Lancet Oncology最新文献

{"title":"Sequential [¹⁷⁷Lu]Lu-PSMA-617 and docetaxel versus docetaxel in patients with metastatic hormone-sensitive prostate cancer (UpFrontPSMA): a multicentre, open-label, randomised, phase 2 study.","authors":"Arun A Azad, Mathias Bressel, Hsiang Tan, Mark Voskoboynik, Aneta Suder, Andrew J Weickhardt, Alexander Guminski, Roslyn J Francis, Javad Saghebi, Nattakorn Dhiantravan, Anthony M Joshua, Louise Emmett, Lisa Horvath, Declan G Murphy, Edward Hsiao, Bavanthi Balakrishnar, Peter Lin, Andrew Redfern, William Macdonald, Siobhan Ng, Sze-Ting Lee, David A Pattison, David Nadebaum, Ian D Kirkwood, Michael S Hofman","doi":"10.1016/S1470-2045(24)00440-6","DOIUrl":"10.1016/S1470-2045(24)00440-6","url":null,"abstract":"<p><strong>Background: </strong>Lutetium-177 [<sup>177</sup>Lu]Lu-prostate-specific membrane antigen (PSMA)-617 improves survival and quality of life in patients with metastatic castration-resistant prostate cancer, but whether it confers a benefit in hormone-sensitive disease is unknown. We aimed to evaluate [<sup>177</sup>Lu]Lu-PSMA-617 before docetaxel treatment in patients with de-novo high-volume metastatic hormone-sensitive prostate cancer.</p><p><strong>Methods: </strong>UpFrontPSMA was an investigator-initiated, multicentre, open-label, randomised, phase 2 trial done at 11 Australian hospitals. Eligible patients had prostate adenocarcinoma without clinically significant neuroendocrine differentiation or small-cell histology, were aged 18 years or older, had less than 4 weeks on androgen deprivation therapy, had an Eastern Cooperative Oncology Group performance status of 0-2, and had high-volume PSMA-avid disease on [<sup>68</sup>Ga]Ga-PSMA-11 PET-CT with no major discordance on 2-[<sup>18</sup>F] fluorodeoxyglucose-PET-CT. Patients were randomly assigned (1:1) to the experimental treatment ([<sup>177</sup>Lu]Lu-PSMA-617 followed 6 weeks later by docetaxel) or standard-of-care treatment (docetaxel alone) using computer-based block randomisation with random block sizes, stratified by disease volume by conventional imaging and duration of androgen deprivation therapy at the time of registration. Neither patients nor investigators were masked to treatment assignment. Patients in the experimental group received two cycles of [<sup>177</sup>Lu]Lu-PSMA-617 7·5 GBq every 6 weeks intravenously, followed 6 weeks later by six cycles of docetaxel 75 mg/m<sup>2</sup> every 3 weeks intravenously, whereas patients in the standard-of-care treatment group received six cycles of docetaxel 75 mg/m<sup>2</sup> every 3 weeks intravenously. All patients received continuous androgen deprivation therapy. The primary endpoint was undetectable prostate-specific antigen (≤0·2 ng/mL) at 48 weeks, assessed using a modified intention-to-treat analysis. The trial is registered with ClinicalTrials.gov, NCT04343885.</p><p><strong>Findings: </strong>Between May 5, 2020, and April 18, 2023, 130 patients were randomly assigned, 63 (48%) to [<sup>177</sup>Lu]Lu-PSMA-617 plus docetaxel and 67 (52%) to docetaxel alone. All patients were male and no race or ethnicity data were collected. Median follow-up was 2·5 years (IQR 1·8-3·0). Four patients in the docetaxel alone group withdrew consent after randomisation and no data beyond screening were collected. An additional four patients were not evaluable for the primary endpoint at 48 weeks (two in each group). 25 (41%) of 61 patients (95% CI 30-54) in the [<sup>177</sup>Lu]Lu-PSMA-617 plus docetaxel group had undetectable PSA at 48 weeks compared with ten (16%) of 61 patients (9-28) in the docetaxel alone group (OR 3·88, 95% CI 1·61-9·38; p=0·0020). The most common grade 3 or 4 treatment-related adverse events were febrile neutro","PeriodicalId":17942,"journal":{"name":"Lancet Oncology","volume":" ","pages":"1267-1276"},"PeriodicalIF":41.6,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142290316","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}

{"title":"Treatment of Richter transformation-immunotherapy to the rescue?","authors":"Othman Al-Sawaf, Barbara Eichhorst","doi":"10.1016/S1470-2045(24)00485-6","DOIUrl":"10.1016/S1470-2045(24)00485-6","url":null,"abstract":"","PeriodicalId":17942,"journal":{"name":"Lancet Oncology","volume":" ","pages":"1248-1249"},"PeriodicalIF":41.6,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142290318","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}

{"title":"Radiation oncology: a call for papers for ESTRO 2025.","authors":"David Collingridge, Pierre Blanchard","doi":"10.1016/S1470-2045(24)00483-2","DOIUrl":"10.1016/S1470-2045(24)00483-2","url":null,"abstract":"","PeriodicalId":17942,"journal":{"name":"Lancet Oncology","volume":" ","pages":"1254-1255"},"PeriodicalIF":41.6,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142140391","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}

{"title":"Over US$100 million pledged to improve cancer care across Africa.","authors":"Paul Adepoju","doi":"10.1016/S1470-2045(24)00433-9","DOIUrl":"10.1016/S1470-2045(24)00433-9","url":null,"abstract":"","PeriodicalId":17942,"journal":{"name":"Lancet Oncology","volume":" ","pages":"1119"},"PeriodicalIF":41.6,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141788551","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}

{"title":"Use of PROMISE criteria on PSMA-PET for prediction of overall survival in prostate cancer.","authors":"Kirsten Bouchelouche, Peter L Choyke","doi":"10.1016/S1470-2045(24)00339-5","DOIUrl":"10.1016/S1470-2045(24)00339-5","url":null,"abstract":"","PeriodicalId":17942,"journal":{"name":"Lancet Oncology","volume":" ","pages":"1107-1108"},"PeriodicalIF":41.6,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141875255","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}

{"title":"Completion axillary lymph node dissection for the identification of pN2-3 status as an indication for adjuvant CDK4/6 inhibitor treatment: a post-hoc analysis of the randomised, phase 3 SENOMAC trial.","authors":"Jana de Boniface, Matilda Appelgren, Robert Szulkin, Sara Alkner, Yvette Andersson, Leif Bergkvist, Jan Frisell, Oreste Davide Gentilini, Michalis Kontos, Thorsten Kühn, Dan Lundstedt, Birgitte Vrou Offersen, Roger Olofsson Bagge, Toralf Reimer, Malin Sund, Peer Christiansen, Lisa Rydén, Tove Filtenborg Tvedskov","doi":"10.1016/S1470-2045(24)00350-4","DOIUrl":"10.1016/S1470-2045(24)00350-4","url":null,"abstract":"<p><strong>Background: </strong>In luminal breast cancer, adjuvant CDK4/6 inhibitors (eg, abemaciclib) improve invasive disease-free survival. In patients with T1-2, grade 1-2 tumours, and one or two sentinel lymph node metastases, completion axillary lymph node dissection (cALND) is the only prognostic tool available that can reveal four or more nodal metastases (pN2-3), which is the only indication for adjuvant abemaciclib in this setting. However, this technique can lead to substantial arm morbidity in patients. We aimed to pragmatically describe the potential benefit and harm of this strategy on the individual patient level in patients from the ongoing SENOMAC trial.</p><p><strong>Methods: </strong>In the randomised, phase 3, SENOMAC trial, patients aged 18 years or older, of any performance status, with clinically node-negative T1-T3 breast cancer and one or two sentinel node macrometastases from 67 sites in five European countries (Denmark, Germany, Greece, Italy, and Sweden) were randomly assigned (1:1), via permutated block randomisation (random block size of 2 and 4) stratified by country, to either cALND or its omission (ie, they had a sentinel lymph node biopsy only). The primary outcome is overall survival, which is yet to be reported. In this post-hoc analysis, patients from the SENOMAC per-protocol population, with luminal oestrogen-receptor positive, HER2-negative, T1-2, histological grade 1-2 breast cancer, with tumour size of 5 cm or smaller were selected to match the characteristics of cohort 1 of the monarchE trial who would only have an indication for adjuvant abemaciclib if found to have 4 or more nodal metastases. The primary study objective was to determine the number of patients who developed patient-reported severe or very severe impairment of physical arm function after cALND (as measured by the Lymphedema Functioning, Disability, and Health [Lymph-ICF] Questionnaire) 1 year after surgery to avoid one invasive disease-free survival event at 5 years with 2 years of adjuvant abemaciclib, using invasive disease-free survival event data from cohort 1 of the monarchE trial. The SENOMAC trial is registered with ClincialTrials.gov, NCT02240472, and is closed to accrual and ongoing.</p><p><strong>Findings: </strong>Between Jan 31, 2015, and Dec 31, 2021, 2766 patients were enrolled in SENOMAC and randomly assigned to cALND (n=1384) or sentinel node biopsy only (n=1382), of whom 2540 were included in the per-protocol population. 1705 (67%) of 2540 patients met this post-hoc study's eligibility criteria, of whom 802 (47%) had a cALND and 903 (53%) had a sentinel lymph node biopsy only. Median age at randomisation was 62 years (IQR 52-71), 1699 (>99%) of 1705 patients were female, and six (<1%) were male. Among 1342 patients who responded to questionnaires, after a median follow-up of 45·2 months (IQR 25·6-59·8; data cutoff Nov 17, 2023), patient-reported severe or very severe impairment of physical arm function was reported in 84 ","PeriodicalId":17942,"journal":{"name":"Lancet Oncology","volume":" ","pages":"1222-1230"},"PeriodicalIF":41.6,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141913130","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}

{"title":"Imatinib in advanced GIST: if it's working, don't stop a good thing.","authors":"Ryan A Denu, Neeta Somaiah","doi":"10.1016/S1470-2045(24)00403-0","DOIUrl":"10.1016/S1470-2045(24)00403-0","url":null,"abstract":"","PeriodicalId":17942,"journal":{"name":"Lancet Oncology","volume":" ","pages":"1105-1107"},"PeriodicalIF":41.6,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141913132","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}

{"title":"Enhancing equity and long-term impact assessments in radiotherapy environmental studies.","authors":"Xiang Li, Guo-Bao Huang","doi":"10.1016/S1470-2045(24)00340-1","DOIUrl":"https://doi.org/10.1016/S1470-2045(24)00340-1","url":null,"abstract":"","PeriodicalId":17942,"journal":{"name":"Lancet Oncology","volume":"25 9","pages":"e397"},"PeriodicalIF":41.6,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142108845","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}

{"title":"The oncological role of resection in newly diagnosed diffuse adult-type glioma defined by the WHO 2021 classification: a Review by the RANO resect group.","authors":"Philipp Karschnia, Jasper K W Gerritsen, Nico Teske, Daniel P Cahill, Asgeir S Jakola, Martin van den Bent, Michael Weller, Oliver Schnell, Einar O Vik-Mo, Niklas Thon, Arnaud J P E Vincent, Michelle M Kim, Guido Reifenberger, Susan M Chang, Shawn L Hervey-Jumper, Mitchel S Berger, Joerg-Christian Tonn","doi":"10.1016/S1470-2045(24)00130-X","DOIUrl":"https://doi.org/10.1016/S1470-2045(24)00130-X","url":null,"abstract":"<p><p>Glioma resection is associated with prolonged survival, but neuro-oncological trials have frequently refrained from quantifying the extent of resection. The Response Assessment in Neuro-Oncology (RANO) resect group is an international, multidisciplinary group that aims to standardise research practice by delineating the oncological role of surgery in diffuse adult-type gliomas as defined per WHO 2021 classification. Favourable survival effects of more extensive resection unfold over months to decades depending on the molecular tumour profile. In tumours with a more aggressive natural history, supramaximal resection might correlate with additional survival benefit. Weighing the expected survival benefits of resection as dictated by molecular tumour profiles against clinical factors, including the introduction of neurological deficits, we propose an algorithm to estimate the oncological effects of surgery for newly diagnosed gliomas. The algorithm serves to select patients who might benefit most from extensive resection and to emphasise the relevance of quantifying the extent of resection in clinical trials.</p>","PeriodicalId":17942,"journal":{"name":"Lancet Oncology","volume":"25 9","pages":"e404-e419"},"PeriodicalIF":41.6,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142108850","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}

{"title":"Improving cancer control initiatives in Indigenous people.","authors":"Karl Gruber","doi":"10.1016/S1470-2045(24)00432-7","DOIUrl":"10.1016/S1470-2045(24)00432-7","url":null,"abstract":"","PeriodicalId":17942,"journal":{"name":"Lancet Oncology","volume":" ","pages":"1117-1118"},"PeriodicalIF":41.6,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141788549","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}