{"title":"B-Cell Maturation Antigen/CD19 Dual-Targeting Immunotherapy in Newly Diagnosed Multiple Myeloma.","authors":"Wanting Qiang, Jing Lu, Yanchun Jia, Jia Liu, Jin Liu, Haiyan He, Xiaoxiang Wang, Xiaoqiang Fan, Lina Jin, Qianqi Ruan, Qi Zhang, Lianjun Shen, Lihong Weng, Wei Cao, Wenling Li, Juan Du","doi":"10.1001/jamaoncol.2024.2172","DOIUrl":"10.1001/jamaoncol.2024.2172","url":null,"abstract":"<p><strong>Importance: </strong>Patients with high-risk newly diagnosed multiple myeloma (NDMM) often have poor outcomes with standard treatments, necessitating novel effective frontline therapies to enhance clinical outcomes. GC012F, a B-cell maturation antigen/CD19 dual-targeting chimeric antigen receptor (CAR) T-cell therapy, has been developed on the novel FasTCAR platform. Notably, its use as a frontline therapy for patients with high-risk NDMM who are eligible for transplant has not been thoroughly explored.</p><p><strong>Objective: </strong>To examine the safety, pharmacokinetics, and patient health and survival outcomes associated with GC012F in individuals with NDMM.</p><p><strong>Design, setting, and participants: </strong>Patients were enrolled in this single-arm, open-label phase 1 cohort study between June 28, 2021, and June 1, 2023 (the data cutoff date). All patients included in this study were treated at a single center, Shanghai Changzheng Hospital. The patients in the efficacy evaluation were followed up for a minimum period of 3 months.</p><p><strong>Intervention: </strong>Patients underwent 2 cycles of induction therapy, followed by GC012F infusion (at 1 × 105 cells/kg, 2 × 105 cells/kg, or 3 × 105 cells/kg).</p><p><strong>Main outcomes and measures: </strong>The primary goals were to assess the safety, efficacy, and pharmacokinetics of GC012F at various dose levels.</p><p><strong>Results: </strong>Of 22 patients receiving GC012F treatment, 6 experienced mild to moderate cytokine release syndrome (grade 1-2) and none experienced neurotoxic effects. Nineteen patients were included in the efficacy evaluation, and all 19 patients showed stringent complete responses and achieved minimal residual disease negativity. The treatment's effectiveness was consistent across different dose levels. GC012F demonstrated a rapid response, with a median time to first stringent complete response of 84 days (range, 26-267 days) and achieving minimal residual disease negativity within 28 days (range, 23-135 days). The CAR T-cell expansion was robust, with a median peak copy number of 60 652 copies/μg genomic DNA (range, 8754-331 159 copies/μg genomic DNA), and the median time to median peak copy number was 10 days (range, 9-14 days).</p><p><strong>Conclusions and relevance: </strong>The findings of this single-arm, open-label phase 1 cohort study suggest that GC012F may be a safe treatment associated with positive health and survival outcomes for patients with high-risk NDMM eligible for transplant. Owing to the small sample size, further studies with larger cohorts and longer follow-up durations are needed.</p>","PeriodicalId":48661,"journal":{"name":"Jama Oncology","volume":null,"pages":null},"PeriodicalIF":28.4,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11273281/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141761826","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}
Jama OncologyPub Date : 2024-09-01DOI: 10.1001/jamaoncol.2024.2744
Andrew Hantel, Colin Cernik, Thomas P Walsh, Hajime Uno, Dalia Larios, Jonathan E Slutzman, Gregory A Abel
{"title":"Assessing the Environmental and Downstream Human Health Impacts of Decentralizing Cancer Care.","authors":"Andrew Hantel, Colin Cernik, Thomas P Walsh, Hajime Uno, Dalia Larios, Jonathan E Slutzman, Gregory A Abel","doi":"10.1001/jamaoncol.2024.2744","DOIUrl":"10.1001/jamaoncol.2024.2744","url":null,"abstract":"<p><strong>Importance: </strong>Greenhouse gas (GHG) emissions from health care are substantial and disproportionately harm persons with cancer. Emissions from a central component of oncology care, outpatient clinician visits, are not well described, nor are the reductions in emissions and human harms that could be obtained through decentralizing this aspect of cancer care (ie, telemedicine and local clinician care when possible).</p><p><strong>Objective: </strong>To assess potential reductions in GHG emissions and downstream health harms associated with telemedicine and fully decentralized cancer care.</p><p><strong>Design, setting, and participants: </strong>This population-based cohort study and counterfactual analyses using life cycle assessment methods analyzed persons receiving cancer care at Dana-Farber Cancer Institute between May 2015 and December 2020 as well as persons diagnosed with cancer over the same period from the Cancer in North America (CiNA) public dataset. Data were analyzed from October 2023 to April 2024.</p><p><strong>Main outcomes and measures: </strong>The adjusted per-visit day difference in GHG emissions in kilograms of carbon dioxide (CO2) equivalents between 2 periods: an in-person care model period (May 2015 to February 2020; preperiod) and a telemedicine period (March to December 2020; postperiod), and the annual decrease in disability-adjusted life-years in a counterfactual model where care during the preperiod was maximally decentralized nationwide.</p><p><strong>Results: </strong>Of 123 890 included patients, 73 988 (59.7%) were female, and the median (IQR) age at first diagnosis was 59 (48-68) years. Patients were seen over 1.6 million visit days. In mixed-effects log-linear regression, the mean absolute reduction in per-visit day CO2 equivalent emissions between the preperiod and postperiod was 36.4 kg (95% CI, 36.2-36.6), a reduction of 81.3% (95% CI, 80.8-81.7) compared with the baseline model. In a counterfactual decentralized care model of the preperiod, there was a relative emissions reduction of 33.1% (95% CI, 32.9-33.3). When demographically matched to 10.3 million persons in the CiNA dataset, decentralized care would have reduced national emissions by 75.3 million kg of CO2 equivalents annually; this corresponded to an estimated annual reduction of 15.0 to 47.7 disability-adjusted life-years.</p><p><strong>Conclusions and relevance: </strong>This cohort study found that using decentralization through telemedicine and local care may substantially reduce cancer care's GHG emissions; this corresponds to small reductions in human mortality.</p>","PeriodicalId":48661,"journal":{"name":"Jama Oncology","volume":null,"pages":null},"PeriodicalIF":28.4,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11148788/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141200025","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}
Jama OncologyPub Date : 2024-09-01DOI: 10.1001/jamaoncol.2024.2057
Marian L Neuhouser, Jeannette M Schenk, Jonathan L Wright
{"title":"Exercise for Prostate Cancer-Worthy Goals but Suboptimal Trial Designs.","authors":"Marian L Neuhouser, Jeannette M Schenk, Jonathan L Wright","doi":"10.1001/jamaoncol.2024.2057","DOIUrl":"10.1001/jamaoncol.2024.2057","url":null,"abstract":"","PeriodicalId":48661,"journal":{"name":"Jama Oncology","volume":null,"pages":null},"PeriodicalIF":28.4,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141635053","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}
Jama OncologyPub Date : 2024-09-01DOI: 10.1001/jamaoncol.2024.2205
Seema Ahsan Khan, Masha Kocherginsky
{"title":"Contralateral Breast Cancer Remains a Complex Biologic Conundrum.","authors":"Seema Ahsan Khan, Masha Kocherginsky","doi":"10.1001/jamaoncol.2024.2205","DOIUrl":"10.1001/jamaoncol.2024.2205","url":null,"abstract":"","PeriodicalId":48661,"journal":{"name":"Jama Oncology","volume":null,"pages":null},"PeriodicalIF":28.4,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141761831","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}
Jama OncologyPub Date : 2024-09-01DOI: 10.1001/jamaoncol.2024.2112
Chelsea C Pinnix, Bouthaina S Dabaja, Jillian R Gunther, Penny Q Fang, Susan Y Wu, Loretta J Nastoupil, Paolo Strati, Ranjit Nair, Sairah Ahmed, Raphael Steiner, Jason Westin, Sattva Neelapu, Maria A Rodriguez, Hun Ju Lee, Michael Wang, Christopher Flowers, Lei Feng, Bita Esmaeli
{"title":"Response-Adapted Ultralow-Dose Radiation Therapy for Orbital Indolent B-Cell Lymphoma: A Phase 2 Nonrandomized Controlled Trial.","authors":"Chelsea C Pinnix, Bouthaina S Dabaja, Jillian R Gunther, Penny Q Fang, Susan Y Wu, Loretta J Nastoupil, Paolo Strati, Ranjit Nair, Sairah Ahmed, Raphael Steiner, Jason Westin, Sattva Neelapu, Maria A Rodriguez, Hun Ju Lee, Michael Wang, Christopher Flowers, Lei Feng, Bita Esmaeli","doi":"10.1001/jamaoncol.2024.2112","DOIUrl":"10.1001/jamaoncol.2024.2112","url":null,"abstract":"<p><strong>Importance: </strong>Radiation therapy to doses of 24 to 36 Gy is currently used to treat indolent B-cell lymphoma of the ocular adnexa; however, ocular adverse effects are common.</p><p><strong>Objective: </strong>To determine if a response-adapted radiation therapy strategy will result in excellent disease outcomes while reducing orbital morbidity.</p><p><strong>Design, setting, and participants: </strong>This single-institution, phase 2 prospective nonrandomized controlled trial of a response-adapted strategy involved 50 evaluable patients with stage I to IV indolent B-cell lymphoma of the ocular adnexa enrolled between July 2015 and January 2021. This treatment approach was also retrospectively evaluated with a separate 55-patient cohort treated between March 2013 and October 2021. All data were analyzed between November 2021 and December 2023.</p><p><strong>Interventions: </strong>Patients were treated with ultralow-dose radiation therapy to 4 Gy in 2 fractions and assessed for response at 3-month intervals. Patients with persistent orbital lymphoma were offered an additional 20 Gy in 10 fractions to complete the response-adapted treatment.</p><p><strong>Main outcome and measures: </strong>The primary end point was 2-year local orbital control within the irradiated field after response-adapted therapy. Secondary end points included overall survival and complete response rate.</p><p><strong>Results: </strong>The 50 prospective patients were a median (range) of 63 (29-88) years old, and 31 (62%) were female. Among the 50 patients, 32 (64%) had mucosa-associated lymphoid tissue lymphoma, 12 (24%) had follicular lymphoma, and 6 (12%) had unclassifiable low-grade B-cell lymphoma. Thirty-one patients (62%) had stage I disease, and 36 (72%) were newly diagnosed. At a median follow-up of 37.4 (95% CI, 33.7-52.5) months, the 2-year local control rate was 89.4% (95% CI, 81.0%-98.7%), and the 2-year overall survival rate was 98.0% (95% CI, 94.1%-100%); 45 patients (90.0%; 95% CI, 78.2%-96.7%) experienced a complete response to response-adapted radiation, including 44 patients with a complete response to ultralow-dose radiation and 1 patient with a complete response after an additional 20 Gy. No local recurrences were observed among patients with a complete response to response-adapted therapy. No grade 3 or higher toxic effects were observed. In a planned subset analysis of 22 patients with newly diagnosed, untreated stage I mucosa-associated lymphoid tissue lymphoma, the 2-year local control rate was 90.7% (95% CI, 79.2%-100%), and the 2-year freedom from distant relapse rate was 95.2% (95% CI, 86.6%-100%).</p><p><strong>Conclusion and relevance: </strong>In this nonrandomized controlled trial, response-adapted ultralow-dose therapy for indolent orbital B-cell lymphoma resulted in reduced radiation exposure, negligible toxic effects, and excellent disease outcomes.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov Identifier: NC","PeriodicalId":48661,"journal":{"name":"Jama Oncology","volume":null,"pages":null},"PeriodicalIF":28.4,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11240230/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141581262","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}
Jama OncologyPub Date : 2024-09-01DOI: 10.1001/jamaoncol.2024.1887
Mutlay Sayan, Derya Tilki, Anthony V D'Amico
{"title":"Postoperative Management of Prostate Cancer-Optimizing Prostate Cancer Care.","authors":"Mutlay Sayan, Derya Tilki, Anthony V D'Amico","doi":"10.1001/jamaoncol.2024.1887","DOIUrl":"10.1001/jamaoncol.2024.1887","url":null,"abstract":"","PeriodicalId":48661,"journal":{"name":"Jama Oncology","volume":null,"pages":null},"PeriodicalIF":28.4,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141581261","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}
Jama OncologyPub Date : 2024-09-01DOI: 10.1001/jamaoncol.2024.0993
Narjust Florez
{"title":"Immunotherapy Before Chemoradiotherapy-More Is Better?","authors":"Narjust Florez","doi":"10.1001/jamaoncol.2024.0993","DOIUrl":"10.1001/jamaoncol.2024.0993","url":null,"abstract":"","PeriodicalId":48661,"journal":{"name":"Jama Oncology","volume":null,"pages":null},"PeriodicalIF":28.4,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141761833","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}
Jama OncologyPub Date : 2024-09-01DOI: 10.1001/jamaoncol.2024.1816
Binbin Zheng-Lin, Katalin Kelemen, Allison Rosenthal
{"title":"A Case of Gastric Thickening and a Large Ovarian Mass.","authors":"Binbin Zheng-Lin, Katalin Kelemen, Allison Rosenthal","doi":"10.1001/jamaoncol.2024.1816","DOIUrl":"10.1001/jamaoncol.2024.1816","url":null,"abstract":"","PeriodicalId":48661,"journal":{"name":"Jama Oncology","volume":null,"pages":null},"PeriodicalIF":28.4,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141460139","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}
Jama OncologyPub Date : 2024-09-01DOI: 10.1001/jamaoncol.2024.2456
Naomi Takemura, Chia-Chin Lin
{"title":"More Benefits of Tai Chi Than Aerobic Exercise in Patients With Advanced Lung Cancer-Reply.","authors":"Naomi Takemura, Chia-Chin Lin","doi":"10.1001/jamaoncol.2024.2456","DOIUrl":"10.1001/jamaoncol.2024.2456","url":null,"abstract":"","PeriodicalId":48661,"journal":{"name":"Jama Oncology","volume":null,"pages":null},"PeriodicalIF":28.4,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141493947","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}