Lancet Oncology最新文献

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Progress in NCD screening in Mongolia. 蒙古在非传染性疾病筛查方面取得的进展。
IF 41.6 1区 医学
Lancet Oncology Pub Date : 2024-09-01 Epub Date: 2024-08-16 DOI: 10.1016/S1470-2045(24)00454-6
Sharmila Devi
{"title":"Progress in NCD screening in Mongolia.","authors":"Sharmila Devi","doi":"10.1016/S1470-2045(24)00454-6","DOIUrl":"10.1016/S1470-2045(24)00454-6","url":null,"abstract":"","PeriodicalId":17942,"journal":{"name":"Lancet Oncology","volume":null,"pages":null},"PeriodicalIF":41.6,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142004520","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"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
Poor progress on reducing alcohol consumption in Europe. 欧洲在减少酒精消费方面进展缓慢。
IF 41.6 1区 医学
Lancet Oncology Pub Date : 2024-09-01 Epub Date: 2024-08-01 DOI: 10.1016/S1470-2045(24)00435-2
Talha Burki
{"title":"Poor progress on reducing alcohol consumption in Europe.","authors":"Talha Burki","doi":"10.1016/S1470-2045(24)00435-2","DOIUrl":"10.1016/S1470-2045(24)00435-2","url":null,"abstract":"","PeriodicalId":17942,"journal":{"name":"Lancet Oncology","volume":null,"pages":null},"PeriodicalIF":41.6,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141889670","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"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
Clinical research in endometrial cancer: consensus recommendations from the Gynecologic Cancer InterGroup. 子宫内膜癌的临床研究:妇科癌症国际小组的共识建议。
IF 41.6 1区 医学
Lancet Oncology Pub Date : 2024-09-01 DOI: 10.1016/S1470-2045(24)00192-X
Carien L Creutzberg, Jae-Weon Kim, Gemma Eminowicz, Emma Allanson, Lauriane Eberst, Se Ik Kim, Remi A Nout, Jeong-Yeol Park, Domenica Lorusso, Linda Mileshkin, Petronella B Ottevanger, Alison Brand, Delia Mezzanzanica, Amit Oza, Val Gebski, Bhavana Pothuri, Tania Batley, Carol Gordon, Tina Mitra, Helen White, Brooke Howitt, Xavier Matias-Guiu, Isabelle Ray-Coquard, David Gaffney, William Small, Austin Miller, Nicole Concin, Matthew A Powell, Gavin Stuart, Michael A Bookman
{"title":"Clinical research in endometrial cancer: consensus recommendations from the Gynecologic Cancer InterGroup.","authors":"Carien L Creutzberg, Jae-Weon Kim, Gemma Eminowicz, Emma Allanson, Lauriane Eberst, Se Ik Kim, Remi A Nout, Jeong-Yeol Park, Domenica Lorusso, Linda Mileshkin, Petronella B Ottevanger, Alison Brand, Delia Mezzanzanica, Amit Oza, Val Gebski, Bhavana Pothuri, Tania Batley, Carol Gordon, Tina Mitra, Helen White, Brooke Howitt, Xavier Matias-Guiu, Isabelle Ray-Coquard, David Gaffney, William Small, Austin Miller, Nicole Concin, Matthew A Powell, Gavin Stuart, Michael A Bookman","doi":"10.1016/S1470-2045(24)00192-X","DOIUrl":"10.1016/S1470-2045(24)00192-X","url":null,"abstract":"<p><p>The Gynecologic Cancer InterGroup (GCIG) Endometrial Cancer Consensus Conference on Clinical Research (ECCC) was held in Incheon, South Korea, Nov 2-3, 2023. The aims were to develop consensus statements for future trials in endometrial cancer to achieve harmonisation on design elements, select important questions, and identify unmet needs. All 33 GCIG member groups participated in the development, refinement, and finalisation of 18 statements within four topic groups, addressing adjuvant treatment in high-risk disease; treatment for metastatic and recurrent disease; trial designs for rare endometrial cancer subgroups and special circumstances; and specific methodology and adaptation for trials in low-resource settings. In addition, eight areas of unmet need were identified. This was the first GCIG Consensus Conference to include patient advocates and an expert on inclusion, diversity, equity, and access to take part in all aspects of the process and output. Four early-career investigators were also selected for participation, ensuring that they represented different GCIG member groups and regions. Unanimous consensus was obtained for 16 of the 18 statements, with 97% concordance for the remaining two. Using the described methodology from previous Ovarian Cancer Consensus Conferences, this conference did not require even one minority statement. The high acceptance rate following active involvement in the preparation, discussion, and refinement of the statements by all representatives confirmed the consensus progress within a global academic setting, and the expectation that the ECCC will lead to greater harmonisation, actualisation, inclusion, and resolution of unmet needs in clinical research for individuals living with and beyond endometrial cancer worldwide.</p>","PeriodicalId":17942,"journal":{"name":"Lancet Oncology","volume":null,"pages":null},"PeriodicalIF":41.6,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142108839","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"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
Improving individualised therapies in localised gastro-oesophageal adenocarcinoma. 改进局部胃食管腺癌的个体化疗法。
IF 41.6 1区 医学
Lancet Oncology Pub Date : 2024-09-01 DOI: 10.1016/S1470-2045(24)00180-3
Magali Svrcek, Thibault Voron, Thierry André, Elizabeth C Smyth, Christelle de la Fouchardière
{"title":"Improving individualised therapies in localised gastro-oesophageal adenocarcinoma.","authors":"Magali Svrcek, Thibault Voron, Thierry André, Elizabeth C Smyth, Christelle de la Fouchardière","doi":"10.1016/S1470-2045(24)00180-3","DOIUrl":"https://doi.org/10.1016/S1470-2045(24)00180-3","url":null,"abstract":"<p><p>Despite our increased understanding of the biological and molecular aspects of gastro-oesophageal tumourigenesis, the identification of prognostic or predictive factors remains challenging. Patients with resectable gastric and oesophageal adenocarcinoma are often treated similarly after surgical resection, regardless of their tumour biology, clinical characteristics, and histological treatment response. Substantial progress has been made in the past 5 years in managing patients with gastric or oesophageal adenocarcinoma, including the use of immune checkpoint inhibitors and new targeted therapies, leading to substantial improvements in clinical outcomes. These advancements have primarily been established in advanced and metastatic disease, while the management framework for local and locoregional disease is just beginning to shift. We provide an overview of existing data on biomarkers and tumour-related and host-related factors that are relevant to stratify patients into low-risk and high-risk recurrence groups, both before and after surgery, paving the way for more personalised treatment approaches.</p>","PeriodicalId":17942,"journal":{"name":"Lancet Oncology","volume":null,"pages":null},"PeriodicalIF":41.6,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142108847","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"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
Defining the quality of interdisciplinary care for patients with brain metastases: modified Delphi panel recommendations. 确定脑转移患者跨学科治疗的质量:修改后的德尔菲小组建议。
IF 41.6 1区 医学
Lancet Oncology Pub Date : 2024-09-01 DOI: 10.1016/S1470-2045(24)00198-0
Camilo E Fadul, Jason P Sheehan, Julio Silvestre, Gloribel Bonilla, Joseph A Bovi, Manmeet Ahluwalia, Riccardo Soffietti, David Hui, Roger T Anderson
{"title":"Defining the quality of interdisciplinary care for patients with brain metastases: modified Delphi panel recommendations.","authors":"Camilo E Fadul, Jason P Sheehan, Julio Silvestre, Gloribel Bonilla, Joseph A Bovi, Manmeet Ahluwalia, Riccardo Soffietti, David Hui, Roger T Anderson","doi":"10.1016/S1470-2045(24)00198-0","DOIUrl":"https://doi.org/10.1016/S1470-2045(24)00198-0","url":null,"abstract":"<p><p>The value of interdisciplinary teams in improving outcomes and quality of care of patients with brain metastases remains uncertain, partly due to the lack of consensus on key indicators to evaluate interprofessional care. We aimed to obtain expert consensus across disciplines on indicators that evaluate the quality and value of brain metastases care. A steering committee of key opinion leaders curated relevant outcomes and process indicators from a literature review and a stakeholder needs assessment, and an international panel of physicians rated the outcomes and process indicators using a modified Delphi method. After three rounds, a consensus was reached on 29 indicators encompassing brain-directed oncological treatment, surgery, whole-brain radiotherapy, stereotactic radiosurgery, supportive or palliative care, and interdisciplinary team care. The Brain Metastases Quality-of-Care measure reflects the value and quality of brain metastases team-based care according to treatment modality and provides a benchmark of care for this under-studied patient population. The adoption, implementation, and sustainability of this set of indicators could help address the need expressed by patients with cancer, caregivers, and clinicians for more coordinated care across inpatient, outpatient, home, community, and tertiary academic settings.</p>","PeriodicalId":17942,"journal":{"name":"Lancet Oncology","volume":null,"pages":null},"PeriodicalIF":41.6,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142108842","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"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
Translating the theranostic concept to neuro-oncology: disrupting barriers. 将治疗概念转化为神经肿瘤学:打破障碍。
IF 41.6 1区 医学
Lancet Oncology Pub Date : 2024-09-01 DOI: 10.1016/S1470-2045(24)00145-1
Nathalie L Albert, Emilie Le Rhun, Giuseppe Minniti, Maximilian J Mair, Norbert Galldiks, Nelleke Tolboom, Asgeir S Jakola, Maximilian Niyazi, Marion Smits, Antoine Verger, Francesco Cicone, Michael Weller, Matthias Preusser
{"title":"Translating the theranostic concept to neuro-oncology: disrupting barriers.","authors":"Nathalie L Albert, Emilie Le Rhun, Giuseppe Minniti, Maximilian J Mair, Norbert Galldiks, Nelleke Tolboom, Asgeir S Jakola, Maximilian Niyazi, Marion Smits, Antoine Verger, Francesco Cicone, Michael Weller, Matthias Preusser","doi":"10.1016/S1470-2045(24)00145-1","DOIUrl":"https://doi.org/10.1016/S1470-2045(24)00145-1","url":null,"abstract":"<p><p>Theranostics integrate molecular imaging and targeted radionuclide therapy for personalised cancer therapy. Theranostic treatments have shown meaningful efficacy in randomised clinical trials and are approved for clinical use in prostate cancer and neuroendocrine tumours. Brain tumours represent an unmet clinical need and theranostics might offer effective treatment options, although specific issues need to be considered for clinical development. In this Policy Review, we discuss opportunities and challenges of developing targeted radionuclide therapies for the treatment of brain tumours including glioma, meningioma, and brain metastasis. The rational choice of molecular treatment targets is highlighted, including the potential relevance of different types of targeted radionuclide therapeutics, and the role of the blood-brain barrier and blood-tumour barrier. Furthermore, we discuss considerations for effective clinical trial design and conduct, as well as logistical and regulatory challenges for implementation of radionuclide therapies into neuro-oncological practice. Rational development will foster successful translation of the theranostic concept to brain tumours.</p>","PeriodicalId":17942,"journal":{"name":"Lancet Oncology","volume":null,"pages":null},"PeriodicalIF":41.6,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142108851","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"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
Combining PSMA-PET and PROMISE to re-define disease stage and risk in patients with prostate cancer: a multicentre retrospective study. 结合 PSMA-PET 和 PROMISE 重新定义前列腺癌患者的疾病分期和风险:一项多中心回顾性研究。
IF 41.6 1区 医学
Lancet Oncology Pub Date : 2024-09-01 Epub Date: 2024-07-29 DOI: 10.1016/S1470-2045(24)00326-7
Madeleine J Karpinski, Johannes Hüsing, Kevin Claassen, Lennart Möller, Hiltraud Kajüter, Florian Oesterling, Viktor Grünwald, Lale Umutlu, Jens Kleesiek, Tugce Telli, Anja Merkel-Jens, Anika Hüsing, Claudia Kesch, Ken Herrmann, Matthias Eiber, Sebastian Hoberück, Philipp T Meyer, Felix Kind, Kambiz Rahbar, Michael Schäfers, Andreas Stang, Boris A Hadaschik, Wolfgang P Fendler
{"title":"Combining PSMA-PET and PROMISE to re-define disease stage and risk in patients with prostate cancer: a multicentre retrospective study.","authors":"Madeleine J Karpinski, Johannes Hüsing, Kevin Claassen, Lennart Möller, Hiltraud Kajüter, Florian Oesterling, Viktor Grünwald, Lale Umutlu, Jens Kleesiek, Tugce Telli, Anja Merkel-Jens, Anika Hüsing, Claudia Kesch, Ken Herrmann, Matthias Eiber, Sebastian Hoberück, Philipp T Meyer, Felix Kind, Kambiz Rahbar, Michael Schäfers, Andreas Stang, Boris A Hadaschik, Wolfgang P Fendler","doi":"10.1016/S1470-2045(24)00326-7","DOIUrl":"10.1016/S1470-2045(24)00326-7","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Prostate-specific membrane antigen (PSMA)-PET was introduced into clinical practice in 2012 and has since transformed the staging of prostate cancer. Prostate Cancer Molecular Imaging Standardized Evaluation (PROMISE) criteria were proposed to standardise PSMA-PET reporting. We aimed to compare the prognostic value of PSMA-PET by PROMISE (PPP) stage with established clinical nomograms in a large prostate cancer dataset with follow-up data for overall survival.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;In this multicentre retrospective study, we used data from patients of any age with histologically proven prostate cancer who underwent PSMA-PET at the University Hospitals in Essen, Münster, Freiburg, and Dresden, Germany, between Oct 30, 2014, and Dec 27, 2021. We linked a subset of patient hospital records with patient data, including mortality data, from the Cancer Registry North-Rhine Westphalia, Germany. Patients from Essen University Hospital were randomly assigned to the development or internal validation cohorts (2:1). Patients from Münster, Freiburg, and Dresden University Hospitals were included in an external validation cohort. Using the development cohort, we created quantitative and visual PPP nomograms based on Cox regression models, assessing potential PPP predictors for overall survival, with least absolute shrinkage and selection operator penalty for overall survival as the primary endpoint. Performance was measured using Harrell's C-index in the internal and external validation cohorts and compared with established clinical risk scores (International Staging Collaboration for Cancer of the Prostate [STARCAP], European Association of Urology [EAU], and National Comprehensive Cancer Network [NCCN] risk scores) and a previous nomogram defined by Gafita et al (hereafter referred to as GAFITA) using receiver operating characteristic (ROC) curves and area under the ROC curve (AUC) estimates.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Findings: &lt;/strong&gt;We analysed 2414 male patients (1110 included in the development cohort, 502 in the internal cohort, and 802 in the external validation cohort), among whom 901 (37%) had died as of data cutoff (June 30, 2023; median follow-up of 52·9 months [IQR 33·9-79·0]). Predictors in the quantitative PPP nomogram were locoregional lymph node metastases (molecular imaging N2), distant metastases (extrapelvic nodal metastases, bone metastases [disseminated or diffuse marrow involvement], and organ metastases), tumour volume (in L), and tumour mean standardised uptake value. Predictors in the visual PPP nomogram were distant metastases (extrapelvic nodal metastases, bone metastases [disseminated or diffuse marrow involvement], and organ metastases) and total tumour lesion count. In the internal and external validation cohorts, C-indices were 0·80 (95% CI 0·77-0·84) and 0·77 (0·75-0·78) for the quantitative nomogram, respectively, and 0·78 (0·75-0·82) and 0·77 (0·75-0·78) for the visual nomogram, respectively. ","PeriodicalId":17942,"journal":{"name":"Lancet Oncology","volume":null,"pages":null},"PeriodicalIF":41.6,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141875254","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"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
Trastuzumab deruxtecan in HER2-positive metastatic colorectal cancer: less is more? 曲妥珠单抗德鲁替康治疗 HER2 阳性转移性结直肠癌:少即是多?
IF 41.6 1区 医学
Lancet Oncology Pub Date : 2024-09-01 Epub Date: 2024-08-05 DOI: 10.1016/S1470-2045(24)00397-8
Jeanine M L Roodhart, Miriam Koopman
{"title":"Trastuzumab deruxtecan in HER2-positive metastatic colorectal cancer: less is more?","authors":"Jeanine M L Roodhart, Miriam Koopman","doi":"10.1016/S1470-2045(24)00397-8","DOIUrl":"10.1016/S1470-2045(24)00397-8","url":null,"abstract":"","PeriodicalId":17942,"journal":{"name":"Lancet Oncology","volume":null,"pages":null},"PeriodicalIF":41.6,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141906967","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"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
Adjuvant pembrolizumab versus placebo in resected stage III melanoma (EORTC 1325-MG/KEYNOTE-054): long-term, health-related quality-of-life results from a double-blind, randomised, controlled, phase 3 trial. 在切除的 III 期黑色素瘤(EORTC 1325-MG/KEYNOTE-054)中使用 pembrolizumab 与安慰剂的辅助治疗:一项双盲、随机对照 3 期试验的长期健康相关生活质量结果。
IF 41.6 1区 医学
Lancet Oncology Pub Date : 2024-09-01 Epub Date: 2024-08-12 DOI: 10.1016/S1470-2045(24)00338-3
Emanuel Bührer, Michal Kicinski, Mario Mandala, Madeline Pe, Georgina V Long, Victoria Atkinson, Christian U Blank, Andrew Haydon, Stéphane Dalle, Adnan Khattak, Matteo S Carlino, Andrey Meshcheryakov, Shahneen Sandhu, Susana Puig, Dirk Schadendorf, Rahima Jamal, Piotr Rutkowski, Alfonsus J M van den Eertwegh, Corneel Coens, Dmitri Grebennik, Clemens Krepler, Caroline Robert, Alexander M M Eggermont
{"title":"Adjuvant pembrolizumab versus placebo in resected stage III melanoma (EORTC 1325-MG/KEYNOTE-054): long-term, health-related quality-of-life results from a double-blind, randomised, controlled, phase 3 trial.","authors":"Emanuel Bührer, Michal Kicinski, Mario Mandala, Madeline Pe, Georgina V Long, Victoria Atkinson, Christian U Blank, Andrew Haydon, Stéphane Dalle, Adnan Khattak, Matteo S Carlino, Andrey Meshcheryakov, Shahneen Sandhu, Susana Puig, Dirk Schadendorf, Rahima Jamal, Piotr Rutkowski, Alfonsus J M van den Eertwegh, Corneel Coens, Dmitri Grebennik, Clemens Krepler, Caroline Robert, Alexander M M Eggermont","doi":"10.1016/S1470-2045(24)00338-3","DOIUrl":"10.1016/S1470-2045(24)00338-3","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;In the European Organisation for Research and Treatment of Cancer (EORTC) 1325-MG/KEYNOTE-054 study, adjuvant pembrolizumab improved recurrence-free survival and distant-metastasis-free survival in patients with resected stage III melanoma. Earlier results showed no effect of pembrolizumab on health-related quality of life (HRQOL). Little is known about HRQOL after completion of treatment with pembrolizumab, an important research area concerning patients who are likely to become long-term survivors. This study reports long-term HRQOL results.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;This double-blind, randomised, controlled, phase 3 trial compared adjuvant pembrolizumab with placebo in patients aged 18 years or older with previously untreated stage IIIA, IIIB, or IIIC resected cutaneous melanoma and an Eastern Cooperative Oncology Group performance status score of 1 or 0, recruited from 123 academic centres and community hospitals in 23 countries. Patients were randomly assigned (1:1) with a minimisation technique stratified for stage and geographical region to receive 200 mg of intravenous pembrolizumab or placebo every 3 weeks for up to 18 doses. Investigators, patients, and those collecting or analysing data were masked to group assignment. The primary endpoint of the trial was recurrence-free survival (reported elsewhere). HRQOL was a prespecified exploratory endpoint, measured with the EORTC Quality of Life Questionnaire-Core 30. All patients with a baseline HRQOL evaluation available who were alive 108 weeks from randomisation were included in this analysis of long-term HRQOL. Long-term HRQOL included assessments measured every 6 months between 108 weeks and 48 months after randomisation. The threshold of clinical relevance for all HRQOL scales used was an average change of 5 points. The trial is ongoing, recruitment is completed, and HRQOL data collection is finalised. This study is registered with ClinicalTrials.gov, NCT02362594, and EudraCT, 2014-004944-37.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Findings: &lt;/strong&gt;Between Aug 26, 2015, and Nov 14, 2016, 1019 patients were randomly assigned to pembrolizumab (n=514) or placebo (n=505). Completion of the HRQOL evaluation at baseline exceeded 90% (481 [94%] patients in the pembrolizumab group and 467 [92%] in the placebo group), and ranged between 60% and 90% for post-baseline timepoints. Among patients with a baseline HRQOL evaluation, 365 (39%) were female and 583 (61%) were male. The mean change from baseline to long-term HRQOL was -0·56 (95% CI -2·33 to 1·22) in the pembrolizumab group and 1·63 (-0·12 to 3·38) in the placebo group. The difference between the two groups was -2·19 (-4·65 to 0·27, p=0·081). Differences for all other scales were smaller than 5 and not statistically significant.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Interpretation: &lt;/strong&gt;Adjuvant pembrolizumab did not have a significant impact on long-term HRQOL compared with placebo in patients with resected stage III melanoma. These findings, tog","PeriodicalId":17942,"journal":{"name":"Lancet Oncology","volume":null,"pages":null},"PeriodicalIF":41.6,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141988301","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"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
Postoperative radiotherapy in women with early operable breast cancer (Scottish Breast Conservation Trial): 30-year update of a randomised, controlled, phase 3 trial. 早期可手术乳腺癌妇女的术后放疗(苏格兰乳房保护试验):随机对照 3 期试验的 30 年更新。
IF 41.6 1区 医学
Lancet Oncology Pub Date : 2024-09-01 Epub Date: 2024-08-07 DOI: 10.1016/S1470-2045(24)00347-4
Linda J Williams, Ian H Kunkler, Karen J Taylor, Joanna Dunlop, Tammy Piper, Jacqueline Caldwell, Wilma Jack, Joseph F Loane, Kenneth Elder, John M S Bartlett, J Michael Dixon, David A Cameron
{"title":"Postoperative radiotherapy in women with early operable breast cancer (Scottish Breast Conservation Trial): 30-year update of a randomised, controlled, phase 3 trial.","authors":"Linda J Williams, Ian H Kunkler, Karen J Taylor, Joanna Dunlop, Tammy Piper, Jacqueline Caldwell, Wilma Jack, Joseph F Loane, Kenneth Elder, John M S Bartlett, J Michael Dixon, David A Cameron","doi":"10.1016/S1470-2045(24)00347-4","DOIUrl":"10.1016/S1470-2045(24)00347-4","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Breast-conserving surgery, adjuvant systemic therapy, and radiotherapy are the standard of care for most women with early breast cancer. There are few reports of clinical outcomes beyond the first decade of follow-up of randomised trials comparing breast-conserving surgery with or without radiotherapy. We present a 30-year update of the Scottish Breast Conservation Trial.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;In this randomised, controlled, phase 3 trial across 14 hospitals in Scotland, women aged younger than 70 years with early breast cancer (tumours ≤4 cm [T1 or T2 and N0 or N1]) were included. They underwent breast-conserving surgery (1 cm margin) with axillary node sampling or clearance. Oestrogen receptor (ER)-rich patients (≥20 fmol/mg protein) received 20 mg oral tamoxifen daily for 5 years. ER-poor patients (&lt;20 fmol/mg protein) received chemotherapy (cyclophosphamide 600 mg/m&lt;sup&gt;2&lt;/sup&gt;, methotrexate 50 mg/m&lt;sup&gt;2&lt;/sup&gt;, and fluorouracil 600 mg/m&lt;sup&gt;2&lt;/sup&gt; every 21 days intravenously in eight courses). Stratification was by menstrual status (within or more than 12 months from last menstrual period) and ER status (oestrogen concentration ≥20 fmol/mg protein, &lt;20 fmol/mg protein, or unknown) and patients were randomly assigned (1:1) to high-dose (50 Gy in 20-25 fractions) local or locoregional radiotherapy versus no radiotherapy. No blinding was possible due to the nature of the treatment. We report the primary endpoint of the original trial, ipsilateral breast tumour recurrence, and the co-primary endpoint, overall survival. Clinical outcomes were compared by the log-rank test. Hazard ratios (HRs) are reported, with no radiotherapy as the reference group. Failures of the proportional hazards assumption are reported if significant. All analyses are by intention to treat.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Findings: &lt;/strong&gt;Between April 1, 1985, and Oct 2, 1991, 589 patients were enrolled and randomly assigned to the two treatment groups (293 to radiotherapy and 296 to no radiotherapy). After exclusion of four ineligible patients (two in each group), there were 291 patients in the radiotherapy group and 294 patients in the no radiotherapy group. Median follow-up was 17·5 years (IQR 8·4-27·9). Ipsilateral breast tumour recurrence was significantly lower in the radiotherapy group than in the no radiotherapy group (46 [16%] of 291 vs 107 [36%] of 294; HR 0·39 [95% CI 0·28-0·55], p&lt;0·0001). Although there were differences in the hazard rate for ipsilateral breast tumour recurrence in the first decade after treatment (HR 0·24 [95% CI 0·15-0·38], p&lt;0·0001), subsequent risks of ipsilateral breast tumour recurrence were similar in both groups (0·98 [0·54-1·79], p=0·95). There was no difference in overall survival between the two groups (median 18·7 years [95% CI 16·5-21·5] in the no radiotherapy group vs 19·2 years [16·9-21·3] in the radiotherapy group; HR 1·08 [95% CI 0·89-1 ·30], log-rank p=0·43).&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Interpretation: &lt;/strong","PeriodicalId":17942,"journal":{"name":"Lancet Oncology","volume":null,"pages":null},"PeriodicalIF":41.6,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141913133","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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