The Lancet Oncology最新文献

{"title":"Inter-rater reliability of CTCAE assessments with or without EORTC patient-reported outcome data in a mixed cancer population: a multinational, open-label, randomised controlled trial","authors":"Lisa M Wintner, Monika Sztankay, Hikmat Abdel-Razeq, Renad Hamdan-Mansour, Giovanni Caocci, Guillaume Mouillet, Yuichiro Kikawa, Nobuhiro Shibata, Manjunath Nookala Krishnamurthy, Amit Joshi, Rahul Krishnatry, Aditi Jain, Helle Pappot, Duška Petranović, Antonela Trobentar, Heike Schmidt, Susann Schulze, Anastasia Tararykova, August Zabernigg, Johannes M Giesinger, Bernhard Holzner","doi":"10.1016/s1470-2045(25)00679-5","DOIUrl":"https://doi.org/10.1016/s1470-2045(25)00679-5","url":null,"abstract":"<h3>Background</h3>The Common Terminology Criteria for Adverse Events (CTCAE) is the standard for provider-based rating of adverse events in oncology, but its reliability for symptomatic adverse events is low. Patient-reported outcome (PRO) data might improve the inter-rater reliability of CTCAE assessments. We investigated whether providers' access to PRO data enhances the inter-rater reliability of CTCAE ratings and the detection of symptomatic adverse events.<h3>Methods</h3>This multinational, open-label, randomised controlled trial was done in 11 hospitals in ten countries. Adults (aged ≥18 years) with any cancer diagnosis receiving chemotherapy, immunotherapy, or radiotherapy of curative or palliative intent were eligible. Patients were randomly assigned (1:1) to the intervention group (in which providers saw patients' PRO data as they were doing CTCAE assessments) or the control group (in which providers did not have access to PRO data) within each centre through a minimisation algorithm and a weighted cutoff; no additional stratification factors were applied. Patients completed the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 and 16 additional items from the EORTC Item Library, covering 17 symptomatic adverse events. Two independent providers (oncologists or trained nurses) did CTCAE ratings. The primary endpoint was the inter-rater reliability of CTCAE ratings, expressed as intraclass correlation coefficients (ICCs), for all patients with complete assessments. The trial was registered at <span><span>ClinicalTrials.gov</span><svg aria-label=\"Opens in new window\" focusable=\"false\" height=\"20\" viewbox=\"0 0 8 8\"><path d=\"M1.12949 2.1072V1H7V6.85795H5.89111V2.90281L0.784057 8L0 7.21635L5.11902 2.1072H1.12949Z\"></path></svg></span> (<span><span>NCT04066868</span><svg aria-label=\"Opens in new window\" focusable=\"false\" height=\"20\" viewbox=\"0 0 8 8\"><path d=\"M1.12949 2.1072V1H7V6.85795H5.89111V2.90281L0.784057 8L0 7.21635L5.11902 2.1072H1.12949Z\"></path></svg></span>) and is now closed.<h3>Findings</h3>Between Feb 10, 2020, and Dec 6, 2024, a total of 1067 patients were enrolled (538 in the control group and 529 in the intervention group), with full data from 512 patients in the control group and 501 in the intervention group included in the analysis. Median age was 59 years (IQR 46–68); 558 (55·1%) of 1013 were female and 455 (44·9%) were male. Most had good functional status (403 [79%] of 512 had ECOG 0–1 in the control group and 371 [74%] of 501 in the intervention group). The most common cancer types were haematological (control group: 137 [27%] of 512; intervention group: 131 [26%] of 501), breast (control group: 118 [23%]; intervention group: 107 [21%]), and gastrointestinal (control group: 98 [19%]; intervention group: 89 [18%]). Inter-rater reliability was significantly higher in the intervention group for 13 of 17 symptomatic adverse events, with the largest differences for memory impairment (ICC 0·176; p<","PeriodicalId":22865,"journal":{"name":"The Lancet Oncology","volume":"18 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2026-01-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146000880","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Cabozantinib and temozolomide in patients with unresectable or metastatic leiomyosarcoma and other soft tissue sarcomas: a multicentre, single-arm, lead-in phase 2 trial","authors":"Varun Monga, Scott Okuno, Brian Van Tine, Seth M Pollack, Mia Weiss, Angela Hirbe, Pedro Viveiros, Brian Schulte, Steven Attia, Brittany Siontis, Mohammad M Milhem, John A Charlson, Steven Robinson, Oluwatimilehin Okunowo, Paul Frankel, Doni Woo, Janet Yoon, Mark Agulnik","doi":"10.1016/s1470-2045(25)00654-0","DOIUrl":"https://doi.org/10.1016/s1470-2045(25)00654-0","url":null,"abstract":"","PeriodicalId":22865,"journal":{"name":"The Lancet Oncology","volume":"60 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2026-01-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145995253","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Pembrolizumab plus lenvatinib in recurrent gynaecological clear cell carcinoma (LARA): a multicentre, single-arm, phase 2 trial","authors":"Natalie Y L Ngoi, Jung-Yun Lee, Diana Lim, Yee Liang Thian, Yi Wan Lim, Jack J Chan, Wen Yee Chay, Zewen Zhang, Anil Gopinathan, Siew Eng Lim, Jeffrey Low, Joseph Ng, Pearl Tong, Yong-Jae Lee, Junsik Park, Jae-Weon Kim, Tuan Zea Tan, Junxian Zhu, Bee Choo Tai, Chel Hun Choi, Byoung-Gie Kim, David S P Tan","doi":"10.1016/s1470-2045(25)00662-x","DOIUrl":"https://doi.org/10.1016/s1470-2045(25)00662-x","url":null,"abstract":"BACKGROUNDCombined targeting of angiogenic and immune pathways is an emerging strategy in clear cell carcinomas arising from the gynaecological tract (CCGCs), given the unique molecular and microenvironmental features of this gynaecological cancer. We aimed to evaluate the preliminary activity and safety of pembrolizumab plus lenvatinib in patients with recurrent CCGC.METHODSWe conducted a multicentre, single-arm, phase 2 trial (LARA) across three tertiary hospitals in Singapore and South Korea. Adult patients (aged ≥18 years) with histologically confirmed CCGC, which had progressed or recurred after at least one previous line of platinum-based chemotherapy; an Eastern Cooperative Oncology Group performance status score of 0-1; and no previous exposure to immune checkpoint inhibitor therapy were eligible for inclusion. Patients received 200 mg intravenous pembrolizumab every 3 weeks plus 20 mg oral lenvatinib daily, until disease progression, unacceptable toxicity, or withdrawal of consent, whichever occurred first, for up to 2 years. The primary endpoint was objective response rate in the first 24 weeks of treatment, as per investigator-assessed Response Evaluation Criteria in Solid Tumours (RECIST; version 1.1), analysed by modified intention to treat. This trial is registered with ClinicalTrials.gov (NCT04699071) and is ongoing.FINDINGSBetween March 26, 2021, and Oct 10, 2023, 30 patients were assessed for eligibility, of whom 27 (90%) participants received at least one dose of pembrolizumab plus lenvatinib. 25 (83%) patients were included in the primary outcome analysis. Median participant age was 52 years (IQR 40-66). Among the 27 patients, 12 (44%) were Chinese, 12 (44%) were Korean, two (7%) were Malay, and one (4%) was Filipino. 24 (89%) patients had primary ovarian clear cell carcinoma; three (11%) had primary endometrial cancer. All tumours had proficient mismatch repair or microsatellite stability. At data cutoff on March 19, 2025, median follow-up was 21middot;0 months (IQR 12middot;5-25middot;2). Ten of 25 patients had confirmed objective response within 24 weeks (objective response rate at 24 weeks 40% [95% CI 21-61]). Grade 3-4 treatment-related adverse events occurred in 14 (52%) of 27 patients, the most common of which were hypertension (six [22%] patients), decreased platelet count (two [7%]), elevated aspartate aminotransferase (AST; two [7%]), and elevated alanine aminotransferase (ALT; two [7%]). Serious adverse events occurred in five (19%) patients, the most common of which were immune-related hepatitis in two (7%) patients and decreased platelet count in two (7%) patients. No treatment-related deaths occurred.INTERPRETATIONPembrolizumab plus lenvatinib showed promising anti-tumour activity and manageable safety in patients with recurrent CCGC, including in patients with disease progression following previous treatment with anti-angiogenic therapy. These findings support further evaluation of this combination in randomised ","PeriodicalId":22865,"journal":{"name":"The Lancet Oncology","volume":"38 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2026-01-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145995254","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"WHO on global taxation of alcoholic and sugar-sweetened drinks","authors":"Udani Samarasekera","doi":"10.1016/s1470-2045(26)00011-2","DOIUrl":"https://doi.org/10.1016/s1470-2045(26)00011-2","url":null,"abstract":"","PeriodicalId":22865,"journal":{"name":"The Lancet Oncology","volume":"62 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2026-01-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145995255","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"PFAS in biosolids used in US food supply could pose cancer risk","authors":"Elizabeth Gourd","doi":"10.1016/s1470-2045(26)00010-0","DOIUrl":"https://doi.org/10.1016/s1470-2045(26)00010-0","url":null,"abstract":"","PeriodicalId":22865,"journal":{"name":"The Lancet Oncology","volume":"23 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2026-01-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145995256","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Aumolertinib as adjuvant therapy in resected EGFR-mutated non-small-cell lung cancer (ARTS): a double-blind, multicentre, randomised, controlled, phase 3 trial","authors":"Liang Zhang, Xiqin Zhang, Lin Wu, Wenqun Xing, Chunling Liu, Peng Zhang, Kai Chen, Jianhua Shi, Shidong Xu, Xiaodong Zhang, Xiaorong Dong, Haohui Fang, Xinmin Yu, Yang Gao, Gaofeng Li, Zhenming Chen, Shaonan Fan, Xiaoqing Zhang, Ying Cheng","doi":"10.1016/s1470-2045(25)00643-6","DOIUrl":"https://doi.org/10.1016/s1470-2045(25)00643-6","url":null,"abstract":"<h3>Background</h3>Patients with resectable non-small-cell lung cancer (NSCLC), particularly those with <em>EGFR</em> mutations, face a high risk of recurrence and mortality post-surgery. Aumolertinib, a third-generation EGFR tyrosine-kinase inhibitor, is approved in China for adjuvant treatment in patients with NSCLC harbouring <em>EGFR</em> with an exon 19 deletion (ex19del) or exon 21 substitution (Leu858Arg) mutation. The ARTS study aimed to evaluate the efficacy and safety of adjuvant therapy with aumolertinib in patients with stage II–IIIB <em>EGFR</em>-mutated NSCLC.<h3>Methods</h3>This double-blind, multicentre, randomised, controlled, phase 3 trial enrolled patients from 48 hospitals in mainland China. Eligible patients were 18 years or older with stage II–IIIB NSCLC, had undergone a complete resection followed by standard adjuvant therapy, and had an <em>EGFR</em> ex19del or Leu858Arg mutation and an Eastern Cooperative Oncology Group performance status score of 0 or 1. Patients were stratified by <em>EGFR</em> mutation status and tumour stage and were randomly assigned (1:1) to receive aumolertinib 110 mg or placebo orally, once daily for 3 years or until disease recurrence or other discontinuation criteria were met. Patients were randomly allocated to groups using an interactive web response system; the double‑dummy technique masked patients, investigators, and assessors. The primary endpoint was disease-free survival in the modified intention-to treat (mITT) population (ie, all patients with stage II–IIIB NSCLC harbouring <em>EGFR</em> mutations who had undergone complete tumour resection and standard adjuvant therapy), assessed by blinded independent central review (BICR). Safety was assessed in all patients who received at least one dose of study treatment. Although the study is ongoing, with some patients remaining in follow-up, this analysis represents the protocol-specified primary analysis. This study is registered with <span><span>ClinicalTrials.gov</span><svg aria-label=\"Opens in new window\" focusable=\"false\" height=\"20\" viewbox=\"0 0 8 8\"><path d=\"M1.12949 2.1072V1H7V6.85795H5.89111V2.90281L0.784057 8L0 7.21635L5.11902 2.1072H1.12949Z\"></path></svg></span> (<span><span>NCT04687241</span><svg aria-label=\"Opens in new window\" focusable=\"false\" height=\"20\" viewbox=\"0 0 8 8\"><path d=\"M1.12949 2.1072V1H7V6.85795H5.89111V2.90281L0.784057 8L0 7.21635L5.11902 2.1072H1.12949Z\"></path></svg></span>).<h3>Findings</h3>Between April 30, 2021, and May 17, 2022, 399 individuals were screened for study eligibility; of these, 214 patients were randomly assigned to receive aumolertinib or placebo (107 in each group). 120 (56%) patients were female, 94 (44%) were male, median age was 59 years (IQR 54–66), and all patients were Chinese. 204 (95%) of 214 patients had received prior adjuvant chemotherapy. One patient in the aumolertinib group and three patients in the placebo group had stage I disease; therefore, 106 patients in the aumolertinib g","PeriodicalId":22865,"journal":{"name":"The Lancet Oncology","volume":"146 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2026-01-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145955123","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Precision oncology in resected EGFR-mutant NSCLC","authors":"Antonio Passaro, Xiuning Le","doi":"10.1016/s1470-2045(25)00667-9","DOIUrl":"https://doi.org/10.1016/s1470-2045(25)00667-9","url":null,"abstract":"","PeriodicalId":22865,"journal":{"name":"The Lancet Oncology","volume":"29 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2026-01-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145956747","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Correction to Lancet Oncol 2025; 26: 1227–39","authors":"","doi":"10.1016/s1470-2045(25)00563-7","DOIUrl":"https://doi.org/10.1016/s1470-2045(25)00563-7","url":null,"abstract":"","PeriodicalId":22865,"journal":{"name":"The Lancet Oncology","volume":"3 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2025-12-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145814008","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Development of a core outcome set for adolescents and young adults with cancer","authors":"Anne-Sophie Darlington PhD, Kirsty Way MSc, Nicole Collaço PhD, Charlotte Cairns MSc, Simone Hanebaum PhD, Silvie H M Janssen PhD, Urška Košir DPhil, Martin G McCabe MD, Daniel Stark MD, Samantha C Sodergren PhD, Winette T A van der Graaf PhD, Olga Husson PhD, STRONG AYA Consortium","doi":"10.1016/s1470-2045(25)00533-9","DOIUrl":"https://doi.org/10.1016/s1470-2045(25)00533-9","url":null,"abstract":"Adolescents and young adults aged 15–39 years diagnosed with cancer are faced with unique challenges, which affect key developmental milestones and can create complex care needs. The aim of this study was to reach international consensus on the minimum set of outcomes to measure through the development of a core outcome set (COS). The COS development followed published methodological standards. A literature review and interviews with adolescents and young adults with cancer and health-care professionals generated a comprehensive list of 129 outcomes, spanning clinical and patient-reported outcomes relevant to adolescents and young adults with cancer. A three-round online Delphi survey involving three stakeholder groups globally, was implemented to reach international consensus. Overall, 262 respondents participated in the Delphi survey and 126 (48·1%) completed three survey rounds. 59 outcomes met consensus in round 3 and were taken forward to the consensus meeting. The final COS consists of 20 outcomes, including two on-treatment specific domains and three off-treatment specific domains. This study developed an adolescents and young adult-specific COS that, when implemented in clinical care and research, will improve the relevance of research findings, enhance care delivery, and enable consistent data synthesis across studies. Future efforts will focus on refining measurement methods and ensuring global applicability.","PeriodicalId":22865,"journal":{"name":"The Lancet Oncology","volume":"29 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2025-12-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145814011","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"De-escalation of adjuvant radiotherapy in HPV-associated oropharyngeal cancer","authors":"Imran Petkar","doi":"10.1016/s1470-2045(25)00726-0","DOIUrl":"https://doi.org/10.1016/s1470-2045(25)00726-0","url":null,"abstract":"","PeriodicalId":22865,"journal":{"name":"The Lancet Oncology","volume":"50 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2025-12-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145813994","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}