对基线患者的外周血进行LB检测。此外,对基线时出现可操作基因改变的患者,在治疗期间重复进行肺活检。在 NGS 中采用 Oncomine™ Lung cfTNA 研究试剂盒处理血浆样本。LB 发现 28 例患者存在基因改变,包括 EGFR(7 例)、KRAS(12 例)、ERBB2(1 例)、TP53(2 例)、BRAF(1 例)突变,1 例 ALK 重排,以及 4 例 EGFR、KRAS 和 PIK3CA 联合突变患者。结论尽管人数有限,但我们的研究支持一线肺结核治疗在改善无症状肺癌患者管理方面的作用,有可能导致早期靶向治疗的启动。
{"title":"Front-line liquid biopsy for early molecular assessment and treatment of hospitalized lung cancer patients","authors":"","doi":"10.1016/j.ctarc.2024.100839","DOIUrl":"10.1016/j.ctarc.2024.100839","url":null,"abstract":"<div><h3>Background</h3><p>Molecular characterization is pivotal for managing non-small cell lung cancer (NSCLC), although this process is often time-consuming and patients’ conditions might worsen while molecular analyses are processed.</p><p>Our primary aim was to evaluate the performance of “up-front” next-generation sequencing (NGS) through liquid biopsy (LB) of hospitalized patients with newly detected lung neoplasm in parallel with conventional diagnosis. The secondary aim included longitudinal monitoring through LB of patients with oncogenic alterations at baseline.</p></div><div><h3>Methods</h3><p>We enrolled 47 consecutive patients immediately after hospitalization and radiological detection of symptomatic lung neoplasm. LB from peripheral blood was performed at baseline, in parallel with conventional biopsy (CB), when feasible. Additionally, LBs were repeated during treatment in patients with actionable gene alterations at baseline. Oncomine™ Lung cfTNA Research Assay panel was employed for processing plasma samples in NGS.</p></div><div><h3>Results</h3><p>47 hospitalized patients were enrolled. LB identified 28 patients with gene alterations, including mutations of <em>EGFR</em> (<em>n</em> = 7), <em>KRAS</em> (<em>n</em> = 12), <em>ERBB2</em> (<em>n</em> = 1), <em>TP53</em> (<em>n</em> = 2), <em>BRAF</em> (<em>n</em> = 1), one <em>ALK</em> rearrangement, and 4 patients with combined mutations involving <em>EGFR, KRAS</em> and <em>PIK3CA</em>.</p><p>LB and CB were consistent, except for two patients. Three patients with positive LB for oncogenic drivers did not undergo CB due to contraindications.</p><p>Median time to molecular results after LB was significantly lower compared to time to molecular report after CB (11 <em>versus</em> 22 days, <em>p</em> &lt; 0.001).</p></div><div><h3>Conclusions</h3><p>Despite limited numbers, our study supports the role of front-line LB for improving management of symptomatic patients with lung cancer, potentially leading to early targeted therapy initiation.</p></div>","PeriodicalId":9507,"journal":{"name":"Cancer treatment and research communications","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2468294224000510/pdfft?md5=7de73d36aa806d8764a34cae1943472b&pid=1-s2.0-S2468294224000510-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142096668","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Neoadjuvant treatment for pancreatic cancer: Controversies and advances 胰腺癌的新辅助治疗:争议与进展
Q3 Medicine Pub Date : 2024-01-01 DOI: 10.1016/j.ctarc.2024.100804
Douglas Dias e Silva, Vincent Chung

Despite the advancements in the treatment of localized pancreatic cancer, several unresolved issues persist in clinical practice, especially in the neoadjuvant setting. These include determining the criteria for selecting patients for treatment, identifying the most effective chemotherapy regimens, understanding the role of radiotherapy, and accurately assessing how patients respond to treatment. Current strategies for assessing patients before surgery involve thoroughly evaluating their overall health status, analyzing tumor markers, and using advanced imaging techniques. However, existing methods for staging the disease still have limitations when it comes to accurately detecting metastatic cancer. The ongoing debate between performing surgery upfront or administering neoadjuvant therapy highlights the need for robust clinical evidence to guide treatment decisions effectively. This review analyzes the evidence regarding controversial topics in neoadjuvant pancreatic cancer treatment and discusses further research efforts to enhance patient outcomes. To improve the outcomes found with surgery alone, multimodal treatment with chemotherapy.

尽管局部胰腺癌的治疗取得了进展,但临床实践中仍存在一些尚未解决的问题,尤其是在新辅助治疗方面。这些问题包括确定选择患者接受治疗的标准、确定最有效的化疗方案、了解放疗的作用以及准确评估患者对治疗的反应。目前的术前评估策略包括全面评估患者的整体健康状态、分析肿瘤标志物和使用先进的成像技术。然而,现有的疾病分期方法在准确检测转移性癌症方面仍存在局限性。关于先期手术还是进行新辅助治疗的争论仍在继续,这凸显出需要强有力的临床证据来有效指导治疗决策。本综述分析了有关胰腺癌新辅助治疗中争议性话题的证据,并讨论了为提高患者预后所做的进一步研究工作。为了改善单纯手术的疗效,化疗与多模式治疗相结合。
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引用次数: 0
Implant reconstruction after mastectomy–A review and summary of current literature 乳房切除术后的植入物重建--当前文献综述与总结
Q3 Medicine Pub Date : 2024-01-01 DOI: 10.1016/j.ctarc.2024.100821
Thomas Kidd, Gerard Mccabe, Joanna Tait, Dhananjay Kulkarni

Introduction

The landscape of breast reconstruction has changed significantly with a shift in focus to include the restoration of a patient's quality of life after cancer. Reconstructive options can be divided into alloplastic (implant based) and autologous (tissue based). This paper aims to provide a current educational summary regarding implant-based reconstruction after breast cancer surgery and review the current literature.

Method

A review of the literature was conducted utilising standard PRISMA flowchart. Databases searched included Pubmed, EMBASE, and MEDLINE.

Results

Current practice is explored within the text, including types of implants, indications, and surgical approaches. Heterogenous cohorts, surgical technique variation, and selection bias can make comparison of the literature challenging. The major evidence reviews of implant-based reconstruction topics are discussed including, ADM use, radiotherapy, and complications. Despite the benefits of autologous reconstruction, implant-based techniques still represent a significant proportion of reconstructive breast procedures. However, implant-reconstruction is not without its risks and limitations and, with such variety in practice, there remains a lack of high-quality evidence guiding practice. Most importantly, patients need to be counselled about the pros and cons of each choice, particularly with the increasing utilisation of radiotherapy post-reconstruction. Ultimately, the patient and surgeon should reach a decision in full knowledge of the risks and potential outcomes.

Conclusions

Further research is required into implant-based reconstructive therapy, which will allow a greater consensus for management and a pathway for both surgeons and patients.

导言:随着癌症患者生活质量的恢复,乳房重建的重点发生了重大变化。重建方法可分为异体(以植入物为基础)和自体(以组织为基础)两种。本文旨在提供一份有关乳腺癌术后植入物重建的教育摘要,并对现有文献进行回顾。方法采用标准的 PRISMA 流程图对文献进行回顾。结果文中探讨了当前的做法,包括植入物的类型、适应症和手术方法。不同的队列、手术技术的差异和选择偏差会使文献比较具有挑战性。文中讨论了基于植入物的重建的主要证据回顾,包括 ADM 的使用、放射治疗和并发症。尽管自体重建有很多优点,但植入物重建技术在乳房重建手术中仍占很大比例。然而,植入物再造并非没有风险和局限性,而且由于实践中的多样性,仍然缺乏高质量的证据来指导实践。最重要的是,患者需要了解每种选择的利弊,尤其是在乳房再造术后越来越多地使用放射治疗的情况下。最终,患者和外科医生应该在充分了解风险和潜在结果的基础上做出决定。结论需要进一步研究以植入物为基础的重建疗法,这将为外科医生和患者的管理和治疗路径达成更多共识。
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引用次数: 0
On-body injector pegfilgrastim for chemotherapy-induced neutropenia prophylaxis: Current Status 用于预防化疗引起的中性粒细胞减少症的体外注射器 pegfilgrastim:现状。
Q3 Medicine Pub Date : 2024-01-01 DOI: 10.1016/j.ctarc.2024.100824
Ivo Abraham , Jeffrey Crawford , Lee Schwartzberg

Introduction

Myelosuppression, a challenge in cancer treatment, often results in severe complications. Prophylactic granulocyte colony-stimulating factors, particularly pegfilgrastim, mitigate chemotherapy-induced neutropenia. This narrative review evaluates the role of on-body injector (OBI) devices for pegfilgrastim administration. A comprehensive search strategy of PubMed and AI-powered intuitive search tools, complemented by authors’ contributions, yielded a body of papers presenting evidence on OBI devices, their effectiveness and safety, the benefits and challenges of OBI versus pre-filled syringe administration, patient preferences for pegfilgrastim administration, and economic considerations.

Discussion

OBI devices prove effective and safe, with advantages such as reduced clinic visits and enhanced adherence. Studies highlight cost-efficiency and expanded access, emphasizing the socioeconomic context. Patient and provider preferences underscore the potential of OBI devices in cancer care, with implications for healthcare resource utilization and pharmacoeconomics.

Conclusion

The value proposition of OBI devices lies in improving patient outcomes, convenience, resource optimization, and enhancing the overall cancer care experience. As biosimilar OBIs enter the market, they may offer cost savings, further influencing their adoption and their positioning as a cost-efficient alternative in cancer care. Ongoing research and technological advancements are expected to contribute to the broader acceptance of OBI devices in cancer care delivery.

简介骨髓抑制是癌症治疗中的一个难题,往往会导致严重的并发症。预防性粒细胞集落刺激因子,尤其是 pegfilgrastim,可减轻化疗引起的中性粒细胞减少症。这篇叙述性综述评估了体外注射器(OBI)设备在pegfilgrastim给药中的作用。通过对 PubMed 和人工智能直观搜索工具的综合搜索策略以及作者的贡献,我们获得了大量论文,这些论文提供了有关 OBI 装置的证据、其有效性和安全性、OBI 与预灌封注射器给药的优势和挑战、患者对培吉司汀给药的偏好以及经济考虑因素:讨论:事实证明,OBI 装置既有效又安全,具有减少就诊次数和提高依从性等优点。研究强调了成本效益和扩大使用范围,并强调了社会经济背景。患者和医疗服务提供者的偏好强调了 OBI 设备在癌症治疗中的潜力,并对医疗资源利用和药物经济学产生了影响:结论:OBI 设备的价值主张在于改善患者预后、提高便利性、优化资源以及改善整体癌症治疗体验。随着生物仿制药 OBI 进入市场,它们可能会节约成本,从而进一步影响其采用率,并将其定位为癌症治疗中具有成本效益的替代品。正在进行的研究和技术进步预计将有助于在癌症治疗中更广泛地接受 OBI 设备。
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引用次数: 0
ctDNA-based minimal residual disease detection in lung cancer patients treated with curative intended chemoradiotherapy using a clinically transferable approach 基于ctDNA的肺癌患者最小残留病检测,采用一种可临床移植的方法进行治疗性预期放化疗
Q3 Medicine Pub Date : 2024-01-01 DOI: 10.1016/j.ctarc.2024.100802
Lærke Rosenlund Nielsen , Simone Stensgaard , Peter Meldgaard , Boe Sandahl Sorensen

Background

Reliable biomarkers are needed to identify tumor recurrence of non-small cell lung cancer (NSCLC) patients after chemoradiotherapy (CRT) with curative intent. This could improve consolidation therapy of progressing patients. However, the approach of existing studies has limited transferability to the clinic.

Materials and methods

A retrospective analysis of 135 plasma samples from 56 inoperable NSCLC patients who received CRT with curative intent was performed. Plasma samples collected at baseline, at the first check-up (average 1.6 months post-RT), and at the second check-up (average 4.5 months post-RT) were analyzed by deep sequencing with a commercially available cancer personalized profiling strategy (CAPP-Seq) using a tumor-agnostic approach.

Results

Detection of circulating tumor DNA (ctDNA) at 4.5 months after therapy was significantly associated with higher odds of tumor recurrence (OR: 5.4 (CI: 1.1–31), Fisher's exact test: p-value = 0.022), and shorter recurrence-free survival (RFS) (HR: 4.1 (CI: 1.7–10); log-rank test: p-value = 9e-04). In contrast, detection of ctDNA at 1.6 months after therapy was not associated with higher odds of tumor recurrence (OR: 2.7 (CI: 0.67–12), Fisher's exact test: p-value = 0.13) or shorter RFS (HR: 1.5 (CI: 0.67–3.3); log-rank test: p-value = 0.32).

Conclusion

This study demonstrates that the detection of ctDNA can be used to identify minimal residual disease 4.5 months after CRT in NSCLC patients using a commercially available kit and a tumor-agnostic approach. Furthermore, the time point of collecting the plasma sample after CRT has decisive importance for the prognostic value of ctDNA.

Micro abstract

This study analysed 135 plasma samples from 56 NSCLC patients treated with curative intent chemoradiotherapy using a tumor-agnostic approach. Detecting ctDNA at 4.5 months post-treatment was linked to higher recurrence odds, indicating ctDNA's potential as a biomarker for identifying residual disease after treatment with curative intent. Importantly, the study emphasizes the importance of timing for accurate ctDNA analysis results.

背景需要可靠的生物标志物来识别非小细胞肺癌(NSCLC)患者在接受治愈性化疗(CRT)后的肿瘤复发情况。这可以改善进展期患者的巩固治疗。然而,现有研究的方法在临床上的可移植性有限。材料与方法对56名接受了以治愈为目的的CRT的不能手术的NSCLC患者的135份血浆样本进行了回顾性分析。对基线、首次检查(RT 后平均 1.6 个月)和第二次检查(RT 后平均 4.5 个月)收集的血浆样本进行了深度测序分析,采用的是市售的癌症个体化图谱分析策略(CAPP-Seq),采用的是肿瘤诊断方法。结果治疗后4.5个月检测到循环肿瘤DNA(ctDNA)与较高的肿瘤复发几率(OR:5.4(CI:1.1-31);费雪精确检验:P值=0.022)和较短的无复发生存期(RFS)(HR:4.1(CI:1.7-10);log-rank检验:P值=9e-04)显著相关。相反,治疗后 1.6 个月检测到 ctDNA 与肿瘤复发几率升高(OR:2.7 (CI:0.67-12);费雪精确检验:P 值 = 0.13)或 RFS 缩短(HR:1.5 (CI:0.67-3.3);对数秩检验:P 值 = 0.32)无关。结论本研究表明,使用市售试剂盒和肿瘤诊断方法,ctDNA检测可用于识别NSCLC患者CRT 4.5个月后的最小残留病。此外,CRT后收集血浆样本的时间点对ctDNA的预后价值具有决定性意义。微摘要这项研究采用肿瘤诊断方法分析了56名接受治愈性化疗的NSCLC患者的135份血浆样本。在治疗后4.5个月检测到ctDNA与较高的复发几率有关,这表明ctDNA有可能成为一种生物标志物,用于识别治愈性化疗后的残留疾病。重要的是,该研究强调了时机对准确的ctDNA分析结果的重要性。
{"title":"ctDNA-based minimal residual disease detection in lung cancer patients treated with curative intended chemoradiotherapy using a clinically transferable approach","authors":"Lærke Rosenlund Nielsen ,&nbsp;Simone Stensgaard ,&nbsp;Peter Meldgaard ,&nbsp;Boe Sandahl Sorensen","doi":"10.1016/j.ctarc.2024.100802","DOIUrl":"https://doi.org/10.1016/j.ctarc.2024.100802","url":null,"abstract":"<div><h3>Background</h3><p>Reliable biomarkers are needed to identify tumor recurrence of non-small cell lung cancer (NSCLC) patients after chemoradiotherapy (CRT) with curative intent. This could improve consolidation therapy of progressing patients. However, the approach of existing studies has limited transferability to the clinic.</p></div><div><h3>Materials and methods</h3><p>A retrospective analysis of 135 plasma samples from 56 inoperable NSCLC patients who received CRT with curative intent was performed. Plasma samples collected at baseline, at the first check-up (average 1.6 months post-RT), and at the second check-up (average 4.5 months post-RT) were analyzed by deep sequencing with a commercially available cancer personalized profiling strategy (CAPP-Seq) using a tumor-agnostic approach.</p></div><div><h3>Results</h3><p>Detection of circulating tumor DNA (ctDNA) at 4.5 months after therapy was significantly associated with higher odds of tumor recurrence (OR: 5.4 (CI: 1.1–31), Fisher's exact test: <em>p</em>-value = 0.022), and shorter recurrence-free survival (RFS) (HR: 4.1 (CI: 1.7–10); log-rank test: <em>p</em>-value = 9e-04). In contrast, detection of ctDNA at 1.6 months after therapy was not associated with higher odds of tumor recurrence (OR: 2.7 (CI: 0.67–12), Fisher's exact test: <em>p</em>-value = 0.13) or shorter RFS (HR: 1.5 (CI: 0.67–3.3); log-rank test: <em>p</em>-value = 0.32).</p></div><div><h3>Conclusion</h3><p>This study demonstrates that the detection of ctDNA can be used to identify minimal residual disease 4.5 months after CRT in NSCLC patients using a commercially available kit and a tumor-agnostic approach. Furthermore, the time point of collecting the plasma sample after CRT has decisive importance for the prognostic value of ctDNA.</p></div><div><h3>Micro abstract</h3><p>This study analysed 135 plasma samples from 56 NSCLC patients treated with curative intent chemoradiotherapy using a tumor-agnostic approach. Detecting ctDNA at 4.5 months post-treatment was linked to higher recurrence odds, indicating ctDNA's potential as a biomarker for identifying residual disease after treatment with curative intent. Importantly, the study emphasizes the importance of timing for accurate ctDNA analysis results.</p></div>","PeriodicalId":9507,"journal":{"name":"Cancer treatment and research communications","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2468294224000145/pdfft?md5=47b4ed51e233a53acd993e7bdb48e2c2&pid=1-s2.0-S2468294224000145-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139999323","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Assessment of safety and tolerability of subcutaneous trastuzumab in patients with HER2-positive early breast cancer: Results of an open-label, randomized, multicenter, phase IIIB ESCAPE trial 评估 HER2 阳性早期乳腺癌患者皮下注射曲妥珠单抗的安全性和耐受性:开放标签、随机、多中心、IIIB ESCAPE 试验结果
Q3 Medicine Pub Date : 2024-01-01 DOI: 10.1016/j.ctarc.2024.100817
Dilyara Kaidarova , Edvard Zhavrid , Oxana Shatkovskaya , Aliaksandr Prokharau , Nina Akhmed , Dauren Sembayev , Zhanna Rutzhanova , Alexandr Ivankov

Aim

To assess the safety and tolerability of subcutaneous (SC) trastuzumab (Herceptin) administered either with a single-use injection device (SID) or manually from a vial using a hand-held syringe.

Methods

The ESCAPE trial (NCT02194166) included 90 women aged 18 years or older with HER2-positive early breast cancer who underwent surgical treatment and completed (neo) adjuvant chemotherapy and radiotherapy (if indicated). Patients enrolled in the study were first subjected to 4 cycles of trastuzumab IV (8 mg/kg loading dose followed by 6 mg/kg maintenance dose, q3w) prior to being randomized into groups: [A] SC trastuzumab (fixed dose 600 mg, q3w) administered through a hand-held syringe followed by 7 cycles of SC trastuzumab administered with an SID or [B] the reverse sequence.

Results

Patient-reported outcomes revealed that 78 (94.0 % [95 % CI: 90.4–99.0]) out of 83 patients preferred SC trastuzumab over IV trastuzumab, among whom 28 patients indicated a strong preference. Sixteen out of 17 HCPs (94.1 %) were very satisfied with the use of SC trastuzumab, while 1/17 (5.9 %) remained uncertain. The mean time spent for IV vs. SC trastuzumab administration, including pre- and postinjection procedures, was 93.8 and 22 min, respectively. A total of 49 (54.4 %) patients reported 164 AEs.

Conclusions

In this trial, SC trastuzumab was preferred over IV trastuzumab. The duration of SC trastuzumab administration was significantly shorter than that of IV trastuzumab, saving patients and HCPs time. Safety and efficacy results were consistent with other published trials and were not associated with any new safety signal.

方法ESCAPE试验(NCT02194166)纳入了90名年龄在18岁或18岁以上、患有HER2阳性早期乳腺癌、接受过手术治疗并完成(新)辅助化疗和放疗(如有指征)的女性患者。参加研究的患者首先接受4个周期的曲妥珠单抗静脉注射(8毫克/千克负荷剂量,然后是6毫克/千克维持剂量,q3w),然后被随机分为以下两组:[A] 用手持注射器注射固定剂量600毫克的SC曲妥珠单抗,然后用SID注射7个周期的SC曲妥珠单抗;或[B] 相反顺序。结果患者报告结果显示,与静脉注射曲妥珠单抗相比,83 名患者中有 78 人(94.0% [95 % CI:90.4-99.0])更倾向于使用皮下注射曲妥珠单抗,其中 28 名患者表示强烈倾向于皮下注射曲妥珠单抗。17名高级保健人员中有16名(94.1%)对使用皮下注射曲妥珠单抗非常满意,1/17(5.9%)仍不确定。静脉注射曲妥珠单抗与皮下注射曲妥珠单抗所花费的平均时间(包括注射前和注射后的程序)分别为 93.8 分钟和 22 分钟。共有 49 名(54.4%)患者报告了 164 例 AE。与静脉注射曲妥珠单抗相比,静注曲妥珠单抗的用药时间明显缩短,为患者和医护人员节省了时间。安全性和疗效结果与其他已发表的试验结果一致,没有出现任何新的安全信号。
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引用次数: 0
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Cancer treatment and research communications
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