Pub Date : 2025-01-09DOI: 10.1001/jamaoncol.2024.6154
Bahadir Köylü, Deniz Can Güven
{"title":"Uncertain Prognostic Impact of Visceral Pleural Invasion.","authors":"Bahadir Köylü, Deniz Can Güven","doi":"10.1001/jamaoncol.2024.6154","DOIUrl":"https://doi.org/10.1001/jamaoncol.2024.6154","url":null,"abstract":"","PeriodicalId":48661,"journal":{"name":"Jama Oncology","volume":" ","pages":""},"PeriodicalIF":28.4,"publicationDate":"2025-01-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142957067","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}
Pub Date : 2025-01-02DOI: 10.1001/jamaoncol.2024.5627
Stephen Daw, Peter D Cole, Bradford S Hoppe, David Hodgson, Auke Beishuizen, Nathalie Garnier, Salvatore Buffardi, Maurizio Mascarin, Andrej Lissat, Christine Mauz-Körholz, Jennifer Krajewski, Alev Akyol, Russell Crowe, Bailey Anderson, Yan Xu, Richard A Drachtman, Kara M Kelly, Thierry Leblanc, Paul Harker-Murray
<p><strong>Importance: </strong>Retrieval strategies for children, adolescents, and young adults with relapsed classic Hodgkin lymphoma (cHL) aim to maintain efficacy while minimizing long-term toxic effects. Children, adolescents, and young adults with low-risk, relapsed cHL may benefit from replacing high-dose chemotherapy and autologous stem cell transplant with less intensive involved-site radiotherapy (ISRT).</p><p><strong>Objective: </strong>To evaluate a risk-stratified, response-adapted, transplant-free approach for treatment of children, adolescents, and young adults with low-risk relapsed cHL with nivolumab plus brentuximab vedotin (BV) followed by BV plus bendamustine for patients with suboptimal response and ISRT (30.0 to 30.6 Gy).</p><p><strong>Design, setting, and participants: </strong>CheckMate 744 (R1 cohort) was a phase 2, nonrandomized, single-arm study enrolling children, adolescents, and young adults aged 5 to 30 years with low-risk cHL between September 25, 2017, and December 16, 2020, across the US, Canada, and Europe. Data were analyzed from September 2017 to November 2022.</p><p><strong>Exposures: </strong>Patients received 4 cycles of nivolumab plus BV induction; patients with complete metabolic response (CMR) received an additional 2 cycles of nivolumab plus BV while patients with suboptimal response received 2 cycles of BV plus bendamustine intensification. Patients with CMR after induction or intensification received ISRT consolidation.</p><p><strong>Main outcomes and measures: </strong>Prespecified coprimary end points were CMR rate (Lugano 2014 classification) any time before ISRT and 3-year event-free survival (EFS) rate, per blinded independent central review (BICR).</p><p><strong>Results: </strong>Of 28 included patients treated in the low-risk cohort, 18 (64%) were female, and the median (range) age was 17 (6-27) years. At a median (range) follow-up of 31.9 (2.2-55.3) months, CMR per BICR any time before ISRT was 93% (26 of 28; 90% CI, 79.2-98.7; objective response rate [ORR], 100%), and 23 of 28 (82%) achieved CMR per BICR after 4 cycles of nivolumab plus BV (ORR, 96.4%). Kaplan-Meier estimates of EFS and progression-free survival rates at 3 years were 87% (3 of 18; 90% CI, 69.5-94.7) and 95% (1 of 18; 90% CI, 76.7-99.0), respectively. During induction, 22 patients (79%) had treatment-related adverse events, including 7 with grade 3 or 4 adverse events, 2 with anemia, 1 with neutropenia, and 6 with immune-mediated adverse events. Serious adverse events leading to discontinuation occurred in 2 patients.</p><p><strong>Conclusions and relevance: </strong>This nonrandomized clinical trial found that for children, adolescents, and young adults with low-risk, relapsed cHL, a transplant-free, risk-adapted, response-based approach with nivolumab plus BV and ISRT offered high CMR rates and high 3-year EFS rate, with a safety profile consistent with that of each agent used.</p><p><strong>Trial registration: </strong>Clin
{"title":"Transplant-Free Approach in Relapsed Hodgkin Lymphoma in Children, Adolescents, and Young Adults: A Nonrandomized Clinical Trial.","authors":"Stephen Daw, Peter D Cole, Bradford S Hoppe, David Hodgson, Auke Beishuizen, Nathalie Garnier, Salvatore Buffardi, Maurizio Mascarin, Andrej Lissat, Christine Mauz-Körholz, Jennifer Krajewski, Alev Akyol, Russell Crowe, Bailey Anderson, Yan Xu, Richard A Drachtman, Kara M Kelly, Thierry Leblanc, Paul Harker-Murray","doi":"10.1001/jamaoncol.2024.5627","DOIUrl":"https://doi.org/10.1001/jamaoncol.2024.5627","url":null,"abstract":"<p><strong>Importance: </strong>Retrieval strategies for children, adolescents, and young adults with relapsed classic Hodgkin lymphoma (cHL) aim to maintain efficacy while minimizing long-term toxic effects. Children, adolescents, and young adults with low-risk, relapsed cHL may benefit from replacing high-dose chemotherapy and autologous stem cell transplant with less intensive involved-site radiotherapy (ISRT).</p><p><strong>Objective: </strong>To evaluate a risk-stratified, response-adapted, transplant-free approach for treatment of children, adolescents, and young adults with low-risk relapsed cHL with nivolumab plus brentuximab vedotin (BV) followed by BV plus bendamustine for patients with suboptimal response and ISRT (30.0 to 30.6 Gy).</p><p><strong>Design, setting, and participants: </strong>CheckMate 744 (R1 cohort) was a phase 2, nonrandomized, single-arm study enrolling children, adolescents, and young adults aged 5 to 30 years with low-risk cHL between September 25, 2017, and December 16, 2020, across the US, Canada, and Europe. Data were analyzed from September 2017 to November 2022.</p><p><strong>Exposures: </strong>Patients received 4 cycles of nivolumab plus BV induction; patients with complete metabolic response (CMR) received an additional 2 cycles of nivolumab plus BV while patients with suboptimal response received 2 cycles of BV plus bendamustine intensification. Patients with CMR after induction or intensification received ISRT consolidation.</p><p><strong>Main outcomes and measures: </strong>Prespecified coprimary end points were CMR rate (Lugano 2014 classification) any time before ISRT and 3-year event-free survival (EFS) rate, per blinded independent central review (BICR).</p><p><strong>Results: </strong>Of 28 included patients treated in the low-risk cohort, 18 (64%) were female, and the median (range) age was 17 (6-27) years. At a median (range) follow-up of 31.9 (2.2-55.3) months, CMR per BICR any time before ISRT was 93% (26 of 28; 90% CI, 79.2-98.7; objective response rate [ORR], 100%), and 23 of 28 (82%) achieved CMR per BICR after 4 cycles of nivolumab plus BV (ORR, 96.4%). Kaplan-Meier estimates of EFS and progression-free survival rates at 3 years were 87% (3 of 18; 90% CI, 69.5-94.7) and 95% (1 of 18; 90% CI, 76.7-99.0), respectively. During induction, 22 patients (79%) had treatment-related adverse events, including 7 with grade 3 or 4 adverse events, 2 with anemia, 1 with neutropenia, and 6 with immune-mediated adverse events. Serious adverse events leading to discontinuation occurred in 2 patients.</p><p><strong>Conclusions and relevance: </strong>This nonrandomized clinical trial found that for children, adolescents, and young adults with low-risk, relapsed cHL, a transplant-free, risk-adapted, response-based approach with nivolumab plus BV and ISRT offered high CMR rates and high 3-year EFS rate, with a safety profile consistent with that of each agent used.</p><p><strong>Trial registration: </strong>Clin","PeriodicalId":48661,"journal":{"name":"Jama Oncology","volume":" ","pages":""},"PeriodicalIF":28.4,"publicationDate":"2025-01-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142916075","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}
Pub Date : 2025-01-02DOI: 10.1001/jamaoncol.2024.5648
Bradford S Hoppe, Sarah A Milgrom, Lindsay A Renfro, Yue Wu, Cindy L Schwartz, Louis S Constine, Kathleen M McCarten, Kara M Kelly, David Hodgson, Sharon M Castellino, Frank G Keller
{"title":"Transplant-Free Salvage Therapy for Low-Risk Relapsed Pediatric Hodgkin Lymphoma: A Nonrandomized Clinical Trial.","authors":"Bradford S Hoppe, Sarah A Milgrom, Lindsay A Renfro, Yue Wu, Cindy L Schwartz, Louis S Constine, Kathleen M McCarten, Kara M Kelly, David Hodgson, Sharon M Castellino, Frank G Keller","doi":"10.1001/jamaoncol.2024.5648","DOIUrl":"10.1001/jamaoncol.2024.5648","url":null,"abstract":"","PeriodicalId":48661,"journal":{"name":"Jama Oncology","volume":" ","pages":""},"PeriodicalIF":28.4,"publicationDate":"2025-01-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142916004","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}
Pub Date : 2025-01-02DOI: 10.1001/jamaoncol.2024.5636
Stephen Daw, Alexander Claviez, Lars Kurch, Dietrich Stoevesandt, Andishe Attarbaschi, Walentyna Balwierz, Auke Beishuizen, Michaela Cepelova, Francesco Ceppi, Ana Fernandez-Teijeiro, Alexander Fosså, Thomas W Georgi, Lisa Lyngsie Hjalgrim, Andrea Hraskova, Thierry Leblanc, Maurizio Mascarin, Jane Pears, Judith Landman-Parker, Tomaž Prelog, Wolfram Klapper, Alan Ramsay, Regine Kluge, Karin Dieckmann, Tanja Pelz, Dirk Vordermark, Dieter Körholz, Dirk Hasenclever, Christine Mauz-Körholz
<p><strong>Importance: </strong>The current standard-of-care salvage therapy in relapsed/refractory classic Hodgkin lymphoma (cHL) includes consolidation high-dose chemotherapy (HDCT)/autologous stem cell transplant (aSCT).</p><p><strong>Objective: </strong>To investigate whether presalvage risk factors and fludeoxyglucose-18 (FDG) positron emission tomography (PET) response to reinduction chemotherapy can guide escalation or de-escalation between HDCT/aSCT or transplant-free consolidation with radiotherapy to minimize toxic effects while maintaining high cure rates.</p><p><strong>Design, setting, and participants: </strong>EuroNet-PHL-R1 was a nonrandomized clinical trial that enrolled patients younger than 18 years with first relapsed/refractory cHL across 68 sites in 13 countries in Europe between January 2007 and January 2013. Data were analyzed between September 2022 and July 2024.</p><p><strong>Intervention: </strong>Reinduction chemotherapy consisted of alternating IEP (ifosfamide, etoposide, prednisolone) and ABVD (adriamycin, bleomycin, vinblastine, dacarbazine). Patients with low-risk disease (late relapse after 2 cycles of first-line chemotherapy and any relapse with an adequate response after 1 IEP/ABVD defined as complete metabolic response on FDG-PET and at least 50% volume reduction) received a second IEP/ABVD cycle and radiotherapy (RT) to all sites involved at relapse. Patients with high-risk disease (all primary progressions and relapses with inadequate response after 1 IEP/ABVD cycle) received a second IEP/ABVD cycle plus HDCT/aSCT with or without RT.</p><p><strong>Main outcomes and measures: </strong>The primary end point was 5-year event-free survival. Secondary end points were overall survival (OS) and progression-free survival (PFS). PFS was identical to event-free survival because no secondary cancers were observed. PFS data alone are presented for simplicity.</p><p><strong>Results: </strong>Of 118 patients analyzed, 58 (49.2%) were female, and the median (IQR) age was 16.3 () years. The median (IQR) follow-up was 67.5 (58.5-77.0) months. The overall 5-year PFS was 71.3% (95% CI, 63.5%-80.1%), and OS was 82.7% (95% CI, 75.8%-90.1%). For patients in the low-risk group (n = 59), 41 received nontransplant salvage with a 5-year PFS of 89.7% (95% CI, 80.7%-99.8%) and OS of 97.4% (95% CI, 92.6%-100%). In contrast, 18 received HDCT/aSCT off protocol, with a 5-year PFS of 88.9% (95% CI, 75.5%-100%) and OS of 100%. All 59 patients with high-risk disease received HDCT/aSCT (and 23 received post-HDCT/aSCT RT) with a 5-year PFS of 53.3% (95% CI, 41.8%-67.9%) and OS of 66.5% (95% CI, 54.9%-80.5%).</p><p><strong>Conclusion and relevance: </strong>In this nonrandomized clinical trial, FDG-PET response-guided salvage in relapsed cHL may identify patients in whom transplant-free salvage achieves excellent outcomes. HDCT/aSCT may be reserved for primary progression and relapsed cHL with inadequate response.</p><p><strong>Trial registration:
{"title":"Transplant and Nontransplant Salvage Therapy in Pediatric Relapsed or Refractory Hodgkin Lymphoma: The EuroNet-PHL-R1 Phase 3 Nonrandomized Clinical Trial.","authors":"Stephen Daw, Alexander Claviez, Lars Kurch, Dietrich Stoevesandt, Andishe Attarbaschi, Walentyna Balwierz, Auke Beishuizen, Michaela Cepelova, Francesco Ceppi, Ana Fernandez-Teijeiro, Alexander Fosså, Thomas W Georgi, Lisa Lyngsie Hjalgrim, Andrea Hraskova, Thierry Leblanc, Maurizio Mascarin, Jane Pears, Judith Landman-Parker, Tomaž Prelog, Wolfram Klapper, Alan Ramsay, Regine Kluge, Karin Dieckmann, Tanja Pelz, Dirk Vordermark, Dieter Körholz, Dirk Hasenclever, Christine Mauz-Körholz","doi":"10.1001/jamaoncol.2024.5636","DOIUrl":"https://doi.org/10.1001/jamaoncol.2024.5636","url":null,"abstract":"<p><strong>Importance: </strong>The current standard-of-care salvage therapy in relapsed/refractory classic Hodgkin lymphoma (cHL) includes consolidation high-dose chemotherapy (HDCT)/autologous stem cell transplant (aSCT).</p><p><strong>Objective: </strong>To investigate whether presalvage risk factors and fludeoxyglucose-18 (FDG) positron emission tomography (PET) response to reinduction chemotherapy can guide escalation or de-escalation between HDCT/aSCT or transplant-free consolidation with radiotherapy to minimize toxic effects while maintaining high cure rates.</p><p><strong>Design, setting, and participants: </strong>EuroNet-PHL-R1 was a nonrandomized clinical trial that enrolled patients younger than 18 years with first relapsed/refractory cHL across 68 sites in 13 countries in Europe between January 2007 and January 2013. Data were analyzed between September 2022 and July 2024.</p><p><strong>Intervention: </strong>Reinduction chemotherapy consisted of alternating IEP (ifosfamide, etoposide, prednisolone) and ABVD (adriamycin, bleomycin, vinblastine, dacarbazine). Patients with low-risk disease (late relapse after 2 cycles of first-line chemotherapy and any relapse with an adequate response after 1 IEP/ABVD defined as complete metabolic response on FDG-PET and at least 50% volume reduction) received a second IEP/ABVD cycle and radiotherapy (RT) to all sites involved at relapse. Patients with high-risk disease (all primary progressions and relapses with inadequate response after 1 IEP/ABVD cycle) received a second IEP/ABVD cycle plus HDCT/aSCT with or without RT.</p><p><strong>Main outcomes and measures: </strong>The primary end point was 5-year event-free survival. Secondary end points were overall survival (OS) and progression-free survival (PFS). PFS was identical to event-free survival because no secondary cancers were observed. PFS data alone are presented for simplicity.</p><p><strong>Results: </strong>Of 118 patients analyzed, 58 (49.2%) were female, and the median (IQR) age was 16.3 () years. The median (IQR) follow-up was 67.5 (58.5-77.0) months. The overall 5-year PFS was 71.3% (95% CI, 63.5%-80.1%), and OS was 82.7% (95% CI, 75.8%-90.1%). For patients in the low-risk group (n = 59), 41 received nontransplant salvage with a 5-year PFS of 89.7% (95% CI, 80.7%-99.8%) and OS of 97.4% (95% CI, 92.6%-100%). In contrast, 18 received HDCT/aSCT off protocol, with a 5-year PFS of 88.9% (95% CI, 75.5%-100%) and OS of 100%. All 59 patients with high-risk disease received HDCT/aSCT (and 23 received post-HDCT/aSCT RT) with a 5-year PFS of 53.3% (95% CI, 41.8%-67.9%) and OS of 66.5% (95% CI, 54.9%-80.5%).</p><p><strong>Conclusion and relevance: </strong>In this nonrandomized clinical trial, FDG-PET response-guided salvage in relapsed cHL may identify patients in whom transplant-free salvage achieves excellent outcomes. HDCT/aSCT may be reserved for primary progression and relapsed cHL with inadequate response.</p><p><strong>Trial registration:","PeriodicalId":48661,"journal":{"name":"Jama Oncology","volume":" ","pages":""},"PeriodicalIF":28.4,"publicationDate":"2025-01-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142916044","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}
Pub Date : 2025-01-01DOI: 10.1001/jamaoncol.2024.5689
{"title":"Change of Article Status to Open Access.","authors":"","doi":"10.1001/jamaoncol.2024.5689","DOIUrl":"10.1001/jamaoncol.2024.5689","url":null,"abstract":"","PeriodicalId":48661,"journal":{"name":"Jama Oncology","volume":" ","pages":"80"},"PeriodicalIF":28.4,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11565291/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142630737","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}
Pub Date : 2025-01-01DOI: 10.1001/jamaoncol.2024.4958
Ayse Ece Cali Daylan, Daniel Morgensztern, Saiama N Waqar
{"title":"Toripalimab for Extensive-Stage Small Cell Lung Cancer.","authors":"Ayse Ece Cali Daylan, Daniel Morgensztern, Saiama N Waqar","doi":"10.1001/jamaoncol.2024.4958","DOIUrl":"10.1001/jamaoncol.2024.4958","url":null,"abstract":"","PeriodicalId":48661,"journal":{"name":"Jama Oncology","volume":" ","pages":"26-27"},"PeriodicalIF":28.4,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142630835","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}
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