Pub Date : 2024-11-04DOI: 10.1016/s1470-2045(24)00637-5
Talha Burki
No Abstract
无摘要
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Pub Date : 2024-11-04DOI: 10.1016/s1470-2045(24)00513-8
Karl Semaan, Rashad Nawfal, Elizabeth Nally, Yelena Y Janjigian, Caroline Robert, Solange Peters, Thomas Powles, Toni K Choueiri
<h2>Section snippets</h2><section><section><h2>Patients receiving subsequent therapy</h2>Initially, we assessed the number of patients in the control groups who underwent any subsequent treatment (including surgery, radiotherapy, or systemic therapy) after a disease-free survival event. Among the 15 perioperative ICI trials examined, only eight trials provided data on the number of patients receiving any subsequent therapy. In the melanoma clinical trials, 62 (89·8%) of 69 patients (CheckMate 76K) and 282 (87·3%) of 323 patients (EORTC 18071) who had a disease-free survival event</section></section><section><section><h2>Patients receiving subsequent systemic therapy</h2>We examined the number of patients who underwent systemic therapy following disease-free survival events in the control group. Among the 15 perioperative ICI trials examined, 13 provided data on the number of patients receiving subsequent systemic therapy. In the melanoma trials, 44 (38·2%) of 115 patients (KEYNOTE-716), 49 (71·0%) of 69 (CheckMate 76K), and 218 (72·2%) of 302 (KEYNOTE-054) who experienced a disease-free survival event received systemic therapy. In the NSCLC trials, 131 (61·8%)</section></section><section><section><h2>Patients receiving subsequent immunotherapy</h2>We then reviewed the proportion of patients receiving subsequent systemic immunotherapy among the patients who experienced a disease-free survival event in the control or non-experimental group. In the melanoma trials KEYNOTE-716 and KEYNOTE-054, which were the only trials with a built-in cross-over, 35 (30·4%) of 115 patients (KEYNOTE-716) and 195 (64·6%) of 302 (KEYNOTE-054) with a disease-free survival event received ICI as subsequent therapy. In the NSCLC trials, 102 (48·1%) of 212 patients</section></section><section><section><h2>Non-immune subsequent systemic therapy</h2>Relapses after surgery in some types of cancers are typically aggressive and surveillance or local therapies are not recommended. An example is urothelial carcinoma, for which regular radiology monitoring within adjuvant trials should enable early detection, necessitating timely intervention.<sup>5</sup> Chemotherapy has been considered the global standard of care for the management of patients with metastatic urothelial carcinoma and is globally available. Therefore, upon relapse, most patients should</section></section><section><section><h2>Real-world scenarios after recurrence</h2>To further understand the vast range of scenarios following tumour relapses, we created a visualisation of real-world instances of reporting subsequent therapies in perioperative trials, specifically focusing on renal cell carcinoma from KEYNOTE-564 (appendix p 3), the only pure adjuvant immunotherapy trial in solid cancers with an overall survival benefit. Our point was to illustrate that analyses of subsequent therapies are time-dependent and complex. For instance, by capturing subsequent</section></section><section><section><h2>Discussion</h2>Only
{"title":"Landscape of subsequent therapies in perioperative immunotherapy trials across multiple cancer types","authors":"Karl Semaan, Rashad Nawfal, Elizabeth Nally, Yelena Y Janjigian, Caroline Robert, Solange Peters, Thomas Powles, Toni K Choueiri","doi":"10.1016/s1470-2045(24)00513-8","DOIUrl":"https://doi.org/10.1016/s1470-2045(24)00513-8","url":null,"abstract":"<h2>Section snippets</h2><section><section><h2>Patients receiving subsequent therapy</h2>Initially, we assessed the number of patients in the control groups who underwent any subsequent treatment (including surgery, radiotherapy, or systemic therapy) after a disease-free survival event. Among the 15 perioperative ICI trials examined, only eight trials provided data on the number of patients receiving any subsequent therapy. In the melanoma clinical trials, 62 (89·8%) of 69 patients (CheckMate 76K) and 282 (87·3%) of 323 patients (EORTC 18071) who had a disease-free survival event</section></section><section><section><h2>Patients receiving subsequent systemic therapy</h2>We examined the number of patients who underwent systemic therapy following disease-free survival events in the control group. Among the 15 perioperative ICI trials examined, 13 provided data on the number of patients receiving subsequent systemic therapy. In the melanoma trials, 44 (38·2%) of 115 patients (KEYNOTE-716), 49 (71·0%) of 69 (CheckMate 76K), and 218 (72·2%) of 302 (KEYNOTE-054) who experienced a disease-free survival event received systemic therapy. In the NSCLC trials, 131 (61·8%)</section></section><section><section><h2>Patients receiving subsequent immunotherapy</h2>We then reviewed the proportion of patients receiving subsequent systemic immunotherapy among the patients who experienced a disease-free survival event in the control or non-experimental group. In the melanoma trials KEYNOTE-716 and KEYNOTE-054, which were the only trials with a built-in cross-over, 35 (30·4%) of 115 patients (KEYNOTE-716) and 195 (64·6%) of 302 (KEYNOTE-054) with a disease-free survival event received ICI as subsequent therapy. In the NSCLC trials, 102 (48·1%) of 212 patients</section></section><section><section><h2>Non-immune subsequent systemic therapy</h2>Relapses after surgery in some types of cancers are typically aggressive and surveillance or local therapies are not recommended. An example is urothelial carcinoma, for which regular radiology monitoring within adjuvant trials should enable early detection, necessitating timely intervention.<sup>5</sup> Chemotherapy has been considered the global standard of care for the management of patients with metastatic urothelial carcinoma and is globally available. Therefore, upon relapse, most patients should</section></section><section><section><h2>Real-world scenarios after recurrence</h2>To further understand the vast range of scenarios following tumour relapses, we created a visualisation of real-world instances of reporting subsequent therapies in perioperative trials, specifically focusing on renal cell carcinoma from KEYNOTE-564 (appendix p 3), the only pure adjuvant immunotherapy trial in solid cancers with an overall survival benefit. Our point was to illustrate that analyses of subsequent therapies are time-dependent and complex. For instance, by capturing subsequent</section></section><section><section><h2>Discussion</h2>Only ","PeriodicalId":22865,"journal":{"name":"The Lancet Oncology","volume":"126 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-11-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142579844","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 : 2024-10-30DOI: 10.1016/s1470-2045(24)00635-1
Karpinski MJ, Hüsing J, Claassen K, et al Combining PSMA-PET and PROMISE to re-define disease stage and risk in patients with prostate cancer: a multicentre retrospective study. Lancet Oncol 2024; 25: 1188–201—The appendix of this Article has been corrected as of Oct 30, 2024.
Karpinski MJ, Hüsing J, Claassen K, et al Combining PSMA-PET and PROMISE to redefine disease stage and risk in patients with prostate cancer: a multicentre retrospective study.Lancet Oncol 2024; 25: 1188-201-本文附录已于2024年10月30日更正。
{"title":"Correction to Lancet Oncol 2024; 25: 1188–201","authors":"","doi":"10.1016/s1470-2045(24)00635-1","DOIUrl":"https://doi.org/10.1016/s1470-2045(24)00635-1","url":null,"abstract":"<em>Karpinski MJ, Hüsing J, Claassen K, et al Combining PSMA-PET and PROMISE to re-define disease stage and risk in patients with prostate cancer: a multicentre retrospective study.</em> Lancet Oncol <em>2024;</em> 25: <em>1188–201</em>—The appendix of this Article has been corrected as of Oct 30, 2024.","PeriodicalId":22865,"journal":{"name":"The Lancet Oncology","volume":"87 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-10-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142542089","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 : 2024-10-29DOI: 10.1016/s1470-2045(24)00503-5
Pier Luigi Zinzani, Koji Izutsu, Neha Mehta-Shah, Stefan K Barta, Kenji Ishitsuka, Raul Córdoba, Shigeru Kusumoto, Emmanuel Bachy, Kate Cwynarski, Giuseppe Gritti, Anca Prica, Eric Jacobsen, Tatyana Feldman, Yann Guillermin, Daisuke Ennishi, Dok Hyun Yoon, Eva Domingo Domenech, Jasmine Zain, Jie Wang, Jin Seok Kim, Steven M Horwitz
<h3>Background</h3>Peripheral T-cell lymphomas are aggressive non-Hodgkin lymphomas with few treatment options for relapsed or refractory disease. Valemetostat tosylate (valemetostat) is a potent, novel, dual inhibitor of EZH2 and EZH1. We investigated the clinical activity and safety of valemetostat in patients with relapsed or refractory peripheral T-cell lymphoma, and its safety in patients with relapsed or refractory adult T-cell leukaemia/lymphoma.<h3>Methods</h3>VALENTINE-PTCL01 was a multicentre, open-label, single-arm, phase 2 trial performed at 47 hospitals in 12 countries across Asia, Europe, North America, and Oceania. Patients with either peripheral T-cell lymphoma or adult T-cell leukaemia/lymphoma, aged 18 years or older with an Eastern Cooperative Oncology Group performance status of 0–2 received oral valemetostat at 200 mg per day in continuous 28-day cycles until disease progression or unacceptable toxicity. The primary endpoint for patients with peripheral T-cell lymphoma was the CT-based objective response rate by blinded independent central review (BICR) using 2014 Lugano response criteria. Patients who received valemetostat and had a confirmed eligible peripheral T-cell lymphoma subtype on central review were included in the efficacy analysis. The primary endpoint for patients with adult T-cell leukaemia/lymphoma was the safety and tolerability of valemetostat. Safety in both cohorts was assessed in all patients who received at least one dose of valemetostat. The trial 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>NCT04703192</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 EudraCT, 2020-004954-31, and is closed to enrolment.<h3>Findings</h3>Between June 16, 2021, and Aug 10, 2022, 133 patients with relapsed or refractory peripheral T-cell lymphoma (median age 69·0 years [IQR 58·0–74·0]; 91 [68%] were male, and 42 [32%] were female) and 22 patients with adult T-cell leukaemia/lymphoma (66·5 years [54·0–73·0]; 15 [68%] were male, and seven [32%] were female) were enrolled. The median follow-up time was 12·3 months (95% CI 11·8–13·8). 52 (44%; 95% CI 35–53) of 119 efficacy-evaluable patients with relapsed or refractory peripheral T-cell lymphoma had an objective response. The most common grade 3−4 adverse events were thrombocytopenia (31 [23%] of 133 patients in the peripheral T-cell lymphoma group and 11 [50%] of 22 patients in the adult T-cell leukaemia/lymphoma group), anaemia (25 [19%] and ten [46%]), and neutropenia (23 [17%] and four [18%]). Serious treatment-emergent adverse events were reported in 53 (40%) patients with peripheral
背景外周T细胞淋巴瘤是一种侵袭性非霍奇金淋巴瘤，复发或难治性疾病的治疗方案很少。Valemetostat tosylate（缬美托司他）是一种强效、新型的 EZH2 和 EZH1 双抑制剂。我们研究了valemetostat对复发或难治性外周T细胞淋巴瘤患者的临床活性和安全性，以及对复发或难治性成人T细胞白血病/淋巴瘤患者的安全性。方法VALENTINE-PTCL01是一项多中心、开放标签、单臂的2期试验，在亚洲、欧洲、北美洲和大洋洲12个国家的47家医院进行。外周T细胞淋巴瘤或成人T细胞白血病/淋巴瘤患者年龄在18岁或18岁以上，东部合作肿瘤学组表现状态为0-2级，每天口服200毫克伐麦司他，连续28天为一个周期，直到疾病进展或出现不可接受的毒性。外周T细胞淋巴瘤患者的主要终点是采用2014年卢加诺反应标准进行盲法独立中央审查（BICR）得出的基于CT的客观反应率。接受伐麦司他治疗且经中央审查确认符合条件的外周T细胞淋巴瘤亚型患者纳入疗效分析。成人T细胞白血病/淋巴瘤患者的主要终点是伐麦司他的安全性和耐受性。对所有至少接受过一次伐麦司他治疗的患者进行了安全性评估。该试验已在ClinicalTrials.gov（NCT04703192）和EudraCT（2020-004954-31）上注册，目前已截止注册。研究结果2021年6月16日至2022年8月10日期间，133名复发或难治性外周T细胞淋巴瘤患者（中位年龄69-0岁[IQR 58-0-74-0]；91[68%]为男性，42[32%]为女性）和22名成人T细胞白血病/淋巴瘤患者（66-5岁[54-0-73-0]；15[68%]为男性，7[32%]为女性）入组。中位随访时间为 12-3 个月（95% CI 11-8-13-8）。在119例有疗效的复发或难治性外周T细胞淋巴瘤患者中，52例（44%；95% CI 35-53）患者获得了客观应答。最常见的3-4级不良反应是血小板减少症（外周T细胞淋巴瘤组133名患者中的31例[23%]和成人T细胞白血病/淋巴瘤组22名患者中的11例[50%]）、贫血（25例[19%]和10例[46%]）和中性粒细胞减少症（23例[17%]和4例[18%]）。53例（40%）外周T细胞淋巴瘤患者和15例（68%）成人T细胞白血病/淋巴瘤患者出现了严重的治疗突发不良事件；分别有9例（7%）和1例（5%）患者出现了被认为与治疗相关的严重治疗突发不良事件。这些数据表明，使用伐麦司他治疗复发或难治性外周T细胞淋巴瘤患者可获得持久的应答，且安全性可控。
{"title":"Valemetostat for patients with relapsed or refractory peripheral T-cell lymphoma (VALENTINE-PTCL01): a multicentre, open-label, single-arm, phase 2 study","authors":"Pier Luigi Zinzani, Koji Izutsu, Neha Mehta-Shah, Stefan K Barta, Kenji Ishitsuka, Raul Córdoba, Shigeru Kusumoto, Emmanuel Bachy, Kate Cwynarski, Giuseppe Gritti, Anca Prica, Eric Jacobsen, Tatyana Feldman, Yann Guillermin, Daisuke Ennishi, Dok Hyun Yoon, Eva Domingo Domenech, Jasmine Zain, Jie Wang, Jin Seok Kim, Steven M Horwitz","doi":"10.1016/s1470-2045(24)00503-5","DOIUrl":"https://doi.org/10.1016/s1470-2045(24)00503-5","url":null,"abstract":"<h3>Background</h3>Peripheral T-cell lymphomas are aggressive non-Hodgkin lymphomas with few treatment options for relapsed or refractory disease. Valemetostat tosylate (valemetostat) is a potent, novel, dual inhibitor of EZH2 and EZH1. We investigated the clinical activity and safety of valemetostat in patients with relapsed or refractory peripheral T-cell lymphoma, and its safety in patients with relapsed or refractory adult T-cell leukaemia/lymphoma.<h3>Methods</h3>VALENTINE-PTCL01 was a multicentre, open-label, single-arm, phase 2 trial performed at 47 hospitals in 12 countries across Asia, Europe, North America, and Oceania. Patients with either peripheral T-cell lymphoma or adult T-cell leukaemia/lymphoma, aged 18 years or older with an Eastern Cooperative Oncology Group performance status of 0–2 received oral valemetostat at 200 mg per day in continuous 28-day cycles until disease progression or unacceptable toxicity. The primary endpoint for patients with peripheral T-cell lymphoma was the CT-based objective response rate by blinded independent central review (BICR) using 2014 Lugano response criteria. Patients who received valemetostat and had a confirmed eligible peripheral T-cell lymphoma subtype on central review were included in the efficacy analysis. The primary endpoint for patients with adult T-cell leukaemia/lymphoma was the safety and tolerability of valemetostat. Safety in both cohorts was assessed in all patients who received at least one dose of valemetostat. The trial 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>NCT04703192</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 EudraCT, 2020-004954-31, and is closed to enrolment.<h3>Findings</h3>Between June 16, 2021, and Aug 10, 2022, 133 patients with relapsed or refractory peripheral T-cell lymphoma (median age 69·0 years [IQR 58·0–74·0]; 91 [68%] were male, and 42 [32%] were female) and 22 patients with adult T-cell leukaemia/lymphoma (66·5 years [54·0–73·0]; 15 [68%] were male, and seven [32%] were female) were enrolled. The median follow-up time was 12·3 months (95% CI 11·8–13·8). 52 (44%; 95% CI 35–53) of 119 efficacy-evaluable patients with relapsed or refractory peripheral T-cell lymphoma had an objective response. The most common grade 3−4 adverse events were thrombocytopenia (31 [23%] of 133 patients in the peripheral T-cell lymphoma group and 11 [50%] of 22 patients in the adult T-cell leukaemia/lymphoma group), anaemia (25 [19%] and ten [46%]), and neutropenia (23 [17%] and four [18%]). Serious treatment-emergent adverse events were reported in 53 (40%) patients with peripheral","PeriodicalId":22865,"journal":{"name":"The Lancet Oncology","volume":"12 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-10-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142541492","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 : 2024-10-29DOI: 10.1016/s1470-2045(24)00502-3
Dai Maruyama, Eric Jacobsen, Pierluigi Porcu, Pamela Allen, Kenji Ishitsuka, Shigeru Kusumoto, Tomoko Narita, Kensei Tobinai, Francine Foss, Kunihiro Tsukasaki, Tatyana Feldman, Yoshitaka Imaizumi, Koji Izutsu, Satoko Morishima, Nobuhiko Yamauchi, Junichiro Yuda, Jonathan E Brammer, Toyotaka Kawamata, Jia Ruan, Kisato Nosaka, Steven M Horwitz
<h3>Background</h3>Few treatment options exist for patients with non-Hodgkin lymphoma, and outcomes remain poor for relapsed or refractory disease. We evaluated the safety and preliminary clinical activity of valemetostat, a novel inhibitor of EZH2 and EZH1, in patients with relapsed or refractory non-Hodgkin lymphomas.<h3>Methods</h3>This first-in-human, multicentre, open-label, single-arm, phase 1, dose-escalation and dose-expansion trial was done in 19 hospitals across Japan and the USA. Patients were included if they were aged 18 years or older in the USA or 20 years or older in Japan with a primary diagnosis of relapsed or refractory non-Hodgkin lymphoma and an Eastern Cooperative Oncology Group performance status of 0 or 1. In the dose-escalation part, patients received oral valemetostat at doses of 150 mg per day, 200 mg per day, 250 mg per day, and 300 mg per day continuously in 28-day cycles until progressive disease or unacceptable toxicities. All patients received 200 mg per day in the dose-expansion part. The primary endpoints were safety, pharmacokinetics, and the recommended phase 2 dose; the secondary endpoints were the maximum tolerated dose and the antitumour activity of valemetostat. Responses were assessed in patients who received at least one dose, with measurable lesions at baseline according to the International Working Group 2007 revised criteria for malignant lymphoma (peripheral T-cell lymphoma and B-cell non-Hodgkin lymphoma) and the modified 2009 criteria for adult T-cell leukaemia/lymphoma. The trial 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>NCT02732275</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 currently active, but not recruiting.<h3>Findings</h3>Between April 7, 2016, and June 10, 2021, 90 patients (53 [59%] males and 37 [41%] females; 49 [54%] Asian, 33 [37%] White, and eight [9%] Black) were enrolled and treated with valemetostat and included in the safety analysis set. 57 (63%) patients had peripheral T-cell lymphoma, 14 (16%) had adult T-cell leukaemia/lymphoma, and 19 (21%) had B-cell non-Hodgkin lymphoma. Seven (8%) patients received valemetostat 150 mg per day, 74 (82%) received 200 mg per day, seven received 250 mg per day, and two received 300 mg per day. Median follow-up was 7·4 months (IQR 3·4–17·6). All patients had at least one treatment-emergent adverse event; the most common treatment-emergent adverse events of any grade were decreased platelet count (52 [58%] of 90 patients), dysgeusia (45 [50%]), and anaemia (38 [42%]). The most common grade 3–4 adverse events were decreased neutrophil count (21 [
{"title":"Valemetostat monotherapy in patients with relapsed or refractory non-Hodgkin lymphoma: a first-in-human, multicentre, open-label, single-arm, phase 1 study","authors":"Dai Maruyama, Eric Jacobsen, Pierluigi Porcu, Pamela Allen, Kenji Ishitsuka, Shigeru Kusumoto, Tomoko Narita, Kensei Tobinai, Francine Foss, Kunihiro Tsukasaki, Tatyana Feldman, Yoshitaka Imaizumi, Koji Izutsu, Satoko Morishima, Nobuhiko Yamauchi, Junichiro Yuda, Jonathan E Brammer, Toyotaka Kawamata, Jia Ruan, Kisato Nosaka, Steven M Horwitz","doi":"10.1016/s1470-2045(24)00502-3","DOIUrl":"https://doi.org/10.1016/s1470-2045(24)00502-3","url":null,"abstract":"<h3>Background</h3>Few treatment options exist for patients with non-Hodgkin lymphoma, and outcomes remain poor for relapsed or refractory disease. We evaluated the safety and preliminary clinical activity of valemetostat, a novel inhibitor of EZH2 and EZH1, in patients with relapsed or refractory non-Hodgkin lymphomas.<h3>Methods</h3>This first-in-human, multicentre, open-label, single-arm, phase 1, dose-escalation and dose-expansion trial was done in 19 hospitals across Japan and the USA. Patients were included if they were aged 18 years or older in the USA or 20 years or older in Japan with a primary diagnosis of relapsed or refractory non-Hodgkin lymphoma and an Eastern Cooperative Oncology Group performance status of 0 or 1. In the dose-escalation part, patients received oral valemetostat at doses of 150 mg per day, 200 mg per day, 250 mg per day, and 300 mg per day continuously in 28-day cycles until progressive disease or unacceptable toxicities. All patients received 200 mg per day in the dose-expansion part. The primary endpoints were safety, pharmacokinetics, and the recommended phase 2 dose; the secondary endpoints were the maximum tolerated dose and the antitumour activity of valemetostat. Responses were assessed in patients who received at least one dose, with measurable lesions at baseline according to the International Working Group 2007 revised criteria for malignant lymphoma (peripheral T-cell lymphoma and B-cell non-Hodgkin lymphoma) and the modified 2009 criteria for adult T-cell leukaemia/lymphoma. The trial 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>NCT02732275</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 currently active, but not recruiting.<h3>Findings</h3>Between April 7, 2016, and June 10, 2021, 90 patients (53 [59%] males and 37 [41%] females; 49 [54%] Asian, 33 [37%] White, and eight [9%] Black) were enrolled and treated with valemetostat and included in the safety analysis set. 57 (63%) patients had peripheral T-cell lymphoma, 14 (16%) had adult T-cell leukaemia/lymphoma, and 19 (21%) had B-cell non-Hodgkin lymphoma. Seven (8%) patients received valemetostat 150 mg per day, 74 (82%) received 200 mg per day, seven received 250 mg per day, and two received 300 mg per day. Median follow-up was 7·4 months (IQR 3·4–17·6). All patients had at least one treatment-emergent adverse event; the most common treatment-emergent adverse events of any grade were decreased platelet count (52 [58%] of 90 patients), dysgeusia (45 [50%]), and anaemia (38 [42%]). The most common grade 3–4 adverse events were decreased neutrophil count (21 [","PeriodicalId":22865,"journal":{"name":"The Lancet Oncology","volume":"15 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-10-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142541565","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 : 2024-10-28DOI: 10.1016/s1470-2045(24)00587-4
Iliopoulos O, Iversen AB, Narayan V, et al. Belzutifan for patients with von Hippel-Lindau disease-associated CNS haemangioblastomas (LITESPARK-004): a multicentre, single-arm, phase 2 study. Lancet Oncol 2024; 25: 1325–36—In this Article, the second sentence in the fifth paragraph of the Results section, should read “After initiating belzutifan treatment, one patient (2%) underwent two CNS-related surgeries (cyst drainage and haemangioblastoma removal for the same lesion), and one patient (2%) received local radiotherapy approximately 5 weeks after starting belzutifan treatment.” These corrections have been made to the online version as of Oct 28, 2024.
Iliopoulos O, Iversen AB, Narayan V, et al. Belzutifan for patients with von Hippel-Lindau disease-associated CNS haemangioblastomas (LITESPARK-004): a multicentre, single-arm, phase 2 study.Lancet Oncol 2024; 25: 1325-36-在这篇文章中，结果部分第五段的第二句应为 "在开始接受贝珠单抗治疗后，一名患者（2%）接受了两次中枢神经系统相关手术（囊肿引流术和同一病灶的血管母细胞瘤切除术），一名患者（2%）在开始接受贝珠单抗治疗约5周后接受了局部放疗"。截至2024年10月28日的在线版本已做了上述更正。
{"title":"Correction to Lancet Oncol 2024; 25: 1325–36","authors":"","doi":"10.1016/s1470-2045(24)00587-4","DOIUrl":"https://doi.org/10.1016/s1470-2045(24)00587-4","url":null,"abstract":"<em>Iliopoulos O, Iversen AB, Narayan V, et al. Belzutifan for patients with von Hippel-Lindau disease-associated CNS haemangioblastomas (LITESPARK-004): a multicentre, single-arm, phase 2 study.</em> Lancet Oncol <em>2024; <strong>25:</strong> 1325–36</em>—In this Article, the second sentence in the fifth paragraph of the Results section, should read “After initiating belzutifan treatment, one patient (2%) underwent two CNS-related surgeries (cyst drainage and haemangioblastoma removal for the same lesion), and one patient (2%) received local radiotherapy approximately 5 weeks after starting belzutifan treatment.” These corrections have been made to the online version as of Oct 28, 2024.","PeriodicalId":22865,"journal":{"name":"The Lancet Oncology","volume":"13 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-10-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142519978","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}
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