Pub Date : 2025-02-01DOI: 10.1016/j.clml.2024.08.007
Efstathios Kastritis , Meral Beksac , Sorina Nicoleta Badelita , Eirini Katodritou , Jelena Bila , Emmanouil Spanoudakis , Guldane Cengiz Seval , Zorica Cvetkovic , Olivera Markovic , Selami Koçak Toprak , Dimitra Dalampira , Daniel Coriu , Zoi Bezirgiannidou , Mario Pirsic , Toni Valkovic , Iulia Ursuleac , Aleksandra Sretenovic , Angeliki Sevastoudi , Josip Batinic , Sinziana Barbu , Meletios A. Dimopoulos
Background
Bortezomib, dexamethasone and cyclophosphamide (VCd) remains a popular regimen, due to its activity and low toxicity, while bortezomib, lenalidomide and dexamethasone (VRd) is widely used in US and Europe; both are combined with anti-CD38 monoclonal antibodies but VCd and VRd have not been compared directly in adequately powered prospective trials.
Aim
We compared the outcomes of 1216 patients treated with VCd (N = 690) or VRd (N = 526) in a real-world setting.
Results
Patients treated with VCd had more often severe renal dysfunction, ISS-3 disease, hypercalcemia, elevated LDH, anemia, thrombocytopenia, poor performance while VRd-treated were older and received less often autologous transplant but more frequently maintenance but the duration of induction was similar. VRd was associated with substantially higher overall response and CR/VGPR rates to induction(P < .001) and improved PFS and OS in univariate analysis, especially among patients with standard risk disease, without renal dysfunction and in the elderly; however, in multivariate analysis there was no significant difference in either PFS or OS. In patients strictly matched 1:1 for major prognostic variables (188 in each group, total N = 376), the superiority of VRd in terms of responses rates and depth of response was confirmed, but without significant PFS or OS difference.
Conclusion
VRd is a more active induction regimen than VCd, although use of maintenance with lenalidomide may dilute the PFS or OS benefit. VCd induction remains an option in special circumstances. With the implementation of monoclonal antibodies, VCd backbone can be considered for patients without access to or who do not tolerate VRd.
{"title":"VCd versus VRd in Newly Diagnosed Multiple Myeloma: Matched Real-World Analysis from the Balkan Myeloma Study Group (BMSG)","authors":"Efstathios Kastritis , Meral Beksac , Sorina Nicoleta Badelita , Eirini Katodritou , Jelena Bila , Emmanouil Spanoudakis , Guldane Cengiz Seval , Zorica Cvetkovic , Olivera Markovic , Selami Koçak Toprak , Dimitra Dalampira , Daniel Coriu , Zoi Bezirgiannidou , Mario Pirsic , Toni Valkovic , Iulia Ursuleac , Aleksandra Sretenovic , Angeliki Sevastoudi , Josip Batinic , Sinziana Barbu , Meletios A. Dimopoulos","doi":"10.1016/j.clml.2024.08.007","DOIUrl":"10.1016/j.clml.2024.08.007","url":null,"abstract":"<div><h3>Background</h3><div>Bortezomib, dexamethasone and cyclophosphamide (VCd) remains a popular regimen, due to its activity and low toxicity, while bortezomib, lenalidomide and dexamethasone (VRd) is widely used in US and Europe; both are combined with anti-CD38 monoclonal antibodies but VCd and VRd have not been compared directly in adequately powered prospective trials.</div></div><div><h3>Aim</h3><div>We compared the outcomes of 1216 patients treated with VCd (<em>N</em> = 690) or VRd (<em>N</em> = 526) in a real-world setting.</div></div><div><h3>Results</h3><div>Patients treated with VCd had more often severe renal dysfunction, ISS-3 disease, hypercalcemia, elevated LDH, anemia, thrombocytopenia, poor performance while VRd-treated were older and received less often autologous transplant but more frequently maintenance but the duration of induction was similar. VRd was associated with substantially higher overall response and CR/VGPR rates to induction(<em>P</em> < .001) and improved PFS and OS in univariate analysis, especially among patients with standard risk disease, without renal dysfunction and in the elderly; however, in multivariate analysis there was no significant difference in either PFS or OS. In patients strictly matched 1:1 for major prognostic variables (188 in each group, total <em>N</em> = 376), the superiority of VRd in terms of responses rates and depth of response was confirmed, but without significant PFS or OS difference.</div></div><div><h3>Conclusion</h3><div>VRd is a more active induction regimen than VCd, although use of maintenance with lenalidomide may dilute the PFS or OS benefit. VCd induction remains an option in special circumstances. With the implementation of monoclonal antibodies, VCd backbone can be considered for patients without access to or who do not tolerate VRd.</div></div>","PeriodicalId":10348,"journal":{"name":"Clinical Lymphoma, Myeloma & Leukemia","volume":"25 2","pages":"Pages e71-e81"},"PeriodicalIF":2.7,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142281238","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-02-01DOI: 10.1016/j.clml.2024.05.019
Aseel Alsouqi , Jennifer A. Woyach
Inhibitors of Bruton's tyrosine kinase (BTK) are among the most widely used therapies for chronic lymphocytic leukemia (CLL) and established a new expectation for efficacy and safety in the treatment of this disease. Currently there are 3 covalent inhibitors of BTK approved for the treatment of CLL: ibrutinib, acalabrutinib, and zanubrutinib. The first-in-class covalent BTK inhibitor is ibrutinib, which as monotherapy has excellent efficacy in the front-line setting with a 7-year progression free survival (PFS) of 59%. Ibrutinib-based therapies have also demonstrated superiority over standard chemoimmunotherapy in the front-line and the relapsed/refractory setting. Acalabrutinib is a second-generation BTK inhibitor that has higher selectivity to BTK. Acalabrutinib has efficacy in both frontline and relapsed CLL and is associated with a decreased incidence of atrial fibrillation and hypertension when compared to ibrutinib. Like acalabrutinib, zanubrutinib was designed to be more selective for BTK than ibrutinib and to maximize BTK inhibition in tissues. Zanubrutinib has demonstrated clinical efficacy in first line and relapsed/refractory setting. These agents are indicated as monotherapy, with dosing until disease progression or intolerable toxicity, and are mainly differentiated by safety profile, although efficacy differences may exist as well. Combination with CD20 monoclonal antibodies and/or BCL2 inhibitors are alternative options for use. Here we will review efficacy and safety considerations with these agents.
{"title":"SOHO State of the Art Updates and Next Questions | Covalent Bruton's Tyrosine Kinase Inhibitors in Chronic Lymphocytic Leukemia","authors":"Aseel Alsouqi , Jennifer A. Woyach","doi":"10.1016/j.clml.2024.05.019","DOIUrl":"10.1016/j.clml.2024.05.019","url":null,"abstract":"<div><div><span><span><span>Inhibitors of Bruton's tyrosine kinase (BTK) are among the most widely used therapies for </span>chronic lymphocytic leukemia (CLL) and established a new expectation for efficacy and safety in the treatment of this disease. Currently there are 3 covalent inhibitors of BTK approved for the treatment of CLL: </span>ibrutinib, </span>acalabrutinib<span><span>, and zanubrutinib<span>. The first-in-class covalent BTK inhibitor<span><span> is ibrutinib, which as </span>monotherapy<span> has excellent efficacy in the front-line setting with a 7-year progression free survival (PFS) of 59%. Ibrutinib-based therapies have also demonstrated superiority over standard </span></span></span></span>chemoimmunotherapy<span><span><span><span> in the front-line and the relapsed/refractory setting. Acalabrutinib is a second-generation BTK inhibitor that has higher selectivity to BTK. Acalabrutinib has efficacy in both frontline and relapsed CLL and is associated with a decreased incidence of </span>atrial fibrillation<span> and hypertension when compared to ibrutinib. Like acalabrutinib, </span></span>zanubrutinib<span> was designed to be more selective for BTK than ibrutinib and to maximize BTK inhibition in tissues. Zanubrutinib has demonstrated clinical efficacy in first line and relapsed/refractory setting. These agents are indicated as monotherapy, with dosing until </span></span>disease progression<span><span> or intolerable toxicity, and are mainly differentiated by safety profile, although efficacy differences may exist as well. Combination with CD20 </span>monoclonal antibodies<span> and/or BCL2 inhibitors are alternative options for use. Here we will review efficacy and safety considerations with these agents.</span></span></span></span></div></div>","PeriodicalId":10348,"journal":{"name":"Clinical Lymphoma, Myeloma & Leukemia","volume":"25 2","pages":"Pages 89-95"},"PeriodicalIF":2.7,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141426480","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-02-01DOI: 10.1016/j.clml.2024.07.017
Mark A. Fiala , Mengmeng Ji , Yi-Hsuan Shih , John Huber , Mei Wang , Kimberly J. Johnson , Hamlet Gasoyan , Rong Wang , Graham A. Colditz , Shi-Yi Wang , Su-Hsin Chang
Purpose
Continuous Medicaid coverage prior to a cancer diagnosis has been associated with earlier detection and better outcomes, for patients with solid tumors. In this study, we aimed to determine if this was observed among patients with multiple myeloma, a hematologic cancer where there are no routine screening tests and most are diagnosed through acute medical events.
Materials and methods
This is an analysis of the Merative MarketScan Multistate Medicaid Database, a claims-based dataset. In total, 1105 patients < 65 years old were included in the analyses. Among them, 66% had continuous enrollment (at least 6 months enrollment prior to myeloma), and 34% had discontinuous enrollment (2-6 months enrollment prior to myeloma). Multivariable Cox regression was used to estimate the association between continuous enrollment status and receipt of myeloma treatment within 1 year of index date.
Results
Only 54% of all Medicaid enrollees received myeloma therapy and only 12% received stem cell transplant within the 1st year. Those with continuous enrollment were less likely to receive any treatment (adjusted hazard ratio [aHR] 0.59; 95% confidence interval [CI] 0.59-0.70; P < .001) and to receive stem cell transplant (aHR 0.51; 95% CI 0.32-0.81; P = .005).
Conclusion
Patients with continuous Medicaid coverage prior to diagnosis were less likely to receive myeloma therapy. Future studies should examine whether myeloma patients with continuous Medicaid enrollment have more chronic financial instability and/or higher medical needs and, thus, have higher barriers to care.
{"title":"Treatment Access among Younger Medicaid Beneficiaries with Multiple Myeloma","authors":"Mark A. Fiala , Mengmeng Ji , Yi-Hsuan Shih , John Huber , Mei Wang , Kimberly J. Johnson , Hamlet Gasoyan , Rong Wang , Graham A. Colditz , Shi-Yi Wang , Su-Hsin Chang","doi":"10.1016/j.clml.2024.07.017","DOIUrl":"10.1016/j.clml.2024.07.017","url":null,"abstract":"<div><h3>Purpose</h3><div>Continuous Medicaid coverage prior to a cancer diagnosis has been associated with earlier detection and better outcomes, for patients with solid tumors. In this study, we aimed to determine if this was observed among patients with multiple myeloma, a hematologic cancer where there are no routine screening tests and most are diagnosed through acute medical events.</div></div><div><h3>Materials and methods</h3><div>This is an analysis of the Merative MarketScan Multistate Medicaid Database, a claims-based dataset. In total, 1105 patients < 65 years old were included in the analyses. Among them, 66% had continuous enrollment (at least 6 months enrollment prior to myeloma), and 34% had discontinuous enrollment (2-6 months enrollment prior to myeloma). Multivariable Cox regression was used to estimate the association between continuous enrollment status and receipt of myeloma treatment within 1 year of index date.</div></div><div><h3>Results</h3><div>Only 54% of all Medicaid enrollees received myeloma therapy and only 12% received stem cell transplant within the 1<sup>st</sup> year. Those with continuous enrollment were less likely to receive any treatment (adjusted hazard ratio [aHR] 0.59; 95% confidence interval [CI] 0.59-0.70; <em>P</em> < .001) and to receive stem cell transplant (aHR 0.51; 95% CI 0.32-0.81; <em>P</em> = .005).</div></div><div><h3>Conclusion</h3><div>Patients with continuous Medicaid coverage prior to diagnosis were less likely to receive myeloma therapy. Future studies should examine whether myeloma patients with continuous Medicaid enrollment have more chronic financial instability and/or higher medical needs and, thus, have higher barriers to care.</div></div>","PeriodicalId":10348,"journal":{"name":"Clinical Lymphoma, Myeloma & Leukemia","volume":"25 2","pages":"Pages 109-115"},"PeriodicalIF":2.7,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142104988","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-02-01DOI: 10.1016/j.clml.2024.07.019
Izel Okcu , Yucai Wang , Allison M. Bock , Jihao Zhou , Muhamad Alhaj Moustafa , Han W. Tun , Allison C. Rosenthal , Patrick B. Johnston , Firas Baidoun , Arushi Khurana , Brian F. Kabat , Rebecca L. King , Thomas M. Habermann , Grzegorz S. Nowakowski
Background
Primary mediastinal large B-cell lymphoma (PMBCL) is an uncommon type of aggressive B-cell non-Hodgkin lymphoma. PMBCL shares some clinical and biologic features with nodular sclerosis classic Hodgkin lymphoma (cHL). Central nervous system (CNS) relapse is exceedingly rare in cHL. Therefore, it may be expected that CNS relapse in PMBCL is also uncommon. Herein, we examined the incidence of CNS relapse in patients with PMBCL treated with standard chemoimmunotherapy.
Patients and Methods
This retrospective single center analysis included 154 patients with newly diagnosed PMBCL seen at Mayo Clinic. The CNS relapse rate was calculated using a competing risk model, with death considered as a competing risk.
Results
With a median follow-up of 39 months, 3 patients experienced CNS relapse, all associated with systemic relapse. The cumulative incidence of CNS relapse for the entire cohort was 1.43% (95% CI, 0.3%-4.6%) at 1 year and 2.21% (95% CI, 0.6%-5.8%) at both 2 and 5 years. For those who did not receive CNS prophylaxis (n = 131), the incidence was 0.85% (95% CI, 0.1%-4.2%) at 1 year and 1.80% (95% CI, 0.3%-5.8%) at both 2 and 5 years. All 3 patients who experienced CNS relapse had R-CHOP as frontline therapy; 2 patients did not receive any CNS prophylaxis, while 1 patient received intrathecal CNS prophylaxis.
Conclusion
The risk of CNS relapse in PMBCL appears to be very low after treatment with standard chemoimmunotherapy, suggesting routine CNS prophylaxis is not necessary.
{"title":"Incidence of Central Nervous System Relapse in Primary Mediastinal Large B-Cell Lymphoma: Implications for Central Nervous System Prophylaxis","authors":"Izel Okcu , Yucai Wang , Allison M. Bock , Jihao Zhou , Muhamad Alhaj Moustafa , Han W. Tun , Allison C. Rosenthal , Patrick B. Johnston , Firas Baidoun , Arushi Khurana , Brian F. Kabat , Rebecca L. King , Thomas M. Habermann , Grzegorz S. Nowakowski","doi":"10.1016/j.clml.2024.07.019","DOIUrl":"10.1016/j.clml.2024.07.019","url":null,"abstract":"<div><h3>Background</h3><div>Primary mediastinal large B-cell lymphoma (PMBCL) is an uncommon type of aggressive B-cell non-Hodgkin lymphoma. PMBCL shares some clinical and biologic features with nodular sclerosis classic Hodgkin lymphoma (cHL). Central nervous system (CNS) relapse is exceedingly rare in cHL. Therefore, it may be expected that CNS relapse in PMBCL is also uncommon. Herein, we examined the incidence of CNS relapse in patients with PMBCL treated with standard chemoimmunotherapy.</div></div><div><h3>Patients and Methods</h3><div>This retrospective single center analysis included 154 patients with newly diagnosed PMBCL seen at Mayo Clinic. The CNS relapse rate was calculated using a competing risk model, with death considered as a competing risk.</div></div><div><h3>Results</h3><div>With a median follow-up of 39 months, 3 patients experienced CNS relapse, all associated with systemic relapse. The cumulative incidence of CNS relapse for the entire cohort was 1.43% (95% CI, 0.3%-4.6%) at 1 year and 2.21% (95% CI, 0.6%-5.8%) at both 2 and 5 years. For those who did not receive CNS prophylaxis (n = 131), the incidence was 0.85% (95% CI, 0.1%-4.2%) at 1 year and 1.80% (95% CI, 0.3%-5.8%) at both 2 and 5 years. All 3 patients who experienced CNS relapse had R-CHOP as frontline therapy; 2 patients did not receive any CNS prophylaxis, while 1 patient received intrathecal CNS prophylaxis.</div></div><div><h3>Conclusion</h3><div>The risk of CNS relapse in PMBCL appears to be very low after treatment with standard chemoimmunotherapy, suggesting routine CNS prophylaxis is not necessary.</div></div>","PeriodicalId":10348,"journal":{"name":"Clinical Lymphoma, Myeloma & Leukemia","volume":"25 2","pages":"Pages 116-123"},"PeriodicalIF":2.7,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142132037","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-02-01DOI: 10.1016/j.clml.2024.09.007
Anveshika Soni , Sujay Rainchwar , Reema Singh , Dikshat Gopal Gupta , Nakul Tikare , Rohan Halder , Roy J. Palatty , Vipul Sharad Sheth , Narendra Agrawal , Dinesh Bhurani , Tribikram Panda
Introduction
High risk myeloma is heterogeneous with significant variation in risk stratifications. Real world outcomes differ from controlled clinical trials and affected by socioeconomical determinants.
Material and methods
This retrospective study was performed in a North Indian teriarty care cancer hospital. Out of 384,76(19.7%) high risk myeloma patients (median age 58 years) were analyzed.
Result and conclusion
Most common HRCA was 1 q gain 36(47.4%) followed by del17p 32(42.1%). 61/76(80.2%) received bortezomib based triplets and 15(19.74%) daratumumab based quadruplets induction, 31(40.79%) received ASCT. Median duration of follow up was 19.5 months. The 2 year OS and PFS was 73.8%, 52.6% respectively. Estimated 3 year OS was 74.7% in ASCT cohort versus 52.9% (P = .0067) without. Estimated 3-year PFS in the ASCT cohort was 72.1% versus 30.3% (P = .0026) without. Estimated 3-year OS for single hit and multi hit ultra HRMM was 67.7% and 61.9% (P = .642) whereas PFS was 58.2% and 35.2% (P = .486) respectively. In multivariate analysis ASCT correlated with better OS (HR 0.3, P = .041) and PFS (HR 0.35, P = .012). Absence of baseline renal impairment correlated with better OS (HR 4.12, P = .004) only. Early aggressive therapy with prompt ASCT translates to a better survival in high risk myeloma. Emphasis on real world clinical outcome is the need of the hour for addressing practical issues and improving global myeloma outcome.
{"title":"Real World Outcome of High-Risk Multiple Myeloma: An Indian Tertiary Care Centre Experience","authors":"Anveshika Soni , Sujay Rainchwar , Reema Singh , Dikshat Gopal Gupta , Nakul Tikare , Rohan Halder , Roy J. Palatty , Vipul Sharad Sheth , Narendra Agrawal , Dinesh Bhurani , Tribikram Panda","doi":"10.1016/j.clml.2024.09.007","DOIUrl":"10.1016/j.clml.2024.09.007","url":null,"abstract":"<div><h3>Introduction</h3><div>High risk myeloma is heterogeneous with significant variation in risk stratifications. Real world outcomes differ from controlled clinical trials and affected by socioeconomical determinants.</div></div><div><h3>Material and methods</h3><div>This retrospective study was performed in a North Indian teriarty care cancer hospital. Out of 384,76(19.7%) high risk myeloma patients (median age 58 years) were analyzed.</div></div><div><h3>Result and conclusion</h3><div>Most common HRCA was 1 q gain 36(47.4%) followed by del17p 32(42.1%). 61/76(80.2%) received bortezomib based triplets and 15(19.74%) daratumumab based quadruplets induction, 31(40.79%) received ASCT. Median duration of follow up was 19.5 months. The 2 year OS and PFS was 73.8%, 52.6% respectively. Estimated 3 year OS was 74.7% in ASCT cohort versus 52.9% (<em>P</em> = .0067) without. Estimated 3-year PFS in the ASCT cohort was 72.1% versus 30.3% (<em>P</em> = .0026) without. Estimated 3-year OS for single hit and multi hit ultra HRMM was 67.7% and 61.9% (<em>P</em> = .642) whereas PFS was 58.2% and 35.2% (<em>P</em> = .486) respectively. In multivariate analysis ASCT correlated with better OS (HR 0.3, <em>P</em> = .041) and PFS (HR 0.35, <em>P</em> = .012). Absence of baseline renal impairment correlated with better OS (HR 4.12, <em>P</em> = .004) only. Early aggressive therapy with prompt ASCT translates to a better survival in high risk myeloma. Emphasis on real world clinical outcome is the need of the hour for addressing practical issues and improving global myeloma outcome.</div></div>","PeriodicalId":10348,"journal":{"name":"Clinical Lymphoma, Myeloma & Leukemia","volume":"25 2","pages":"Pages e110-e119"},"PeriodicalIF":2.7,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142459531","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-02-01DOI: 10.1016/j.clml.2024.09.010
Somya Khare, Staci Williamson, Brittany O'Barr, Levanto Schachter, Andy Chen, Brandon Hayes-Lattin, Jessica Leonard, Amrita Desai, Peter Ferreira-Gandolfo, Kevin Christmas, Denise Lackey, Richard T Maziarz, Eneida R. Nemecek
Background
Chimeric antigen receptor T-cell (CAR-T) therapies are available for patients with Non-Hodgkin Lymphoma (NHL); however, their use has been limited in accessibility due to nondisease factors.
Patients & Methods
We conducted a retrospective study evaluating the influence of sociodemographic factors on access and outcomes after CAR-T therapy for adult patients with B-cell NHL in our institution treated between 2016 and 2023.
Results
Among 154 patients treated with CAR-T, 43% were older than 65 years, 68% male, and 14% non-White (including Hispanic). Of those under 65, 66% had private insurance, while 82% over 65 had Medicare. Most patients (85%) were from in-state, 29% from areas below the national poverty level and 18% from nonmetropolitan areas. Distance to the treatment center was greater than 30, 60 or 120 miles for 52%, 40% and 29% of patients, respectively. No significant differences were found in the use of commercial versus investigational products among racial/ethnic minorities or those living >60 miles from the center. However, patients from nonmetropolitan areas and those below the national poverty level were less likely to receive commercial products. With a median follow-up of 11 months, the 1-year overall survival (OS) was 63.2% (95th CI 59.9%-66.8%). Poverty was associated with lower 1-year OS (HR 0.4, 95th CI 0.17-0.90, P = .031).
Conclusion
Our study shows that CAR-T therapy can be delivered across sociodemographic barriers and underscores the importance of considering social determinants of health to optimize access for all patients.
背景：嵌合抗原受体T细胞（CAR-T）疗法可用于非霍奇金淋巴瘤（NHL）患者；然而，由于非疾病因素，其使用的可及性受到限制：我们开展了一项回顾性研究，评估社会人口因素对2016年至2023年期间在本院接受治疗的B细胞NHL成年患者接受CAR-T疗法的机会和治疗后的结果的影响：在154名接受CAR-T治疗的患者中，43%年龄超过65岁，68%为男性，14%为非白人（包括西班牙裔）。65岁以下的患者中，66%有私人保险，而65岁以上的患者中，82%有医疗保险。大多数患者（85%）来自州内，29%来自全国贫困线以下地区，18%来自非大都市地区。距离治疗中心超过 30 英里、60 英里或 120 英里的患者分别占 52%、40% 和 29%。在少数种族/族裔或距离治疗中心超过 60 英里的患者中，使用商业产品和研究产品的比例没有明显差异。不过，来自非大都市地区和低于国家贫困线的患者使用商业产品的可能性较低。中位随访时间为11个月，1年总生存率（OS）为63.2%（95th CI 59.9%-66.8%）。贫困与较低的1年OS相关（HR 0.4，95th CI 0.17-0.90，P = .031）：我们的研究表明，CAR-T疗法可以跨越社会人口学障碍，并强调了考虑健康的社会决定因素以优化所有患者获得治疗的重要性。
{"title":"Sociodemographic Factors Influencing Access to Chimeric Antigen T-Cell Receptor Therapy for Patients With Non-Hodgkin Lymphoma","authors":"Somya Khare, Staci Williamson, Brittany O'Barr, Levanto Schachter, Andy Chen, Brandon Hayes-Lattin, Jessica Leonard, Amrita Desai, Peter Ferreira-Gandolfo, Kevin Christmas, Denise Lackey, Richard T Maziarz, Eneida R. Nemecek","doi":"10.1016/j.clml.2024.09.010","DOIUrl":"10.1016/j.clml.2024.09.010","url":null,"abstract":"<div><h3>Background</h3><div>Chimeric antigen receptor T-cell (CAR-T) therapies are available for patients with Non-Hodgkin Lymphoma (NHL); however, their use has been limited in accessibility due to nondisease factors.</div></div><div><h3>Patients & Methods</h3><div>We conducted a retrospective study evaluating the influence of sociodemographic factors on access and outcomes after CAR-T therapy for adult patients with B-cell NHL in our institution treated between 2016 and 2023.</div></div><div><h3>Results</h3><div>Among 154 patients treated with CAR-T, 43% were older than 65 years, 68% male, and 14% non-White (including Hispanic). Of those under 65, 66% had private insurance, while 82% over 65 had Medicare. Most patients (85%) were from in-state, 29% from areas below the national poverty level and 18% from nonmetropolitan areas. Distance to the treatment center was greater than 30, 60 or 120 miles for 52%, 40% and 29% of patients, respectively. No significant differences were found in the use of commercial versus investigational products among racial/ethnic minorities or those living >60 miles from the center. However, patients from nonmetropolitan areas and those below the national poverty level were less likely to receive commercial products. With a median follow-up of 11 months, the 1-year overall survival (OS) was 63.2% (95<sup>th</sup> CI 59.9%-66.8%). Poverty was associated with lower 1-year OS (HR 0.4, 95<sup>th</sup> CI 0.17-0.90, <em>P</em> = .031).</div></div><div><h3>Conclusion</h3><div>Our study shows that CAR-T therapy can be delivered across sociodemographic barriers and underscores the importance of considering social determinants of health to optimize access for all patients.</div></div>","PeriodicalId":10348,"journal":{"name":"Clinical Lymphoma, Myeloma & Leukemia","volume":"25 2","pages":"Pages e120-e125"},"PeriodicalIF":2.7,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142459533","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-02-01DOI: 10.1016/j.clml.2024.08.003
Jing Christine Ye , Noa Biran , Sandhya Nair , Xiwu Lin , Keqin Qi , Anil Londhe , Eric Ammann , Thomas Renaud , Colleen Kane , Trilok Parekh , Kathleen Gray , Steve Peterson , Luciano J. Costa
Background
Talquetamab is approved for treatment of triple-class exposed (TCE) patients with relapsed/refractory multiple myeloma (RRMM). We evaluated the comparative effectiveness of talquetamab in the MonumenTAL-1 study versus real-world physician's choice (RW) treatment.
Materials and Methods
An external control arm for MonumenTAL-1 was created from patients in the Flatiron Health database who satisfied MonumenTAL-1 eligibility criteria (n = 629 with 1169 eligible lines of therapy). Patient-level data from MonumenTAL-1 were included for patients who received subcutaneous talquetamab 0.4 mg/kg QW (n = 143) and 0.8 mg/kg Q2W (n = 145). After adjusting for baseline covariate imbalances, comparative effectiveness was assessed for progression-free survival (PFS), time to next treatment (TTNT), and overall survival (OS).
Results
Baseline covariates were comparable across cohorts after adjustment. Talquetamab 0.4 mg/kg QW and 0.8 mg/kg Q2W cohorts, respectively, showed significant improvement in PFS (HR, 0.55 [95% CI, 0.44-0.69; P < .0001; median, 7.5 vs. 4.0 months] and 0.40 [95% CI, 0.31-0.53; P < .0001; median, 14.2 vs. 4.0 months]), TTNT (HR, 0.59 [95% CI, 0.47-0.74; P < .0001; median, 9.1 vs. 5.1 months] and 0.45 [95% CI, 0.35-0.59; P < .0001; median, 13.3 vs. 5.1 months]), and OS (HR, 0.56 [95% CI, 0.40-0.78; P = .0007; median, NR vs. 16.5 months] and 0.48 [95% CI, 0.33-0.70; P = 0.0002; median NR vs. 15.9 months]) versus RW treatment.
Conclusion
Both talquetamab schedules demonstrated superior effectiveness over RW treatment for all outcomes assessed. These data suggest talquetamab as an effective immunotherapy option in patients with TCE RRMM.
背景：他克单抗被批准用于治疗复发/难治性多发性骨髓瘤（RRMM）的三类暴露（TCE）患者。我们评估了MonumenTAL-1研究中的他昔单抗与现实世界中医生选择（RW）治疗的疗效比较：MonumenTAL-1 的外部对照组由 Flatiron Health 数据库中符合 MonumenTAL-1 资格标准的患者组成（n = 629，1169 个符合条件的治疗方案）。MonumenTAL-1的患者水平数据包括接受皮下注射talquetamab 0.4 mg/kg QW（n = 143）和0.8 mg/kg Q2W（n = 145）的患者。调整基线协变量不平衡后，评估了无进展生存期（PFS）、下次治疗时间（TTNT）和总生存期（OS）的比较效果：结果：经调整后，各组群的基线协变量具有可比性。Talquetamab 0.4 mg/kg QW队列和0.8 mg/kg Q2W队列的PFS（HR，0.55 [95% CI，0.44-0.69；P < .0001；中位数，7.5个月对4.0个月]和0.40 [95% CI，0.31-0.53；P < .0001；中位数，14.2个月对4.0个月]）、TTNT（HR，0.59 [95% CI，0.47-0.74；P < .0001；中位数，9.2个月对4.0个月]）和OS均有显著改善。0001; 中位数，9.1 个月 vs. 5.1 个月] 和 0.45 [95% CI, 0.35-0.59; P < .0001; 中位数，13.3 个月 vs. 5.1 个月]），以及 OS（与 RW 治疗相比，HR，0.56 [95% CI, 0.40-0.78; P = .0007; 中位数，NR vs. 16.5 个月] 和 0.48 [95% CI, 0.33-0.70; P = 0.0002; 中位数，NR vs. 15.9 个月]）：结论：在所有评估结果中，两种talquetamab治疗方案的疗效均优于RW治疗方案。这些数据表明，在TCE RRMM患者中，talquetamab是一种有效的免疫疗法。
{"title":"Talquetamab Versus Real-World Physician's Choice Treatment: Comparative Effectiveness in Patients With Triple-Class Exposed Relapsed/Refractory Multiple Myeloma","authors":"Jing Christine Ye , Noa Biran , Sandhya Nair , Xiwu Lin , Keqin Qi , Anil Londhe , Eric Ammann , Thomas Renaud , Colleen Kane , Trilok Parekh , Kathleen Gray , Steve Peterson , Luciano J. Costa","doi":"10.1016/j.clml.2024.08.003","DOIUrl":"10.1016/j.clml.2024.08.003","url":null,"abstract":"<div><h3>Background</h3><div>Talquetamab is approved for treatment of triple-class exposed (TCE) patients with relapsed/refractory multiple myeloma (RRMM). We evaluated the comparative effectiveness of talquetamab in the MonumenTAL-1 study versus real-world physician's choice (RW) treatment.</div></div><div><h3>Materials and Methods</h3><div>An external control arm for MonumenTAL-1 was created from patients in the Flatiron Health database who satisfied MonumenTAL-1 eligibility criteria (<em>n</em> = 629 with 1169 eligible lines of therapy). Patient-level data from MonumenTAL-1 were included for patients who received subcutaneous talquetamab 0.4 mg/kg QW (<em>n</em> = 143) and 0.8 mg/kg Q2W (<em>n</em> = 145). After adjusting for baseline covariate imbalances, comparative effectiveness was assessed for progression-free survival (PFS), time to next treatment (TTNT), and overall survival (OS).</div></div><div><h3>Results</h3><div>Baseline covariates were comparable across cohorts after adjustment. Talquetamab 0.4 mg/kg QW and 0.8 mg/kg Q2W cohorts, respectively, showed significant improvement in PFS (HR, 0.55 [95% CI, 0.44-0.69; <em>P</em> < .0001; median, 7.5 vs. 4.0 months] and 0.40 [95% CI, 0.31-0.53; <em>P</em> < .0001; median, 14.2 vs. 4.0 months]), TTNT (HR, 0.59 [95% CI, 0.47-0.74; <em>P</em> < .0001; median, 9.1 vs. 5.1 months] and 0.45 [95% CI, 0.35-0.59; <em>P</em> < .0001; median, 13.3 vs. 5.1 months]), and OS (HR, 0.56 [95% CI, 0.40-0.78; <em>P</em> = .0007; median, NR vs. 16.5 months] and 0.48 [95% CI, 0.33-0.70; <em>P</em> = 0.0002; median NR vs. 15.9 months]) versus RW treatment.</div></div><div><h3>Conclusion</h3><div>Both talquetamab schedules demonstrated superior effectiveness over RW treatment for all outcomes assessed. These data suggest talquetamab as an effective immunotherapy option in patients with TCE RRMM.</div></div>","PeriodicalId":10348,"journal":{"name":"Clinical Lymphoma, Myeloma & Leukemia","volume":"25 2","pages":"Pages 124-134.e5"},"PeriodicalIF":2.7,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142281224","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-02-01DOI: 10.1016/j.clml.2024.09.003
Andrew Lin , Nicole Pearl , Jessica Flynn , Sean Devlin , Parastoo Dahi , Miguel-Angel Perales , Michael Scordo , Gunjan L. Shah
Hematopoietic cell transplantation requires higher doses of chemotherapy, and practices of adjusting the weight because of concerns of organ toxicity are common. This retrospective analysis of 239 adult recipients of autologous hematopoietic cell transplantation for lymphoma assessed the effect of obesity on transplantation outcomes.
Background
Prior data evaluating the impact of obesity in autologous hematopoietic cell transplantation (AHCT) for lymphomas have provided differing results when assessing overall (OS) and progression-free survival (PFS). Impact on survival outcomes have been described, but direct comparison of discrete toxicities is lacking. Patients and methods: We retrospectively compared outcomes with patients divided between 3 groups: nonobese patients (n = 129), obese patients dosed on adjusted body weight (AdjBW) (n = 32), and obese patients dosed on total body weight (TBW) (n = 78).
Results
In multivariate analysis of OS with the nonobese group as the comparator, outcomes trended worse in obese patients dosed on AdjBW (HR 1.22, 95% CI 0.52-2.85) but were improved in obese patients dosed on TBW (HR 0.19, 95% CI 0.04-0.85, P = .012). PFS of obese patients dosed on AdjBW vs. the nonobese group was comparable (HR 1.19, 95% CI 0.63-2.24), but improved in obese patients dosed on TBW (HR 0.45, 95% CI 0.23-0.89, P = .021). Notably, no differences were noted between groups in gastrointestinal, infectious, renal, or hepatic toxicities.
Conclusion
In summary, our data suggest that recipients of AHCT for lymphoma should be dosed on TBW to maximize curative outcomes with no apparent increase in toxicities.
造血细胞移植需要更高的化疗剂量，因担心器官毒性而调整体重的做法很常见。这项对239名淋巴瘤自体造血细胞移植成年受者的回顾性分析评估了肥胖对移植结果的影响：背景：先前评估肥胖对淋巴瘤自体造血细胞移植（AHCT）影响的数据在评估总生存期（OS）和无进展生存期（PFS）时提供了不同的结果。对生存结果的影响已有描述，但缺乏对离散毒性的直接比较：我们回顾性比较了分为三组的患者的治疗结果：非肥胖患者（n = 129）、按调整体重（AdjBW）用药的肥胖患者（n = 32）和按总重量（TBW）用药的肥胖患者（n = 78）：结果：以非肥胖组为对比组进行OS多变量分析，按调整体重（AdjBW）用药的肥胖患者的结果呈恶化趋势（HR 1.22，95% CI 0.52-2.85），但按总体重用药的肥胖患者的结果有所改善（HR 0.19，95% CI 0.04-0.85，P = .012）。使用 AdjBW 的肥胖患者与非肥胖组患者的 PFS 相当（HR 1.19，95% CI 0.63-2.24），但使用 TBW 的肥胖患者的 PFS 有所改善（HR 0.45，95% CI 0.23-0.89，P = .021）。值得注意的是，在胃肠道、感染、肾脏或肝脏毒性方面，组间没有差异：总之，我们的数据表明，淋巴瘤 AHCT 受者的剂量应为 TBW，以便在不明显增加毒性的情况下最大限度地提高治疗效果。
{"title":"Influence of Obesity on the Efficacy and Toxicity of Patients Undergoing Autologous Hematopoietic Cell Transplantation for Lymphoma","authors":"Andrew Lin , Nicole Pearl , Jessica Flynn , Sean Devlin , Parastoo Dahi , Miguel-Angel Perales , Michael Scordo , Gunjan L. Shah","doi":"10.1016/j.clml.2024.09.003","DOIUrl":"10.1016/j.clml.2024.09.003","url":null,"abstract":"<div><div>Hematopoietic cell transplantation requires higher doses of chemotherapy, and practices of adjusting the weight because of concerns of organ toxicity are common. This retrospective analysis of 239 adult recipients of autologous hematopoietic cell transplantation for lymphoma assessed the effect of obesity on transplantation outcomes.</div></div><div><h3>Background</h3><div>Prior data evaluating the impact of obesity in autologous hematopoietic cell transplantation (AHCT) for lymphomas have provided differing results when assessing overall (OS) and progression-free survival (PFS). Impact on survival outcomes have been described, but direct comparison of discrete toxicities is lacking. Patients and methods: We retrospectively compared outcomes with patients divided between 3 groups: nonobese patients (n = 129), obese patients dosed on adjusted body weight (AdjBW) (n = 32), and obese patients dosed on total body weight (TBW) (n = 78).</div></div><div><h3>Results</h3><div>In multivariate analysis of OS with the nonobese group as the comparator, outcomes trended worse in obese patients dosed on AdjBW (HR 1.22, 95% CI 0.52-2.85) but were improved in obese patients dosed on TBW (HR 0.19, 95% CI 0.04-0.85, <em>P</em> = .012). PFS of obese patients dosed on AdjBW vs. the nonobese group was comparable (HR 1.19, 95% CI 0.63-2.24), but improved in obese patients dosed on TBW (HR 0.45, 95% CI 0.23-0.89, <em>P</em> = .021). Notably, no differences were noted between groups in gastrointestinal, infectious, renal, or hepatic toxicities.</div></div><div><h3>Conclusion</h3><div>In summary, our data suggest that recipients of AHCT for lymphoma should be dosed on TBW to maximize curative outcomes with no apparent increase in toxicities.</div></div>","PeriodicalId":10348,"journal":{"name":"Clinical Lymphoma, Myeloma & Leukemia","volume":"25 2","pages":"Pages e90-e95"},"PeriodicalIF":2.7,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142342794","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
T-cell lymphomas are a heterogeneous group of lymphoid malignancies with poor outcomes. Frontline multiagent chemotherapy options include CHOP (prednisone, vincristine, cyclophosphamide, and doxorubicin), brentuximab-CHP, CHOEP, and EPOCH (etoposide, prednisone, vincristine, cyclophosphamide, and doxorubicin).
Patients and Methods
We report our single institution data for safety and efficacy of EPOCH in 38 patients with aggressive T-cell lymphoma including both peripheral T cell lymphoma (PTCL) and cutaneous T-cell lymphoma (CTCL).
Results
Eighteen patients received EPOCH as first-line and 21 in the relapsed/refractory (R/R) setting. In 36 evaluable patients, the overall response rate (ORR) was 77% (95% CI, 61%-89%) with 19 (53%) patients achieving complete response (CR) (95% CI, 36%-69%). The ORR in first line and R/R settings were 80% (95% CI, 46%-94%) and 75% (95% CI, 52%-90%), respectively. Response rate was similar in African American versus Caucasian patients but was higher in CD30 negative versus positive patients. Most common grade 3/4 adverse events included cytopenias.
Conclusions
Overall, EPOCH was well tolerated with high response rates in first line and R/R setting.
{"title":"Real World Data on Efficacy and Safety of EPOCH in T-Cell Lymphoma","authors":"Rachael Straining , Francine Foss , Molly Schiffer , Kejal Amin , Sonal Agarwal , Iris Isufi , Scott Huntington , Shalin Kothari , Stuart Seropian , Michael Girardi , Tarsheen Sethi","doi":"10.1016/j.clml.2024.09.005","DOIUrl":"10.1016/j.clml.2024.09.005","url":null,"abstract":"<div><h3>Background</h3><div>T-cell lymphomas are a heterogeneous group of lymphoid malignancies with poor outcomes. Frontline multiagent chemotherapy options include CHOP (prednisone, vincristine, cyclophosphamide, and doxorubicin), brentuximab-CHP, CHOEP, and EPOCH (etoposide, prednisone, vincristine, cyclophosphamide, and doxorubicin).</div></div><div><h3>Patients and Methods</h3><div>We report our single institution data for safety and efficacy of EPOCH in 38 patients with aggressive T-cell lymphoma including both peripheral T cell lymphoma (PTCL) and cutaneous T-cell lymphoma (CTCL).</div></div><div><h3>Results</h3><div>Eighteen patients received EPOCH as first-line and 21 in the relapsed/refractory (R/R) setting. In 36 evaluable patients, the overall response rate (ORR) was 77% (95% CI, 61%-89%) with 19 (53%) patients achieving complete response (CR) (95% CI, 36%-69%). The ORR in first line and R/R settings were 80% (95% CI, 46%-94%) and 75% (95% CI, 52%-90%), respectively. Response rate was similar in African American versus Caucasian patients but was higher in CD30 negative versus positive patients. Most common grade 3/4 adverse events included cytopenias.</div></div><div><h3>Conclusions</h3><div>Overall, EPOCH was well tolerated with high response rates in first line and R/R setting.</div></div>","PeriodicalId":10348,"journal":{"name":"Clinical Lymphoma, Myeloma & Leukemia","volume":"25 2","pages":"Pages e96-e102"},"PeriodicalIF":2.7,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142379170","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"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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