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570 citation(s) found for "Wagner, LI".

Verification of Amyotrophic Lateral Sclerosis (ALS) Cases Reported to the State and Metropolitan Area ALS Surveillance Projects (P5.074)
Kaye, Wendy, Wagner, Laurie, Sorenson, Eric, Antao, Vinicius C.

Neurology | December 7, 2023 | Volume: 82 | Issue: 10_supplement | Pages: No page available

10.1212/wnl.82.10_supplement.p5.074 Get It

Alternative Lymphodepletion Strategies Lead to Similar Response Rates and Toxicities in Standard-of-Care BCMA-Directed CAR-T Therapy in Relapsed Refractory Multiple Myeloma
Midha, Shonali , Gurumurthi, Ashwath , Freeman, Ciara L. , Castaneda, Omar, Gonzalez, Rebecca , Gaballa, Mahmoud , Kalariya, Nilesh, Khouri, Jack , Sborov, Douglas W. , Voorhees, Peter M. , Hashmi, Hamza , Davis, James A. , Forsberg, Peter A. , Shune, Leyla , Htut, Myo , Martin, Thomas , Sidana, Surbhi , Patel, Krina K. , Sidana, Surbhi , Davis, James A , Costello, Patrick , Redd, Robert , Puglianini, Omar Castañeda , Ionescu, Filip , Dima, Danai , Kocoglu, Mehmet H. , Wagner, Charlotte B , Atrash, Shebli , McGuirk, Joseph P. , Herr, Megan M. , Reshef, Ran , Lin, Yi , Hansen, Doris K. , Nadeem, Omar

Blood | December 1, 2023 | Volume: 142 | Issue: Supplement 1 | Pages: 3499-3499

10.1182/blood-2023-187565 Get It

Introduction: Lymphodepletion (LD) chemotherapy is critical for the efficacy of CAR-T therapy by eradicating immunosuppressive cells, inducing costimulatory molecules, and promoting expansion and persistence of CAR-T cells. It also can contribute to an increased risk of infections, cytopenia, and other toxicities. We evaluated the utilization of varying LD regimens used in standard-of-care (SOC) autologous B-cell maturation antigen-directed (BCMA) CAR-T therapy with ide-cel or cilta-cel for relapsed/refractory multiple myeloma (RRMM) and the effect on outcomes and toxicity. Methods: Data were retrospectively collected from patients with RRMM who underwent LD and CAR-T cell infusion by December 31, 2022, from 13 US academic institutions with SOC ide-cel or cilta-cel. Response rates and other categorical variables, specifically LD regimen, were tested for association using Wilcoxon rank-sum (or Kruskal-Wallis for three or more groups) or Fisher's exact tests, respectively. Results: A total of 523 patients were infused at the time of data cut-off with 489 patients evaluable for safety and survival analyses; 368 (75%) were infused with ide-cel and 121 (25%) with cilta-cel. The median age was 65 years old (range 30-90) with 206 females (42%) and 283 males (58%), and 13% with ECOG performance status ≥ 2 at time of LD. Fludarabine and cyclophosphamide (Flu/Cy) LD was used in 422 patients while 67 patients received other LD regimens including bendamustine-based (n = 35, 52%), cladribine-based (n = 25, 37%) or cyclophosphamide alone (n = 7, 10%). The primary reason for use of Flu/Cy LD was institutional guidance or SOC in 378 patients (90%), while the primary reason for use of other LD regimens was due to the fludarabine shortage in 65 patients (97%) with 3% citing physician's choice or institutional guidance. No significant difference was identified among response outcomes, with those receiving Flu/Cy LD achieving an ORR of 84% compared to 81% with other LD regimens (p = 0.59) and no difference observed in rates of ≥ VGPR (66% Flu/Cy LD vs 60% other LD; p = 0.48). Of those evaluable for MRD at 1 and 3 months, the MRD negative rate at 10 -6 for those with Flu/Cy LD was 77% (n= 137) and 77% (n=113) and with other LD regimens was 66% (n=35) and 79% (n=28), respectively. At a median follow-up of 9.7 months, no statistically significant difference was noted in median progression free survival (mPFS) with Flu/Cy vs other LD regimens (9.3 mos vs NR) or overall survival (OS) (19.4 mos vs NR). When stratified by type of CAR-T therapy, treatment with bendamustine-based LD was associated with an inferior mPFS compared to those receiving Flu/Cy LD in patients treated with ide-cel (3.8 vs 8.5 mos; p=0.0056), though not by multivariate analysis. Univariate analysis of patients treated with ide-cel between Flu/Cy and bendamustine LD did not reveal any significant differences in age, gender, ECOG, R-ISS stage, extramedullary disease, high-risk cytogenetics or renal dysfunction (Cr < 45 ml/min). LD regimen was not a predictor for PFS on multivariable analyses amongst patients treated with ide-cel, while ECOG ≥ 3 (hazard ratio [HR]= 4.44, 95% confidence interval [CI]= 1.40, 14.08) and t(4,14) (HR= 2.02, 95% CI=1.14, 3.59) were associated with worse PFS. No difference in mPFS by LD regimen was observed in patients receiving cilta-cel, which was a smaller cohort (mPFS: Flu/Cy 11.7 mos, bendamustine-based NR, cladribine-based NR, cyclophosphamide NR). Rates of all grade CRS (81% vs 70%), Grade ≥ 3 CRS (3% vs 3%), all grade ICANS (19% vs 12%, and Grade ≥ 3 ICANS (4% vs 2%) were similar among those receiving Flu/Cy or other LD regimens, respectively. Patients receiving Flu/Cy LD were less likely to have any grade cytopenia at 1 month (33% vs 55%, p < 0.001) and 3 months (52% vs 69%, p < 0.001), with no observed difference in infection rate. Conclusions: The fludarabine shortage experienced in the US in late 2022 necessitated the use of alternative LD regimens with BCMA-directed CAR-T therapy with most centers relying on bendamustine- or cladribine-based regimens. Use of bendamustine-based LD was associated with inferior PFS in patients receiving ide-cel on univariate analysis, but not on multivariate analysis after adjusting for other prognostic factors. In summary, there is no clear difference in efficacy or safety between Flu/Cy and non-Flu/Cy LD in patients receiving BCMA-directed CAR-T therapy. *Authors contributed equally
Prolonged Cytopenia Following CAR T-Cell Therapy in Relapsed/Refractory Multiple Myeloma: A Prospective Comprehensive Biomarker Study
Zhou, Xiang , Wagner, Vivien, Stanojkovska, Emilia, Riedhammer, Christine , Xiao, Xianghui, John, Mara , Scheller, Lukas , Topp, Max S. , Duell, Johannes , Rasche, Leo , Wagner, Vivien, Munawar, Umair , Han, Seungbin , Waldschmidt, Johannes M , Einsele, Hermann , Riedel, Angela , Kortüm, K. Martin

Blood | December 1, 2023 | Volume: 142 | Issue: Supplement 1 | Pages: 95-95

10.1182/blood-2023-180534 Get It

Background Chimeric antigen receptor (CAR) modified T-cells are leading to a paradigm shift in the treatment of relapsed/refractory (RR) multiple myeloma (MM). A high proportion of patients treated with CAR T-cells, however, experience prolonged cytopenia, with the mechanism remaining poorly understood. Here, we aimed to explore potential biomarkers that might correlate with cytopenia following CAR T-cell therapy in RRMM. Methods We prospectively collected peripheral blood (PB) of RRMM patients treated with idecabtagen-vicleucel (ide-cel) at the following time points: prior to lymphodepleting chemotherapy (LDC) (baseline), after ide-cel on day 4, 7, 14 and 28, and monthly thereafter. Cytopenia was determined according to the CTCAE version 5.0. Flow cytometry was performed with the following markers: CD45, CD3, CD4, CD8, CD62L, CD45RA, CD19, CD14, CD138, CD38 and a BCMA-CAR-detection marker. Results We included 222 PB samples at different sampling time points from 35 RRMM patients, who were pretreated with a median of 5 therapy lines (range 2-10). All patients were triple-class exposed and, 34 (97%) and 9 (26%) patients underwent autologous and allogeneic stem cell transplant (SCT), respectively. First, we analyzed the relationship between baseline parameters and the duration of grade ≥3 cytopenia after ide-cel (n=35). Notably, patients who received allogeneic SCT or >4 lines of therapy did not develop longer lasting cytopenia than the remaining patients. We found a correlation between the baseline hemoglobin level and the duration of grade ≥3 anemia (r=-0.55, P<0.001). Similarly, low baseline platelet count indicated long duration of grade ≥3 thrombocytopenia (r=-0.48, P=0.003). Moreover, high baseline ferritin level correlated with long duration of grade ≥3 anemia (r=0.52, P<0.001) and thrombocytopenia (r=0.51, P=0.002). Furthermore, the maximum ferritin level after ide-cel was an indicator for long lasting grade ≥3 anemia (r=0.73, P<0.001) and thrombocytopenia (r=0.71, P<0.001). Interestingly, we found significant correlations between the duration of grade ≥3 lymphopenia and baseline CD4+ T-cell frequency (r=0.41, P=0.02), CD8+ T-cell frequency (r=-0.38, P=0.04) and CD4+/CD8+ ratio (r=0.4, P=0.03). Noteworthy, patients with β2-microglobulin level >3.5 mg/l displayed longer duration of grade ≥3 anemia (median: 9 vs 0 day, P=0.007) and neutropenia (median: 43 vs 12 days, P=0.02) compared with the remaining patients, suggesting that high tumor load might be a risk factor for prolonged cytopenia after ide-cel. Second, we divided the follow-up PB samples (n=187) into two groups: early (<d60) and prolonged (≥d60) cytopenia to account for direct toxic effects related to LDC. A high ferritin level was associated with low hemoglobin level (<d60: r=-0.45, P<0.001, ≥d60: r=-0.62, P<0.001) and low platelet count (<d60: r=-0.58, P<0.001, ≥d60: r=-0.81, P<0.001) in both groups. In prolonged cytopenia (≥d60), lymphocyte count correlated with the T-cell count (r=0.7, P<0.001), suggesting that prolonged lymphopenia was mainly attributed to the reduced T-cell count after ide-cel. Of note, the frequency of naïve CD4+ T-cells (CD3+CD4+CD62L+CD45RA+) positively correlated with neutrophil count (r=0.58, P<0.001), hemoglobin level (r=0.37, P=0.03) and white blood cell count (r=0.5, P=0.002) in the ≥d60 group, suggesting that delayed immune reconstruction with reduced naïve CD4+ T-cells might contribute to prolonged cytopenia after ide-cel. Moreover, in the ≥d60 group, lymphocyte count was related with the frequency of CAR+CD4+ (r=-0.58, P<0.001), CAR+CD8+ (r=0.58, P<0.001), CAR-CD4+ (r=-0.72, P<0.001), CAR-CD8+ (r=0.75, P<0.001) T-cells, as well as the ratios of CAR+CD8+/CAR+CD4+ (r=-0.6, P<0.001) and CAR-CD8+/CAR-CD4+ (r=-0.75, P<0.001). Conclusion Here, we present one of the first prospective studies investigating the factors associated with prolonged cytopenia after CAR T-cell therapy in RRMM. High tumor load, preexisting cytopenia and high ferritin level are related with prolonged cytopenia after ide-cel. Delayed immune reconstruction, characterized by reduced naïve CD4+ T-cell count, indicates prolonged cytopenia following ide-cel therapy. Patients with high CD4+/CD8+ ratio are at risk of prolonged lymphopenia (with reduced T-cell count), which may be a risk factor for infectious complications and an issue for subsequent T-cell based immunotherapies.
Real-World Treatment Outcomes of Teclistamab Under an Outpatient Model for Step-up Dosing Administration
Sandahl, Tyler B. , Calay, Ediz S. , Lin, Dee , Wu, Bingcao , Silvert, Eli , Carpenter, Corinne , Wagner, Tyler , Fowler, Jessica , Hester, Laura , Marshall, Alexander Mclean, Stoy, Patrick, Gifkins, Dina , Kumar, Shaji , Calay, Ediz S , Soefje, Scott A. , Lin, Yi , Fonseca, Rafaël , Ailawadhi, Sikander , Parrondo, Ricardo D , Kim, Nina , Fowler, Jessica, Marshall, Alexander

Blood | December 1, 2023 | Volume: 142 | Issue: Supplement 1 | Pages: 5154-5154

10.1182/blood-2023-174270 Get It

Background Teclistamab, the first-in-class B-cell maturation antigen (BCMA) x CD3 bispecific therapy was recently approved by the FDA for the treatment of triple-class exposed relapsed or refractory multiple myeloma (MM) after ≥ 4 prior lines of therapy. Because of the risk of cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS), the step-up dosing (SUD) of teclistamab is commonly administered in an inpatient setting among early users. Mayo Clinic has a well-established hospital-based outpatient program for novel immunotherapies. Since the FDA approval, teclistamab SUD has been administered as part of this program. Each dose of the SUD is administered in an outpatient setting, and the patient is given a remote monitoring kit to regularly measure vital signs and stay connected with the command center for signs and symptoms of CRS and ICANS throughout the entire SUD period. This study aimed to evaluate early safety outcomes and healthcare resource utilization during SUD in real-world (RW) patients who initiated teclistamab under the outpatient administration model across 3 Mayo Clinic locations (Rochester, MN, Phoenix/Scottsdale, AZ, Jacksonville, FL). Methods This was a retrospective study using Mayo Clinic's electronic medical records from October 26, 2022 to June 12, 2023. Eligible patients were adults diagnosed with MM who had initiated commercial teclistamab at any of the 3 Mayo Clinic locations. Patient characteristics, rates and severity of CRS and ICANS, as well as healthcare resource utilization during SUD were described. Time between teclistamab administration and patient check-out was reported for SUD and treatment doses, respectively. Results At the time of data cutoff, 39 patients received at least 1 teclistamab dose across the 3 locations (median age 67.2 years; male: 74%; White: 87%; non-Hispanic: 92%), including 36 patients who initiated teclistamab SUD directly in an outpatient setting. A total of 8 (21%) patients had MM with high-risk cytogenetics and 14 (36%) had prior exposure to other BCMA-targeted therapies. Prevalent comorbidities prior to receiving teclistamab included anemia (77%), hypertension (56%), lytic bone lesions (51%), neutropenia (49%), and hypogammaglobulinemia (41%). Renal impairment or failure was observed in 31% of the patients (Table 1). Almost all patients received acetaminophen (95%), diphenhydramine (95%), and dexamethasone (92%) as pre-medications on the same day as teclistamab administrations during SUD. Of the teclistamab doses with clinic time data, the majority (62%) of doses during SUD required 30 minutes to 1 hour of clinic time for monitoring between administration and check-out. After SUD, the clinic time for weekly treatment doses decreased to less than 30 minutes for most (79%) doses (Figure 1). In patients who completed SUD by data cutoff (n = 37), most patients (70%) received the SUD on a 3-day dose interval (i.e., day 1, 4, 7). The mean time between the first and third doses was 6.3 days. Among the 37 patients with complete SUD, 12 (32%) developed CRS. The highest CRS grade was grade 1 for 10 patients; 1 patient had a grade 2 CRS, and 1 patient had a grade 4 CRS. The patient with grade 4 CRS concurrently decompensated during a dialysis session and all symptoms were considered for CRS grading. A total of 6 patients had recurrent CRS, including 1 patient with 3 events during SUD. All patients who developed CRS during SUD (n=12) were admitted to the hospital for treatment, with a total of 19 admissions across all patients and a median length of stay of 1.7 days per admission. Among patients who were admitted for CRS (n=12), the majority were treated with acetaminophen (92%), diphenhydramine (83%) and dexamethasone (83%); tocilizumab was given to the 2 patients with CRS grade 2 or higher. Only 1 ICANS event (grade 2) was observed in 1 patient during SUD, after dose 3, and the patient was admitted to the hospital for treatment. Conclusion This study evaluated early RW safety outcomes of teclistamab under an outpatient administration model and found the CRS rate and severity to be comparable with other RW evidence generated from various data sources. Outcomes related to teclistamab SUD from Mayo Clinic supported the safety and feasibility of outpatient administration model as a potential option to reduce healthcare resource utilization and improve treatment experiences.
Older Adults with Acute Myeloid Leukemia (AML) Experience Improvement in Health-Related Quality of Life (HRQoL) Scores with Intensive Therapy: Prospective Study from ECOG-ACRIN (EA) E2906 Phase 3 Trial
Foran, James M. , Luger, Selina M. , Sun, Zhuoxin , Rowe, Jacob M. , Altman, Jessica K. , Al‐Kali, Aref , Zheng, Hong , Pratz, Keith W. , Broun, E. Randolph, Powell, Bayard L., O’Dwyer, Kristen M. , Litzow, Mark R. , Tallman, Martin S. , Zheng, Hong , Chen, Li , Klepin, Heidi D. , Claxton, David F. , Lazarus, Hillard M. , O'Dwyer, Kristin , Ofran, Yishai , Godwin, John E. , Wagner, Lynne I.

Blood | December 1, 2023 | Volume: 142 | Issue: Supplement 1 | Pages: 594-594

10.1182/blood-2023-189734 Get It

Background There is limited prospective or comparative data evaluating the HRQoL impact of intensive chemotherapy (IC) in older adults (age ≥60 years) with AML. In the recent EA E2906 phase 3 study of '7&3' (daunorubicin & cytarabine) vs. clofarabine (CLO), a putative lower intensity therapy, we incorporated a prospective patient-reported outcomes (PRO) assessment of HRQoL and fatigue to understand treatment impact from the patients' (pts) perspective. Methods E2906 study design and results have been presented previously [n=727, med. age 68 years (range 60-86), randomized 1:1 to ‘standard’ ‘7&3‘ & high dose cytarabine (Arm A) vs. single agent CLO (Arm B), as remission induction (Step 1) and consolidation (Step 2), respectively]. There was no difference in composite complete remission (CCR, 50%) or 30-day mortality rates (8.5%), and in primary analysis CLO was inferior for Overall Survival. HRQoL was a key secondary protocol endpoint. PROs assessed HRQoL and leukemia-specific symptoms and concerns using Functional Assessment of Cancer Therapy-Leukemia scale (FACT-Leu), & Fatigue using FACT-Fatigue subscale. PROs were administered at prespecified time points: (1) Baseline; (2) Cycle 1 at nadir (approx. Day 15); (3) End of Step 1 restaging (approx. D 40); (4) Beginning of Step 2 (1 st consolidation, approx. D 45); and (5) 2 nd cycle consolidation/End Step 2 (approx. D 60). The FACT-Leu Trial Outcome Index ( TOI) was calculated by summing physical well-being, functional well-being, and leukemia-specific concerns subscales to create a single composite score. Higher TOI scores correspond to better HRQoL. The primary endpoint was to evaluate TOI difference from randomization to day 30 after induction therapy between arms, evaluated using Wilcoxon rank sum test. We also compared Clinically Meaningful differences (CMiD) in TOI (defined as patient change ≥½ standard deviation from baseline TOI) between arms, using the X2 test. Pts not completing at least 2 assessment forms (including baseline) were excluded. Testing of constructs of Physical Well-being (PWB), Functional, Leukemia & Fatigue scales demonstrated high Cronbach's a values (a >0.7) except for PWB (a=0.672) at a single time point (End of Step 2). Results Baseline TOI was available for n=489, and 364 pts (n=182 each Arm) were evaluable in this planned analysis. Evaluating CMiD during Cycle 1 induction, pts in Arm B were less likely to experience ‘Worse’ TOI score (32% vs. 40.7%, Arm A), more likely to maintain stable TOI scores (49.1% vs. 39%, Arm A), and had a similar proportion of ‘Better’ TOI scores (20.3%, A vs. 18.9%, B) although differences were not significant (p=0.1389). Conversely in cycle 1 consolidation, more patients in Arm A experienced Better TOI (45.1% vs. 29.2%, Arm B), fewer had stable TOI (45.1% vs. 58.3%, Arm B), and rates of ‘Worse’ TOI were similar (9.8%, A vs 12.5%, Arm B), again differences were not significant (p=0.2616). There was no difference in Fatigue scores between Arms (p=0.49). We evaluated whether TOI and Fatigue scores could predict the ability to complete protocol therapy. In univariate analysis baseline TOI (p=0.0059) and Fatigue (p=0.0057) were associated with Step 1 completion, however on multivariate analysis (adjusting for age, sex, and Arm) were no longer significant [TOI, Odds Ratio (OR) 1.03 (0.98-1.08, p=0.27); Fatigue, OR 1.03 (0.96-1.11, p=0.42)]. There was a borderline association of TOI with Step 2 completion [TOI OR 1.10 (1.00-1.23, p=0.06)]. Using a multivariable linear mixed effects model, we observed similar and significant changes in TOI scores in both Arms, demonstrating the effect of IC & CLO on HRQoL (Figure). Comparing to baseline, TOI scores decreased significantly at C1 induction nadir (-4.0873, p<0.0001), and increased by 5.0762 (p=0.0004) at end Step 1, by 6.9047 at cycle 1 consolidation (p<0.0001), and by 11.4601 (p<0.0001) at end Step 2. Differences were mainly apparent in those who achieved CCR, and there was significant attrition in PRO responses in non-CCR pts. Conclusions Older adults experienced significant improvement in HRQoL after nadir regardless of therapy, and those achieving CCR report significantly higher scores. We did not observe differences in leukemia specific HRQoL or fatigue between treatment Arms (7&3 vs. CLO). Patient-reported HRQoL & Fatigue was not predictive of completion of protocol therapy. These results serve as a benchmark for expectations with IC in older adults.
Oncological and functional outcomes after resection of malignant tumours of the scapula
Sullivan, Mikaela H. , Sánchez‐Sotelo, Joaquín , Rose, Peter S. , Houdek, Matthew T. , Morrey, Mark, Sanchez-Sotelo, J. , Houdek, Matthew T , Broida, Samuel E. , Barlow, Jonathan D. , Morrey, Mark E. , Scorianz, Maurizio , Wagner, Eric R.

The Bone & Joint Journal | December 1, 2023 | Volume: 105-B | Issue: 12 | Pages: 1314-1320

10.1302/0301-620x.105b12.bjj-2023-0552.r1 | PMID 38035605 Get It

AimsThe scapula is a rare site for a primary bone tumour. Only a small number of series have studied patient outcomes after treatment. Previous studies have shown a high rate of recurrence, with functional outcomes determined by the preservation of the glenohumeral joint and deltoid. The purpose of the current study was to report the outcome of patients who had undergone tumour resection that included the scapula.MethodsWe reviewed 61 patients (37 male, 24 female; mean age 42 years (SD 19)) who had undergone resection of the scapula. The most common resection was type 2 (n = 34) according to the Tikhoff-Linberg classification, or type S1A (n = 35) on the Enneking classification.ResultsThe ten-year disease-specific survival was 76%. High tumour grade (hazard ratio (HR) 4.27; p = 0.016) and a total resection of the scapula (HR 3.84; p = 0.015) were associated with worse survival. The ten-year metastasis-free and local recurrence-free survivals were 82% and 86%, respectively. Total scapular resection (HR 6.29; p = 0.004) was associated with metastatic disease and positive margins were associated with local recurrence (HR 12.86; p = 0.001). At final follow-up, the mean shoulder forward elevation and external rotation were 79° (SD 62°) and 27° (SD 25°), respectively. The most recent functional outcomes evaluated included the mean Musculoskeletal Tumor Society Score (76% (SD 17%)), the American Shoulder and Elbow Score (73% (SD 20%)), and the Simple Shoulder Test (7 (SD 3)). Preservation of the glenoid (p = 0.001) and scapular spine (p < 0.001) improved clinical outcomes; interestingly, preservation of the scapular spine without the glenoid improved outcomes (p < 0.001) compared to preservation of the glenoid alone (p = 0.05).ConclusionResection of the scapula is a major undertaking with an oncological outcome related to tumour grade, and a functional outcome associated with the status of the scapular spine and glenoid. Positive resection margins are associated with local recurrence.Cite this article: Bone Joint J 2023;105-B(12):1314–1320.
Obstructive Sleep Apnea Associated With Increased Failure Rate of Ptosis Repair
Nirmalan, Aravindh, Tran, Meagan , Tailor, Prashant D. , Hodge, David O. , Wagner, Lilly H. , Bartley, George B., Tooley, Andrea A. , Tran, Meagan T , Tailor, Prashant, Hodge, David, Tooley, Andrea A , Tailor, Prashant D , Bradley, Elizabeth A.

Ophthalmic Plastic & Reconstructive Surgery | November 23, 2023 | Volume: 40 | Issue: 2 | Pages: 201-205

10.1097/iop.0000000000002547 | PMID 37995148 Get It

Purpose: This study investigates how Obstructive sleep apnea (OSA) affects the outcomes of ptosis repair. We hypothesized that patients with OSA have an increased rate of reoperation after ptosis repair. Methods: This retrospective cohort study included patients age >18 from the Mayo Clinic who underwent ptosis repair by levator advancement or Müller muscle-conjunctiva resection between 2018 and 2021. Outcomes were measured at 1 to 3 months of follow-up with surgical failure defined as asymmetry or unsatisfactory eyelid height requiring revision surgery within 1 year. Results: A total of 577 patients met the inclusion criteria. There was a statistically significant difference in surgical failure between patients with OSA and those without (20.5% vs. 13.1%, p = 0.02). Patients with OSA showed a statistically significant difference in risk of revision by a factor of 1.70 (95% CI: 1.06–2.07). Revisions were attributed to unsatisfactory eyelid height in 72.6% of patients and eyelid asymmetry in 21.1%. All patients who had revision surgery had satisfactory outcomes. On logistic regression analysis, when adjusting for age and sex, OSA was significantly associated with ptosis revision (p = 0.007). Conclusions: OSA increases risk of surgical failure and need for revision surgery in patients undergoing blepharoptosis repair but is not a sole risk factor.
Clinician Perspectives Regarding the Impact of Information Technology on Multidisciplinary Tumor Boards: A National Comprehensive Cancer Network Survey
Arafat, Waddah , Wagner, Andrew J. , Osterman, Travis , Martin, Daniel , Sugalski, Jessica , Heinrichs, Tricia , Racz, Jennifer M. , Tevaarwerk, Amyé , Wagner, Andrew J , Osterman, Travis , Martin, Daniel B , Sugalski, Jessica , Heinrichs, Tricia , Racz, Jennifer , Tevaarwerk, Amye J , Fu, Paul C.

JCO Clinical Cancer Informatics | November 9, 2023 | Volume: No volume available | Issue: 7 | Pages: No page available

10.1200/cci.23.00056 | PMID 37944060 Get It

PURPOSE Multidisciplinary tumor boards (MTBs) support high-quality cancer care. Little is known about the impact of information technology (IT) tools on the operational and technical aspects of MTBs. The National Comprehensive Cancer Network EHR Oncology Advisory Group formed a workgroup to investigate the impact of IT tools such as EHRs and virtual conferencing on MTBs. METHODS The workgroup created a cross-sectional survey for oncology clinicians (eg, pathology, medical, surgical, radiation, etc) participating in MTBs at 31 National Comprehensive Cancer Network member institutions. A standard invitation e-mail was shared with each EHR Advisory Group Member with a hyperlink to the survey, and each member distributed the survey to MTB participants at their institution or identified the appropriate person at their institution to do so. The survey was open from February 26, 2022, to April 26, 2022. Descriptive statistics were applied in the analysis of responses, and a qualitative thematic analysis of open-ended responses was completed. RESULTS Individuals from 27 institutions participated. Almost all respondents (99%, n = 764 of 767) indicated that their MTBs had participants attending virtually. Most indicated increased attendance (69%, n = 514 of 741) after virtualization with the same or improved quality of discussion (75%, n = 557 of 741) compared with in-person MTBs. Several gaps between the current and ideal state emerged regarding EHR integration: 57% (n = 433 of 758) of respondents noted the importance of adding patients for MTB presentation via the EHR, but only 40% (n = 302 of 747) reported being able to do so most of the time. Similarly, 87% (n = 661 of 760) indicated the importance of documenting recommendations in the EHR, but only 53% (n = 394 of 746) reported this occurring routinely. CONCLUSION Major gaps include the lack of EHR integration for MTBs. Clinical workflows and EHR functionalities could be improved to further optimize EHRs for MTB management and documentation.
Outcomes of patients with blastoid and pleomorphic variant mantle cell lymphoma
Gerson, James N. , Villa, Diego , Chapani, Parv , Li, Shaoying , Medeiros, L. Jeffrey , Wang, Michael , Cohen, Jonathon B. , Churnetski, Michael C. , Hill, Brian T. , Hernandez‐Ilizaliturri, Francisco J. , Kothari, Shalin , Bast, Martin, Fenske, Timothy S. , Gari, Swapna Narayana Rao, Maddocks, Kami J. , Bachanová, Veronika , Kolla, Bhaskar , Donovan, Alexandra M., Wagner‐Johnston, Nina D. , Messmer, Marcus , Anderson, Jennifer K., Reddy, Nishitha , Glenn, Martha, Inwards, David J. , Ristow, Kay M., Rajguru, Saurabh, Evens, Andrew M. , Klein, Andreas K. , Umyarova, Elvira , Pulluri, Bhargavi , Amengual, Jennifer E. , Diefenbach, Catherine , Fisher, Richard I., Villa, Diego , Gerrie, Alina S , Chapani, Parv , Li, Shaoying , Medeiros, L Jeffrey , Wang, Michael L , Sawalha, Yazeed , Vose, Julie , Bond, David A , Kolla, Bhaskar , Lansigan, Frederick , Wagner-Johnston, Nina , Messmer, Marcus , Mehta, Amitkumar , Ristow, Kay, Karmali, Reem , Caimi, Paolo F , Evens, Andrew M , Amengual, Jennifer E , Bachanova, Veronika , Diefenbach, Catherine S , Handorf, Elizabeth A. , Gerrie, Alina S. , Sawalha, Yazeed , Vose, Julie M. , Bond, David A. , Chavez, Julio C , Shah, Bijal , Lansigan, Frederick , Burns, Timothy Francis , Mehta, Amitkumar , Kovach, Alexandra E. , Landsburg, Daniel J. , Karmali, Reem , Kaplan, Jason , Caimi, Paolo F. , Lue, Jennifer Kimberly , Barta, Stefan K

Blood Advances | October 24, 2023 | Volume: 7 | Issue: 24 | Pages: 7393-7401

10.1182/bloodadvances.2023010757 | PMID 37874912 Get It

Abstract Mantle cell lymphoma (MCL) is a B-cell non-Hodgkin lymphoma; data indicate that blastoid and pleomorphic variants have a poor prognosis. We report characteristics and outcomes of patients with blastoid/pleomorphic variants of MCL. We retrospectively studied adults with newly diagnosed MCL treated from 2000 to 2015. Primary objectives were to describe progression-free survival (PFS) and overall survival (OS). Secondary objectives included characterization of patient characteristics and treatments. Of the 1029 patients with MCL studied, a total of 207 neoplasms were blastoid or pleomorphic variants. Median follow-up period was 82 months (range, 0.1-174 months); median PFS was 38 months (95% confidence interval [CI], 28-66) and OS was 68 months (95% CI, 45-96). Factors associated with PFS were receipt of consolidative autologous hematopoietic transplantation (auto-HCT; hazard ratio [HR], 0.52; 95% CI, 0.31-0.80; P &lt; .05), MCL International Prognostic Index (MIPI) intermediate (HR, 2.3; 95% CI, 1.2-4.3; P &lt; .02) and high (HR, 3.8; 95% CI, 2.0-7.4; P &lt; .01) scores, and complete response to induction (HR, 0.29 (95% CI, 0.17-0.51). Receipt of auto-HCT was not associated with OS (HR, 0.69; 95% CI, 0.41-1.16; P = .16) but was associated with MIPI intermediate (HR, 5.7; 95% CI, 2.5-13.2; P &lt; .01) and high (HR, 10.8; 95% CI, 4.7-24.9; P &lt; .01) scores. We report outcomes in a large cohort of patients with blastoid/pleomorphic variant MCL. For eligible patients, receipt of auto-HCT after induction was associated with improved PFS but not OS. Higher MIPI score and auto-HCT ineligibility were associated with worse survival.
Racial and ethnic differences in clinical outcomes among patients with multiple myeloma treated with CAR T-cell therapy
Peres, Lauren C. , Oswald, Laura B. , Dillard, Christen , Avila, Gabriel De, Nishihori, Taiga , Blue, Brandon , Freeman, Ciara L. , Alsina, Melissa , Puglianini, Omar Castañeda , Shune, Leyla , Sborov, Douglas W. , Wagner, Charlotte B , Hashmi, Hamza , Davis, James A. , Badros, Ashraf , Simmons, Gary , Kalariya, Nilesh, Ferreri, Christopher J. , Anderson, Larry D. , Afrough, Aimaz , Liu, Lawrence , Voorhees, Peter M. , Khouri, Jack , Sidana, Surbhi , Patel, Krina K. , Dillard, Christen M , Castaneda Puglianini, Omar , Sborov, Douglas W , Wagner, Charlotte , Dima, Danai , Hashmi, Hamza , Davis, James A , Kocoglu, Mehmet H , Badros, Ashraf Z , Ferreri, Christopher , Anderson, Larry D , Kaur, Gurbakhash , Liu, Lawrence , Voorhees, Peter , Khouri, Jack , McGuirk, Joseph , Sidana, Surbhi , Patel, Krina , Nishihori, Taiga , Locke, Frederick L. , Dima, Danai , Kocoglu, Mehmet H. , Atrash, Shebli , Kaur, Gurbakhash , Lin, Yi , Nadeem, Omar , McGuirk, Joseph P. , Hansen, Doris K.

Blood Advances | October 19, 2023 | Volume: 8 | Issue: 1 | Pages: 251-259

10.1182/bloodadvances.2023010894 | PMID 37855718 Get It

Abstract Idecabtagene vicleucel (ide-cel) was the first chimeric antigen receptor T-cell therapy to gain US Food and Drug Administration approval for patients with relapsed/refractory multiple myeloma (RRMM). The clinical outcomes of standard of care (SOC) ide-cel in racially and ethnically diverse populations have been understudied. This study pooled data from 207 patients with RRMM (28% patients of racial and ethnic minority groups) treated with SOC ide-cel across 11 institutions to examine racial and ethnic differences in the incidence of toxicities and adverse events, response to ide-cel, and survival. This study included 22 (11%) Hispanic, 36 (17%) non-Hispanic Black, and 149 (72%) non-Hispanic White patients with RRMM. Compared with Hispanic and non-Hispanic White patients, non-Hispanic Black patients had higher median levels of C-reactive protein (1.0, 0.8, and 3.5 mg/dL, respectively; P = .02) and baseline ferritin (362.0 vs 307.0 vs 680.5, respectively; P = .08) and were more likely to develop cytokine release syndrome (77%, 85%, and 97%, respectively; P = .04). Although best overall response rate was lower among Hispanic patients (59%) than among non-Hispanic Black (86%) and White patients (86%; P = .01), there were no racial and ethnic differences in progression-free or overall survival. We provide, to our knowledge, the first and largest investigation of clinical outcomes of SOC ide-cel by race and ethnicity. Despite differences in safety and response to ide-cel, our findings encourage the use of ide-cel in all patients with RRMM. These findings should be confirmed in larger samples of diverse patients with RRMM, with longer follow-up time.