Journal of Clinical Oncology最新文献

{"title":"Significance of Measurable Residual Disease in Adult Philadelphia Chromosome-Positive ALL: A GRAAPH-2014 Study.","authors":"Rathana Kim, Yves Chalandon, Philippe Rousselot, Jean-Michel Cayuela, Françoise Huguet, Marie Balsat, Marie Passet, Patrice Chevallier, Yosr Hicheri, Emmanuel Raffoux, Thibaut Leguay, Sylvain Chantepie, Sébastien Maury, Sandrine Hayette, Françoise Solly, Thorsten Braun, Bernard De Prijck, Victoria Cacheux, Celia Salanoubat, Laure Farnault, Isabelle Guibaud, Mathilde Lamarque, Lauris Gastaud, Emilie Lemasle, Eolia Brissot, Emmanuelle Tavernier, Karine Bilger, Alban Villate, Jean Soulier, Carlos Graux, Véronique Lhéritier, Hervé Dombret, Nicolas Boissel, Emmanuelle Clappier","doi":"10.1200/JCO.24.00108","DOIUrl":"10.1200/JCO.24.00108","url":null,"abstract":"<p><strong>Purpose: </strong><i>BCR::ABL1</i> quantification is widely regarded as the standard for monitoring measurable residual disease (MRD) in Philadelphia chromosome-positive (Ph+) ALL. However, recent evidence of <i>BCR::ABL1</i> multilineage involvement questions the significance of <i>BCR::ABL1</i> MRD. We aimed to define the prognostic role of MRD as assessed by <i>BCR::ABL1</i> or lymphoid-specific immunoglobulin/T-cell receptor (<i>IG/TR</i>) gene markers.</p><p><strong>Patients and methods: </strong>We conducted <i>BCR::ABL1</i> and <i>IG/TR</i> quantification after each treatment cycle in 264 patients treated in the GRAAPH-2014 trial, which used four cycles of reduced-intensity chemotherapy with nilotinib, followed by hematopoietic stem-cell transplantation (HSCT).</p><p><strong>Results: </strong>Comparing <i>BCR::ABL1</i> and <i>IG/TR</i> MRD revealed residual <i>BCR::ABL1</i>-positive non-ALL cells in 98 (43%) of 228 patients, defining multilineage Ph+ ALL. Despite poorer <i>BCR::ABL1</i> responses, patients with multilineage Ph+ ALL had similar disease-free survival (DFS; hazard ratio [HR], 0.83 [95% CI, 0.49 to 1.41]; <i>P</i> = .50). Although <i>BCR::ABL1</i> response failed to predict outcomes, <i>IG/TR</i> positivity (≥0.01%) was strongly associated with lower DFS (after cycle 2, HR, 2.49 [95% CI, 1.40 to 4.40]; <i>P</i> = .002; after cycle 4, HR, 4.13 [95% CI, 1.82 to 9.38]; <i>P</i> = .001). In multivariable analysis, both <i>IG/TR</i> positivity after cycle 2 and initial WBC count ≥30 × 10⁹/L predicted poorer DFS, enabling to define a high-risk group having a 4-year DFS of 56.5% compared with 87.6% (HR, 3.72 [95% CI, 1.93 to 7.15]; <i>P</i> < .001). Moreover, allogeneic HSCT significantly improved DFS in the high-risk group (HR, 0.33 [95% CI, 0.18 to 0.60]; <i>P</i> < .001), whereas the standard-risk group had favorable outcomes regardless of allogeneic HSCT.</p><p><strong>Conclusion: </strong>Our findings challenge the significance of <i>BCR::ABL1</i> monitoring in adult Ph+ ALL and demonstrate the prognostic role of <i>IG/TR</i> MRD. This study provides a framework for using MRD to guide treatment strategies in adults with Ph+ ALL.</p>","PeriodicalId":15384,"journal":{"name":"Journal of Clinical Oncology","volume":null,"pages":null},"PeriodicalIF":42.1,"publicationDate":"2024-09-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141727252","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":"Scalp Cooling in Preventing Persistent Chemotherapy-Induced Alopecia: A Randomized Controlled Trial.","authors":"Danbee Kang, Juhee Cho, Di Zhao, Jeonghyun Kim, Nayeon Kim, Hoyoung Kim, Sooyeon Kim, Ji-Yeon Kim, Yeon Hee Park, Young Hyuck Im, Eliseo Guallar, Jin Seok Ahn","doi":"10.1200/JCO.23.02374","DOIUrl":"10.1200/JCO.23.02374","url":null,"abstract":"<p><strong>Purpose: </strong>Current studies of the efficacy of scalp cooling are limited by short-term duration. Therefore, we conducted a randomized controlled trial to evaluate the efficacy of scalp cooling in reducing persistent chemotherapy-induced alopecia (PCIA) 6 months after chemotherapy.</p><p><strong>Methods: </strong>We conducted an open-label randomized controlled trial comparing scalp cooling versus control in newly diagnosed patients with breast cancer stages I-III scheduled to receive neoadjuvant or adjuvant chemotherapy with curative intent between December 2020 and August 2021. Patients were randomly assigned (2:1 ratio) to scalp cooling or usual clinical practice. The primary outcome was PCIA 6 months after chemotherapy. Hair thickness and density were measured using Folliscope 5.0. CIA-related distress was assessed using the CIA distress scale (CADS), with a higher score reflecting higher stress.</p><p><strong>Results: </strong>The proportion of patients with PCIA at 6 months was 13.5% (12/89) in the scalp-cooling group and 52.0% (26/50) in the control group. The average difference in the change in hair thickness from baseline between the scalp-cooling and control groups was 9.0 μm in favor of the intervention group. The average difference in the change in hair density between intervention and control at the end of the study was -3.3 hairs/cm². At 6 months after chemotherapy, the average difference in the change in CADS score between the intervention and control groups was -3.2 points, reflecting reduced CIA-related stress in the intervention group.</p><p><strong>Conclusion: </strong>Scalp cooling reduced the incidence of PCIA, primarily by increasing hair thickness compared with control. Scalp cooling is helpful in promoting qualitative hair regrowth. Yet, further research is necessary to observe longer-term benefits of scalp cooling.</p>","PeriodicalId":15384,"journal":{"name":"Journal of Clinical Oncology","volume":null,"pages":null},"PeriodicalIF":42.1,"publicationDate":"2024-09-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141283854","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":"At the Crossroads of Local and Systemic Treatment of Operable Non-Small Cell Lung Cancer.","authors":"Rafal Dziadziuszko, Witold Rzyman","doi":"10.1200/JCO.24.01099","DOIUrl":"10.1200/JCO.24.01099","url":null,"abstract":"","PeriodicalId":15384,"journal":{"name":"Journal of Clinical Oncology","volume":null,"pages":null},"PeriodicalIF":42.1,"publicationDate":"2024-09-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141751820","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":"Dendritic Cell-Based Immunotherapy in Patients With Resected Pancreatic Cancer.","authors":"Freek R van 't Land, Marcella Willemsen, Koen Bezemer, Sjoerd H van der Burg, Thierry P P van den Bosch, Michail Doukas, Amine Fellah, P Martijn Kolijn, Anton W Langerak, Miranda Moskie, Elise van der Oost, Nina E M Rozendaal, Sara J Baart, Joachim G J V Aerts, Casper H J van Eijck","doi":"10.1200/JCO.23.02585","DOIUrl":"10.1200/JCO.23.02585","url":null,"abstract":"<p><strong>Purpose: </strong>Immunotherapies have shown limited responses in patients with advanced pancreatic cancer. Recently, we reported that dendritic cell (DC)-based immunotherapy induced T-cell responses against pancreatic cancer antigens. The primary objective of this study was to determine the efficacy of DC-based immunotherapy to prevent recurrence of disease.</p><p><strong>Methods: </strong>This was a single-center, open-label, single-arm, combined phase I/II trial. The primary end point was the 2-year recurrence-free survival (RFS) rate. A 2-year RFS rate of ≥60% was defined as a clinically meaningful improvement. We included patients with pancreatic cancer after resection and completion of standard-of-care (SOC) treatment without recurrent disease on cross-sectional imaging. Patients were treated with autologous DCs pulsed with an allogeneic mesothelioma tumor cell lysate, comprising antigens also expressed in pancreatic ductal adenocarcinoma.</p><p><strong>Results: </strong>Thirty-eight patients were included in the analysis of the primary end point (47% male, 53% female). The median age was 62 years (IQR, 55-68). Twenty-eight patients (74%) received five DC vaccinations and completed the study protocol. Three patients (8%) received four vaccinations, and seven patients (16%) received three vaccinations. After a median follow-up of 25.5 months, 26 patients (68%) had not developed recurrence of disease. The estimated 2-year RFS was 64%. Vaccination led to the enrichment of circulating activated CD4+ T cells and the detection of treatment-induced immune responses in vitro. T-cell receptor-sequencing analyses of a resected solitary lung metastasis showed influx of vaccine-specific T cells.</p><p><strong>Conclusion: </strong>This study reached its primary end point of a 2-year RFS rate of ≥60% following pancreatectomy after SOC treatment and adjuvant DC-based immunotherapy in patients with pancreatic cancer. These results warrant a future randomized trial.</p>","PeriodicalId":15384,"journal":{"name":"Journal of Clinical Oncology","volume":null,"pages":null},"PeriodicalIF":42.1,"publicationDate":"2024-09-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11379361/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141476701","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":"Future of Dendritic Cell-Based Approaches in Pancreatic Cancer.","authors":"Ashwin Somasundaram, Jen Jen Yeh","doi":"10.1200/JCO.24.00846","DOIUrl":"10.1200/JCO.24.00846","url":null,"abstract":"","PeriodicalId":15384,"journal":{"name":"Journal of Clinical Oncology","volume":null,"pages":null},"PeriodicalIF":42.1,"publicationDate":"2024-09-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11377165/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141590388","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":"Circulating Tumor DNA Assay Detects Merkel Cell Carcinoma Recurrence, Disease Progression, and Minimal Residual Disease: Surveillance and Prognostic Implications.","authors":"Tomoko Akaike, Manisha Thakuria, Ann W Silk, Daniel S Hippe, Song Youn Park, Naomi A So, Nolan J Maloney, Lindsay Gunnell, Alec Eschholz, Emily Y Kim, Sumi Sinha, Evan Thomas Hall, Shailender Bhatia, Sunil Reddy, Angel Augusto Rodriguez, Alexey Aleshin, Jacob S Choi, Kenneth Y Tsai, Sue S Yom, Siegrid S Yu, Jaehyuk Choi, Sunandana Chandra, Paul Nghiem, Lisa C Zaba","doi":"10.1200/JCO.23.02054","DOIUrl":"10.1200/JCO.23.02054","url":null,"abstract":"<p><strong>Purpose: </strong>Merkel cell carcinoma (MCC) is an aggressive skin cancer with a 40% recurrence rate, lacking effective prognostic biomarkers and surveillance methods. This prospective, multicenter, observational study aimed to evaluate circulating tumor DNA (ctDNA) as a biomarker for detecting MCC recurrence.</p><p><strong>Methods: </strong>Plasma samples, clinical data, and imaging results were collected from 319 patients. A tumor-informed ctDNA assay was used for analysis. Patients were divided into discovery (167 patients) and validation (152 patients) cohorts. Diagnostic performance, including sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV), was assessed.</p><p><strong>Results: </strong>ctDNA showed high sensitivity, 95% (discovery; 95% CI, 87 to 99) and 94% (validation; 95% CI, 85 to 98), for detecting disease at enrollment, with corresponding specificities of 90% (95% CI, 82 to 95) and 86% (95% CI, 77 to 93). A positive ctDNA during surveillance indicated increased recurrence risk, with hazard ratios (HRs) of 6.8 (discovery; 95% CI, 2.9 to 16) and 20 (validation; 95% CI, 8.3 to 50). The PPV for clinical recurrence at 1 year after a positive ctDNA test was 69% (discovery; 95% CI, 32 to 91) and 94% (validation; 95% CI, 71 to 100), respectively. The NPV at 135 days after a negative ctDNA test was 94% (discovery; 95% CI, 90 to 97) and 93% (validation; 95% CI, 89 to 97), respectively. Patients positive for ctDNA within 4 months after treatment had higher rates of recurrence, with 1-year rates of 74% versus 21% (adjusted HR, 7.4 [95% CI, 2.7 to 20]).</p><p><strong>Conclusion: </strong>ctDNA testing exhibited high prognostic accuracy in detecting MCC recurrence, suggesting its potential to reduce frequent surveillance imaging. ctDNA also identifies high-risk patients who need more frequent imaging and may be best suited for adjuvant therapy trials.</p>","PeriodicalId":15384,"journal":{"name":"Journal of Clinical Oncology","volume":null,"pages":null},"PeriodicalIF":42.1,"publicationDate":"2024-09-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11379364/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141758969","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":"Helicobacter pylori and Gastric Cancer Screening.","authors":"Steven Sorscher","doi":"10.1200/JCO.24.00509","DOIUrl":"10.1200/JCO.24.00509","url":null,"abstract":"","PeriodicalId":15384,"journal":{"name":"Journal of Clinical Oncology","volume":null,"pages":null},"PeriodicalIF":42.1,"publicationDate":"2024-09-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141468363","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 A. Jain et al.","authors":"Mariana Chávez-Villa, Luis I Ruffolo, Matthew Byrne, Pål-Dag Line, Svein Dueland, Koji Tomiyama, Roberto Hernandez-Alejandro","doi":"10.1200/JCO.24.00922","DOIUrl":"10.1200/JCO.24.00922","url":null,"abstract":"","PeriodicalId":15384,"journal":{"name":"Journal of Clinical Oncology","volume":null,"pages":null},"PeriodicalIF":42.1,"publicationDate":"2024-09-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141558865","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":"Tailored Dose-Dense Versus Standard Adjuvant Chemotherapy for High-Risk Early Breast Cancer: End-of-Study Results of the Randomized PANTHER Trial.","authors":"Alexios Matikas, Volker Möbus, Richard Greil, Anne Andersson, Günther G Steger, Michael Untch, Tommy Fornander, Per Malmström, Sabine Schmatloch, Hemming Johansson, Mats Hellström, Yvonne Brandberg, Michael Gnant, Sibylle Loibl, Theodoros Foukakis, Jonas Bergh","doi":"10.1200/JCO.24.00178","DOIUrl":"10.1200/JCO.24.00178","url":null,"abstract":"<p><p><i>Clinical trials frequently include multiple end points that mature at different times. The initial report, typically based on the primary end point, may be published when key planned co-primary or secondary analyses are not yet available. Clinical Trial Updates provide an opportunity to disseminate additional results from studies, published in</i> JCO <i>or elsewhere, for which the primary end point has already been reported</i>.Although dose-dense adjuvant chemotherapy administered once every 2 weeks leads to superior outcomes compared with standard regimens once every 3 weeks, the observed improvement is largely limited to studies using the suboptimal paclitaxel schedule once every 3 weeks as control. PANTHER is an international phase III trial which compared sequential epirubicin/cyclophosphamide and docetaxel administered either once every 2 or once every 3 weeks, with tailored dosing at the dose-dense schedule according to hematologic toxicity. In this end-of-study analysis, the median follow-up was 10.3 years. Compared with standard adjuvant chemotherapy, dose-dense treatment improved breast cancer recurrence-free survival (hazard ratio [HR], 0.80 [95% CI, 0.65 to 0.98]; <i>P</i> = .030), event-free survival (HR, 0.78 [95% CI, 0.65 to 0.94]; <i>P</i> = .009), and distant disease-free survival (HR, 0.79 [95% CI, 0.64 to 0.98]; <i>P</i> = .030) while the improvement in overall survival was not statistically significant (HR, 0.82 [95% CI, 0.65 to 1.04]; <i>P</i> = .109). To our knowledge, this is the first trial that confirms the benefit of a dose-dense regimen over a control regimen containing docetaxel once every 3 weeks.</p>","PeriodicalId":15384,"journal":{"name":"Journal of Clinical Oncology","volume":null,"pages":null},"PeriodicalIF":42.1,"publicationDate":"2024-09-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11379357/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141633585","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":"Genetic Counseling, Testing, and Family Communication Into Survivorship After Diagnosis of Breast Cancer.","authors":"Steven J Katz, Paul Abrahamse, Allison Furgal, Rachel Hodan, Rachel S Tocco, Kevin C Ward, Ann S Hamilton, Lauren P Wallner, Allison W Kurian","doi":"10.1200/JCO.24.00122","DOIUrl":"10.1200/JCO.24.00122","url":null,"abstract":"<p><strong>Purpose: </strong>To examine receipt of genetic testing and communication with relatives about results into survivorship after diagnosis of breast cancer.</p><p><strong>Methods: </strong>Women age 20-79 years diagnosed with early-stage breast cancer in 2014-2015 and reported to the Georgia and Los Angeles County SEER registries were surveyed approximately 7 months and 6 years after diagnosis (n = 1,412). We asked about genetic counseling, testing, and communication with relatives about results. We categorized women into indications for testing on the basis of clinical guidelines at the time of diagnosis and at the time of the follow-up survey (FUPs).</p><p><strong>Results: </strong>A total of 47.4% had indications for genetic testing at any time: 28.0% at baseline and an additional 19.4% at the time of the FUPs (only); 71.9% (95% CI, 67.4 to 76.4) of those with a baseline indication reported genetic testing versus 53.3% (95% CI, 47.3 to 59.2) with an indication at FUPs only and 35.0% (95% CI, 31.6 to 38.4) with no indication (<i>P</i> < .001). There were no significant racial or ethnic differences in receipt of testing, controlling for age and clinical indications (<i>P</i> = .239); results for genetic counseling were similar. Only 3.4% of survivors had direct-to-consumer genetic testing (DTCt) for cancer. Testers who reported a pathogenic variant (n = 62) were much more likely to have talked to most or all their first-degree adult relatives about genetic testing than those with a variant of unknown significance (n = 49) or a negative finding (n = 419): 62.7% versus 38.8% and 38.0%, respectively (<i>P</i> < .001).</p><p><strong>Conclusion: </strong>Many women with indications for genetic counseling and testing into survivorship do not receive it. But those tested reach out to family members on the basis of the clinical relevance of their results. Very few patients obtained DTCt, which suggests that these tests do not substitute for clinical testing in breast cancer survivors.</p>","PeriodicalId":15384,"journal":{"name":"Journal of Clinical Oncology","volume":null,"pages":null},"PeriodicalIF":42.1,"publicationDate":"2024-09-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11377164/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141620034","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}