{"title":"Five-Year Follow-Up of the Phase III ASCOT Trial of Adjuvant S-1 After Resection for Biliary Tract Cancer.","authors":"Masafumi Ikeda, Kohei Nakachi, Masaru Konishi, Riku Kajikawa, Hiroshi Katayama, Yusuke Sano, Teiichi Sugiura, Sohei Satoi, Masaaki Murakawa, Akira Tomokuni, Satoshi Nara, Yu Takahashi, Ken-Ichi Okada, Naoki Hama, Keiko Kamei, Ken Kamata, Seiji Natsume, Takuji Okusaka, Junji Furuse, Makoto Ueno","doi":"10.1200/JCO-26-00017","DOIUrl":"10.1200/JCO-26-00017","url":null,"abstract":"<p><p>The ASCOT phase III trial demonstrated that adjuvant S-1, an oral fluoropyrimidine, improved 3-year overall survival (OS) from 67.6% to 77.1% in patients with resected biliary tract cancer (BTC). We report the prespecified final 5-year follow-up analysis. In this multicenter, open-label, randomized trial conducted in Japan, 440 patients with resected BTC were assigned to observation (n = 222) or S-1 (n = 218). S-1 (40 mg/m<sup>2</sup> twice daily, 4 weeks on/2 weeks off, for four cycles) was orally administered. The primary end point was OS in the intention-to-treat population. At a median follow-up of 61.5 months, the 5-year OS was 64% in the S-1 arm and 52% in the observation arm (hazard ratio [HR], 0.72 [95% CI, 0.55 to 0.95]; one-sided <i>P</i> = .01). The median OS was 8.2 years with S-1 and 5.9 years with observation. The median relapse-free survival was 3.5 versus 6.1 years (observation <i>v</i> S-1); unstratified and stratified (by primary tumor site and lymph node status) HRs were 0.80 (95% CI, 0.62 to 1.03) and 0.76 (95% CI, 0.59 to 0.98), respectively. Treatment effects were generally consistent across subgroups. These findings confirm a sustained survival benefit with adjuvant S-1 and support its role as a standard treatment for resected BTC.</p>","PeriodicalId":15384,"journal":{"name":"Journal of Clinical Oncology","volume":" ","pages":"2903-2907"},"PeriodicalIF":44.7,"publicationDate":"2026-10-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149030461","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}
Rhea Sehgal, Tiana L Clemons, Charles S Day, Aditi Prabhu, Parita Patel, Carinne Jarvis, Ahmad Yousef
{"title":"Retraction: Palliative Care Involvement at the End of Life in Advanced Cancer.","authors":"Rhea Sehgal, Tiana L Clemons, Charles S Day, Aditi Prabhu, Parita Patel, Carinne Jarvis, Ahmad Yousef","doi":"10.1200/JCO-26-02300","DOIUrl":"https://doi.org/10.1200/JCO-26-02300","url":null,"abstract":"","PeriodicalId":15384,"journal":{"name":"Journal of Clinical Oncology","volume":"44 30","pages":"e151"},"PeriodicalIF":44.7,"publicationDate":"2026-10-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149193768","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":"Bridging the Gap: Precision Oncology for Cancers of Unknown Primary.","authors":"Ajeet Gajra, David B Zhen, E Gabriela Chiorean","doi":"10.1200/JCO-26-01847","DOIUrl":"10.1200/JCO-26-01847","url":null,"abstract":"","PeriodicalId":15384,"journal":{"name":"Journal of Clinical Oncology","volume":" ","pages":"2886-2890"},"PeriodicalIF":44.7,"publicationDate":"2026-10-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148968640","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":"Can Biomarkers Effectively Guide Treatment Tailoring in Human Epidermal Growth Factor 2-Positive Early Breast Cancer?","authors":"Heather A Parsons","doi":"10.1200/JCO-26-01857","DOIUrl":"10.1200/JCO-26-01857","url":null,"abstract":"","PeriodicalId":15384,"journal":{"name":"Journal of Clinical Oncology","volume":" ","pages":"2883-2885"},"PeriodicalIF":44.7,"publicationDate":"2026-10-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148976957","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}
Ajay Subramanian, Serey C L Nouth, Neda Nemat-Gorgani, Shaghayegh Soudi, Karla V Ballman, Rachel S Heise, Claire Johns, Timothy J Sears, Siyer Roohani, Reinhardt Krcek, Angela M Hong, Kent J Weinhold, Matt van de Rijn, Brian E Brigman, Richard F Riedel, Yvonne M Mowery, David G Kirsch, Everett J Moding
{"title":"Personalized Circulating Tumor DNA Analysis for Predicting Outcomes and Tracking Response to Radiotherapy and Pembrolizumab in Localized Sarcomas: Analysis of the SU2C-SARC032 Trial.","authors":"Ajay Subramanian, Serey C L Nouth, Neda Nemat-Gorgani, Shaghayegh Soudi, Karla V Ballman, Rachel S Heise, Claire Johns, Timothy J Sears, Siyer Roohani, Reinhardt Krcek, Angela M Hong, Kent J Weinhold, Matt van de Rijn, Brian E Brigman, Richard F Riedel, Yvonne M Mowery, David G Kirsch, Everett J Moding","doi":"10.1200/JCO-26-00769","DOIUrl":"10.1200/JCO-26-00769","url":null,"abstract":"<p><strong>Purpose: </strong>Circulating tumor DNA (ctDNA) holds promise for prognostication and disease monitoring in solid tumors. However, rare and heterogenous tumors with low mutational burden like soft tissue sarcomas (STS) present a technical challenge for ctDNA analysis. We investigated the ability of personalized ctDNA analysis to predict outcomes and track response to radiotherapy and pembrolizumab in patients with localized STS.</p><p><strong>Methods: </strong>We analyzed 313 plasma samples collected pretreatment, postradiotherapy/presurgery, and postsurgery from 106 patients treated with preoperative radiotherapy with or without perioperative pembrolizumab for high-risk, localized STS in the SU2C-SARC032 phase II randomized trial. Personalized ctDNA assays were designed to track a median of 46 somatic mutations per patient. Associations between ctDNA levels and outcomes were assessed using univariable and multivariable models adjusting for clinical risk factors.</p><p><strong>Results: </strong>Personalized ctDNA profiling detected baseline ctDNA in 85% of patients. Baseline ctDNA levels correlated with tumor size, grade 3 disease, and expression of genes related to hypoxia and the cell cycle. ctDNA levels pretreatment, after radiotherapy with or without immunotherapy but before surgery, and postsurgery were strongly associated with disease-free and overall survival on univariable and multivariable analyses. Patients treated with pembrolizumab, who had significantly better disease-free survival, had a greater decrease in their ctDNA levels after neoadjuvant therapy. Finally, personalized ctDNA analysis enabled noninvasive subclone tracking and patients with multiple tumor clones detected by ctDNA analysis after surgery had inferior outcomes.</p><p><strong>Conclusion: </strong>Tumor-informed, personalized profiling enables sensitive ctDNA detection and quantitative monitoring in localized STS, providing independent prognostic information across the perioperative course. These findings support prospective ctDNA-guided interventional trials in STS.</p>","PeriodicalId":15384,"journal":{"name":"Journal of Clinical Oncology","volume":" ","pages":"2941-2952"},"PeriodicalIF":44.7,"publicationDate":"2026-10-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148919950","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":"Purple Blossoms.","authors":"Ramesh Gopal","doi":"10.1200/JCO-26-00469","DOIUrl":"10.1200/JCO-26-00469","url":null,"abstract":"<p><p>Purple Blossoms explores the challenge of maintaining the positive attitude of a coach while treating an aggressive disease in an underserved area.</p>","PeriodicalId":15384,"journal":{"name":"Journal of Clinical Oncology","volume":" ","pages":"2972-2974"},"PeriodicalIF":44.7,"publicationDate":"2026-10-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148912282","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":"Time-of-Day Immunotherapy: Why the Field Still Needs Randomized Evidence.","authors":"Vivek Subbiah, Alfredo Addeo, Timothée Olivier","doi":"10.1200/JCO-26-01876","DOIUrl":"https://doi.org/10.1200/JCO-26-01876","url":null,"abstract":"","PeriodicalId":15384,"journal":{"name":"Journal of Clinical Oncology","volume":" ","pages":"JCO2601876"},"PeriodicalIF":44.7,"publicationDate":"2026-10-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149223907","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}
Xiaofang Wang, Xiaomeng Zhang, Xingxing Chen, Zhaozhi Yang, Xin Mei, Li Zhang, Jin Meng, Wei Shi, Jurui Luo, Kairui Jin, Yu Gu, Miao Mo, Zhen Zhang, Keda Yu, Guangyu Liu, Jiong Wu, Zhimin Shao, Xiaomao Guo, Xiaoli Yu, Jinli Ma
{"title":"Hypofractionated Versus Conventionally Fractionated Postmastectomy Radiotherapy With Internal Mammary Node Irradiation for High-Risk Breast Cancer (HypoMast-IMNI): A Randomized Phase III Trial.","authors":"Xiaofang Wang, Xiaomeng Zhang, Xingxing Chen, Zhaozhi Yang, Xin Mei, Li Zhang, Jin Meng, Wei Shi, Jurui Luo, Kairui Jin, Yu Gu, Miao Mo, Zhen Zhang, Keda Yu, Guangyu Liu, Jiong Wu, Zhimin Shao, Xiaomao Guo, Xiaoli Yu, Jinli Ma","doi":"10.1200/JCO-25-02843","DOIUrl":"https://doi.org/10.1200/JCO-25-02843","url":null,"abstract":"<p><strong>Purpose: </strong>When coverage of internal mammary nodes (IMN) is required, the efficacy and safety of hypofractionated regimens within postmastectomy radiotherapy (PMRT) remain to be established. This study evaluated hypofractionated radiotherapy (HypoRT) in patients with high-risk, operable breast cancer undergoing PMRT with IMN irradiation (IMNI).</p><p><strong>Methods: </strong>In this phase III noninferiority trial, eligible patients with high-risk disease after mastectomy (including pT1-4N2-3, pT3-4N1, or pT1-2N1 disease with additional high-risk factors) were randomly assigned (1:1) to HypoRT (42.56 Gy in 16 fractions) or conventionally fractionated radiotherapy (ConvRT; 50 Gy in 25 fractions), both targeting the chest wall and regional lymph nodes, including the IMN. The primary end point was locoregional recurrence (LRR). Secondary end points were distant metastasis-free survival (DMFS), breast cancer recurrence-free survival (BCRFS), disease-free survival (DFS), overall survival (OS), and treatment-related toxicity. The trial is registered with ClinicalTrial.gov (identifier: NCT03856372).</p><p><strong>Results: </strong>Between September 2018 and July 2022, 1,494 patients were randomly assigned. After a median follow-up of 58.1 months in the modified intention-to-treat population (n = 1,429), the 5-year cumulative incidence of LRR was 1.7% (95% CI, 0.9 to 2.9) with HypoRT and 2.2% (95% CI, 1.3 to 3.5) with ConvRT (hazard ratio, 0.69 [95% CI, 0.32 to 1.51]), meeting the noninferiority criterion (<i>P</i> = .017). No significant differences were observed in 5-year DMFS, BCRFS, DFS, or OS. Grade 3 acute skin toxicity was significantly lower with HypoRT (1.7% <i>v</i> 12.2%, <i>P</i> < .001). The incidence of grade ≥2 radiation pneumonitis and pulmonary fibrosis was low and comparable between arms, with no ischemic cardiac events recorded.</p><p><strong>Conclusion: </strong>For patients with high-risk, operable breast cancer requiring PMRT with IMNI, the 16-fraction HypoRT regimen is noninferior to ConvRT for locoregional control, offers a superior acute toxicity profile, and demonstrates excellent cardiopulmonary safety.</p>","PeriodicalId":15384,"journal":{"name":"Journal of Clinical Oncology","volume":" ","pages":"JCO2502843"},"PeriodicalIF":44.7,"publicationDate":"2026-10-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149223941","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":"Promise and Challenge of Personalized Lung Cancer Screening.","authors":"M Patricia Rivera, Louise M Henderson","doi":"10.1200/JCO-26-01951","DOIUrl":"https://doi.org/10.1200/JCO-26-01951","url":null,"abstract":"","PeriodicalId":15384,"journal":{"name":"Journal of Clinical Oncology","volume":" ","pages":"JCO2601951"},"PeriodicalIF":44.7,"publicationDate":"2026-10-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149207112","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}
Stephanie B Wheeler, Austin R Waters, Camille R Murray, Michelle L Manning, Allison M Deal, Kevin Pignone, Lisa P Spees, Arrianna Marie Planey, Bridgette Thom, Katherine E Reeder-Hayes, Sarah A Birken, Mindy Gellin, Neda R Padilla, Donald L Rosenstein
{"title":"Effectiveness of a Multisite Oncology Financial Navigation Intervention: The Lessening the Impact of Financial Toxicity Clinical Trial.","authors":"Stephanie B Wheeler, Austin R Waters, Camille R Murray, Michelle L Manning, Allison M Deal, Kevin Pignone, Lisa P Spees, Arrianna Marie Planey, Bridgette Thom, Katherine E Reeder-Hayes, Sarah A Birken, Mindy Gellin, Neda R Padilla, Donald L Rosenstein","doi":"10.1200/JCO-26-00617","DOIUrl":"https://doi.org/10.1200/JCO-26-00617","url":null,"abstract":"<p><strong>Purpose: </strong>Financial toxicity (FT) among cancer survivors is prevalent and associated with excess morbidity and mortality. Although financial navigation (FN) has reduced FT in limited academic and urban settings, evaluation of FN within broader practice settings is needed.</p><p><strong>Methods: </strong>We conducted a pragmatic hybrid II implementation-effectiveness clinical trial (Lessening the Impact of Financial Toxicity [LIFT]) in eight oncology practice sites, tailoring FN for four rural sites and four nonrural sites. All patients with cancer within 5 years of diagnosis, or those living with advanced disease, with a Comprehensive Score for financial Toxicity (FACIT-COST) score of ≤22 (indicating moderate-to-severe FT) who understood English were eligible. The primary effectiveness outcome was change in FACIT-COST score, pre- versus post-LIFT implementation. Patient-level secondary outcomes included the following: uptake (number served by FN/number screened positive for FT), acceptability, responsiveness, alignment with needs, patient-centeredness, and timeliness.</p><p><strong>Results: </strong>Of 258 patients consented, 233 screened FT-positive, 179 received FN, 134 completed post-intervention measures, and 21 died before study completion. Participants were, on average, 53.0 years (standard deviation [SD], 13.0), mostly female (65.7%), and non-Hispanic White (56.0%) or Black (33.6%), with 9.0% identifying as Hispanic and 39.6% from a rural ZIP code. After LIFT, FACIT-COST scores significantly improved by an average 8.1 (SD, 10.0) points (<i>P</i> < .0001), Pre: 6.6 (SD, 5.1), Post: 14.7 (SD, 10.2), with significant increases at both rural (6.3 [SD, 9.2], <i>P</i> < .0001) and nonrural sites (9.3 [SD, 10.4], <i>P</i> < .0001). Intervention uptake was high, with nearly three quarters of those who screened positive for FT receiving FN. LIFT was broadly perceived as acceptable, responsive, aligned with patient needs, and timely.</p><p><strong>Conclusion: </strong>Patient-centered interventions like FN can clearly reduce FT in diverse patient populations across clinical settings and should be considered best practice.</p>","PeriodicalId":15384,"journal":{"name":"Journal of Clinical Oncology","volume":" ","pages":"JCO2600617"},"PeriodicalIF":44.7,"publicationDate":"2026-10-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149192832","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}