Journal of Clinical Oncology最新文献

{"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":null,"pages":null},"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":null,"pages":null},"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}

{"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":null,"pages":null},"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}

{"title":"Establishing a Role for Local Therapy in Oligometastatic Pancreatic Cancer.","authors":"Hannah J Roberts, Colin D Weekes, Jennifer Y Wo","doi":"10.1200/JCO-24-01264","DOIUrl":"10.1200/JCO-24-01264","url":null,"abstract":"","PeriodicalId":15384,"journal":{"name":"Journal of Clinical Oncology","volume":null,"pages":null},"PeriodicalIF":42.1,"publicationDate":"2024-11-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142371960","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":"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":null,"pages":null},"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}

{"title":"Molecular and Clinicopathologic Impact of GNAS Variants Across Solid Tumors.","authors":"Paul Johannet, Somer Abdelfattah, Callahan Wilde, Shrey Patel, Henry Walch, Benoit Rousseau, Guillem Argiles, Oliver Artz, Miteshkumar Patel, Andrea Arfe, Andrea Cercek, Rona Yaeger, Karuna Ganesh, Nikolaus Schultz, Luis A Diaz, Michael B Foote","doi":"10.1200/JCO.24.00186","DOIUrl":"10.1200/JCO.24.00186","url":null,"abstract":"<p><strong>Purpose: </strong>The molecular drivers underlying mucinous tumor pathogenicity are poorly understood. <i>GNAS</i> mutations predict metastatic burden and treatment resistance in mucinous appendiceal adenocarcinoma. We investigated the pan-cancer clinicopathologic relevance of <i>GNAS</i> variants.</p><p><strong>Methods: </strong>We assessed 58,043 patients with Memorial Sloan Kettering-Integrated Mutation Profiling of Actionable Cancer Targets (IMPACT)-sequenced solid tumors to identify oncogenic variants, including <i>GNAS</i>, associated with mucinous tumor phenotype. We then performed comprehensive molecular analyses to compare <i>GNAS-</i>mutant (mut) and wild-type tumors across cancers. Gene expression patterns associated with <i>GNAS-</i>mut tumors were assessed in a The Cancer Genome Atlas cohort. Associations between <i>GNAS</i> variant status and peritoneal metastasis, first-line systemic therapy response, progression-free survival (PFS), and overall survival (OS) were determined using a propensity-matched subcohort of patients with metastatic disease.</p><p><strong>Results: </strong>Mucinous tumors were enriched for oncogenic <i>GNAS</i> variants. <i>GNAS</i> was mutated in >1% of small bowel, cervical, colorectal, pancreatic, esophagogastric, hepatobiliary, and GI neuroendocrine cancers. Across these cancers, <i>GNAS-</i>mut tumors exhibited a generally conserved C-to-T mutation-high, aneuploidy-low molecular profile with co-occurring prevalent <i>KRAS</i> variants (65% of GNAS-mut tumors) and fewer <i>TP53</i> alterations. <i>GNAS-</i>mut tumors exhibited recurrently comutated alternative tumor suppressors (<i>RBM10</i>, <i>INPPL1</i>) and upregulation of MAPK and cell surface modulators. <i>GNAS-</i>mut tumors demonstrate an increased prevalence of peritoneal metastases (odds ratio [OR], 1.7 [95% CI, 1.1 to 2.5]; <i>P =</i> .006), worse response to first-line systemic therapy (OR, 2.2 [95% CI, 1.3 to 3.8]; <i>P =</i> .003), and shorter PFS (median, 5.6 <i>v</i> 7.0 months; <i>P =</i> .047). In a multivariable analysis, <i>GNAS</i> mutated status was independently prognostic of worse OS (hazard ratio, 1.25 [95% CI, 1.01 to 1.56]; adjusted <i>P =</i> .04).</p><p><strong>Conclusion: </strong>Across the assessed cancers, <i>GNAS-</i>mut tumors exhibit a conserved molecular and clinical phenotype defined by mucinous tumor status, increased peritoneal metastasis, poor response to first-line systemic therapy, and worse survival.</p>","PeriodicalId":15384,"journal":{"name":"Journal of Clinical Oncology","volume":null,"pages":null},"PeriodicalIF":42.1,"publicationDate":"2024-11-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11540749/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141909805","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":"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":null,"pages":null},"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":"Stockholm3 in a Multiethnic Cohort: Optimizing Prostate Cancer Screening to Reduce Harm and Improve Equity.","authors":"James D Brooks","doi":"10.1200/JCO.24.00941","DOIUrl":"10.1200/JCO.24.00941","url":null,"abstract":"","PeriodicalId":15384,"journal":{"name":"Journal of Clinical Oncology","volume":null,"pages":null},"PeriodicalIF":42.1,"publicationDate":"2024-11-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11540720/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142371963","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":"Neoadjuvant Sonic Hedgehog Inhibitors Combined With Radiotherapy Is a Promising Strategy for Locally Advanced Basal Cell Carcinoma.","authors":"Marie Boileau, Alexandre Taillez, Pauline Lemoine, Manon Dubois, Laurent Mortier, Xavier Mirabel","doi":"10.1200/JCO.24.01042","DOIUrl":"10.1200/JCO.24.01042","url":null,"abstract":"","PeriodicalId":15384,"journal":{"name":"Journal of Clinical Oncology","volume":null,"pages":null},"PeriodicalIF":42.1,"publicationDate":"2024-11-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141878773","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":"Breast Cancer Screening Interval: Effect on Rate of Late-Stage Disease at Diagnosis and Overall Survival.","authors":"Margarita L Zuley, Andriy I Bandos, Stephen W Duffy, Durwin Logue, Rohit Bhargava, Priscilla F McAuliffe, Adam M Brufsky, Robert M Nishikawa","doi":"10.1200/JCO.24.00285","DOIUrl":"10.1200/JCO.24.00285","url":null,"abstract":"<p><strong>Purpose: </strong>Controversy continues regarding the effect of screening mammography on breast cancer outcomes. We evaluated late-stage cancer rate and overall survival (OS) for different screening intervals using a real-world institutional research data mart.</p><p><strong>Methods: </strong>Patients having both a cancer registry record of new breast cancer diagnosis and prediagnosis screening history between 2004 and 2019 were identified from our institutional research breast data mart. Time interval between the two screening mammograms immediately preceding diagnosis and the time to cancer diagnosis were determined. Screening interval was deemed annual if ≤15 months, biennial if >15 and ≤27 months, intermittent if >27 months, and baseline if only one prediagnosis screen was known. The primary end point was late-stage cancer (TNM stage IIB or worse), and the secondary end point was OS. The association of screening interval and late-stage cancer was analyzed using multivariable logistic regression adjusting for prediagnosis characteristics. Proportional hazards regression was used for survival analysis. Potential lead time was analyzed using survival from a uniform fixed time point.</p><p><strong>Results: </strong>In total, 8,145 patients with breast cancer had prediagnosis screening mammography in the timeframe. The percentage of late-stage cancers diagnosed increased significantly with screening interval with 9%, 14%, and 19% late stages for annual, biennial, and intermittent groups (<i>P</i> < .001), respectively. The trend persisted regardless of age, race, and menopausal status. Biennial and intermittent groups had substantially worse OS than the annual screened group, with relative hazards of 1.42 (95% CI, 1.11 to 1.82) and 2.69 (95% CI, 2.11 to 3.43), respectively, and 1.39 (95% CI, 1.08 to 1.78) and 2.01 (95% CI, 1.58 to 2.55) after adjustment for potential lead time.</p><p><strong>Conclusion: </strong>Annual mammographic screening was associated with lower risk of late-stage cancer and better OS across clinical and demographic subgroups. Our study suggests benefit of annual screening for women 40 years and older.</p>","PeriodicalId":15384,"journal":{"name":"Journal of Clinical Oncology","volume":null,"pages":null},"PeriodicalIF":42.1,"publicationDate":"2024-11-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11540751/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142017670","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}