がん治験とは何ですか？
Cancer Trials がん治験 - The initiative was coordinated by the Society of Interventional Oncology in collaboration with the Definition for the Assessment of Time-to-Event End Points in Cancer Trials, or DATECAN, group. [1] 79) cancer trials. [2] A potentially overlooked contributor to the underenrollment of Black patients may be the increasing enrollment of cancer trials in countries outside the United States. [3] 1092Background: Response Evaluation Criteria in Solid Tumors (RECIST) criteria are often used to measure tumor response in cancer trials, especially in the stage IV setting. [4] There is a clear lack of representation of older adults in clinical trials, including cancer trials. [5] The American Society of Clinical Oncology and The Friends of Cancer Research collaboration reconsidered common eligibility criteria in cancer trials and found many to be unnecessarily restrictive. [6] In June of this year, the US Food and Drug Administration (FDA) released a draft guidance to fill a much-needed gap related to formulating a strategy for the use of patientreported outcomes (PROs) in cancer trials [1]. [7] Background Adaptive model-based dose-finding designs have demonstrated advantages over traditional rule-based designs but have increased statistical complexity but uptake has been slow especially outside of cancer trials. [8] Completing PROs is a key aspect of many clinical programs and cancer trials; assistance in completing PROs should be offered and provided. [9] e18615 Background: It is recommended to include patient-reported outcomes (PROs) in cancer trials to ensure clinical benefit based on patients’ perceptions. [10] Future work should examine the reasons why women are less likely to enrol in cancer trials during the COVID-19 pandemic. [11] OBJECTIVE Engaging community urologists in referring patients to clinical trials could increase the reach of cancer trials and, ultimately, alleviate cancer disparities. [12] 1) is the gold standard for imaging response evaluation in cancer trials. [13] Multivariate Cox regression analysis and Kaplan-Meir curve were used to confirm the predictability for prognosis of NLR and European Organization for Research and Treatment of Cancer trials (EORTC) scoring model. [14] The reference methodology developed here will be invaluable for evaluation of dose-dependent response to treatment for individual patients in cancer trials, aimed at finding more effective therapies. [15] OBJECTIVE In cancer trials, prior cancer is a common exclusion criterion. [16] Open-label designs are frequent in cancer trials. [17] Cancer trials are often open‐label and include patient‐reported outcomes (PROs). [18] Effective drug delivery system with clinical anticancer trials can further strengthen the research in this area. [19] Relabeled as “quality of life measures” they were first used in cancer trials. [20] 1 Nonetheless, because of the highly symptomatic nature of cancer and its treatment, PRO measures have been incorporated in cancer trials for many years, and these trials are increasingly single-arm or open-label comparative studies unable to be blinded owing to differing administration routes or differential overt toxic effects. [21] Background: In cancer trials, prior cancer is a common exclusion criterion. [22] Several approaches, including the development of chimeric antigen receptor (CAR) NK cells, show substantial promise in cancer trials and can be translated to direct and augment NK cell responses to improve HIV control. [23] This analysis adds to mounting evidence of the feasibility and value of patient-reported AEs in oncology, which should be considered for inclusion in cancer trials that incorporate AE evaluation. [24] INTRODUCTION Disease-free survival (DFS) is increasingly being used as surrogate end-point for overall survival (OS) in cancer trials. [25] PURPOSE Participation of racial and ethnic minority groups (REMGs) in cancer trials is disproportionately low despite a high prevalence of certain cancers in REMG populations. [26]このイニシアチブは、がん試験におけるイベントまでの時間のエンドポイントの評価の定義、またはDATECANグループと協力して、Society ofInterventionalOncologyによって調整されました。 [1] 79）がんの試験。 [2] 黒人患者の登録不足の潜在的に見過ごされている要因は、米国以外の国での癌試験の登録の増加である可能性があります。 [3] 1092背景：固形腫瘍の反応評価基準（RECIST）基準は、特にステージIVの設定で、癌試験における腫瘍反応を測定するためによく使用されます。 [4] がんの治験を含む臨床試験では、高齢者の代表が明らかに不足しています。 [5] 米国臨床腫瘍学会とTheFriendsof Cancer Researchの共同研究では、癌試験における一般的な適格基準を再検討し、多くが不必要に制限的であることがわかりました。 [6] 今年の6月、米国食品医薬品局（FDA）は、がん試験で患者報告アウトカム（PRO）を使用するための戦略の策定に関連する待望のギャップを埋めるためのガイダンス草案を発表しました[1]。 [7] 背景適応モデルベースの線量測定デザインは、従来のルールベースのデザインよりも優れていることが実証されていますが、統計の複雑さが増していますが、特にがん試験以外では、取り込みが遅くなっています。 [8] PROを完了することは、多くの臨床プログラムやがん試験の重要な側面です。 PROを完了するための支援を提供し、提供する必要があります。 [9] e18615背景：患者の認識に基づいた臨床的利益を確保するために、がん試験に患者報告の結果（PRO）を含めることをお勧めします。 [10] 今後の作業では、COVID-19パンデミック中に女性ががんの治験に登録する可能性が低い理由を調査する必要があります。 [11] 目的 地域の泌尿器科医に患者を臨床試験に紹介してもらうことで、がん治験の範囲が広がり、最終的にはがんの格差が緩和される可能性があります。 [12] 1) は、がん治験における画像反応評価のゴールド スタンダードです。 [13] 多変量 Cox 回帰分析と Kaplan-Meir 曲線を使用して、NLR および欧州がん研究治療機構 (EORTC) スコアリング モデルの予後の予測可能性を確認しました。 [14] ここで開発された参照方法論は、より効果的な治療法を見つけることを目的とした癌試験における個々の患者の治療に対する用量依存的反応の評価に非常に貴重です。 [15] 目的 がん試験では、以前のがんは一般的な除外基準です。 [16] 非盲検デザインは、がんの治験でよく見られます。 [17] がん試験は多くの場合、非盲検であり、患者報告アウトカム (PRO) が含まれます。 [18] 抗がん剤の臨床試験を伴う効果的な薬物送達システムは、この分野の研究をさらに強化することができます。 [19] 「生活の質の尺度」として再ラベル付けされたそれらは、がんの試験で最初に使用されました. [20] 1 それにもかかわらず、癌とその治療の非常に症候性の性質のため、PRO 対策は長年癌試験に組み込まれてきました。または差別的な明白な毒性効果。 [21] 背景: 癌試験では、以前の癌は一般的な除外基準です。 [22] キメラ抗原受容体 (CAR) NK 細胞の開発を含むいくつかのアプローチは、癌の治験でかなりの見込みを示しており、NK 細胞応答を指示および増強して HIV コントロールを改善するために翻訳することができます。 [23] この分析は、腫瘍学における患者から報告された AE の実現可能性と価値の証拠を追加するものであり、AE 評価を組み込んだがん試験に含めることを検討する必要があります。 [24] 前書き 無病生存期間 (DFS) は、がん試験における全生存期間 (OS) の代替エンドポイントとしてますます使用されています。 [25] 目的 REMG集団における特定の癌の有病率が高いにもかかわらず、癌試験における人種的および民族的少数派グループ(REMG)の参加は不釣り合いに低い。 [26]
Canadian Cancer Trials カナダのがん試験
Radiation Oncology, Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia, Sir Peter MacCallum Department of Oncology, University of Melbourne, Parkville, Victoria, Australia, Canadian Cancer Trials Group, Kingston, Canada, Dept. [1] All data were collected, maintained and analyzed by the Canadian Cancer Trials Group (CCTG) in Kingston, Ontario, Canada. [2] This document describes the method taken by the Canadian Cancer Trials Group (CCTG) to implement meaningful patient centricity and engagement and the benefits realized. [3] We performed descriptive analyses and Cox proportional hazards regressions for three RCTs selected from the Canadian Cancer Trials Group: MA17 (breast cancer), PR7 (prostate cancer), and LY12 (non-Hodgkin’s lymphoma). [4] Methods We re-analyzed the results from four phase III Canadian Cancer Trials Group trials that embedded cost-effectiveness analyses to determine the impact of minimizing potential cost categories on the incremental cost-effectiveness ratios. [5] These limitations result in associated challenges for groups involved in the generation of economic evidence to inform treatment-related decision making, including the Committee of Economic Analysis (CEA) at the Canadian Cancer Trials Group (CCTG). [6] Note the National Cancer Institute of Canada Clinical Trials Group (NCIC CTG) was renamed the Canadian Cancer Trials Group (CCTG) in 2016. [7] Thirteen percent (20/155) of all Canadian trials were affiliated with the Canadian Cancer Trials Group (CCTG). [8] These procedures are also applied to analyze the data from a phase II trial conducted by the Canadian Cancer Trials Group. [9] Funding Cancer Research UK, MRC Clinical Trials Unit at UCL, Canadian Cancer Trials Group. [10] SWOG/Alliance/Canadian Cancer Trials Group/ECOG-ACRIN/NRG Oncology study S0307 compared the efficacy of three bisphosphonates in early stage breast cancer. [11] Published on Canadian Cancer Trials Group (https://www. [12] Finally, we apply the proposed method to a symptom control study conducted by Canadian Cancer Trials Group to explore the prognostic effect of covariates on pain control and overall survival. [13] Methods: Canadian Cancer Trials Group (CCTG) led a randomized phase II trial (CCTG MA38) to estimate the efficacy of palbociclib 100 mg po on CDD schedule (Arm 1) relative to 125 mg po STD schedule (Arm 2) with physician choice endocrine therapy. [14] Design, Setting, and Participants This unblinded randomized phase 3 clinical trial was led by Alliance in collaboration with Eastern Cooperative Oncology Group-American College of Radiology Imaging Network, Canadian Cancer Trials Group, and Southwest Oncology Group. [15] Legal entity responsible for the study Canadian Cancer Trials Group (CCTG). [16] The RECIST Working Group comprises representatives of the EORTC, the National Cancer Institute (NCI) in the United States, and the Canadian Cancer Trials Group, as well as several pharmaceutical companies. [17] Methods We re-examined the ce or cu of regimens previously evaluated in Canadian Cancer Trials Group (cctg) studies that included prospective economic evaluations and where genericization has occurred or is anticipated in Canada. [18] The primary objective of this Canadian Cancer Trials Group phase I study was to determine the recommended phase II dose (RP2D) of vistusertib in patients with GBM receiving TMZ at first progression following primary treatment. [19] MethodsTo illustrate regression-based economic evaluation, we review a cost-effectiveness analysis conducted by the Canadian Cancer Trials Group’s Committee on Economic Analysis and implement net benefit regression. [20] measured the accuracy of selected outcomes of two published RCTs conducted by the Canadian Cancer Trials Group using routinely collected administrative data from the Institute of Clinical Evaluative Sciences (ICES) Ontario. [21] Legal entity responsible for the study Canadian Cancer Trials Group (CCTG). [22] Purpose The aim of this study was to test the feasibility of use of administrative databases in Ontario, Canada, for long-term clinical trial follow-up, specifically (a) to determine whether limited patient identifiers held by the Canadian Cancer Trials Group can be used to probabilistically link with individuals in the Institute for Clinical Evaluative Sciences databases and if so, (b) the level of concordance between the two data sets. [23] This study aims to determine: 1) whether accrual of OA to trials led by the Canadian Cancer Trials Group (CCTG) has increased since 2003; 2) whether exclusion criteria have broadened over time; 3) whether exclusion criteria are associated with lower accrual of OA. [24] Jonker: Research grant / Funding (institution): Hoffman-La Roche; Non-remunerated activity/ies, Chair of the GI Disease Site Committee of the Canadian Cancer Trials Group: Canadian Cancer Trials Group. [25] Legal entity responsible for the study Canadian Cancer Trials Group. [26] METHODS Health administrative data were probabilistically linked to Ontario patient data from the Canadian Cancer Trials Group CO. [27]放射線腫瘍学、ピーターマッカラムがんセンター、メルボルン、ビクトリア、オーストラリア、サーピーターマッカラム腫瘍学部、メルボルン大学、パークビル、ビクトリア、オーストラリア、カナダがん試験グループ、キングストン、カナダ、部門。 [1] すべてのデータは、カナダのオンタリオ州キングストンにあるCanadian Cancer Trials Group（CCTG）によって収集、維持、分析されました。 [2] このドキュメントでは、Canadian Cancer Trials Group（CCTG）が、有意義な患者中心主義と関与を実装するために採用した方法と、実現されたメリットについて説明します。 [3] カナダのがん試験グループから選択された3つのRCT、MA17（乳がん）、PR7（前立腺がん）、およびLY12（非ホジキンリンパ腫）について、記述的分析とCox比例ハザード回帰を実行しました。 [4] nan [5] nan [6] nan [7] nan [8] nan [9] Funding Cancer Research UK、UCL の MRC Clinical Trials Unit、Canadian Cancer Trials Group。 [10] SWOG/Alliance/Canadian Cancer Trials Group/ECOG-ACRIN/NRG Oncology study S0307 では、早期乳がんにおける 3 種類のビスフォスフォネートの有効性が比較されました。 [11] Canadian Cancer Trials Group (https://www. [12] 最後に、提案された方法をCanadian Cancer Trials Groupが実施した症状制御研究に適用して、共変量が疼痛制御と全生存に及ぼす予後効果を調査します。 [13] 方法: Canadian Cancer Trials Group (CCTG) は、CDD スケジュール (Arm 1) でのパルボシクリブ 100 mg po の有効性を、医師が選択した内分泌を伴う 125 mg po STD スケジュール (Arm 2) と比較して評価するための無作為化第 II 相試験 (CCTG MA38) を主導しました。治療。 [14] デザイン、設定、参加者 この非盲検無作為化第 3 相臨床試験は、Eastern Cooperative Oncology Group-American College of Radiology Imaging Network、Canadian Cancer Trials Group、および Southwest Oncology Group と協力して Alliance が主導しました。 [15] 研究を担当する法人である Canadian Cancer Trials Group (CCTG)。 [16] nan [17] nan [18] nan [19] nan [20] nan [21] nan [22] nan [23] nan [24] nan [25] nan [26] nan [27]
Breast Cancer Trials 乳がん試験
Breast cancer trials were most common (n=24) and involved the most patients (n=6248, 71%). [1] Therefore, it appears that PRO data are often collected in breast cancer trials, but have not been methodologically acceptable to FDA reviewers. [2] 6%), whereas breast cancer trials had the greatest number of AYA patients (3032 of 32,693; 9. [3] Results: Eight RCTs (8420 patients) were included: 1 gastro-esophageal; and 7 breast cancer trials. [4] Enrollment in metastatic breast cancer trials usually requires measurable lesions, but patients with invasive lobular carcinoma (ILC) tend to form diffuse disease. [5] RESULTS Among 11 phase III breast cancer trials with primary efficacy end points, three had primary end points that followed STEEP criteria, four used STEEP definitions but not the corresponding end point names, and four used end points that were not included in the original STEEP manuscript. [6] Importance Residual cancer burden (RCB) distributions may improve the interpretation of efficacy in neoadjuvant breast cancer trials. [7] Hence, 3-epipachysamine could also prove effective as an anticancer agent in future animal tumor model and human clinical breast cancer trials. [8] The University of New Mexico Comprehensive Cancer Center (UNMCCC) average annual breast cancer trial accrual rate is approximately 11%, despite an average of 20 open breast cancer trials. [9] Previous positions include Chair of MOGA, President of COSA, Chair of Board of ANZ Breast Cancer Trials. [10] Latin American participation in practice-changing breast cancer trials in the last 25 years [abstract]. [11] A strategy for early-stage breast cancer trials in recent years consists of a neoadjuvant trial with pathological complete response (pCR) at time of surgery as the efficacy endpoint, followed by the collection of long-term data to show efficacy in survival. [12] Thus, the predictive value of HER2 overexpression depends on the tumor type, and results of breast cancer trials cannot a priori be extrapolated to digestive cancers. [13] 8%), and lowest among breast cancer trials (13. [14] ABSTRACT Quality of life (QoL) was an important endpoint in the adjuvant breast cancer trials International Breast Cancer Study Group (IBCSG) Trial VI and VII. [15] METHODS We pooled individual patient data from all phase 3 randomised breast cancer trials of CDKIs plus endocrine therapy submitted to the US Food and Drug Administration before Jan 1, 2019, in support of marketing applications. [16]乳がんの試験は最も一般的であり（n = 24）、最も多くの患者が関与しました（n = 6248、71％）。 [1] したがって、PROデータは乳がんの試験で収集されることが多いようですが、FDAのレビューアには方法論的に受け入れられていません。 [2] 6％）、乳がんの試験ではAYA患者の数が最も多かった（32,693人中3032人; 9）。 [3] 結果：8つのRCT（8420人の患者）が含まれました：1つの胃食道;と7つの乳がんの試験。 [4] nan [5] nan [6] nan [7] nan [8] ニューメキシコ大学総合がんセンター (UNMCCC) の年間平均乳がん試験発生率は、平均 20 件のオープン乳がん試験にもかかわらず、約 11% です。 [9] 以前の役職には、MOGA の会長、COSA の会長、ANZ 乳癌試験の理事会の会長が含まれます。 [10] 過去 25 年間の乳がん臨床試験へのラテンアメリカの参加 [要約]。 [11] 近年の早期乳がん試験の戦略は、有効性エンドポイントとして手術時の病理学的完全奏効（pCR）を使用したネオアジュバント試験と、その後の生存における有効性を示すための長期データの収集で構成されています。 [12] したがって、HER2 過剰発現の予測値は腫瘍の種類に依存し、乳癌試験の結果を先験的に消化器癌に外挿することはできません。 [13] nan [14] nan [15] nan [16]
Lung Cancer Trials 肺がん試験
Progression-free survival (PFS) has been used as a surrogate endpoint for overall survival (OS) in lung cancer trials. [1] In lung cancer trials, overall survival is a well-validated and widely used endpoint; yet, in the context of adjuvant or curative intent treatments, disease-free survival (DFS) may be a better indicator of transformative patient outcomes. [2] Information related to 6092 registered lung cancer trials was downloaded. [3] For colorectal and lung cancer trials, females were less likely than males (EF 0. [4] We analyzed inter-reader discordances in a pool of lung cancer trials using RECIST 1. [5] Safety profile was similar to that reported with the same combination used in lung cancer trials with a higher rate of discontinuation due to treatment toxicity (20% compared to 8%). [6] Although objective response rate and disease control rate are commonly used as primary endpoints of lung cancer trials, it remains unclear whether objective response rate and disease control rate correctly reflect the overall survival in a non-small cell lung cancer phase II trial evaluating a non-first-line chemotherapy. [7] Background The Non–Small Cell Lung Cancer Symptom Assessment Questionnaire (NSCLC-SAQ) was developed to incorporate the patient's perspective into evaluation of clinical benefit in advanced non–small cell lung cancer trials and meet regulatory expectations for doing so. [8] For lung cancer trials, black participants represented only 7. [9] Background: The aim of this study is to assess the quality of reporting of thoracic (T) RT technique for curative intent treatment in prospective lung cancer trials. [10] The study is being conducted by the Asian Thoracic Oncology Research Group (ATORG) – an academic co-operative lung cancer trials group in Asia. [11] HR for OS in the lung cancer trials favoured CM users, however, this should be interpreted with caution given the retrospective/post-hoc nature of this study and the more favourable baseline characteristics. [12] Furthermore, across non-small cell lung cancer trials analyzed, CSO assignment was predictive of progression-free survival (P=0. [13] Age disparities were also larger among trials that evaluated a targeted systemic therapy and among lung cancer trials. [14] Here we describe QoL adoption, reporting and methodology of QoL analysis in lung cancer trials. [15]無増悪生存期間（PFS）は、肺がん試験における全生存期間（OS）の代理エンドポイントとして使用されています。 [1] 肺がんの試験では、全生存期間は十分に検証され、広く使用されているエンドポイントです。それでも、補助療法または治療目的の治療の文脈では、無病生存率（DFS）は、患者の変革的転帰のより良い指標となる可能性があります。 [2] 6092件の登録肺がん試験に関する情報がダウンロードされました。 [3] 結腸直腸がんおよび肺がんの試験では、女性は男性よりも可能性が低かった（EF0。 [4] RECIST 1を使用して、肺がん試験のプールにおける読者間の不一致を分析しました。 [5] nan [6] nan [7] nan [8] nan [9] 背景: この研究の目的は、前向き肺がん試験における根治目的治療のための胸部 (T) RT 技術の報告の質を評価することです。 [10] この研究は、アジアの学術共同肺がん試験グループである Asian Thoracic Oncology Research Group (ATORG) によって実施されています。 [11] nan [12] nan [13] nan [14] nan [15]
Clinical Cancer Trials がん臨床試験
Cancer alarm symptoms in elderly fit for cancer therapy should be investigated promptly and clinical cancer trials focus to also include elderly to set updated standards for cancer therapy in the dominating age group. [1] Inhibitors of IGF-1R signaling were tested in clinical cancer trials aiming to assess the utility of this receptor as a therapeutic target; essentially all IGF-1R inhibitors failed to provide an additional benefit compared to standard-of-care therapy. [2] The ODC inhibitor α-difluoromethylornithine (DFMO, or Eflornithine) has been FDA-approved for the treatment of trypanosomiasis and hirsutism and has advanced to clinical cancer trials including NB as well as cancer-unrelated human diseases. [3] METHODS We conducted a systematic search in seven electronic databases on patient values in relation to patients' decisions to participate in early phase clinical cancer trials. [4] 4 In that year, a total of 443 patients from regional Victoria accessed clinical cancer trials, but 343 of those regional patients travelled to Melbourne to access a trial. [5] These tools have the following characteristics: they screen for vulnerability to select patients who may benefit from a comprehensive geriatric assessment; are predictive tools for survival, postoperative complications, or chemotherapy-related toxicity; are decisional algorithms for cancer treatment; or define a core set of geriatric data to be collected in clinical cancer trials. [6] Here we investigated the changes in the landscape of clinical cancer trials in Germany from 2000-2016. [7] Our review shows that a service delivery approach that is focused on the indigenous population and includes culturally appropriate activities, resources and environments resulted in an increase in cancer knowledge, reduction in treatment interruption, improved access to cancer care and enrolment in clinical cancer trials, and increased satisfaction with health care. [8] This approach has the advantage of reducing user bias in tumor segmentation and improving the accuracy and precision of tumor volume estimations for co-clinical cancer trials. [9] Implementing a geriatric assessment in cooperative group clinical cancer trials: CALGB 360401. [10] Implementing a geriatric assessment in cooperative group clinical cancer trials: CALGB 360401. [11] In addition, despite HDZ being currently tested in clinical cancer trials for its antihypertensive effect, its mechanism of antitumor action remains undefined. [12]癌治療に適した高齢者の癌警報症状は迅速に調査されるべきであり、臨床癌試験は、支配的な年齢層における癌治療の最新の基準を設定するために高齢者も含めることに焦点を合わせています。 [1] IGF-1Rシグナル伝達の阻害剤は、治療標的としてのこの受容体の有用性を評価することを目的とした臨床癌試験でテストされました。本質的にすべてのIGF-1R阻害剤は、標準治療と比較して追加の利点を提供できませんでした。 [2] nan [3] nan [4] nan [5] これらのツールには次の特徴があります。脆弱性をスクリーニングして、包括的な老年医学的評価の恩恵を受ける可能性のある患者を選択します。生存、術後合併症、または化学療法関連毒性の予測ツールです。がん治療の決定アルゴリズムです。または、がんの臨床試験で収集される高齢者データのコアセットを定義します。 [6] ここでは、2000 年から 2016 年までのドイツにおけるがん臨床試験の状況の変化を調査しました。 [7] 私たちのレビューは、先住民族に焦点を当て、文化的に適切な活動、リソース、環境を含むサービス提供アプローチが、がんの知識の増加、治療の中断の減少、がんケアへのアクセスの改善、および臨床がん試験への登録をもたらしたことを示しています。ヘルスケアに対する満足度の向上。 [8] nan [9] nan [10] nan [11] nan [12]
Prostate Cancer Trials 前立腺がん試験
CONCLUSIONS In this novel study, we found prostate cancer trials in areas with low prostate cancer incidence were more likely to fail. [1] Among counties with cancer facilities, those with higher %AAs had significantly fewer prostate cancer trials per capita per year (rate ratio per 10% increase in %AAs: 0. [2] Within each area, one or more specific applications is demonstrated, such as automated structural brain MRI quality control assessment in a core lab environment, super-resolution MRI preprocessing for neurodegenerative disease quantification in translational clinical trials, and multimodal PET/CT tumor segmentation in prostate cancer trials. [3] Department of Urology, Lille University, Lille, France; UMR8161/CNRS, Institut de Biologie de Lille, Lille, France; Division of Urology, Rush University, Chicago, IL, USA; d Fiona Stanley Hospital, Murdoch, Australia; UWA Medical School, University of Western Australia, Crawley, Australia; Australian and New Zealand Urogenital and Prostate Cancer Trials Group, Sydney, Australia E U R O P E A N U R O L O G Y O P E N S C I E N C E 3 1 ( 2 0 2 1 ) 1 2 – 1 3. [4] Protein kinase inhibitors are small molecules that target varying pathways including the breakpoint cluster region (BCR)-Abelson tyrosine kinase (ABL), colony stimulating factor-1 receptor (CSF1R), vascular endothelial growth factor (VEGF)/VEGF receptor (VEGFR) and phosphoinositide 3-kinase (PI3K) pathways and have been studied in prostate cancer trials with variable results. [5] To identify cytokines that can activate and expand NK cells in the presence of prostate cancer cells in order to determine whether these agents may be useful in future intra‐tumoural administration in pre‐clinical and clinical prostate cancer trials. [6] PATIENT SUMMARY: We report how a worldwide research effort will review results and anonymised data from advanced prostate cancer trials in new and different ways. [7] The Functional Assessment of Cancer Therapy–Prostate (FACT‐P) and the National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy–Prostate Symptom Index‐17 (NFPSI‐17) are 2 commonly used measures for patient‐reported outcomes in prostate cancer trials. [8] We analyzed enrollment trends of major racial/ethnic groups in the United States in phase III prostate cancer trials between 2003 and 2014 compared to SEER (Surveillance, Epidemiology and End Results) incidence data. [9]結論 この新しい研究では、前立腺がんの発生率が低い地域での前立腺がんの試験が失敗する可能性が高いことがわかりました。 [1] がん施設のある郡では、％AAが高い郡では、1人あたりの年間前立腺がん試験が大幅に少なくなっています（％AAの10％増加あたりの割合は0です。 [2] 各領域内で、コアラボ環境での自動構造脳MRI品質管理評価、翻訳臨床試験での神経変性疾患の定量化のための超解像MRI前処理、前立腺でのマルチモーダルPET / CT腫瘍セグメンテーションなど、1つ以上の特定のアプリケーションが示されます。がんの試験。 [3] フランス、リールのリール大学泌尿器科。 UMR8161 / CNRS、Institut de Biologie de Lille、リール、フランス;米国イリノイ州シカゴのラッシュ大学泌尿器科。 dオーストラリア、マードックのフィオナスタンリー病院。西オーストラリア大学、クローリー、オーストラリアのUWA医科大学。オーストラリアおよびニュージーランドの泌尿生殖器および前立腺がん試験グループ、オーストラリア、シドニーE U R O P E A N U R O L O G Y O P E N S C I E N C E 3 1（2 0 2 1）1 2 –13。 [4] nan [5] 前立腺癌細胞の存在下で NK 細胞を活性化および拡大できるサイトカインを特定し、これらの薬剤が前立腺癌の前臨床および臨床試験における将来の腫瘍内投与に有用であるかどうかを判断すること。 [6] 患者の概要: 世界的な研究活動が、進行性前立腺癌試験の結果と匿名化されたデータを新しく異なる方法でどのようにレビューするかを報告します。 [7] nan [8] nan [9]
Phase Cancer Trials
ABSTRACT Introduction: Precision medicine is impacting clinical practice and drug development in oncology, promoting notable changes in the design of early-phase cancer trials. [1] We outline the advantages and disadvantages of each approach, and discuss progress in evaluating these agents, including factors that contributed to the failure of many of these novel therapeutics in early phase cancer trials. [2] Applications in early-phase cancer trials have motivated the development of many statistical designs since the late 1980s, including dose-finding methods, futility screening, treatment selection, and early stopping rules. [3] Purpose Some patients who participate in early phase cancer trials enroll to more than one trial. [4]要約はじめに：精密医療は、腫瘍学における臨床診療と医薬品開発に影響を与えており、初期段階のがん試験の設計における顕著な変化を促進しています。 [1] 各アプローチの長所と短所を概説し、初期段階の癌試験でこれらの新しい治療法の多くが失敗した要因を含め、これらの薬剤の評価における進歩について説明します。 [2] 1980 年代後半以降、初期段階のがん試験への応用が、用量設定方法、無益性スクリーニング、治療選択、早期中止規則など、多くの統計的デザインの開発の動機となってきました。 [3] 目的 がんの初期段階の試験に参加する一部の患者は、複数の試験に登録します。 [4]
Ius Cancer Trials Iusがん試験
Methods: We analysed recent Phase II cancer trials comprising 2165 response rates to uncover trends in cancer therapies and used a null model of non-interacting agents to infer synergistic and antagonistic drug combinations. [1] The glutaminase inhibitor, telaglenastat (CB-839), has been tested in Phase I/II cancer trials and is well tolerated by patients. [2] Despite evidence of significant reduction in cancer occurrence in diabetic patients taking metformin, phase II cancer trials of the agent have been disappointing, quite possibly because of the lack of molecular mechanism-based patient stratification. [3] We illustrate the proposed procedure by simulations in the context of phase II cancer trials. [4]方法：2165の奏効率を含む最近の第II相がん試験を分析して、がん治療の傾向を明らかにし、非相互作用薬のヌルモデルを使用して相乗的および拮抗的な薬剤の組み合わせを推測しました。 [1] グルタミナーゼ阻害剤であるテラグレナスタット（CB-839）は、第I / II相のがん試験でテストされており、患者さんの忍容性は良好です。 [2] メトホルミンを服用している糖尿病患者における癌発生の有意な減少の証拠にもかかわらず、薬剤の第II相癌試験は、おそらく分子メカニズムに基づく患者の層別化の欠如のために、期待外れでした. [3] フェーズ II がん試験のコンテキストでのシミュレーションによって提案された手順を説明します。 [4]
I Cancer Trials
Many argue that phase I cancer trials are a therapeutic option for eligible patients. [1] However, there is a big potential to be unleashed in early phase studies including phase I cancer trials in China. [2] PURPOSE In this nationwide registry study, we investigated socioeconomic and structural patterns in referral to phase I cancer trials in a case-control study design. [3]多くの人が、がんの第 I 相試験は適格な患者にとって治療の選択肢であると主張しています。 [1] ただし、中国での第I相がん試験を含む初期段階の研究で解き放たれる大きな可能性があります. [2] nan [3]
Ovarian Cancer Trials
These findings support the reliability of PFS by INV in ovarian cancer trials. [1] METHODS We carried out a simulation study to assess methodological reasons behind these discrepancies and corroborated our findings in a case study of three BRCA-mutated ovarian cancer trials. [2] METHODS We carried out a simulation study to assess methodological reasons behind these discrepancies and corroborated our findings in a case study of three BRCA-mutated ovarian cancer trials. [3]これらの発見は、卵巣癌試験におけるINVによるPFSの信頼性を裏付けています。 [1] 方法 これらの不一致の背後にある方法論的理由を評価するためにシミュレーション研究を実施し、3 つの BRCA 変異卵巣がん試験のケーススタディで私たちの調査結果を裏付けました。 [2] 方法 これらの不一致の背後にある方法論的理由を評価するためにシミュレーション研究を実施し、3 つの BRCA 変異卵巣がん試験のケーススタディで私たちの調査結果を裏付けました。 [3]
Pediatric Cancer Trials 小児がん試験
7%) of 3383 therapeutic pediatric cancer trials were international and 182 (5. [1] We searched EMBASE and PubMed for phase II pediatric cancer trials testing targeted agents. [2] We contend that current approaches to approving phase 1 pediatric cancer trials may inappropriately hinge on perceptions of therapeutic benefit without adequate consideration of the unlikelihood of such benefit in many cases and the magnitude of associated risks. [3]3383件の小児がん治療試験のうち7％）が国際的であり、182件（5。 [1] EMBASEとPubMedで、標的薬剤をテストする第II相小児がん試験を検索しました。 [2] nan [3]
Iius Cancer Trials 右がん試験
BACKGROUND AND AIM Trial designs using multiple primary endpoints (MPEs) are increasing in phase III cancer trials. [1] Thus, we will suggest application of FGFR inhibitors, which are currently used in Phase II and III cancer trials, as a therapeutic option to reduce inflammation and induce remyelination in EAE and eventually MS. [2] gov was screened for finding phase I/II/III cancer trials on the use of new immune checkpoint targets, including LAG-3, TIM-3, TIGIT, and VISTA, which are active (recruiting or not) or completed. [3]背景と目的 複数の主要エンドポイント（MPE）を使用した試験デザインは、第III相がん試験で増加しています。 [1] したがって、炎症を軽減し、EAEおよび最終的にはMSの髄鞘再形成を誘発する治療オプションとして、現在第II相および第III相の癌試験で使用されているFGFR阻害剤の適用を提案します。 [2] nan [3]
Pancreatic Cancer Trials
The infrastructure and collaborative nature of cooperative oncology groups offer many advantages, such as providing an ideal mechanism through which multidisciplinary pancreatic cancer trials are performed. [1] CONCLUSIONS This international Delphi study among patients and HCPs established a core set of PROs in pancreatic cancer, which should facilitate the design of future pancreatic cancer trials and outcomes research. [2] In this context, results from prior pancreatic and non-pancreatic cancer trials, which contained a significant proportion of the patient population treated with Metformin, will have to be reexamined in light of the observed anti-cancerous effects to gain additional insights. [3]nan [1] 結論 患者と HCP を対象としたこの国際的な Delphi 研究は、膵臓がんにおける PRO のコア セットを確立しました。これは、将来の膵臓がん試験の設計とアウトカム研究を促進するはずです。 [2] これに関連して、メトホルミンで治療された患者集団のかなりの割合を含む以前の膵臓および非膵臓がん試験の結果は、観察された抗がん効果に照らして再検討し、さらなる洞察を得る必要があります. [3]
Future Cancer Trials 今後のがん治験
These findings aid mounting efforts to reduce fatigue in oncology by introducing a more sensitive instrument to measure perceived physical fatigability to better evaluate patient-reported outcomes in future cancer trials. [1] Therefore, the PFS serves as a more sensitive instrument to measure perceived physical fatigability and can better evaluate patient-reported outcomes in future cancer trials, especially those focused on cancer survivorship. [2] Current findings may contribute to better informing the development of an internationally agreed core outcome set for future cancer trials. [3]これらの調査結果は、将来のがん試験で患者から報告された結果をより適切に評価するために、知覚される身体的疲労感を測定するためのより感度の高い機器を導入することにより、腫瘍学における疲労を軽減するための取り組みを強化するのに役立ちます。 [1] したがって、PFSは、知覚される身体的疲労を測定するためのより感度の高い手段として機能し、将来のがん試験、特にがんの生存に焦点を当てた試験で患者から報告された結果をより適切に評価できます。 [2] 現在の調査結果は、将来のがん試験のために設定された国際的に合意されたコアアウトカムの開発をよりよく知らせることに貢献するかもしれません。 [3]
Gej Cancer Trials
2-positive advanced gastric or GEJ adenocarcinomas, with response rates similar to those reported for single-agent targeted agents in gastric/GEJ cancer trials. [1] 2-positive advanced gastric or GEJ adenocarcinomas, with response rates similar to those reported for single-agent targeted agents in gastric/GEJ cancer trials. [2]2 陽性の進行性胃または GEJ 腺癌。奏効率は、胃/GEJ 癌試験で単剤標的薬剤について報告されたものと同様です。 [1] 2 陽性の進行性胃または GEJ 腺癌。奏効率は、胃/GEJ 癌試験で単剤標的薬剤について報告されたものと同様です。 [2]
Multiple Cancer Trials
Targeting the diverse functions of PLKs (tumor suppressor, oncogenic) are currently at the center of numerous investigations in particular with the inhibition of PLK1 and PLK4, respectively in multiple cancer trials. [1] Taken together, these measures form a reliable and validated list of measurement tools that are easily available and used in multiple cancer trials to assess patient‐reported outcomes in relevant patients. [2]Within Cancer Trials
Although artificial intelligence promises some relief from mistakes, its routine application for assessing tumors within cancer trials is still an aspiration. [1] Background Patient-reported outcomes (PROs) are captured within cancer trials to help future patients and their clinicians make more informed treatment decisions. [2]人工知能は間違いからのある程度の救済を約束しますが、癌試験内の腫瘍を評価するためのその日常的な適用は依然として願望です。 [1] nan [2]
Acros Cancer Trials
CONCLUSIONS Disparate enrollment of older adults is not equal across cancer trials. [1] We used a meta-analytic approach to estimate DPHs across cancer trials, investigate associated factors, and evaluate data-analysis approaches for future trials. [2]結論 高齢者の異なる登録は、がんの試験全体で等しくありません。 [1] nan [2]
Interventional Cancer Trials
The secondary purpose of the meeting was to address the belief that Africa was incapable of conducting interventional cancer trials but showed the in-continent strengths, such as available capacities, trained local clinical trialists with clinical trial experiences, clinical trial consortia, local capabilities, mapping out logistics, ethical consideration, political will, real-time benefits of clinical trials to clinical practice, and future directions for trials. [1] gov, we were able to compare the available information regarding new interventional cancer trials evaluating PDx with that of all interventional cancer trials. [2]Colorectal Cancer Trials 大腸がんの治験
In England, National Health Service (NHS) hospitals in the cancer research network that participated in colorectal cancer trials had lower mortality rates from colorectal cancer than other hospitals, after adjusting for case mix and hospital-level variables. [1] Results Data from 577, 337, and 126 patients were included for the analysis (from two stage IV colorectal cancer trials (N9741, N9841) and an advanced non-small cell lung cancer trial (N0026), respectively). [2]イギリスでは、結腸直腸癌の試験に参加した癌研究ネットワークの国民保健サービス（NHS）病院は、症例構成と病院レベルの変数を調整した後、他の病院よりも結腸直腸癌による死亡率が低かった。 [1] 結果577、337、および126人の患者からのデータが分析に含まれました（2つのステージIV結腸直腸癌試験（N9741、N9841）および進行した非小細胞肺癌試験（N0026）からそれぞれ）。 [2]
Randomized Cancer Trials 無作為化がん試験
Materials and Methods: Systematic literature review of AEs reported from the placebo arms of randomized cancer trials between 2008 and 2021. [1] Materials and Methods: This is a systematic literature review of AEs reported from the placebo arms of randomized cancer trials in PubMed between 2008 and 2020. [2]材料と方法：2008年から2021年までのランダム化がん試験のプラセボ群から報告されたAEの系統的文献レビュー。 [1] 材料と方法：これは、2008年から2020年の間にPubMedで行われたランダム化がん試験のプラセボ群から報告されたAEの系統的文献レビューです。 [2]
Endometrial Cancer Trials 子宮内膜がん試験
We performed a meta-analysis of endometrial cancer trials comparing chemotherapy and radiotherapy versus radiotherapy alone. [1] The so-called “sandwich” regimen of pelvic external beam radiation administered between cycles of Carboplatin/Paclitaxel (CT-RT-CT) is commonly used in clinical practice but has not been evaluated in randomized endometrial cancer trials. [2]化学療法と放射線療法を放射線療法のみと比較した子宮内膜がん試験のメタアナリシスを実施しました。 [1] カルボプラチン/パクリタキセル（CT-RT-CT）のサイクルの間に投与される骨盤外照射のいわゆる「サンドイッチ」レジメンは、臨床診療で一般的に使用されていますが、ランダム化された子宮内膜がん試験では評価されていません。 [2]