Pub Date : 2026-01-19DOI: 10.1016/s1470-2045(25)00679-5
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
<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<
{"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}
Pub Date : 2026-01-16DOI: 10.1016/s1470-2045(25)00654-0
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
{"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}
Pub Date : 2026-01-15DOI: 10.1016/s1470-2045(25)00662-x
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
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
背景：考虑到妇科透明细胞癌独特的分子和微环境特征，血管生成和免疫途径的联合靶向治疗是妇科透明细胞癌的一种新兴策略。我们的目的是评估派姆单抗联合lenvatinib在复发性CCGC患者中的初步活性和安全性。方法：我们在新加坡和韩国的三家三级医院进行了一项多中心、单臂、2期试验（LARA）。组织学证实的CCGC成年患者（年龄≥18岁），既往至少一次铂类化疗后进展或复发；a东部肿瘤合作组绩效状态评分0-1；既往未接受免疫检查点抑制剂治疗的患者符合纳入条件。患者每3周接受200mg静脉注射派姆单抗加20mg每日口服lenvatinib，直至疾病进展、不可接受的毒性或撤销同意（以先发生者为例），疗程长达2年。主要终点是治疗前24周的客观缓解率，根据研究者评估的实体肿瘤反应评价标准（RECIST； 1.1版），通过修改的治疗意向进行分析。该试验已在ClinicalTrials.gov注册（NCT04699071），并正在进行中。在2021年3月26日至2023年10月10日期间，30名患者被评估为合格，其中27名（90%）参与者接受了至少一剂派姆单抗加lenvatinib。25例（83%）患者被纳入主要结局分析。参与者年龄中位数为52岁（IQR 40-66）。27例患者中，华人12例（44%），韩裔12例（44%），马来人2例（7%），菲律宾人1例（4%），原发性卵巢透明细胞癌24例（89%）；3例（11%）患有原发性子宫内膜癌。所有肿瘤均具有良好的错配修复或微卫星稳定性。截至2025年3月19日数据截止，随访中位数为21点；0个月（IQR 12中点；5-25中点；2）。25例患者中有10例在24周内客观缓解（24周客观缓解率为40% [95% CI 21-61]）。27例患者中有14例（52%）发生3-4级治疗相关不良事件，其中最常见的是高血压（6例[22%]）、血小板减少（2例[7%]）、天冬氨酸转氨酶（AST， 2例[7%]）升高、丙氨酸转氨酶（ALT， 2例[7%]）升高。5例（19%）患者发生了严重不良事件，其中最常见的是2例（7%）患者的免疫相关性肝炎和2例（7%）患者的血小板计数下降。无治疗相关死亡发生。pembrolizumab联合lenvatinib在复发性CCGC患者中显示出有希望的抗肿瘤活性和可控的安全性，包括在先前接受抗血管生成治疗后疾病进展的患者。这些发现支持在随机对照试验中进一步评价这种组合。国家医学研究理事会（新加坡）、Pangestu家族基金会妇科癌症研究基金和MSD。
{"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}
Pub Date : 2026-01-15DOI: 10.1016/s1470-2045(26)00011-2
Udani Samarasekera
{"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}
Pub Date : 2026-01-15DOI: 10.1016/s1470-2045(26)00010-0
Elizabeth Gourd
{"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}
<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
{"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}
京公网安备 11010802042870号
京ICP备2023020795号-1
扫码关注我们
求助内容：
应助结果提醒方式：