bluuebunny/crossref_metadata_2025_split huggingface dataset:
Resource use and costs in patients with relapsed/refractory diffuse large C-cell lymphoma who initiated a third-line therapy in the post CAR-T era: A longitudinal outlook.
Authors: Chen Lei , Xie Jipan , Wu Aozhou , Liao Laura , Du Ella X. , Noman Ahmed , Nastoupil Loretta J. 
Published: June 2021

e19560 Background: The study described longitudinal costs and healthcare resource utilization (HRU) associated with third-line (3L) treatments in patients with relapsed/refractory diffuse large B-cell lymphoma (R/R DLBCL) post chimeric antigen receptor T-cell (CAR-T) approval. Methods: Adult patients newly diagnosed with DLBCL (ICD-10: C83.3) from 10/01/2015 to 03/31/2020 and receiving 3L after CAR-T approval (10/18/2017) were identified from IQVIA PharMetrics Plus. Monthly HRU and total costs were evaluated during month 1, months 2-6, and months 7-12 following 3L initiation for three treatment groups: CAR-T, stem cell transplantation (SCT), and non-cell therapy including chemoimmunotherapy and the targeted therapies that are recommended by the NCCN guidelines (including brentuximab vedotin, ibrutinib, venetoclax, lenalidomide, polatuzumab, obinutuzumab, nivolumab and pembrolizumab). Results: The study identified 145 R/R DLBCL patients initiating 3L with a mean age of 56.7 years and 66.2% male; 135 patients with ≥1 month of follow-up (median 6.7 months) were included: 24 CAR-T, 15 SCT, 96 non-cell therapy. At each time period, CAR-T had the highest median monthly costs, followed by SCT; both had higher median costs than non-cell therapy. The median monthly costs for CAR-T and SCT were $205,034 and $160,423 in month 1, and reduced to $14,333 and $11,840 in months 2-6, then increased to $27,090 and $17,695 in months 7-12, respectively. The monthly median cost for non-cell therapy was $36,015, $11,878, and $4,806 in month 1, months 2-6 and 7-12, respectively. Inpatient (IP) visits and IP days were higher in month 1 than later months for CAR-T and SCT. In addition, outpatient (OP) and emergency room (ER) visits were more frequent for CAR-T than SCT except for ER visits in month 1 (Table). Conclusions: In R/R DLBCL patients receiving 3L, CAR-T had the highest median monthly costs during month 1, months 2-6 and 7-12. In addition, CAR-T has more frequent OP and ER visits compared with SCT in general.[Table: see text] The maximum observed follow-up time for SCT was 8 months. Other visits were mainly home care visits.
Limited stage mantle cell lymphoma: Results of overall survival based on treatment modality using SEER database.
Authors: Jayarangaiah Apoorva , Wang Shuai , Elrafei Tarek N. , Steinberg Lewis , Kumar Abhishek 
Published: June 2021

e19566 Background: Limited stage mantle cell lymphoma (MCL) (stage I-II) is rare and occurs in 5-15% of patients. The ideal treatment approach among radiation (RT), chemotherapy (CT), chemoradiotherapy (CRT) or close monitoring (NT) has not been defined. Methods: A retrospective analysis of SEER database (1975 to 2018) was conducted for patients with stage I-II MCL to compare overall survival (OS) among the various treatment modalities in patients >18 years. We excluded patients lacking information on demographic characteristics and survival. Patients were analyzed in 4 groups; RT only, CT only, CRT and no treatment groups. ANOVA test and Chi-square test were used to evaluate parametric and non-parametric variables between groups, respectively. Cancer specific survival (CSS) and OS were assessed by Kaplan-Meier. SPSS 26.0 was used for data analysis. Results: There were in total 2266 patients with limited stage MCL. Median age was 71 years (61-78.25) and predominantly male (65.7%). Stage I MCL was noted in 55.6% and stage II in 44.4% of the patients. The number of patients in each group; RT only, CT only, CRT and NT along with the OS are presented in Table. CSS among these four groups showed no statistically significant differences (p <0.26). OS showed that CT only group has worse survival compared to RT only and CRT groups (p <0.001). CRT has no significant difference in survival compared to RT only (p<0.001). NT was associated with poorest survival rates (p<0.001). Conclusions: In limited stage MCL, RT only and CRT resulted in superior OS compared to CT only. Results suggest a role for incorporation of RT in treatment regimens. One limitation of the study is that the SEER database lacks the ability to distinguish between no receipt of therapy versus lack of availability of data.[Table: see text]
A systematic review of post-transplant lymphoproliferative disorder after renal transplantation.
Authors: Zamani Zarlakhta , Haider Mobeen Zaka , Taqi Muhammad , Mirza Hasan Mehmood , Kumar Deepak , Shahid Hafsa , Kiran Fnu , Khalid Yousra , Mughal Mohsin Sheraz , Akbar Usman Ali , Faisal Muhammad Salman , Mushtaq Muhammad Umair , Anwer Faiz 
Published: June 2021

e19577 Background: Post Transplant Lymphoproliferative Disorder (PTLD) is a rare but severe complication following renal transplant. This study aims to explore the treatment modalities, histological types, and risk factors related to PTLD. Methods: Following the PRISMA guideline, we searched the literature on PubMed, Cochrane, Embase & clinicaltrials.gov. A total of 1741 articles were screened and 16 studies were included. Results: We reviewed 275915 adult patients who underwent renal transplantation out of which 2484 (0.9%) patients developed PTLD. Data for gender shows that 61.1% were males and 38.9% females. 576/2484 (23%) cases were EBV positive post-transplant. Seven studies showed the median duration from transplant to the development of PTLD was 80 months (5m-22yrs). Monomorphic PTLD was reported in 585 cases as the most common histological type. 5 studies suggested mortality due to PTLD was 41.38%. OS at 5 and 10 years was 55% and 41% respectively. Conclusions: Our study shows that PTLD is a rare complication after renal transplant which was more common in males. EBV did not show association with PTLD. Monomorphic is the most common histological type of PTLD after renal transplant. Our results show that it is associated with significantly high mortality. [Table: see text]
Daratumumab, pomalidomide, and dexamethasone in relapsed refractory multiple myeloma (RRMM): A comparison with contemporary clinical trials.
Authors: Paul Barry , Robinson Myra M. , Robinson Jordan , Ndiaye Ami , Bhutani Manisha , Voorhees Peter Michael , Symanowski James Thomas , Friend Reed N. , Pineda-Roman Mauricio , Usmani Saad Zafar , Atrash Shebli 
Published: June 2021

e20011 Background: Multiple Myeloma (MM) is an incurable malignancy of terminally differentiated plasma cells. The combination of pomalidomide/dexamethasone with either daratumumab or isatuximab is FDA approved for relapsed refractory multiple myeloma (RRMM) based on randomized phase III trial data. Herein, we compare our center’s experience with published data to help identify the most appropriate patient population for this regimen outside of the context of clinical trials. Methods: We interrogated our internal plasma cell disorder database to identify all patients with RRMM at our institution who were treated with the combination of daratumumab, pomalidomide, and dexamethasone (Dara-Pd). We evaluated the best response achieved, overall response rate (ORR), progression free survival (PFS), and overall survival (OS) measured from initiation on Dara-Pd. Kaplan Meier methods were used to estimate PFS and OS curves. Fisher’s exact tests and log rank tests were used to determine the association between outcomes and variables of interest. Results: Between Dec 2015 and Dec 2020, 98 patients were identified, of which 97 were evaluable for response. Median number of prior lines of therapy was 2 (range 1-12), with 23 patients (23%) previously treated with 3 prior lines and 24 patients (25%) previously treated with ≥4 lines of therapy. Most patients were refractory to an IMiD (79.6%), a PI (65.3%), or both (56.1%). The ORR was 69.1%, > VGPR rate was 33%. ORR was significantly improved for patients who received Dara-Pd after 1 line (p = 0.03), but depth of response (≥VGPR), was similar (p = 0.62). At a median follow up of 10.8 months, 1-year PFS was 76.6% in patients after 1 line, 38.8% in patients after 2-3 lines, and 35% in patients after > 4 lines. Overall response rates appear comparable to published phase III trials comparing the combination of Pd with or without an anti-CD38 monoclonal antibody (Table 1). While PFS was somewhat lower in our population, subset analysis showed that PFS was significantly lower in patients who were PI refractory (10.8 months vs 6 months; p = 0.014), and in patients who were both IMiD and PI refractory (20.4 months vs 6 months p = 0.01), but OS was similar in these populations. Conclusions: Our data suggests that the combination of Dara-Pd has activity in heavily pretreated patients, including patients who are both IMiD and PI refractory and remains a viable option for these patients outside the context of a clinical trial.[Table: see text]
Acute and chronic cancer-related distress among multiple myeloma patients during the COVID-19 pandemic.
Authors: Ahlstrom Jenny , Molina Thomas H. , Sweeney Nathan W. 
Published: June 2021

e20025 Background: Patients with multiple myeloma (MM) are uniquely susceptible to viral and bacterial illnesses. In addition, MM and its treatments lead to immune deficiency, putting patients at a high risk for infection, including the novel coronavirus (COVID-19). The emotional impact of COVID-19 on high-risk groups, such as MM patients, remains unclear. The purpose of this project was to understand psychosocial distress and unmet needs among patients with active MM during the acute and chronic phase of COVID-19 and its impact in the United States. Methods: We utilized the HealthTree Cure Hub (healthtree.org) and invited patients with active MM cancer or precursor conditions to participate in an online CancerSupportSource distress screening questionnaire by the Cancer Support Community. Participants were asked to rate their level of concern (Not at All to Very Seriously) on 12 items assessing physical, psychosocial, and practical needs during the acute and chronic phase of the COVID-19 pandemic. De-identified responses were aggregated and reviewed. Results: 1,079 MM patients analyzed during the acute phase of the pandemic (April 15, 2020, to June 8, 2020) and 246 were analyzed during the chronic phase (January 8, 2021, to February 12, 2021). The percent of patients responding moderately to very seriously concerned are reported here. While eating and nutrition increased 3% from acute (71%) to chronic (74%) phases, physical needs overall decreased 2%. Psychosocial needs (worrying about the future, family concerns, feeling irritable, sad, nervous, or lonely, and relationship concerns) decreased 4% between the two phases, despite the 2% increase in problems with your spouse/partner. Additionally, practical needs (health insurance or money worries) decreased 4% between the acute and chronic phases of the pandemic. Conclusions: Respondents to our survey maintain a concern for eating and nutrition during the acute and chronic phases of the pandemic. Between the three types of needs examined in this survey, physical needs had the smallest change over time. This information can inform patients and medical professionals of the type of distress experienced by patients and help investigators assess the needs of the patient community to enhance patient outcomes.[Table: see text]
A pilot study of physical activity in newly diagnosed elderly patients with multiple myeloma.
Authors: Binder Adam F , Spinelli Bryan , Melillo Rebecca , Crane Nicole , D'Adamo Laura , Martinelli Mary K , Martinez-Outschoorn Ubaldo , Butryn Meghan 
Published: June 2021

e20027 Background: Compared to a baseline normative population, patients with multiple myeloma (MM) have decreased physical function[1]. Studies have revealed that sarcopenia[2, 3], decreased performance status[4], and poor performance on biometric testing[3, 5] predicts worse survival in patients with advanced, incurable malignancies. Physical activity (PA) has been shown to mitigate these effects and in some cases improve cancer specific survival [6-9]. However, there is a need for further research in this area for patients with hematologic malignancies. Here in we describe the results of a pilot study to assess a physical activity intervention in elderly patients with newly diagnosed multiple myeloma. Methods: We designed a single arm, feasibility study utilizing physical and behavioral therapy interventions to help participants adhere to a prescribed exercise program. Eligible patients (age ≥65 years old) were recruited from the multiple myeloma treatment clinic. Baseline, 3-month and 6-month assessments occurred. The intervention included both text messaging and video visits with behavioral coaches and physical therapists to monitor activity levels, review and modify exercise plans, , and enhance motivation and self-efficacy. Our primary aim was to establish the feasibility of recruitment, enrollment, and adherence of the exercise intervention. Our secondary objective was to evaluate changes in fitness (6 minute walk test, grip strength, and the Short Physical Performance Battery). Results: Between 11/18/2019-03/04/2020, 9 participants enrolled on the study (goal of 20). New enrollment was halted due to the COVID-19 pandemic. Median age of the participants was 70 (range 65-86). Six (67%) were female. Eight participants (89%) completed the 6-month intervention. Participants completed 97.8% of the scheduled visits. At 3 and 6 months there was a mean change of moderate/vigorous activity of 26.0% (SD 89.6%) and -0.5% (SD 56.4%) respectively. At 3 and 6 months there was a mean change in step count per day of -5.1% (SD 25.3%) and -1.3% (SD 32.2%) respectively. Overall fitness was preserved over the 6-month period. Conclusions: Prior to COVID-19 pandemic, the study was on track to meet feasibility endpoints of recruitment, enrollment, and retention. The primary endpoint of increasing physical activity was not met. However, adults in our region experienced a 20-30% reduction in physical activity during the pandemic [10]. In the target population, reductions in the absence of intervention may have been even greater, given their pronounced vulnerability to COVID-19 complications. Thus, the true benefits of the intervention may have been difficult to detect during this period. Lack of a control arm is a limiting factor in making further conclusions about the potential benefits of our intervention.
Bispecific CART cells in the treatment of relapsed and refractory multiple myeloma: A review of literature.
Authors: Christy Joshua , Rafae Abdul , Hanif Nazma , Pachika Pranali Santhoshini , Kandah Emad , Ehsan Hamid , Wahab Ahsan , Saleem Tabinda , Ali Rabia , Malik Mustafa Nadeem , Anwer Faiz 
Published: June 2021

e20038 Background: Chimeric antigen receptor T cells (CART) have shown promising results in the treatment of relapsed and refractory multiple myeloma (RRMM). Recently, bispecific-CART cells targeting 2 antigens are being evaluated in various clinical trials. Methods: A comprehensive literature search was done of Pubmed, Embase, and Cochrane. Data presented at annual hematology and oncology conferences were also included. Results: We included 4 phase I clinical trials with a total of 77 RRMM patients between the ages of 18 to 71 years. The median follow-up duration ranged from 1 month to 27.5 months. All were lymphodepleted with Cyclophosphamide and Fludarabine before receiving CAR-T cell therapy. The CAR-T cell targets include BCMA and CD38 (dose range 0.5 x 10^6 - 4 x 10^6 cells/kg), BCMA and TACI (dose range 15 - 900 x 10e6 CAR-T cells), BCMA and CD19 (1 x 10e5/kg - 3 x 10e5 CAR-T cells/kg), and BCMA and CD19 (dose 1 x 10e6 cells/kg). Overall response rate (ORR) was reported by 4 trials (87.5%, 43%, 93.8%, 95%). Complete response (CR) was also reported in 4 trials as 50%, 64%, 56.3% and 14% and partial response (PR) reported as 25%, 28%, 16.6%, 14%, 18% in 5 trials (table). The most common grade 3-4 adverse effects that were reported include cytokine release syndrome, neurotoxicity, neutropenia, lymphopenia, anemia, thrombocytopenia, diarrhea, increased LDH, lower respiratory tract infections (LRTI), dehydration, renal failure (table). Yan et al. reported one death due to cerebral hemorrhage which was considered unrelated to treatment. Jiang et al. reported one death from unknown cause of a patient who presented with fever during the COVID- 19 pandemic. Conclusions: Bispecific CART cells have shown promising results in the treatment of RRMM. However, the clinical trials are ongoing, and a longer follow-up is needed.[Table: see text]
Integrative medicine and plasma cell disorders.
Authors: Okolo Onyemaechi , Wertheim Betsy C. , Larsen Ashley , Sweeney Nathan W. , Gowin Krisstina L. 
Published: June 2021

e20044 Background: Recent advancements in the treatment of plasma cell disorders (PCD) have led to a revolution in treatment options. Despite improved outcomes, patients have unmet symptom management needs. Integrative medicine (IM) is a method for addressing symptoms in cancer, but its use and efficacy is poorly defined in PCD patients. This analysis describes the utilization of IM among myeloma patients and explores associations with symptom burden. Methods: For 3 months, a 70-question online survey was hosted on HealthTree.org, an online resource for myeloma patients and researchers created by the HealthTree Foundation. The survey included questions about demographics, PCD type, disease stage, complementary practice use, PHQ-2 score (depression screen), and quality of life (sum of 6 interference items; possible score range 0-6). Mean outcome values were compared between IM users and non-users using two-sample t-tests. Proportions of supplement users and IM users were compared between patients currently on myeloma-specific treatment and patients not currently on treatment using chi-square tests. Results: Of 195 total respondents, 17 were excluded for not completing the survey section on IM practices. Median age range was 60-69 years old, 61% were female, 91% were non-Hispanic white, and 57% were overweight or obese. Plasma cell subtypes were active myeloma (81%), smoldering myeloma (12%), MGUS (3%), amyloidosis (2%), and plasmacytoma (1%), and 72% of patients were currently on cancer-specific treatment. On a scale of 1-10 (1=very uncomfortable; 10=very comfortable), patients reported a mean score of 3.7 when discussing IM therapies with their oncologist. The top 10 IM modalities reported were aerobic exercise (83%), nutrition (67%), natural products (60%), strength exercise (52%), support groups (48%), breathing exercises (44%), meditation (42%), yoga (40%), mindfulness-based stress reduction (38%), and massage (38%). Those who participated in meditation had significantly higher PHQ-2 scores (worse depression) than non-participants (1.1 vs. 0.8; p=0.05). Users of support groups (3.4 vs. 2.7; p=0.04), medicinal marijuana (4.0 vs. 2.9; p=0.03), or vitamin C (3.6 vs. 2.7; p=0.01) reported higher mean interference (worse quality of life) than non-users. Compared to patients currently on cancer treatment for PCD, untreated patients were significantly more likely to use curcumin (58% vs. 41%; p=0.04) or green tea (44% vs. 17%; p<0.001), were less likely to use medicinal marijuana (6% vs. 18%; p=0.05), and reported significantly lower fatigue (p=0.02). Conclusions: This international survey-based analysis reveals that most patients participated in IM modalities, though felt uncomfortable discussing them with their oncologist. It is unclear if the use of some IM modalities were due to symptom burden or lead to higher symptom burden. This study provides a foundation in the understanding of IM use in PCD, but more research is needed to evaluate its efficacy.
Germline mutations among patients with non-small cell lung cancer.
Authors: Yang Tongtong , Liu Huanhuan , Li Mingwei , Zhang Yanrui , Zhang Yun , Liang Xiayuan , Lou Feng , Cao Shanbo , Wang Huina 
Published: June 2021

e20527 Background: Lung cancer is currently a leading cause of cancer-associated mortality worldwide. Germline mutations potentially predisposing patients to lung cancer have not been systematically defined. In this study, we sought to determine the prevalence of pathogenic/likely pathogenic (P/LP) germline mutations in patients with NSCLC. Methods: A total 1562 patients with NSCLC were included in this study. Leukocyte DNA was extracted and detected were using next generation sequencing technology. Allele frequencies were compared with publicly available database. Interpretation of sequence variations was classified according to the American College of Medical Genetics and Genomics guidelines. Results: Overall, median age at testing of individuals was 63 years (range 12 to 91). The majority of individuals tested were male (56.15%, 877/1562). of 1562 NSCLC, P/LP mutations were identified in 94 (6.02%) in 42 Cancer Susceptibility genes. No individuals carried more than 1 germline variant. The most common P/LP mutations in genes were MUTYH (n = 11, 0.70%), TP53 (n = 10, 0.64%), BRCA2 (n = 8, 0.51%), PALB2(n = 5, 0.32%), PTEN(n = 4, 0.26%), BLM(n = 3, 0.19%), WRN(n = 3, 0.19%), and ATR, BRCA1 and BRIP1 (n = 2, 0.13% each). Twenty eight patients were carried germline mutations in homologous recombination repair(HRR), including BRCA2 (8), PALB2 (5), PTEN (4), BRCA1 (2), BRIP1 (2), CHEK2 (2), FANCA (2), ATM (1), RAD51B (1), RAD54L(1). Of note, the clinical features of patients with HRR mutations were not young adult (median age [range], 57 [41-80] years). Conclusions: Of 1562 patients with NSCLC, 94 (6.02%) had germline mutations and 27 (1.73%) had mutations in HRR genes. The presence of HRR germline mutations could guide cancer screening for patients and their families and serve as predictive biomarkers of response to targeted or immunotherapies. More extensive germline testing in NSCLC should be considered.