{"title":"Erratum: Circulating Tumor DNA Sequencing for Biologic Classification and Individualized Risk Stratification in Patients With Hodgkin Lymphoma.","authors":"","doi":"10.1200/JCO-24-02371","DOIUrl":"https://doi.org/10.1200/JCO-24-02371","url":null,"abstract":"","PeriodicalId":15384,"journal":{"name":"Journal of Clinical Oncology","volume":" ","pages":"JCO2402371"},"PeriodicalIF":42.1,"publicationDate":"2024-11-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142604726","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}
Warren B Fingrut, Andromachi Scaradavou, Juliet N Barker
{"title":"Disparities in Allograft Access in the Era of Post-Transplant Cyclophosphamide-Based Mismatched Unrelated Donor Transplantation.","authors":"Warren B Fingrut, Andromachi Scaradavou, Juliet N Barker","doi":"10.1200/JCO-24-01824","DOIUrl":"https://doi.org/10.1200/JCO-24-01824","url":null,"abstract":"","PeriodicalId":15384,"journal":{"name":"Journal of Clinical Oncology","volume":" ","pages":"JCO2401824"},"PeriodicalIF":42.1,"publicationDate":"2024-11-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142590836","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}
Georgina V Long, James Larkin, Dirk Schadendorf, Jean-Jacques Grob, Christopher D Lao, Iván Márquez-Rodas, John Wagstaff, Céleste Lebbé, Jacopo Pigozzo, Caroline Robert, Paolo A Ascierto, Victoria Atkinson, Michael A Postow, Michael B Atkins, Mario Sznol, Margaret K Callahan, Suzanne L Topalian, Jeffrey A Sosman, Srividya Kotapati, Pratik K Thakkar, Corey Ritchings, Melanie Pe Benito, Sandra Re, Samira Soleymani, F Stephen Hodi
{"title":"Pooled Long-Term Outcomes With Nivolumab Plus Ipilimumab or Nivolumab Alone in Patients With Advanced Melanoma.","authors":"Georgina V Long, James Larkin, Dirk Schadendorf, Jean-Jacques Grob, Christopher D Lao, Iván Márquez-Rodas, John Wagstaff, Céleste Lebbé, Jacopo Pigozzo, Caroline Robert, Paolo A Ascierto, Victoria Atkinson, Michael A Postow, Michael B Atkins, Mario Sznol, Margaret K Callahan, Suzanne L Topalian, Jeffrey A Sosman, Srividya Kotapati, Pratik K Thakkar, Corey Ritchings, Melanie Pe Benito, Sandra Re, Samira Soleymani, F Stephen Hodi","doi":"10.1200/JCO.24.00400","DOIUrl":"https://doi.org/10.1200/JCO.24.00400","url":null,"abstract":"<p><strong>Purpose: </strong>Nivolumab (NIVO) + ipilimumab (IPI) combination and NIVO monotherapy have demonstrated durable clinical benefit in patients with unresectable/metastatic melanoma. This analysis describes long-term overall survival (OS) with the combination or monotherapy pooled across all major company-sponsored trials, as well as clinical factors associated with survival, in patients with immune checkpoint inhibitor (ICI) treatment-naïve unresectable/metastatic melanoma.</p><p><strong>Methods: </strong>Data were pooled from six CheckMate studies in ICI treatment-naïve patients receiving NIVO + IPI (NIVO 1 mg/kg + IPI 3 mg/kg or NIVO 3 mg/kg + IPI 1 mg/kg) or NIVO monotherapy (3 mg/kg). OS was assessed for each treatment, as well as in select subgroups. Cox proportional multivariate analysis (MVA) and classification and regression tree (CART) analyses were performed within treatment arms.</p><p><strong>Results: </strong>Median follow-up for OS was 45.0 months for patients treated with NIVO + IPI (n = 839) and 35.8 months for patients treated with NIVO (n = 536). OS was longer with NIVO + IPI versus NIVO monotherapy (hazard ratio, 0.78 [95% CI, 0.67 to 0.91]), with 6-year OS rates of 52% versus 41%, respectively. Consistent benefit was observed in <i>BRAF</i>-mutant and <i>BRAF</i>-wild-type patients and those with normal and elevated lactate dehydrogenase (LDH). Numerical difference in OS was also observed across PD-L1 expression levels, although more pronounced with no/low PD-L1 expression. Clinical factors associated with decreased survival in both the MVA and CART analyses were LDH > upper limit of normal with either treatment, age ≥65 years with NIVO + IPI, and the presence of liver metastases with NIVO monotherapy.</p><p><strong>Conclusion: </strong>In this large, pooled nonrandomized retrospective analysis, we observed that NIVO + IPI provides longer OS than NIVO in patients with ICI treatment-naïve advanced melanoma and identifies clinical factors that appear to be associated with survival for each treatment, which may assist with treatment decision making.</p>","PeriodicalId":15384,"journal":{"name":"Journal of Clinical Oncology","volume":" ","pages":"JCO2400400"},"PeriodicalIF":42.1,"publicationDate":"2024-11-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142590839","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}
Brian C Shaffer, Mahasweta Gooptu, Todd DeFor, Stephen R Spellman, Heather E Stefanski, Bronwen E Shaw, Jeffery J Auletta, Steven M Devine, Antonio M Jimenez, Monzr M Al Malki
{"title":"Reply to: Disparities in Allograft Access in the Era of Post-Transplant Cyclophosphamide-Based Mismatched Unrelated Donor Transplantation.","authors":"Brian C Shaffer, Mahasweta Gooptu, Todd DeFor, Stephen R Spellman, Heather E Stefanski, Bronwen E Shaw, Jeffery J Auletta, Steven M Devine, Antonio M Jimenez, Monzr M Al Malki","doi":"10.1200/JCO-24-02108","DOIUrl":"10.1200/JCO-24-02108","url":null,"abstract":"","PeriodicalId":15384,"journal":{"name":"Journal of Clinical Oncology","volume":" ","pages":"JCO2402108"},"PeriodicalIF":42.1,"publicationDate":"2024-11-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142590845","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":"Anthracyclines in Early Breast Cancer: The Long Goodbye.","authors":"Thomas Grinda, Harold J Burstein","doi":"10.1200/JCO-24-01916","DOIUrl":"https://doi.org/10.1200/JCO-24-01916","url":null,"abstract":"","PeriodicalId":15384,"journal":{"name":"Journal of Clinical Oncology","volume":" ","pages":"JCO2401916"},"PeriodicalIF":42.1,"publicationDate":"2024-11-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142583029","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":"Combination Immunotherapy for Advanced Melanoma-How to Choose?","authors":"Sophia Kreft, Paul Lorigan","doi":"10.1200/JCO-24-02005","DOIUrl":"https://doi.org/10.1200/JCO-24-02005","url":null,"abstract":"","PeriodicalId":15384,"journal":{"name":"Journal of Clinical Oncology","volume":" ","pages":"JCO2402005"},"PeriodicalIF":42.1,"publicationDate":"2024-11-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142576116","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":"Navigating Gatekeeping Challenges in Pediatric and Young Adult Palliative Oncology and End-of-Life Research.","authors":"Prasanna Ananth, Jennifer M Snaman","doi":"10.1200/JCO-24-01944","DOIUrl":"https://doi.org/10.1200/JCO-24-01944","url":null,"abstract":"<p><p>Participation in research offers families a sense of control and meaning in pediatric cancer care. Gatekeeping limits progress-collaboration is key. #PediatricOncology #PalliativeCare #Research #PallOnc #pedonc #hpm #hapc.</p>","PeriodicalId":15384,"journal":{"name":"Journal of Clinical Oncology","volume":" ","pages":"JCO2401944"},"PeriodicalIF":42.1,"publicationDate":"2024-11-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142576158","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}
Stefania Morganti, Christopher J Gibson, Qingchun Jin, Katheryn Santos, Ashka Patel, Alex Wilson, Margaret Merrill, Julie Vincuilla, Samantha Stokes, Marla Lipsyc-Sharf, Tonia Parker, Tari A King, Elizabeth A Mittendorf, Giuseppe Curigliano, Melissa E Hughes, Daniel G Stover, Sara M Tolaney, Lachelle D Weeks, Nabihah Tayob, Nancy U Lin, Judy E Garber, Peter G Miller, Heather A Parsons
{"title":"Prevalence, Dynamics, and Prognostic Role of Clonal Hematopoiesis of Indeterminate Potential in Patients With Breast Cancer.","authors":"Stefania Morganti, Christopher J Gibson, Qingchun Jin, Katheryn Santos, Ashka Patel, Alex Wilson, Margaret Merrill, Julie Vincuilla, Samantha Stokes, Marla Lipsyc-Sharf, Tonia Parker, Tari A King, Elizabeth A Mittendorf, Giuseppe Curigliano, Melissa E Hughes, Daniel G Stover, Sara M Tolaney, Lachelle D Weeks, Nabihah Tayob, Nancy U Lin, Judy E Garber, Peter G Miller, Heather A Parsons","doi":"10.1200/JCO.23.01071","DOIUrl":"10.1200/JCO.23.01071","url":null,"abstract":"<p><strong>Purpose: </strong>Clonal hematopoiesis of indeterminate potential (CHIP) is frequent in patients with solid tumors. Prospective data about CHIP prevalence at breast cancer diagnosis and its dynamic evolution under treatment selective pressure are limited.</p><p><strong>Patients and methods: </strong>We performed targeted error-corrected sequencing on 614 samples from 380 patients with breast cancer. We investigated the dynamics of CHIP on prospectively collected paired samples from patients with early breast cancer (eBC) receiving chemotherapy (CT) or endocrine therapy (ET). We assessed the correlation of CHIP with survival in patients with metastatic triple-negative breast cancer (mTNBC). We estimated the risk of progression to treatment-related myeloid neoplasms (t-MN) according to the clonal hematopoiesis risk score (CHRS). In exploratory analyses, we considered clonal hematopoiesis (CH) with variant allele fraction (VAF) ≥0.005.</p><p><strong>Results: </strong>CHIP was identified in 15% of patients before treatment. Few CHIP emerged after treatment, and the risk of developing new mutations was similar for patients receiving CT versus ET (odds ratio [OR], 1.16; <i>P</i> = .820). However, CT increased the risk of developing new CH with VAF ≥0.005 (OR, 3.45; <i>P</i> = .002). Five <i>TP53-</i>mutant CH with VAF ≥0.005 emerged among patients receiving CT. Most patients had low risk of t-MN according to the CHRS score. CHIP did not correlate with survival in mTNBC.</p><p><strong>Conclusion: </strong>CHIP is frequent in patients with breast cancer. In this study, CT did not lead to emergence of new CHIP, and most patients had low risk of developing t-MN. This finding is reassuring, given long life expectancy of patients with eBC and the association of CHIP with morbidity and mortality. However, <i>TP53</i>-mutant CH with VAF ≥0.005 emerged with CT, which carries high risk of t-MN. Evolution of these small clones and their clinical significance warrant further investigation.</p>","PeriodicalId":15384,"journal":{"name":"Journal of Clinical Oncology","volume":" ","pages":"3666-3679"},"PeriodicalIF":42.1,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139403109","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}
Jin-Ji Yang, Yan Zhang, Lin Wu, Jie Hu, Zhe-Hai Wang, Jing-Hua Chen, Yun Fan, Gen Lin, Qi-Ming Wang, Yu Yao, Jun Zhao, Yuan Chen, Jian Fang, Yong Song, Wei Zhang, Ying Cheng, Ren-Hua Guo, Xing-Ya Li, He-Peng Shi, Wei-Zhe Xue, Di Han, Pei-Long Zhang, Yi-Long Wu
{"title":"Vebreltinib for Advanced Non-Small Cell Lung Cancer Harboring c-Met Exon 14 Skipping Mutation: A Multicenter, Single-Arm, Phase II KUNPENG Study.","authors":"Jin-Ji Yang, Yan Zhang, Lin Wu, Jie Hu, Zhe-Hai Wang, Jing-Hua Chen, Yun Fan, Gen Lin, Qi-Ming Wang, Yu Yao, Jun Zhao, Yuan Chen, Jian Fang, Yong Song, Wei Zhang, Ying Cheng, Ren-Hua Guo, Xing-Ya Li, He-Peng Shi, Wei-Zhe Xue, Di Han, Pei-Long Zhang, Yi-Long Wu","doi":"10.1200/JCO.23.02363","DOIUrl":"10.1200/JCO.23.02363","url":null,"abstract":"<p><strong>Purpose: </strong>The KUNPENG study aimed to evaluate the efficacy and safety of vebreltinib (also known as bozitinib, APL-101, PLB-1001, and CBT-101), a potent and highly selective inhibitor of c-mesenchymal-epithelial transition (<i>MET</i>), in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring c-Met alterations.</p><p><strong>Methods: </strong>This multicenter, multicohort, open-label, single-arm, phase II trial enrolled patients with c-Met dysregulated, locally advanced or metastatic NSCLC from January 2020 to August 2022 across 17 centers. Cohort 1 included patients with <i>MET</i> exon 14 skipping (<i>MET</i>ex14)-mutant NSCLC who had not previously received <i>MET</i> inhibitors. Participants were administered vebreltinib at a dosage of 200 mg twice a day in 28-day cycles. The primary end point was the objective response rate (ORR), and the key secondary end point was the duration of response (DoR), both evaluated by a blinded independent review committee according to the RECIST version 1.1.</p><p><strong>Results: </strong>As of August 9, 2022, 52 patients had been enrolled in cohort 1, of whom 35 (67.3%) were treatment-naïve. The ORR reached 75% (95% CI, 61.1 to 86). Among treatment-naïve patients, the ORR was 77.1% (95% CI, 59.9 to 89.6), and in previously treated patients, it was 70.6% (95% CI, 44.0 to 89.7). The disease control rate was 96.2%, with a median DoR of 15.9 months, a median progression-free survival of 14.1 months, and a median overall survival of 20.7 months. The most common treatment-related adverse events were peripheral edema (82.7%), QT prolongation (30.8%), and elevated serum creatinine (28.8%).</p><p><strong>Conclusion: </strong>Vebreltinib has shown promising efficacy and a favorable safety profile in patients with <i>MET</i>ex14-mutant NSCLC.</p>","PeriodicalId":15384,"journal":{"name":"Journal of Clinical Oncology","volume":" ","pages":"3680-3691"},"PeriodicalIF":42.1,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11527384/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141766152","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":"Rain Talk.","authors":"Karl A Lorenz","doi":"10.1200/JCO.24.01123","DOIUrl":"10.1200/JCO.24.01123","url":null,"abstract":"","PeriodicalId":15384,"journal":{"name":"Journal of Clinical Oncology","volume":" ","pages":"3761"},"PeriodicalIF":42.1,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142347568","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}