JCOG0603 demonstrated improved disease-free survival (DFS) with adjuvant mFOLFOX6 after hepatectomy compared with hepatectomy alone in colorectal liver-only metastasis (CRLM), but the overall survival (OS) data were immature. Here, we report OS after long-term follow-up. Eligible patients with colorectal adenocarcinoma and an unlimited number of liver metastases were randomized to adjuvant mFOLFOX6 or hepatectomy alone. DFS was the primary endpoint, and OS was a secondary endpoint. Between March 2007 and January 2019, 151 and 149 patients were randomized to adjuvant chemotherapy and hepatectomy alone, respectively. At a median follow-up of 7.7 years for disease-free surviving patients, 54 (35.8%) and 51 (34.2%) patients had died in the respective arms, (hazard ratio [HR], 1.07 [95% CI, 0.73 to 1.57]). Five-year OS was 73.4% (95% CI, 65.5 to 79.7) and 80.1% (95% CI, 72.6 to 85.7) and 7-year OS was 69.4% (95% CI, 61.2 to 76.2) and 72.4% (95% CI, 64.2 to 79.1), respectively. One patient in the adjuvant chemotherapy arm possibly died of protocol treatment-related toxicity, and one in the hepatectomy-alone arm died of post-protocol treatment complications. Five-year DFS was respectively 49.7% (95% CI, 41.5 to 57.3) and 40.5% (95% CI, 32.5 to 48.3) in the adjuvant chemotherapy and hepatectomy-alone arms (HR, 0.72 [95% CI, 0.54 to 0.97]). Long-term OS did not differ with adjuvant mFOLFOX6 compared with hepatectomy alone in resectable CRLM. Adjuvant mFOLFOX6 may delay recurrence but did not improve long-term survival.
{"title":"Randomized Phase II/III Trial Comparing Hepatectomy, Followed by mFOLFOX6 With Hepatectomy Alone for Liver Metastasis From Colorectal Cancer: Long-Term Results of JCOG0603.","authors":"Yukihide Kanemitsu, Yasuhiro Shimizu, Junki Mizusawa, Yoshitaka Inaba, Shunsuke Tsukamoto, Atsuo Takashima, Masayuki Ohue, Koji Komori, Akio Shiomi, Manabu Shiozawa, Yusuke Suwa, Takeshi Suto, Yusuke Kinugasa, Yasumasa Takii, Hiroyuki Bando, Takaya Kobatake, Masafumi Inomata, Yasuhiro Shimada, Hiroshi Katayama, Haruhiko Fukuda","doi":"10.1200/JCO-25-01231","DOIUrl":"https://doi.org/10.1200/JCO-25-01231","url":null,"abstract":"<p><p>JCOG0603 demonstrated improved disease-free survival (DFS) with adjuvant mFOLFOX6 after hepatectomy compared with hepatectomy alone in colorectal liver-only metastasis (CRLM), but the overall survival (OS) data were immature. Here, we report OS after long-term follow-up. Eligible patients with colorectal adenocarcinoma and an unlimited number of liver metastases were randomized to adjuvant mFOLFOX6 or hepatectomy alone. DFS was the primary endpoint, and OS was a secondary endpoint. Between March 2007 and January 2019, 151 and 149 patients were randomized to adjuvant chemotherapy and hepatectomy alone, respectively. At a median follow-up of 7.7 years for disease-free surviving patients, 54 (35.8%) and 51 (34.2%) patients had died in the respective arms, (hazard ratio [HR], 1.07 [95% CI, 0.73 to 1.57]). Five-year OS was 73.4% (95% CI, 65.5 to 79.7) and 80.1% (95% CI, 72.6 to 85.7) and 7-year OS was 69.4% (95% CI, 61.2 to 76.2) and 72.4% (95% CI, 64.2 to 79.1), respectively. One patient in the adjuvant chemotherapy arm possibly died of protocol treatment-related toxicity, and one in the hepatectomy-alone arm died of post-protocol treatment complications. Five-year DFS was respectively 49.7% (95% CI, 41.5 to 57.3) and 40.5% (95% CI, 32.5 to 48.3) in the adjuvant chemotherapy and hepatectomy-alone arms (HR, 0.72 [95% CI, 0.54 to 0.97]). Long-term OS did not differ with adjuvant mFOLFOX6 compared with hepatectomy alone in resectable CRLM. Adjuvant mFOLFOX6 may delay recurrence but did not improve long-term survival.</p>","PeriodicalId":15384,"journal":{"name":"Journal of Clinical Oncology","volume":" ","pages":"JCO2501231"},"PeriodicalIF":41.9,"publicationDate":"2026-01-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146018670","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":"Limitations in Study Design and Stratification in Phase II Stereotactic Radiosurgery Trial for Small Cell Lung Cancer Brain Metastases.","authors":"Orhun Akdogan,Kubra Canaslan,Buket Hamitoglu,Ozan Yazici,Osman Sutcuoglu","doi":"10.1200/jco-25-01729","DOIUrl":"https://doi.org/10.1200/jco-25-01729","url":null,"abstract":"","PeriodicalId":15384,"journal":{"name":"Journal of Clinical Oncology","volume":"63 1","pages":"JCO2501729"},"PeriodicalIF":45.3,"publicationDate":"2026-01-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146005374","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}
Marco Maria Germani,Beatrice Borelli,Chiara Cremolini
{"title":"Reply to: From Thresholds to Tumor Sidedness: Reframing Human Epidermal Growth Factor Receptor 2 in Colorectal Cancer.","authors":"Marco Maria Germani,Beatrice Borelli,Chiara Cremolini","doi":"10.1200/jco-25-02817","DOIUrl":"https://doi.org/10.1200/jco-25-02817","url":null,"abstract":"","PeriodicalId":15384,"journal":{"name":"Journal of Clinical Oncology","volume":"52 1","pages":"JCO2502817"},"PeriodicalIF":45.3,"publicationDate":"2026-01-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146005375","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}
Pub Date : 2026-01-20Epub Date: 2025-11-21DOI: 10.1200/JCO-25-02231
Jeff P Sharman, Bin Liu, Denise Y Wang, Ching Ching Leow, Paul M Barr
{"title":"Reply to: Optimizing Control Arms in Chronic Lymphocytic Leukemia Clinical Trials: The BRUIN-CLL-321 Trial.","authors":"Jeff P Sharman, Bin Liu, Denise Y Wang, Ching Ching Leow, Paul M Barr","doi":"10.1200/JCO-25-02231","DOIUrl":"10.1200/JCO-25-02231","url":null,"abstract":"","PeriodicalId":15384,"journal":{"name":"Journal of Clinical Oncology","volume":" ","pages":"256-257"},"PeriodicalIF":41.9,"publicationDate":"2026-01-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12794705/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145573744","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Mary-Ellen Taplin,Irbaz Bin Riaz,R Bryan Rumble,Syed Arsalan Ahmed Naqvi,Thomas A Hope,Mariane Fontes Dias,Huan He,Sebastien J Hotte,Hamid Emamekhoo,M Hassan Murad,Paul Celano,Terry M Kungel,Steve Hentzen,Michael Thomas Serzan,Rahul A Parikh
Living guidelines are developed for selected topic areas with rapidly evolving evidence that drives frequent change in recommended clinical practice. Living guidelines are updated on a regular schedule by a standing expert panel that systematically reviews the health literature on a continuous basis, as described in the ASCO Guidelines Methodology Manual. ASCO Living Guidelines follow the ASCO Conflict of Interest Policy Implementation for Clinical Practice Guidelines. Living Guidelines and updates are not intended to substitute for independent professional judgment of the treating clinician and do not account for individual variation among patients. See appendix for disclaimers and other important information (Appendix 1 and Appendix 2). Updates are published regularly and can be found at www.asco.org/genitourinary-cancer-guidelines.
{"title":"Systemic Therapy in Patients With Metastatic Castration-Resistant Prostate Cancer: ASCO Living Guideline, Version 2026.1.","authors":"Mary-Ellen Taplin,Irbaz Bin Riaz,R Bryan Rumble,Syed Arsalan Ahmed Naqvi,Thomas A Hope,Mariane Fontes Dias,Huan He,Sebastien J Hotte,Hamid Emamekhoo,M Hassan Murad,Paul Celano,Terry M Kungel,Steve Hentzen,Michael Thomas Serzan,Rahul A Parikh","doi":"10.1200/jco-25-02693","DOIUrl":"https://doi.org/10.1200/jco-25-02693","url":null,"abstract":"Living guidelines are developed for selected topic areas with rapidly evolving evidence that drives frequent change in recommended clinical practice. Living guidelines are updated on a regular schedule by a standing expert panel that systematically reviews the health literature on a continuous basis, as described in the ASCO Guidelines Methodology Manual. ASCO Living Guidelines follow the ASCO Conflict of Interest Policy Implementation for Clinical Practice Guidelines. Living Guidelines and updates are not intended to substitute for independent professional judgment of the treating clinician and do not account for individual variation among patients. See appendix for disclaimers and other important information (Appendix 1 and Appendix 2). Updates are published regularly and can be found at www.asco.org/genitourinary-cancer-guidelines.","PeriodicalId":15384,"journal":{"name":"Journal of Clinical Oncology","volume":"64 1","pages":"JCO2502693"},"PeriodicalIF":45.3,"publicationDate":"2026-01-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146005376","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: Pirtobrutinib for Treatment-Naïve Chronic Lymphatic Leukemia.","authors":"Marc J Braunstein,Michael E Williams","doi":"10.1200/jco-25-02879","DOIUrl":"https://doi.org/10.1200/jco-25-02879","url":null,"abstract":"","PeriodicalId":15384,"journal":{"name":"Journal of Clinical Oncology","volume":"39 1","pages":"JCO2502879"},"PeriodicalIF":45.3,"publicationDate":"2026-01-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146005377","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":"Radiosurgery for Small Cell Lung Cancer Brain Metastases: Comparing the JLGK0901 and BWH/DFCI Trials.","authors":"Chad G Rusthoven,Toru Serizawa,Masaaki Yamamoto","doi":"10.1200/jco-25-01794","DOIUrl":"https://doi.org/10.1200/jco-25-01794","url":null,"abstract":"","PeriodicalId":15384,"journal":{"name":"Journal of Clinical Oncology","volume":"49 1","pages":"JCO2501794"},"PeriodicalIF":45.3,"publicationDate":"2026-01-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146005381","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":"Reply to: \"Limitations in Study Design and Stratification in Phase II Stereotactic Radiosurgery Trial for Small Cell Lung Cancer Brain Metastases,\" \"Radiosurgery for Small Cell Lung Cancer Brain Metastases: Comparing the JLGK0901 and BWH/DFCI Trials,\" and \"Expanding Indications for Stereotactic Radiosurgery in Small Cell Lung Cancer With Brain Metastases\".","authors":"Ayal A Aizer,Paul J Catalano,Rifaquat Rahman","doi":"10.1200/jco-25-02528","DOIUrl":"https://doi.org/10.1200/jco-25-02528","url":null,"abstract":"","PeriodicalId":15384,"journal":{"name":"Journal of Clinical Oncology","volume":"57 1","pages":"JCO2502528"},"PeriodicalIF":45.3,"publicationDate":"2026-01-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146005379","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}
Pub Date : 2026-01-20Epub Date: 2025-11-21DOI: 10.1200/JCO-25-01695
Edward R Scheffer Cliff, Thomas E Lew, Florian Simon, Talal Hilal, Mary Ann Anderson, Philip A Thompson, John F Seymour
{"title":"Optimizing Control Arms in Chronic Lymphocytic Leukemia Clinical Trials: The BRUIN-CLL-321 Trial.","authors":"Edward R Scheffer Cliff, Thomas E Lew, Florian Simon, Talal Hilal, Mary Ann Anderson, Philip A Thompson, John F Seymour","doi":"10.1200/JCO-25-01695","DOIUrl":"10.1200/JCO-25-01695","url":null,"abstract":"","PeriodicalId":15384,"journal":{"name":"Journal of Clinical Oncology","volume":" ","pages":"254-256"},"PeriodicalIF":41.9,"publicationDate":"2026-01-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145573734","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}
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