{"title":"Efficacy, Toxicity, and Cosmesis of Partial Breast Irradiation: Honing in on Dose and Patient Selection.","authors":"Rachel A Rabinovitch","doi":"10.1200/JCO-24-01625","DOIUrl":"https://doi.org/10.1200/JCO-24-01625","url":null,"abstract":"","PeriodicalId":15384,"journal":{"name":"Journal of Clinical Oncology","volume":" ","pages":"JCO2401625"},"PeriodicalIF":42.1,"publicationDate":"2024-11-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142621275","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}
Lyudmila Bazhenova, Nofisat Ismaila, Fawzi Abu Rous, Krishna Alluri, Janet Freeman-Daily, Balazs Halmos, Narinder Malhotra, Kristen A Marrone, Sonam Puri, Angel Qin, Natasha B Leighl
{"title":"Therapy for Stage IV Non-Small Cell Lung Cancer With Driver Alterations: ASCO Living Guideline, Version 2024.2.","authors":"Lyudmila Bazhenova, Nofisat Ismaila, Fawzi Abu Rous, Krishna Alluri, Janet Freeman-Daily, Balazs Halmos, Narinder Malhotra, Kristen A Marrone, Sonam Puri, Angel Qin, Natasha B Leighl","doi":"10.1200/JCO-24-02133","DOIUrl":"https://doi.org/10.1200/JCO-24-02133","url":null,"abstract":"<p><p><i>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</i> <i>ASCO Guidelines Methodology Manual</i>. <i>ASCO Living Guidelines follow the</i> <i>ASCO Conflict of Interest Policy Implementation for Clinical Practice Guidelines</i>. <i>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 the Appendix for disclaimers and other important information (Appendix 1 and Appendix 2</i>, <i>online only). Updates are published regularly and can be found at</i> <i>https://ascopubs.org/nsclc-da-living-guideline</i>.</p>","PeriodicalId":15384,"journal":{"name":"Journal of Clinical Oncology","volume":" ","pages":"JCO2402133"},"PeriodicalIF":42.1,"publicationDate":"2024-11-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142621295","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}
Elisa Agostinetto, Carmela Caballero, Michail Ignatiadis, C Florin Pop
{"title":"Axillary Surgery for Patients With Residual Isolated Tumor Cells (ypN0i+) After Neoadjuvant Systemic Therapy for Early Breast Cancer.","authors":"Elisa Agostinetto, Carmela Caballero, Michail Ignatiadis, C Florin Pop","doi":"10.1200/JCO-24-01711","DOIUrl":"https://doi.org/10.1200/JCO-24-01711","url":null,"abstract":"<p><p><i>The Oncology Grand Rounds series is designed to place original reports published in the</i> Journal <i>into clinical context. A case presentation is followed by a description of diagnostic and management challenges, a review of the relevant literature, and a summary of the authors' suggested management approaches. The goal of this series is to help readers better understand how to apply the results of key studies, including those published in</i> Journal of Clinical Oncology<i>, to patients seen in their own clinical practice</i>.</p>","PeriodicalId":15384,"journal":{"name":"Journal of Clinical Oncology","volume":" ","pages":"JCO2401711"},"PeriodicalIF":42.1,"publicationDate":"2024-11-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142621272","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":"JCCG ALL-B12: Evaluation of Intensified Therapies With Vincristine/Dexamethasone Pulses and Asparaginase and Augmented High-Dose Methotrexate for Pediatric B-ALL.","authors":"Motohiro Kato, Yasuhiro Okamoto, Toshihiko Imamura, Akiko Kada, Akiko M Saito, Yuka Iijima-Yamashita, Takao Deguchi, Kentaro Ohki, Takashi Fukushima, Kenichi Anami, Masashi Sanada, Tomohiko Taki, Yoshiko Hashii, Takeshi Inukai, Nobutaka Kiyokawa, Yoshiyuki Kosaka, Nao Yoshida, Yuki Yuza, Masakatsu Yanagimachi, Kenichiro Watanabe, Atsushi Sato, Chihaya Imai, Takashi Taga, Souichi Adachi, Keizo Horibe, Atsushi Manabe, Katsuyoshi Koh","doi":"10.1200/JCO.24.00811","DOIUrl":"https://doi.org/10.1200/JCO.24.00811","url":null,"abstract":"<p><strong>Purpose: </strong>The JCCG ALL-B12 clinical trial aimed to evaluate the effectiveness of unvalidated treatment phases for pediatric ALL and develop a safety-focused treatment framework.</p><p><strong>Patients and methods: </strong>Patients age 1-19 years with newly diagnosed B-ALL were enrolled in this study. These patients were stratified into standard-risk (SR), intermediate-risk (IR), and high-risk (HR) groups. Randomized comparisons assessed the effectiveness of vincristine (VCR)/dexamethasone pulses in the SR group, evaluated the effects of L-asparaginase (ASP) intensification in the IR group, and compared standard consolidation including block-type treatment with experimental consolidation with high-dose methotrexate (HD-MTX) intensified with VCR and ASP in the HR group.</p><p><strong>Results: </strong>Of 1,936 patients enrolled, 1,804 were eligible for the experimental treatment. The overall 5-year event-free survival and overall survival rates were 85.2% (95% CI, 83.5 to 86.8) and 94.3% (95% CI, 93.1 to 95.3), respectively. The cumulative incidence of relapse and postremission nonrelapse mortality was 13.2% (95% CI, 11.6 to 14.8) and 0.6% (95% CI, 0.3 to 1.0), respectively. Random assignment in the SR group showed no significant benefit from pulse therapy. In the IR group, ASP intensification had limited effects. In the HR group, standard block therapy and HD-MTX yielded equivalent outcomes.</p><p><strong>Conclusion: </strong>The ALL-B12 trial achieved favorable outcomes in a nationwide cohort by stratifying treatment on the basis of risk and balancing treatment intensity. This study not only demonstrated that existing standard of care can be further refined but also indicated that improvement in outcomes with intensified chemotherapy has reached a plateau.</p>","PeriodicalId":15384,"journal":{"name":"Journal of Clinical Oncology","volume":" ","pages":"JCO2400811"},"PeriodicalIF":42.1,"publicationDate":"2024-11-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142621290","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":"Erratum: Clonal MET Amplification as a Determinant of Tyrosine Kinase Inhibitor Resistance in Epidermal Growth Factor Receptor-Mutant Non-Small-Cell Lung Cancer.","authors":"","doi":"10.1200/JCO-24-02413","DOIUrl":"https://doi.org/10.1200/JCO-24-02413","url":null,"abstract":"","PeriodicalId":15384,"journal":{"name":"Journal of Clinical Oncology","volume":" ","pages":"JCO2402413"},"PeriodicalIF":42.1,"publicationDate":"2024-11-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142621281","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":"How Could We Further Improve the Gilteritinib Maintenance After Allogeneic Hematopoietic Cell Transplantation in <i>FLT3</i>-Mutated AML?","authors":"Shigeo Fuji","doi":"10.1200/JCO.24.00566","DOIUrl":"10.1200/JCO.24.00566","url":null,"abstract":"","PeriodicalId":15384,"journal":{"name":"Journal of Clinical Oncology","volume":" ","pages":"3880"},"PeriodicalIF":42.1,"publicationDate":"2024-11-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141859920","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":"Oncology Accelerated Approval Confirmatory Trials: When a Failed Trial Is Not a Failed Drug.","authors":"Gautam U Mehta, Richard Pazdur","doi":"10.1200/JCO-24-01654","DOIUrl":"10.1200/JCO-24-01654","url":null,"abstract":"","PeriodicalId":15384,"journal":{"name":"Journal of Clinical Oncology","volume":" ","pages":"3778-3782"},"PeriodicalIF":42.1,"publicationDate":"2024-11-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11540715/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142390910","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}
Natansh D Modi, Sandra M Swain, Marc Buyse, Nicole M Kuderer, Andrew Rowland, Frank W Rockhold, Michael J Sorich, Ashley M Hopkins
{"title":"Clinical Study Report and Individual Participant Data Transparency for US Food and Drug Administration-Approved Anticancer Drugs: A Call for Systematic Data Availability.","authors":"Natansh D Modi, Sandra M Swain, Marc Buyse, Nicole M Kuderer, Andrew Rowland, Frank W Rockhold, Michael J Sorich, Ashley M Hopkins","doi":"10.1200/JCO.24.00539","DOIUrl":"10.1200/JCO.24.00539","url":null,"abstract":"<p><p>Unlocking the full potential of clinical trials through comprehensive CSR and IPD sharing can revolutionize cancer care, enhance safety evaluations, and reduce bias in systematic reviews. It is time for all stakeholders to embrace transparency and advance patient-centered outcomes.</p>","PeriodicalId":15384,"journal":{"name":"Journal of Clinical Oncology","volume":" ","pages":"3773-3777"},"PeriodicalIF":42.1,"publicationDate":"2024-11-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141450574","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}
Mark J Levis, Mehdi Hamadani, Mary M Horowitz, Yi-Bin Chen
{"title":"Reply to S. Fuji.","authors":"Mark J Levis, Mehdi Hamadani, Mary M Horowitz, Yi-Bin Chen","doi":"10.1200/JCO.24.01091","DOIUrl":"10.1200/JCO.24.01091","url":null,"abstract":"","PeriodicalId":15384,"journal":{"name":"Journal of Clinical Oncology","volume":" ","pages":"3881-3882"},"PeriodicalIF":42.1,"publicationDate":"2024-11-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11540746/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141859921","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}
{"title":"Trastuzumab Deruxtecan in Advanced Solid Tumors With Human Epidermal Growth Factor Receptor 2 Amplification Identified by Plasma Cell-Free DNA Testing: A Multicenter, Single-Arm, Phase II Basket Trial.","authors":"Masataka Yagisawa, Hiroya Taniguchi, Taroh Satoh, Shigenori Kadowaki, Yu Sunakawa, Tomohiro Nishina, Yoshito Komatsu, Taito Esaki, Daisuke Sakai, Ayako Doi, Takeshi Kajiwara, Hiromi Ono, Masatoshi Asano, Nami Hirano, Justin Odegaard, Satoshi Fujii, Shogo Nomura, Hideaki Bando, Akihiro Sato, Takayuki Yoshino, Yoshiaki Nakamura","doi":"10.1200/JCO.23.02626","DOIUrl":"10.1200/JCO.23.02626","url":null,"abstract":"<p><strong>Purpose: </strong>HERALD/EPOC1806 was conducted as a multicenter phase II trial assessing trastuzumab deruxtecan (T-DXd) therapy for patients with human epidermal growth factor receptor 2 (<i>HER2</i>)-amplified progressive stage solid tumors detected by cell-free DNA (cfDNA) testing.</p><p><strong>Patients and methods: </strong>Patients exhibited advanced solid tumors with <i>HER2</i> amplification that was identified via next-generation sequencing of cfDNA testing, without the requirement for immunohistochemical HER2 testing. The studied group was administered T-DXd at 5.4 mg/kg once every 3 weeks until onset of disease progression or intolerable toxicity.</p><p><strong>Results: </strong>Overall, 4,734 patients underwent cfDNA testing from December 2019 to January 2022, and 252 demonstrated <i>HER2</i> amplification. Finally, the study included 62 patients with 16 cancer types with a median baseline plasma <i>HER2</i> copy number (CN) of 8.55 (range, 2.4-73.9). Confirmed overall response rate (ORR) by investigator assessment was 56.5% (95% CI, 43.3 to 69.0), thus showing a value beyond the 5% threshold. Responses were evaluated for 13 cancer types, including <i>KRAS</i>-mutant colorectal (1/3), <i>PIK3CA</i>-mutant endometrial (5/6), and tissue HER2-negative gastric (1/2) cancers. Plasma <i>HER2</i> CN above versus below the baseline median value did not differ for impact response; however, clearance of <i>HER2</i> amplification in cfDNA on cycle 2 day 1 had higher response values compared with persistence. Median progression-free survival and response duration were 7.0 (95% CI, 4.9 to 9.7) and 8.8 (95% CI, 5.8 to 11.2) months, respectively, with the majority of complications being mild to moderate. Interstitial lung diseases were identified in 16 (26%) patients, including 14 patients with grade 1 disease, one patient with grade 2 disease, and one patient with grade 3 disease.</p><p><strong>Conclusion: </strong>T-DXd treatment demonstrated high ORR with durable response in patients with advanced <i>HER2</i>-amplified solid tumors determined with cfDNA testing.</p>","PeriodicalId":15384,"journal":{"name":"Journal of Clinical Oncology","volume":" ","pages":"3817-3825"},"PeriodicalIF":42.1,"publicationDate":"2024-11-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11542975/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141874957","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}