Pub Date : 2026-02-06DOI: 10.1016/s1470-2045(26)00058-6
Emma Wilkinson
No Abstract
没有抽象的
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Pub Date : 2026-02-05DOI: 10.1016/s1470-2045(25)00656-4
Per Nilsson, Adalsteinn Gunnlaugsson, Lars Beckman, Anders Widmark, Per Fransson, Morten Hoyer, Magnus Lagerlund, Jon Kindblom, Bengt Johansson, Kirsten Björnlinger, Claes Ginman, Martha Olsson, Måns Agrup, Elisabeth Kjellén, Björn Zackrisson, Björn Tavelin, Lars Franzén, Harald Anderson, Camilla Thellenberg Karlsson
<h3>Background</h3>HYPO-RT-PC is a phase 3 trial comparing ultra-hypofractionated and conventionally fractionated radiotherapy in intermediate-to-high-risk localised prostate cancer. This 10-year update reports long-term efficacy and toxicity outcomes.<h3>Methods</h3>In this open-label, randomised, phase 3, non-inferiority trial done in ten centres in Sweden and two in Denmark, we recruited men aged 75 years or younger with intermediate-risk or high-risk prostate cancer and a WHO performance status between 0 and 2. Previous or current androgen deprivation therapy was not permitted. Patients were randomly assigned (1:1) to ultra-hypofractionated radiotherapy (42·7 Gy in seven fractions, 3 days per week for 2·5 weeks) or conventionally fractionated radiotherapy (78·0 Gy in 39 fractions, 5 days per week for 8 weeks). Randomisation was performed with a minimisation algorithm balancing T stage, Gleason score, prostate-specific antigen, and trial centre. The primary endpoint was failure-free survival, defined as time from randomisation to the first occurrence of biochemical failure, evidence of clinical progression, initiation of androgen deprivation therapy, or death from prostate cancer, analysed in the per-protocol population. The non-inferiority margin was 4% at 5 years and had previously been met, corresponding to a critical hazard ratio (HR) limit of 1·338. Toxicity was assessed using the Radiation Therapy Oncology Group morbidity scale. Here, we report long-term efficacy and safety results at 10 years. The trial is registered with the ISRCTN registry, ISRCTN45905321, and is closed.<h3>Findings</h3>Between July 1, 2005, and Nov 4, 2015, 1200 patients were randomly assigned to conventional fractionated radiotherapy (n=602) or ultra-hypofractionated radiotherapy (n=598). Ten patients withdrew consent, eight were found to be ineligible, and two died of reasons unrelated to prostate cancer. 1180 patients constituted the per-protocol population (591 in the conventional fractionation group and 589 in the ultra-hypofractionation group). After a median follow-up of 10·6 years (IQR 9·0–13·0) in the conventional fractionation group and 10·7 years (9·1–12·7) in the ultra-hypofractionation group, 205 and 178 primary events were observed, respectively. 10-year failure-free survival was 65% (95% CI 61–69) in the conventionally fractionated group and 72% (68–76) in the ultra-hypofractionated group. The adjusted HR for the primary endpoint was 0·84 (95% CI 0·69–1·03; Cox regression analysis), confirming non-inferiority. The 10-year cumulative incidence of late grade 2 or worse genitourinary toxic effects was 30% (95% CI 26–34) in the conventional fractionation group and 28% (24–32) in the ultra-hypofractionated group (HR 1·01, 95% CI 0·81–1·25; p=0·95). For late grade 2 or worse gastrointestinal toxic effects, the corresponding figures were 14% (95% CI 11–18) and 14% (11–17; HR 0·94, 95% CI 0·70–1·28; p=0·72).<h3>Interpretation</h3>This 10-year follow-up confirm
背景:hyport - pc是一项3期临床试验,比较了超低分割放疗和常规分割放疗治疗中高风险局部前列腺癌的疗效。这份10年更新报告了长期疗效和毒性结果。在这项开放标签、随机、3期、非劣效性试验中,我们在瑞典的10个中心和丹麦的2个中心招募了年龄在75岁或以下、患有中危或高危前列腺癌、WHO评分在0到2之间的男性。以前或现在的雄激素剥夺治疗是不允许的。患者被随机(1:1)分配到超低分割放疗(42.7 Gy,分7次,每周3天,持续2·5周)或常规分割放疗(78·0 Gy,分39次,每周5天,持续8周)。随机化采用最小化算法,平衡T分期、Gleason评分、前列腺特异性抗原和试验中心。主要终点是无失败生存期,定义为从随机化到首次发生生化失败、临床进展证据、开始雄激素剥夺治疗或前列腺癌死亡的时间,在按方案人群中进行分析。在5年时,非劣效性边际为4%,并且先前已满足,对应于临界风险比(HR)极限为1.338。使用放射治疗肿瘤组发病率量表评估毒性。在这里,我们报告了10年的长期疗效和安全性结果。该试验已在ISRCTN注册中心ISRCTN45905321注册,并已关闭。在2005年7月1日至2015年11月4日期间,1200例患者被随机分配到常规分割放疗组(n=602)或超低分割放疗组(n=598)。10名患者撤回了同意,8名患者被发现不符合条件,2名患者死于与前列腺癌无关的原因。1180例患者构成了按方案分组(591例为常规分割组,589例为超低分割组)。常规分割组和超低分割组的中位随访时间分别为10.6年(IQR为9.0 ~ 13.0)和10.7年(IQR为9.1 ~ 12.7),分别观察到205例和178例原发性事件。常规分割组的10年无失败生存率为65% (95% CI 61-69),超低分割组为72%(68-76)。主要终点调整后的HR为0.84 (95% CI 0.69 ~ 1.03; Cox回归分析),证实非劣效性。常规分割组10年累积2级及以上泌尿生殖系统毒性反应发生率为30% (95% CI 26-34),超低分割组10年累积发生率为28% (24-32)(HR 1.01, 95% CI 0.81 - 1·25;p= 0.95)。对于晚期2级或更严重的胃肠道毒性反应,相应的数字分别为14% (95% CI 11-18)和14% (11-17);HR为0.94,95% CI为0.70 - 1·28;p= 0.72)。这项为期10年的随访证实了超低分割放疗方案与常规分割放疗方案相比的非劣效性,具有相似的毒性特征。研究结果支持七分疗法作为一种安全、有效、实用的标准治疗方案,适用于中危前列腺癌患者。资助北欧癌症联盟、瑞典癌症协会、瑞典研究委员会、瑞典前列腺癌协会和挪威皮肤癌协会。
{"title":"Ultra-hypofractionated versus conventionally fractionated radiotherapy for localised prostate cancer (HYPO-RT-PC): 10-year outcomes of an open-label, randomised, phase 3, non-inferiority trial","authors":"Per Nilsson, Adalsteinn Gunnlaugsson, Lars Beckman, Anders Widmark, Per Fransson, Morten Hoyer, Magnus Lagerlund, Jon Kindblom, Bengt Johansson, Kirsten Björnlinger, Claes Ginman, Martha Olsson, Måns Agrup, Elisabeth Kjellén, Björn Zackrisson, Björn Tavelin, Lars Franzén, Harald Anderson, Camilla Thellenberg Karlsson","doi":"10.1016/s1470-2045(25)00656-4","DOIUrl":"https://doi.org/10.1016/s1470-2045(25)00656-4","url":null,"abstract":"<h3>Background</h3>HYPO-RT-PC is a phase 3 trial comparing ultra-hypofractionated and conventionally fractionated radiotherapy in intermediate-to-high-risk localised prostate cancer. This 10-year update reports long-term efficacy and toxicity outcomes.<h3>Methods</h3>In this open-label, randomised, phase 3, non-inferiority trial done in ten centres in Sweden and two in Denmark, we recruited men aged 75 years or younger with intermediate-risk or high-risk prostate cancer and a WHO performance status between 0 and 2. Previous or current androgen deprivation therapy was not permitted. Patients were randomly assigned (1:1) to ultra-hypofractionated radiotherapy (42·7 Gy in seven fractions, 3 days per week for 2·5 weeks) or conventionally fractionated radiotherapy (78·0 Gy in 39 fractions, 5 days per week for 8 weeks). Randomisation was performed with a minimisation algorithm balancing T stage, Gleason score, prostate-specific antigen, and trial centre. The primary endpoint was failure-free survival, defined as time from randomisation to the first occurrence of biochemical failure, evidence of clinical progression, initiation of androgen deprivation therapy, or death from prostate cancer, analysed in the per-protocol population. The non-inferiority margin was 4% at 5 years and had previously been met, corresponding to a critical hazard ratio (HR) limit of 1·338. Toxicity was assessed using the Radiation Therapy Oncology Group morbidity scale. Here, we report long-term efficacy and safety results at 10 years. The trial is registered with the ISRCTN registry, ISRCTN45905321, and is closed.<h3>Findings</h3>Between July 1, 2005, and Nov 4, 2015, 1200 patients were randomly assigned to conventional fractionated radiotherapy (n=602) or ultra-hypofractionated radiotherapy (n=598). Ten patients withdrew consent, eight were found to be ineligible, and two died of reasons unrelated to prostate cancer. 1180 patients constituted the per-protocol population (591 in the conventional fractionation group and 589 in the ultra-hypofractionation group). After a median follow-up of 10·6 years (IQR 9·0–13·0) in the conventional fractionation group and 10·7 years (9·1–12·7) in the ultra-hypofractionation group, 205 and 178 primary events were observed, respectively. 10-year failure-free survival was 65% (95% CI 61–69) in the conventionally fractionated group and 72% (68–76) in the ultra-hypofractionated group. The adjusted HR for the primary endpoint was 0·84 (95% CI 0·69–1·03; Cox regression analysis), confirming non-inferiority. The 10-year cumulative incidence of late grade 2 or worse genitourinary toxic effects was 30% (95% CI 26–34) in the conventional fractionation group and 28% (24–32) in the ultra-hypofractionated group (HR 1·01, 95% CI 0·81–1·25; p=0·95). For late grade 2 or worse gastrointestinal toxic effects, the corresponding figures were 14% (95% CI 11–18) and 14% (11–17; HR 0·94, 95% CI 0·70–1·28; p=0·72).<h3>Interpretation</h3>This 10-year follow-up confirm","PeriodicalId":22865,"journal":{"name":"The Lancet Oncology","volume":"4 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2026-02-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146129456","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 : 2026-02-05DOI: 10.1016/s1470-2045(26)00057-4
Paul Adepoju
{"title":"Unauthorised cancer drug in Zimbabwe raises patient safety concerns","authors":"Paul Adepoju","doi":"10.1016/s1470-2045(26)00057-4","DOIUrl":"https://doi.org/10.1016/s1470-2045(26)00057-4","url":null,"abstract":"","PeriodicalId":22865,"journal":{"name":"The Lancet Oncology","volume":"72 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2026-02-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146134076","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 : 2026-02-02DOI: 10.1016/s1470-2045(25)00661-8
H Lalchungnunga, Christopher H Dampier, Omkar Singh, Danh-Tai Hoang, Eldad D Shulman, Zied Abdullaev, Bochong Li, Zhirui Luo, Zhichao Wu, Thomas M Pearce, Daniel F Marker, Kathleen McCortney, Craig Horbinski, Calixto-Hope G Lucas, Patrick J Cimino, MacLean P Nasrallah, Martha Quezado, Hye-Jung Chung, Leeor Yefet, Gelareh Zadeh, Sebastian Brandner, Eytan Ruppin, Kenneth Aldape
{"title":"Classification accuracy of a hierarchical molecular inference-based deep-learning system for CNS tumour diagnosis: a multi-institutional, retrospective study","authors":"H Lalchungnunga, Christopher H Dampier, Omkar Singh, Danh-Tai Hoang, Eldad D Shulman, Zied Abdullaev, Bochong Li, Zhirui Luo, Zhichao Wu, Thomas M Pearce, Daniel F Marker, Kathleen McCortney, Craig Horbinski, Calixto-Hope G Lucas, Patrick J Cimino, MacLean P Nasrallah, Martha Quezado, Hye-Jung Chung, Leeor Yefet, Gelareh Zadeh, Sebastian Brandner, Eytan Ruppin, Kenneth Aldape","doi":"10.1016/s1470-2045(25)00661-8","DOIUrl":"https://doi.org/10.1016/s1470-2045(25)00661-8","url":null,"abstract":"","PeriodicalId":22865,"journal":{"name":"The Lancet Oncology","volume":"23 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2026-02-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146109906","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 : 2026-02-02DOI: 10.1016/s1470-2045(25)00670-9
Erica C Kaye, Jori Bogetz, Krysta S Barton, Cynthia J Bell, Emily E Johnston, Rachel A Pozzar, Alexandra Superdock, Sally Thorne, Meaghann S Weaver, Lori Wiener, Dylan E Graetz, Asya Agulnik, Prasanna Ananth, Krysta Barton, Cynthia Bell, Tharwa Bilbeisi, Myra Bluebond-Langner, Jori Bogetz, Gemma Bryan, Ana Cáceres, Erica Carlisle, Lara Counts, Gia Ferrara, Lucia Fuentes, Dylan Graetz, Julia Hanebrink, Anthony Herbert, Pamela Hinds, Jason Hodges, Liza Johnson, Emily Johnston, Erica Kaye, Jennifer W. Mack, Sara Malone, Kimberly Montez, Heather Schacht Reisinger, Rawad Rihani, Marta Salek, Bryan A. Sisk, Alexandra Superdock, Sally Thorne, Claire Wakefield, Lori Wiener, Anneliese Williams, Francesca Williamson, Kayla Wynja, Camilla Zimmermann, Meaghann Weaver, Rachel Pozzar
{"title":"Expert recommendations for the conduct and appraisal of qualitative research in oncology","authors":"Erica C Kaye, Jori Bogetz, Krysta S Barton, Cynthia J Bell, Emily E Johnston, Rachel A Pozzar, Alexandra Superdock, Sally Thorne, Meaghann S Weaver, Lori Wiener, Dylan E Graetz, Asya Agulnik, Prasanna Ananth, Krysta Barton, Cynthia Bell, Tharwa Bilbeisi, Myra Bluebond-Langner, Jori Bogetz, Gemma Bryan, Ana Cáceres, Erica Carlisle, Lara Counts, Gia Ferrara, Lucia Fuentes, Dylan Graetz, Julia Hanebrink, Anthony Herbert, Pamela Hinds, Jason Hodges, Liza Johnson, Emily Johnston, Erica Kaye, Jennifer W. Mack, Sara Malone, Kimberly Montez, Heather Schacht Reisinger, Rawad Rihani, Marta Salek, Bryan A. Sisk, Alexandra Superdock, Sally Thorne, Claire Wakefield, Lori Wiener, Anneliese Williams, Francesca Williamson, Kayla Wynja, Camilla Zimmermann, Meaghann Weaver, Rachel Pozzar","doi":"10.1016/s1470-2045(25)00670-9","DOIUrl":"https://doi.org/10.1016/s1470-2045(25)00670-9","url":null,"abstract":"","PeriodicalId":22865,"journal":{"name":"The Lancet Oncology","volume":"117 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2026-02-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146109908","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 : 2026-02-02DOI: 10.1016/s1470-2045(25)00658-8
Chad Tang, Alex D Sherry, Hyunsoo Hwang, David P Farris, Giulio Francolini, Vanessa Di Cataldo, Lorenzo Livi, Phuoc Tran, Paul G Corn, Ana Aparicio, Gabriele Simontacchi, Ana P Kiess, Jarey H Wang, Valerie Fonteyne, Renee Bultijnck, Ryan Phillips, Matthew P Deek, Robert Olson, Stephen Harrow, Giulia Marvaso, Chiara Lorubbio, Barbara A Jereczek-Fossa, Ethan B Ludmir, Pierre Blanchard, Andrew Warner, Ryan Sun, David A Palma, Piet Ost
{"title":"Metastasis-directed therapy and standard of care versus standard of care for oligometastatic prostate cancer (WOLVERINE): a systematic review and individual patient data meta-analysis from the X-MET collaboration","authors":"Chad Tang, Alex D Sherry, Hyunsoo Hwang, David P Farris, Giulio Francolini, Vanessa Di Cataldo, Lorenzo Livi, Phuoc Tran, Paul G Corn, Ana Aparicio, Gabriele Simontacchi, Ana P Kiess, Jarey H Wang, Valerie Fonteyne, Renee Bultijnck, Ryan Phillips, Matthew P Deek, Robert Olson, Stephen Harrow, Giulia Marvaso, Chiara Lorubbio, Barbara A Jereczek-Fossa, Ethan B Ludmir, Pierre Blanchard, Andrew Warner, Ryan Sun, David A Palma, Piet Ost","doi":"10.1016/s1470-2045(25)00658-8","DOIUrl":"https://doi.org/10.1016/s1470-2045(25)00658-8","url":null,"abstract":"","PeriodicalId":22865,"journal":{"name":"The Lancet Oncology","volume":"15 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2026-02-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146109907","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}