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IF 2.4 4区 医学 Q3 ONCOLOGY Pub Date : 2023-02-01 DOI: 10.1159/000529189
Auf dem Kongress der American Society of Hematology (ASH) wurden im Dezember 2022 neue Ergebnisse der internationalen, offenen, randomisierten Phase-III-Studie GLOW* vorgestellt [1]. Ziel war es, die Wirksamkeit und Verträglichkeit von Ibrutinib (Imbruvica®) von Janssen Pharmaceutical Companies of Johnson & Johnson in der Kombination mit Venetoclax zu untersuchen. Für die erste rein orale, zeitlich begrenzte CLL-Erstlinientherapie Ibrutinib + Venetoclax (Ibr + Ven; n = 106) ergab sich bei einer medianen Nachbeobachtungszeit von 46 Monaten der Hinweis, dass das relative Risiko zu versterben unter Ibr + Ven um 51,3% geringer war verglichen mit Chlorambucil + Obinutuzumab (Clb + O; n = 105) (Hazard Ratio (HR) 0,487; 95%-Konfidenzintervall (KI): 0,262–0,907; nomineller p-Wert p = 0,0205; sekundärer Endpunkt) [1, 2] . Die geschätzte 42-Monats-Rate für das Gesamtüberleben (OS) lag im Ibr+Ven-Arm bei 87,5%, verglichen mit 77,6% im Kontrollarm. Die Kombinationstherapie aus Ibr + Ven stellt somit die erste rein orale, zeitlich begrenzte Behandlung für therapienaive CLL-Patient*innen dar, die verglichen mit Clb + O einen nominellen OS-Vorteil aufzeigte [1].
《美国海洋学学会iii》的最新研究成果于2022年12月发表。目标只有一个,就是效力和肤质Ibrutinib (Imbruvica®)的扬森Pharmaceutical Companies of Johnson & Johnson在加上Venetoclax调查.2006年,纽约时报杂志第六期儿童基金会在46个月的介质观察中,x + Ven的相对死亡风险比氯化物+ obb (Clb + O)小了51.3%。用小米换来的小米95个果酱:名义p值p = 0.0205;第二终点)[1,2]总体寿命预期为87.5%,而监管部门为77.6%。因此,ir + Ven组合疗法*是第一个纯粹的口腔治疗法*,也就是治疗创伤的第一个纯粹的口腔病人。
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引用次数: 0
Society Bulletins 社会公告
IF 2.4 4区 医学 Q3 ONCOLOGY Pub Date : 2023-02-01 DOI: 10.1159/000529047
T. Seufferlein
Die steigende Zahl von Arzneimittelengpässen betrifft auch Krebspatientinnen und-patienten. Betroffen sind vor allem Medikamente, die schon seit vielen Jahren eingesetzt werden und heute als Generika auf dem Markt verfügbar sind. Sie machen die Hälfte der aktuell über 200 in Deutschland zugelassenen Krebsmedikamente aus. Da die Überlebenschance von Krebspatientinnen und-patienten von der Verfügbarkeit eines Arzneimittels abhängig sein kann, sind die Ängste groß. Eine besondere Aufgabe ist es deshalb, das Vertrauen in die Sicherheit der Arzneimittelversorgung zu erhalten bzw. wiederherzustellen. In einer gemeinsamen Pressekonferenz hat die DGHO Deutsche Gesellschaft für Hämatologie und Medizinische Onkologie e. V. mit Repräsentanten von weiteren wissenschaftlichen medizinischen Fachgesellschaften und des Bundesinstituts für Arzneimittel und Medizinprodukte (BfArM) auf bereits funktionierende Maßnahmen und auf weiterhin bestehende Lücken in der Arzneimittelversorgung hingewiesen. Die Zahl der Arzneimittelengpässe in der Krebstherapie ist im letzten Jahr deutlich gestiegen. Betroffen waren vor allem Medikamente, die schon seit langem erfolgreich eingesetzt werden. Dazu gehörten Tamoxifen und nab-Paclitaxel, die u. a. bei Brustkrebs, Bauchspeicheldrüsenkrebs, Lungenkrebs und Karzinomen im Magendarmbereich als Standard eingesetzt werden. Darüber hinaus fehlten auch unterstützende Arzneimittel wie Calciumfolinat, Harnsäuresenker, Antibiotika und Immunglobuline. Prof. Dr. med. Hermann Einsele, GeSchutz vor Arzneimittelengpässen bei Krebspatienten
与此同时,药物瓶颈增加也在影响癌症患者和患者。应用已久的药品现在已成为市面上的非专利药,受影响最大。他们占了现在德国200多种获准使用的癌症药物的一半鉴于癌症患者和病人能否生存取决于药效,担忧很大。因此,一个特别的任务是保持并恢复对药品供应安全的信心。在共同记者招待会,DGHO为Hämatologie医疗肿瘤学协会e . v代表的进一步科学医学Fachgesellschaften评估所药物和医疗设备运转(BfArM)已经采取和应用继续填补现有Arzneimittelversorgung .指出癌症治疗中的药物紧缺在去年大幅增加。绝大多数都是有效的药物治疗其中,tamoxiel和naab paclitaxel是乳腺癌的标准,主要用于乳腺癌、胰腺癌、肺癌和胃癌。除此之外,辅助药物也没有西服钙、尿酸剂、抗生素和免疫球蛋白。伟业医生,默曼艾尔曼医生,预防癌症发作发作
{"title":"Society Bulletins","authors":"T. Seufferlein","doi":"10.1159/000529047","DOIUrl":"https://doi.org/10.1159/000529047","url":null,"abstract":"Die steigende Zahl von Arzneimittelengpässen betrifft auch Krebspatientinnen und-patienten. Betroffen sind vor allem Medikamente, die schon seit vielen Jahren eingesetzt werden und heute als Generika auf dem Markt verfügbar sind. Sie machen die Hälfte der aktuell über 200 in Deutschland zugelassenen Krebsmedikamente aus. Da die Überlebenschance von Krebspatientinnen und-patienten von der Verfügbarkeit eines Arzneimittels abhängig sein kann, sind die Ängste groß. Eine besondere Aufgabe ist es deshalb, das Vertrauen in die Sicherheit der Arzneimittelversorgung zu erhalten bzw. wiederherzustellen. In einer gemeinsamen Pressekonferenz hat die DGHO Deutsche Gesellschaft für Hämatologie und Medizinische Onkologie e. V. mit Repräsentanten von weiteren wissenschaftlichen medizinischen Fachgesellschaften und des Bundesinstituts für Arzneimittel und Medizinprodukte (BfArM) auf bereits funktionierende Maßnahmen und auf weiterhin bestehende Lücken in der Arzneimittelversorgung hingewiesen. Die Zahl der Arzneimittelengpässe in der Krebstherapie ist im letzten Jahr deutlich gestiegen. Betroffen waren vor allem Medikamente, die schon seit langem erfolgreich eingesetzt werden. Dazu gehörten Tamoxifen und nab-Paclitaxel, die u. a. bei Brustkrebs, Bauchspeicheldrüsenkrebs, Lungenkrebs und Karzinomen im Magendarmbereich als Standard eingesetzt werden. Darüber hinaus fehlten auch unterstützende Arzneimittel wie Calciumfolinat, Harnsäuresenker, Antibiotika und Immunglobuline. Prof. Dr. med. Hermann Einsele, GeSchutz vor Arzneimittelengpässen bei Krebspatienten","PeriodicalId":19543,"journal":{"name":"Oncology Research and Treatment","volume":"46 1","pages":"58 - 65"},"PeriodicalIF":2.4,"publicationDate":"2023-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"46507664","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"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
Expert Report on Immune Thrombocytopenia: Current Diagnostics and Treatment - Recommendations from an Expert Group from Austria, Germany, and Switzerland. 免疫性血小板减少症专家报告:当前诊断和治疗——奥地利、德国和瑞士专家组的建议。
IF 2.4 4区 医学 Q3 ONCOLOGY Pub Date : 2023-01-01 Epub Date: 2023-02-14 DOI: 10.1159/000529662
Axel Matzdorff, Sonja R Alesci, Johanna Gebhart, Susanne Holzhauer, Marie Luise Hütter-Krönke, Thomas Kühne, Oliver Meyer, Helmut Ostermann, Ingrid Pabinger, Mathias Rummel, Ulrich J Sachs, Thomas Stauch, Karolin Trautmann-Grill, Bernhard Wörmann
no Abstract.
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引用次数: 2
Clinical Impact of Structured Post-Operative Surveillance in Resected Pancreatic Adenocarcinoma: Results from a Retrospective Cohort Study. 胰腺腺癌切除术后结构性监测的临床影响:一项回顾性队列研究的结果。
IF 2.4 4区 医学 Q3 ONCOLOGY Pub Date : 2023-01-01 Epub Date: 2022-12-16 DOI: 10.1159/000528722
Danmei Zhang, Stephan Kruger, Karoline Schirle, Volker Heinemann, Klara Dorman, Christoph Benedikt Westphalen, Lena Weiss, Leonie Gebauer, Michael Günther, Steffen Ormanns, Jens Werner, Michael von Bergwelt-Baildon, Stefan Boeck, Michael Haas

Introduction: To this date, surgery remains the only potentially curative approach in the treatment of pancreatic cancer. To analyse the clinical impact of a structured post-operative follow-up programme, we retrospectively analysed a cohort of resected pancreatic adenocarcinoma patients treated at LMU Munich.

Methods: Pancreatic adenocarcinoma patients who underwent resection and presented for regular follow-up visits at our centre between 2002 and 2017 were identified from two existing study cohorts. Diagnosis of recurrences was categorised by timing (within or outside a scheduled follow-up visit) and detection modality (imaging, CA 19-9 increase, or clinical deterioration) and correlated with disease-free survival and overall survival (OS).

Results: One hundred and twenty-five patients with resected pancreatic adenocarcinoma were included in this analysis. Median OS in the whole cohort was 21.1 months. Of these 125 patients, 103 (82.4%) patients had a documented relapse. Tumour recurrences detected within a scheduled follow-up visit (n = 86, 83.5%) compared to recurrences becoming apparent at an unplanned visit (n = 17, 16.5%) were associated with a significantly improved OS (median 25.5 vs. 20.2 months, p = 0.019). Compared to patients with recurrence detected by clinical deterioration (n = 4, 3.9%), patients with recurrences detected by imaging or laboratory abnormalities (n = 99, 96.0%) had a longer median OS (24.8 vs. 15.1 months, p = 0.007).

Discussion: A structured follow-up after pancreatic ductal adenocarcinoma resection may have an impact on patient outcome. Prospective trials are needed to evaluate the clinical impact of post-operative follow-up programmes.

导言:迄今为止,手术仍是治疗胰腺癌的唯一可能治愈方法。为了分析有组织的术后随访计划对临床的影响,我们对慕尼黑大学治疗的一组胰腺癌切除患者进行了回顾性分析:从现有的两个研究队列中筛选出2002年至2017年期间在本中心接受切除术并进行定期随访的胰腺癌患者。复发诊断按时间(预定随访内或预定随访外)和检测方式(影像学、CA 19-9升高或临床恶化)分类,并与无病生存率和总生存率(OS)相关:本次分析共纳入125例切除胰腺腺癌患者。整个组群的中位生存期为 21.1 个月。在这125名患者中,103名(82.4%)患者有复发记录。与计划外随访时发现的复发(17 例,16.5%)相比,在计划内随访时发现的肿瘤复发(86 例,83.5%)显著提高了患者的生存期(中位 25.5 个月 vs. 20.2 个月,p = 0.019)。与通过临床恶化发现复发的患者(4人,占3.9%)相比,通过影像学或实验室异常发现复发的患者(99人,占96.0%)的中位生存期更长(24.8个月对15.1个月,P = 0.007):讨论:胰腺导管腺癌切除术后的结构性随访可能会对患者的预后产生影响。需要进行前瞻性试验来评估术后随访计划的临床影响。
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引用次数: 0
Immune System Activation in Patients with Metastatic Renal Cell Carcinoma Induced by the Systemic Abscopal Effects of Radiation Therapy. 放射治疗系统性抽离效应诱导转移性肾癌患者免疫系统激活
IF 2.4 4区 医学 Q3 ONCOLOGY Pub Date : 2023-01-01 DOI: 10.1159/000527959
Mark A D'Andrea, G Kesava Reddy

Introduction: Renal cell carcinoma (RCC) is characterized by large histopathologic heterogeneity and classified with multiple histological subtypes. Radiation therapy has long played a key role in the management of both local and metastatic RCC. An out-of-field tumor regression (abscopal response) effect of radiation therapy has gained significant importance in the treatment of different tumor types including RCC. In this study, we provide a detailed overview of the current state of knowledge and clinical experience of radiation therapy-induced abscopal effects in patients with advanced RCC.

Methods: The PRISMA guidelines were followed to identify the published articles for the study. Using electronic databases such as MEDLINE via PubMed and Google Scholar, a systematic literature review was performed to find published clinical evidence for radiation therapy-induced abscopal effects in patients with advanced RCC. The clinical data of radiation therapy-induced abscopal effects were reviewed, and the outcomes have been summarized.

Results: In this study, we evaluated peer-reviewed published reports to find clinical evidence for the abscopal effect following radiation therapy in patients with advanced RCC. The clinical data on the systemic abscopal effects of radiation therapy were reviewed, and the outcomes were summarized. Our literature search indicated that the evidence for abscopal effects of radiation therapy in advanced RCC yielded over 20 case reports. The evidence indicates that abscopal effects of local radiation therapy may occur in RCC through tumor cell destruction with the subsequent release of tumor antigens that systemically stimulate the immune system of the host to activate the body's immune effector cells and produce distant nontarget antitumor effects. The activation of the immune system by local radiation therapy forms the basis to combine immunotherapy to boost its abscopal effects.

Conclusions: Collectively, these findings suggest that radiation therapy can induce systemic abscopal effects through immune system activation, and thus, the addition of immunotherapeutic agents increases the potential to boost the systemic abscopal responses in patients with advanced cancers including RCC.

肾细胞癌(RCC)具有很大的组织病理学异质性,并分为多个组织学亚型。长期以来,放射治疗在局部和转移性肾细胞癌的治疗中起着关键作用。放射治疗的场外肿瘤消退(抽象反应)效应在包括RCC在内的不同类型肿瘤的治疗中具有重要意义。在这项研究中,我们提供了一个详细的概述,目前的知识和临床经验,放射治疗引起的肾癌晚期患者的体外效应。方法:按照PRISMA指南筛选已发表的研究文章。通过PubMed和Google Scholar的MEDLINE等电子数据库,进行了系统的文献综述,以寻找晚期RCC患者放射治疗诱导的体外效应的已发表的临床证据。本文回顾了近年来放射治疗引起的异位效应的临床资料,并对其结果进行了总结。结果:在这项研究中,我们评估了同行评议的已发表的报告,以寻找晚期RCC患者放射治疗后体外效应的临床证据。本文回顾了近年来有关放射治疗全身外显效应的临床资料,并对其结果进行了总结。我们的文献检索表明,放射治疗对晚期RCC的影响超过20例。有证据表明,局部放射治疗在RCC中可能通过破坏肿瘤细胞,随后释放肿瘤抗原,系统性地刺激宿主免疫系统,激活机体的免疫效应细胞,产生远端非靶向抗肿瘤作用。局部放射治疗对免疫系统的激活构成了结合免疫治疗以增强其体外效果的基础。结论:总的来说,这些发现表明放射治疗可以通过免疫系统激活诱导全身抽离效应,因此,免疫治疗剂的加入增加了包括RCC在内的晚期癌症患者全身抽离反应的潜力。
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引用次数: 1
Management of Oligometastatic Disease in Esophagogastric Cancer: What Is the Evidence? 食管胃癌少转移性疾病的治疗:证据是什么?
IF 2.4 4区 医学 Q3 ONCOLOGY Pub Date : 2023-01-01 DOI: 10.1159/000531590
Mohan Hingorani, Hannah Stubley

Background: The concept of oligometastatic disease (OMD) was first introduced in 1995 by Hellman and Weichselbaum and described as stage of transition between localized and widespread metastatic disease. The presence of OMD in esophagogastric (OG) cancer remains controversial. Historically, most experts believe that OG cancer is systemic disease from the outset.

Summary: More recently, there is emerging data indicating improved outcomes in patients with OG cancer and oligometastatic disease. The present manuscript focuses on reviewing the emerging evidence in management of metastatic OG cancer with OMD and highlighting the direction of future research.

Key messages: Multiple retrospective and at least 2 phase II retrospective studies have reported on improved outcomes in patients with metastatic OG cancer and OMD. There is indication of improved outcome with combined systemic and local therapy (surgery or radiation). Further research should include phase III randomized studies to identify the optimal management algorithm in these groups of patients.

背景:寡转移性疾病(OMD)的概念于1995年由Hellman和Weichselbaum首次提出,并将其描述为局部转移性疾病和广泛转移性疾病之间的过渡阶段。食管胃(OG)癌中是否存在OMD仍有争议。从历史上看,大多数专家认为OG癌从一开始就是全身性疾病。摘要:最近,有新的数据表明OG癌和少转移性疾病患者的预后得到改善。本文重点回顾了转移性OG癌合并OMD治疗的新证据,并强调了未来研究的方向。多项回顾性研究和至少2项II期回顾性研究报告了转移性OG癌和OMD患者的预后改善。有迹象表明,全身和局部联合治疗(手术或放疗)改善了结果。进一步的研究应包括III期随机研究,以确定这些患者组的最佳管理算法。
{"title":"Management of Oligometastatic Disease in Esophagogastric Cancer: What Is the Evidence?","authors":"Mohan Hingorani,&nbsp;Hannah Stubley","doi":"10.1159/000531590","DOIUrl":"https://doi.org/10.1159/000531590","url":null,"abstract":"<p><strong>Background: </strong>The concept of oligometastatic disease (OMD) was first introduced in 1995 by Hellman and Weichselbaum and described as stage of transition between localized and widespread metastatic disease. The presence of OMD in esophagogastric (OG) cancer remains controversial. Historically, most experts believe that OG cancer is systemic disease from the outset.</p><p><strong>Summary: </strong>More recently, there is emerging data indicating improved outcomes in patients with OG cancer and oligometastatic disease. The present manuscript focuses on reviewing the emerging evidence in management of metastatic OG cancer with OMD and highlighting the direction of future research.</p><p><strong>Key messages: </strong>Multiple retrospective and at least 2 phase II retrospective studies have reported on improved outcomes in patients with metastatic OG cancer and OMD. There is indication of improved outcome with combined systemic and local therapy (surgery or radiation). Further research should include phase III randomized studies to identify the optimal management algorithm in these groups of patients.</p>","PeriodicalId":19543,"journal":{"name":"Oncology Research and Treatment","volume":"46 7-8","pages":"312-319"},"PeriodicalIF":2.4,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9954220","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"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
Curative Polyendocrine Therapy in a 21-year-Old Patient with Endometrial Carcinoma: Case Report and Review of the Literature. 21岁子宫内膜癌多内分泌治疗1例报告及文献复习。
IF 2.4 4区 医学 Q3 ONCOLOGY Pub Date : 2023-01-01 DOI: 10.1159/000531661
Henning Schäffler, Moritz Dimpfl, Fabienne Schochter, Wolfgang Janni, Nikolaus de Gregorio

Introduction: As the numbers of young patients diagnosed with early-stage endometrial carcinoma continue to rise, the question regarding fertility-preserving therapeutic options will increasingly gain significance in the future.

Case presentation: Here, we present the case of a 21-year-old patient diagnosed with symptomatic atypical endometrial hyperplasia. After 4 months of treatment with medroxyprogesterone acetate, a follow-up dilatation and curettage revealed early-stage, well-differentiated endometrioid endometrial carcinoma. Despite national guidelines recommending hysterectomy, the nulliparous patient expressed a desire to preserve her fertility. Subsequently, she underwent polyendocrine therapy with letrozole, everolimus, metformin, and Zoladex. Forty-three months after diagnosis, the patient successfully gave birth to a healthy child, and there have been no indications of recurrence thus far.

Discussion: This case suggests that triple endocrine therapy may be an option for selected patients with early endometrial cancer and a desire for fertility-sparing therapy.

引言:随着诊断为早期子宫内膜癌的年轻患者数量不断增加,关于保留生育能力的治疗选择的问题将在未来变得越来越重要。病例介绍:在此,我们报告一位21岁的患者被诊断为有症状的不典型子宫内膜增生。经醋酸甲孕酮治疗4个月后,随访扩张刮除显示为早期高分化子宫内膜样子宫内膜癌。尽管国家指南推荐子宫切除术,但未生育的患者表达了保留其生育能力的愿望。随后,她接受了来曲唑、依维莫司、二甲双胍和唑拉迪克斯的多内分泌治疗。确诊43个月后,患者成功生下了一个健康的孩子,到目前为止没有复发的迹象。讨论:本病例提示,三联内分泌治疗可能是选择早期子宫内膜癌患者和生育保留治疗的愿望的一种选择。
{"title":"Curative Polyendocrine Therapy in a 21-year-Old Patient with Endometrial Carcinoma: Case Report and Review of the Literature.","authors":"Henning Schäffler,&nbsp;Moritz Dimpfl,&nbsp;Fabienne Schochter,&nbsp;Wolfgang Janni,&nbsp;Nikolaus de Gregorio","doi":"10.1159/000531661","DOIUrl":"https://doi.org/10.1159/000531661","url":null,"abstract":"<p><strong>Introduction: </strong>As the numbers of young patients diagnosed with early-stage endometrial carcinoma continue to rise, the question regarding fertility-preserving therapeutic options will increasingly gain significance in the future.</p><p><strong>Case presentation: </strong>Here, we present the case of a 21-year-old patient diagnosed with symptomatic atypical endometrial hyperplasia. After 4 months of treatment with medroxyprogesterone acetate, a follow-up dilatation and curettage revealed early-stage, well-differentiated endometrioid endometrial carcinoma. Despite national guidelines recommending hysterectomy, the nulliparous patient expressed a desire to preserve her fertility. Subsequently, she underwent polyendocrine therapy with letrozole, everolimus, metformin, and Zoladex. Forty-three months after diagnosis, the patient successfully gave birth to a healthy child, and there have been no indications of recurrence thus far.</p><p><strong>Discussion: </strong>This case suggests that triple endocrine therapy may be an option for selected patients with early endometrial cancer and a desire for fertility-sparing therapy.</p>","PeriodicalId":19543,"journal":{"name":"Oncology Research and Treatment","volume":"46 7-8","pages":"330-335"},"PeriodicalIF":2.4,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9963857","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"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
A Phase II Study of Nab-Paclitaxel and Gemcitabine as First-Line Therapy in Patients with Cholangiocarcinoma Ineligible for Cisplatin-Based Chemotherapy (NACHO). nab -紫杉醇和吉西他滨作为不适合顺铂化疗(NACHO)的胆管癌患者一线治疗的II期研究
IF 2.4 4区 医学 Q3 ONCOLOGY Pub Date : 2023-01-01 DOI: 10.1159/000529012
Isabel Virchow, Jürgen-Walter Treckmann, Nicole Prasnikar, Gabriele Linden, Peter Markus, Brigitte Schumacher, David Albers, Thomas Herold, Saskia Ting, Hartmut Schmidt, Sonja Radunz, Marcel Wiesweg, Jens Siveke, Martin Schuler, Stefan Kasper

Introduction: Gemcitabine and cisplatin is the standard first-line systemic treatment in patients with advanced cholangiocarcinoma (CCA). However, a substantial number of patients do not qualify for cisplatin due to comorbidities or poor performance status. The phase II pilot study NACHO evaluated the efficacy of nab-paclitaxel (125 mg/m2) and gemcitabine (1000 mg/m2) given on days 1, 8, and 15 every 4 weeks as first-line therapy in patients with advanced CCA ineligible for cisplatin-based chemotherapy.

Methods: Patients with any comorbidity precluding cisplatin therapy, such as renal impairment, impaired hearing, increased risk or history for thromboembolic events, intolerance of extensive hydration, or significant cardiovascular disease were eligible. Primary endpoint was overall response rate (ORR) per RECIST 1.1. Secondary endpoints were progression-free survival (PFS), overall survival (OS), safety, and patient reported outcome.

Results: From December 2016 to July 2017, 10 patients were prospectively enrolled and treated. The ORR with nab-paclitaxel/gemcitabine was 50%, the disease control rate (DCR) was 90%. Median PFS was 5.7 months (95% CI: 5.3-6.1), and median OS was 7.8 months (95% CI: 5.4-10.2). In total, 13 SAEs were documented without any new safety signals. There were 14 grade 3-4 treatment-related adverse events (TRAEs) in 10 patients of the ITT population. Exploratory subgroup analyses including known prognostic markers were performed.

Conclusions: The NACHO trial supports safety and efficacy of nab-paclitaxel and gemcitabine in patients with advanced CCA ineligible for cisplatin-based therapy and should be further evaluated in a larger prospective trial.

吉西他滨和顺铂是晚期胆管癌(CCA)患者的标准一线全身治疗。然而,由于合并症或表现不佳,大量患者不符合顺铂治疗的条件。NACHO II期试点研究评估了nab-紫杉醇(125 mg/m2)和吉西他滨(1000 mg/m2)作为不适合顺铂化疗的晚期CCA患者的一线治疗,每4周给药1、8和15天。方法:有任何排除顺铂治疗的合并症的患者,如肾脏损害、听力受损、血栓栓塞事件风险增加或病史、广泛水合不耐受或显著心血管疾病的患者均符合条件。主要终点是RECIST 1.1的总缓解率(ORR)。次要终点是无进展生存期(PFS)、总生存期(OS)、安全性和患者报告的结果。结果:2016年12月至2017年7月,前瞻性纳入治疗10例患者。nab-紫杉醇/吉西他滨的ORR为50%,疾病控制率(DCR)为90%。中位PFS为5.7个月(95% CI: 5.3-6.1),中位OS为7.8个月(95% CI: 5.4-10.2)。总共记录了13例sae,没有任何新的安全信号。ITT人群中10例患者出现14例3-4级治疗相关不良事件(TRAEs)。进行探索性亚组分析,包括已知的预后指标。结论:NACHO试验支持nab-紫杉醇和吉西他滨治疗晚期CCA患者的安全性和有效性,不适合顺铂为基础的治疗,应在更大的前瞻性试验中进一步评估。
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引用次数: 0
Impact of Geriatric Assessment on the Tolerability of Combination Chemotherapy in Older Patients with Advanced Cancer: A Matched-Pair Analysis. 老年评估对老年晚期癌症患者联合化疗耐受性的影响:配对分析
IF 2.4 4区 医学 Q3 ONCOLOGY Pub Date : 2023-01-01 DOI: 10.1159/000529097
Michael Konrad Stahl, Sebastian Willy Ertl, Pouneh Engelmeyer, Hans-Christoph Heuer, Daniel Christian Christoph

Because of their individual vulnerabilities, treatment decisions for older patients can be difficult. Geriatric assessment (GA) may help to select patients for systemic treatment, but its value is still unproven. Older cancer patients (≥65 years of age) with and without complex GA followed by discussion in the geriatric-oncologic conference, who had been treated in palliative intention with standard combination chemotherapy at the Evang. Kliniken Essen-Mitte, were retrospectively evaluated. All patients had been orally informed about the treatment options and had chosen chemotherapy beside supportive care. To reduce selection bias, the method of propensity-score matching was performed. Patient groups treated in the years 2011-2013 (without GA, group 1) and in the years 2014-2015 (with GA, group 2) were compared regarding different toxicity endpoints. The primary endpoint of the study was defined as numbers of patients with unplanned admission to the hospital or death during first-line chemotherapy and GA should reduce these events by 15%. Overall, 114 patients were evaluated in both groups. The median age was 74 years. Patients suffered from gastrointestinal carcinomas (47%), lung cancer (28%), breast cancer (12%), and other cancer types (3%). Consequently, most patients were treated with platinum-based (41%), fluoropyrimidine-based (35%), or anthracycline-based (13%) combination chemotherapy. In group 2, the events were numerically lower for all toxicity endpoints. The need for a premature stop of treatment was 54.4% in group 1 compared to 29.8% in group 2 (p < 0.01) and also the treatment-related mortality was significantly lower in group 2 (17.5% vs. 5.3%; p = 0.04). The primary endpoint, the rate of unplanned hospital admission, and death was 49.1% versus 35.1% (difference 14.0%), which did not reach the predefined border of 15%. There was a nonsignificant overall survival benefit in the group with GA (22.6 vs. 18.4 months). GA appears useful to better select older patients with advanced cancer for combination chemotherapy. The significant reduction of mortality during chemotherapy justifies the efforts and costs which need to be expended. To evaluate the effect of GA on overall survival, prospective trials are required.

由于他们个人的脆弱性,对老年患者的治疗决定可能很困难。老年评估(GA)可能有助于选择患者进行全身治疗,但其价值仍未得到证实。老年癌症患者(≥65岁),伴有或不伴有复杂GA,在老年肿瘤学会议上进行了讨论,这些患者在Evang接受了标准联合化疗的姑息治疗。Kliniken Essen-Mitte,回顾性评价。所有患者都口头告知了治疗方案,并在支持治疗的同时选择了化疗。为了减少选择偏差,采用倾向-得分匹配方法。比较2011-2013年(无GA组,第1组)和2014-2015年(有GA组,第2组)治疗的患者组的不同毒性终点。该研究的主要终点被定义为在一线化疗期间意外入院或死亡的患者数量,GA应将这些事件减少15%。两组共对114例患者进行了评估。中位年龄为74岁。患者患有胃肠道癌(47%)、肺癌(28%)、乳腺癌(12%)和其他类型的癌症(3%)。因此,大多数患者接受铂类(41%)、氟嘧啶类(35%)或蒽环类(13%)联合化疗。在第2组中,所有毒性终点的事件数值较低。1组患者需要提前停止治疗的比例为54.4%,而2组为29.8% (p < 0.01), 2组治疗相关死亡率也显著降低(17.5%比5.3%;P = 0.04)。主要终点,非计划住院率和死亡率分别为49.1%和35.1%(差14.0%),未达到15%的预定边界。GA组的总生存期获益不显著(22.6个月vs 18.4个月)。GA似乎有助于更好地选择老年晚期癌症患者进行联合化疗。化疗期间死亡率的显著降低证明了需要付出的努力和费用是合理的。为了评估GA对总生存期的影响,需要进行前瞻性试验。
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引用次数: 1
[Vorwort des DGHO-Vorstands]. 【DGHO董事会前言】。
IF 2.4 4区 医学 Q3 ONCOLOGY Pub Date : 2023-01-01 Epub Date: 2023-09-25 DOI: 10.1159/000533464
Hermann Einsele, Andreas Hochhaus, Maike de Wit, Carsten-Oliver Schulz
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引用次数: 0
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Oncology Research and Treatment
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