Citations

Clear

2436 citation(s) found for "Ly, Amy".

Impact of High-Intensity Inspiratory Muscle Training on Inspiratory Muscle Strength in Healthy Adults
Toonstra, Amy , Smith, Joshua

Mayo Clinic

Cardiopulmonary Physical Therapy Journal | December 8, 2025 | Volume: 37 | Issue: 2 | Pages: 92-97

10.1097/cpt.0000000000000309 Get It

Background: Previous research has demonstrated that moderate-intensity inspiratory muscle training (IMT) improves inspiratory strength and exercise performance in athletes, but the impact of high-intensity IMT on inspiratory strength in healthy adults is unclear. The purpose of this study was to compare the effects of high-intensity versus moderate-intensity IMT on inspiratory strength and VO 2 peak in healthy adults. Methods: Twenty-six adults enrolled in this double-blinded randomized controlled trial. Participants completed an inspiratory strength assessment through S-Index and VO 2 peak testing before randomization into a moderate-intensity or high-intensity group. Participants in both groups performed IMT to 40 repetitions or task failure once per day, 5 times per week for 8 weeks. IMT intensity was 50% and 80% of pretraining S-Index for the moderate-intensity and high-intensity groups, respectively. S-Index and VO 2 peak testing were repeated at the end of the trial. Repeated measures ANOVA were used to assess differences of pretraining and post-training S-Index and VO 2 peak between groups. Results: A significant increase in mean (SD) S-Index from pretraining to post-training was present for both moderate-intensity (7.6% (8.9), P = .001) and high-intensity (10.8% (11.7), P < .001) groups. No significant group ( P = .88) or interaction ( P = .44) effects existed for S-Index. There were no significant main effects for group, time, or interaction for VO 2 peak ( P > .05 for all). Conclusions: Both moderate-intensity and high-intensity IMT to task failure in healthy adults led to significant improvements in inspiratory strength. No effects were observed in either group on changes in VO 2 peak. Given that moderate-intensity and high-intensity IMT to task failure were both effective at improving inspiratory strength in healthy adults, training intensity at less intense, moderate levels can be used to achieve similar strength gains.
Immune thrombocytopenia in patients treated with immune checkpoint inhibitors
Leaf, Rebecca Karp , Mones, Jodi V. , Shenoy, Tushar , Warsame, Mohamed , Moreira, Marina Beltrami , Panch, Sandhya , Leavitt, Andrew D., Zon, Rebecca L. , Shahamatdar, Sahar , Lim, Tristan , Cui, Can , Jiang, Debbie , Kaunfer, Sarah Allison , Durai, Lavanya , Hoge, Steven T., Dias, Julie‐Alexia , Sha, Carrie , Holmes, Aaron , Easton, Neil , Corley, Elizabeth M. , Zhao, Ethan, Li, Xingyi , Spelman, Amy, Amos, Christina Briggs, Soebbing, Doris, Shabih, Maria, Jamison, Trevor , Liu, Bolun , Hussein, Guleid , Yadav, Sumeet K. , Meara, Alexa, Juras, Patrick K. , Heskel, Marina, Reynolds, Kerry L. , Kroll, Michael H. , Leaf, David E. , Leaf, Rebecca K , Beltrami-Moreira, Marina , Cui, Can , Jiang, Debbie , Kaunfer, Sarah A , Durai, Lavanya , Dias, Julie-Alexia , Holmes, Aaron N , Easton, Neela , Corley, Elizabeth M , Liu, Bolun , Yadav, Sumeet Kumar , Elsaid, Mohamed I , Suresh, Arvind , Huang, Jennifer J , Glezerman, Ilya G , Al-Samkari, Hanny , Kroll, Michael H , Leaf, David E , Leavitt, Andrew D. , Kendall, Ellen K. , Hoge, Steven T., Li, Xingyi, Amos, Christina Briggs, Owen, Dwight H , Meara, Alexa, Go, Ronald S. , Al‐Samkari, Hanny

Mayo Clinic

Blood | December 8, 2025 | Volume: 147 | Issue: 12 | Pages: 1351-1364

10.1182/blood.2025031449 | PMID 41359796 Get It

Abstract Immune checkpoint inhibitor–associated immune thrombocytopenia (ICI-ITP) has been described in case reports and small case series, but comprehensive data on its incidence, risk factors, clinical features, treatment, and outcomes are lacking. We reviewed medical records of all adults initiating ICI therapy between 2016 and 2023 at 29 US hospitals across 7 major cancer centers to identify patients with ICI-ITP. Multivariable logistic regression was used to identify risk factors, and Cox modeling was performed to assess the association between ICI-ITP, its severity, and mortality. Among 86 467 patients, ICI-ITP occurred in 214 (0.25%). Independent risk factors included lower baseline platelet count, combination ICI therapy, stage IV cancer, and additional immune-related adverse events. ICI-ITP occurred at a median of 8 weeks (interquartile range [IQR], 4-18) after ICI initiation, with a median nadir platelet count of 41 × 109/L (IQR, 17 × 109/L to 64 × 109/L). Patients were treated with glucocorticoids (n = 106 [49.5%]), immune globulin (n = 39 [18.2%]), and thrombopoietin receptor agonists (n = 29 [13.6%]). Recovery occurred in 161 patients (75.2%) at a median of 2.3 weeks (IQR, 1.0-5.3). Of 76 patients rechallenged with ICIs, 23 (30.3%) developed recurrent ICI-ITP. ICI-ITP and its severity were associated with higher all-cause mortality, with a nearly threefold increase in risk among patients with severe ICI-ITP than those without ICI-ITP (adjusted hazard ratio, 2.96 [95% confidence interval, 2.14-4.08]). These findings establish ICI-ITP as a rare but clinically significant complication of ICI therapy, provide, to our knowledge, the first large-scale description of its risk factors and clinical course, and underscore the importance of timely recognition and management.
Comparison of Open, Laparoscopic, and Robotic Approaches for Hartmann’s Reversal: The Mayo Clinic Experience
Ferrari, Davide , Peponis, Thomas , Violante, Tommaso , Glasgow, Amy E. , Perry, William , Perry, William , Violante, Tommaso , Perry, William R , Ferrari, Davide , Larson, David W. , Behm, Kevin T.

Mayo Clinic

Diseases of the Colon & Rectum | December 8, 2025 | Volume: 69 | Issue: 3 | Pages: 432-441

10.1097/dcr.0000000000004066 | PMID 41358658 Get It

BACKGROUND: End colostomy reversal with colorectal anastomosis (Hartmann’s reversal) is a technically challenging procedure associated with significant morbidity due to adhesions and distorted anatomy after the index surgery. OBJECTIVE: To compare perioperative outcomes of open, laparoscopic, and robotic approaches for Hartmann’s reversal. DESIGN: Retrospective analysis of prospectively maintained data. SETTINGS: High-volume tertiary referral center with specialized colorectal surgery expertise. PATIENTS: A total of 218 patients who underwent Hartmann’s reversal between May 2018 and April 2023. MAIN OUTCOME MEASURES: Primary outcomes included hospital length of stay and rate of conversion. Secondary outcomes included overall complication rates and time to return of bowel function. RESULTS: Of 218 patients, 139 (63.8%) underwent open surgery, 48 (22.0%) underwent laparoscopic surgery, and 31 (14.2%) underwent robotic surgery. Robotic surgery had the lowest estimated blood loss (median 77.5 vs 100 mL laparoscopic and 150 mL open, p < 0.0001). Conversion to open surgery occurred in 16.1% of robotic cases compared with 35.4% of laparoscopic cases ( p = 0.0618). Minimally invasive approaches were associated with shorter hospital length of stay (median 3.0 vs 4.0 days, p < 0.0001) and faster return of bowel function (median 2.0 vs 3.0 days, p = 0.0095) compared to open surgery. Overall 30-day morbidity was 23.4%, with no significant difference among approaches ( p = 0.30). The temporal trend showed increasing adoption of robotic techniques, from 0% in 2018 to 53.8% in 2023, and a decrease in the proportion of cases approached by open surgery, from 76.9% in 2018 to 23.1% in 2023. LIMITATIONS: Retrospective design and single-institution experience with limited follow-up duration. CONCLUSIONS: Minimally invasive approaches to Hartmann’s reversal are associated with improved short-term outcomes compared to open surgery. The robotic approach shows promise in reducing conversion rates, potentially extending the benefits of minimally invasive surgery to more patients undergoing this challenging procedure. See Video Abstract . COMPARACIÓN DE LOS ENFOQUES ABIERTO, LAPAROSCÓPICO Y ROBÓTICO PARA LA REVERSIÓN DE HARTMANN: LA EXPERIENCIA DE LA CLÍNICA MAYO ANTECEDENTES: La reversión de la colostomía terminal con anastomosis colorrectal (reversión de Hartmann) es un procedimiento técnicamente complejo asociado a una morbilidad significativa debido a las adherencias y la distorsión anatómica tras la cirugía inicial. OBJETIVO: Comparar los resultados perioperatorios de los abordajes abiertos, laparoscópicos y robóticos para la reversión de Hartmann. DISEÑO: Análisis retrospectivo de datos mantenidos prospectivamente. ENTORNO: Centro terciario de referencia de gran volumen con experiencia especializada en cirugía colorrectal. PACIENTES: Un total de 218 se sometieron a la reversión de Hartmann entre mayo de 2018 y abril de 2023. PRINCIPALES MEDIDAS DE RESULTADOS: Los resultados primarios incluyeron la duración de la estancia hospitalaria y la tasa de conversión. Los resultados secundarios incluyeron las tasas generales de complicaciones y el tiempo de recuperación de la función intestinal. RESULTADOS: De los 218 pacientes, 139 (63,8 %) se sometieron a cirugía abierta, 48 (22,0 %) a cirugía laparoscópica y 31 (14,2 %) a cirugía robótica. La cirugía robótica tuvo la menor pérdida de sangre estimada (mediana, 77,5 ml frente a 100 ml en laparoscopia y 150 ml en cirugía abierta, p < 0,0001). La conversión a cirugía abierta se produjo en el 16,1 % de los casos robóticos frente al 35,4 % de los casos laparoscópicos ( p = 0,0618). Los abordajes mínimamente invasivos se asociaron con una estancia hospitalaria más corta (mediana de 3,0 días frente a 4,0 días, p < 0,0001) y un retorno más rápido de la función intestinal (mediana de 2,0 días frente a 3,0 días, p = 0,0095) en comparación con la cirugía abierta. La morbilidad global a los 30 días fue del 23,4 %, sin diferencias significativas entre los distintos enfoques ( p = 0,30). La tendencia temporal mostró un aumento en la adopción de técnicas robóticas, del 0 % en 2018 al 53,8 % en 2023, y una disminución en la proporción de casos abordados mediante cirugía abierta, del 76,9 % en 2018 al 23,1 % en 2023. LIMITACIONES: Diseño retrospectivo y experiencia de una sola institución con una duración de seguimiento limitada. CONCLUSIONES: Los enfoques mínimamente invasivos para la reversión de Hartmann se asocian con mejores resultados a corto plazo en comparación con la cirugía abierta. El enfoque robótico es prometedor para reducir las tasas de conversión, lo que podría ampliar los beneficios de la cirugía mínimamente invasiva a más pacientes que se someten a este procedimiento tan complejo. ( AI-generated translation ).
New Validated Staging System for Light Chain (AL) Amyloidosis With Stage IIIC Defining Ultra-Poor Risk: AL International Staging System
Kirkwood, Amy A. , Yohannan, Binoy , Theodorakakou, Foteini , Weverling, Flores , Simone, Valeria Di , Kumar, Shaji , Petropoulos, Ιoannis , Cohen, Oliver , Stamatelopoulos, Κimon , Whelan, Carol , Venneri, Lucia , Fontana, Marianna , Mahmood, Shameem, Schwotzer, Rahel , Wechalekar, Ashutosh , Khwaja, Jahanzaib , Milani, Paolo , Yohannan, Binoy , Theodorakakou, Foteini , Weverling, Flores , Di Simone, Valeria , Kumar, Shaji K , Petropoulos, Ioannis , Mussinelli, Roberta , Oerlemans, Marish I F J , Muchtar, E , Stamatelopoulos, Kimon , Gertz, Morie A , Fontana, Marianna , Minnema, Monique C , Dispenzieri, Angela , Palladini, Giovanni , Kastritis, Efstathios , Wechalekar, Ashutosh D. , Gillmore, Julian D , Milani, Paolo , Ravichandran, Sriram , Mussinelli, Roberta , Oerlemans, Marish I.F.J. , Muchtar, Eli , Lachmann, Helen J. , Gillmore, Julian D. , Briasoulis, Αlexandros , Gertz, Morie A. , Dispenzieri, Angela , Palladini, Giovanni , Kastritis, Efstathios

Mayo Clinic

Journal of Clinical Oncology | December 7, 2025 | Volume: 44 | Issue: 4 | Pages: 311-320

10.1200/jco-25-02558 | PMID 41353737 Get It

PURPOSE Outcomes in systemic light chain (AL) amyloidosis have improved with modern therapy limiting utility of existing risk stratification models. We validate a new staging system, incorporating longitudinal strain (LS) to the biomarker-based (NT-proBNP and Troponin-T) staging system in the contemporary treatment era (2015-2024). METHODS AL International Staging System (AL-ISS) was derived from a cohort of patients with AL amyloidosis from the UK National Amyloidosis Centre (2015-2019). The model was validated in patient cohorts from Europe (Greece, Italy, the Netherlands, and Switzerland), the United States (2015-2024), and the United Kingdom (2020-2024). RESULTS In total, 2,493 patients were included (derivation, n = 573; validation n = 1,920). In a multivariable model for the derivation cohort, LS ≥ –9% and cardiac biomarkers at previously validated thresholds (NT-proBNP 332 ng/L and 8,500 ng/L and high-sensitivity troponin T ≥ 50 ng/L) were independent poor prognostic factors stratifying patients into stages I, II, IIIA, IIIB, and IIIC. In the validation cohort, the patient stages were stage I: 317 (17%), II: 782 (41%), IIIA: 551 (29%), IIIB: 174 (9%), and IIIC: 96 (5%), respectively (first-line daratumumab treated: 826; 43%). With a median follow-up of 34 months, median overall survival (OS) was not reached (NR); estimated 1-year, 2-year, and 3-year OS was 82%, 74%, and 70% respectively. The median survival for stages I to II, IIIA, IIIB, and IIIC were NR, 67, 26, and 7 months (1-year OS IIIC 53% v 68% for IIIB in the daratumumab-treated patients), respectively ( P < .001). External validation exhibited good predictive performance: 12-month calibration slope was 1.09, Harrell C 0.69, Royston D 1.19, and R 2 D 0.25. Stage IIIC independently discriminated the poorest outcome across all cohorts. CONCLUSION This defines and validates a new staging system from systemic AL amyloidosis with robust identification of an ultra-poor risk stage (IIIC) in contemporarily treated patients.
In‐Office Steroid Injections for Idiopathic Subglottic Stenosis: A Systematic Review
Rendon, Eric Delgado , Saleem, Nawfal, Weiss, Natalie , Rutt, Amy L. , Delgado Rendon, Eric , Rutt, Amy L. , Saleem, Nawfal

Mayo Clinic

The Laryngoscope | December 6, 2025 | Volume: 136 | Issue: 5 | Pages: 2018-2025

10.1002/lary.70300 | PMID 41351436 Get It

ABSTRACT Objectives To critically evaluate clinical and voice‐related outcomes of in‐office serial intralesional steroid injection (SILSI) in adults diagnosed with idiopathic subglottic stenosis (iSGS). Data Sources MEDLINE, Embase, CINAHL Ultimate, CENTRAL, ClinicalTrials.gov . Review Methods A systematic search of databases was conducted from inception through April 5, 2025. Studies eligible for inclusion must have reported on adult SILSI recipients undergoing management of iSGS. Articles were independently screened and reviewed by two authors for treatment variables including steroid protocol, clinical outcomes, respiratory function, vocal outcomes, and complications. Results Of 383 studies identified, 14 met inclusion criteria ( n = 371). Triamcinolone was the most commonly used agent in 10 studies. Steroid dosage, number of treatment sessions, and injection interval varied widely across studies. Improvements in surgery‐free interval, peak expiratory flow, dyspnea index, degree of stenosis, and voice‐related outcomes were observed in several studies. No major complications were reported in the included studies. Conclusion Current evidence suggests SILSI represents a promising adjunctive therapy in the treatment of iSGS, with improvement noted across several measures. However, significant variability in steroid treatment regimens and inconsistent reporting of outcomes complicate interpretations of efficacy.
Automated Insulin Delivery Is Beneficial in Adults With Insulin-Treated Type 2 Diabetes With and Without GAD65 Antibodies
Beck, Roy W. , Hirsch, Irl B., Raghinaru, Dan, Lum, John W. , Pinsker, Jordan E. , Kudva, Yogish C. , Group*, 2IQP Study, Desjardins, Donna, Kurek, Corey, Kaur, Ravinder Jeet , Livingood, Daine, Rizvi, Shafaq , Graham, Timothy E., Terry, Adrienne, Luker, Ryan, Mellenthin, Melanie, Rezac, Stephanie, Liljenquist, David R., Rogers, Justin, Williams, Jonathan, Christensen, Rochelle, Lee, In‐Kyoung, Malone, Joann, Spanakis, Elias K. , Singh, Lakshmi G., Churchill, Jade, Comen, Kathleen, Scott, William H., Davis, Georgia M. , Arroyo, Lizda Guerrero, Oladejo, Omolade , Usman, Sabeena, Ahmann, Andrew , Schmid, Caleb, Dean, Ariel, Branigan, Deborah , Caswell, Brittany, Heyerman, Tess, Tessman, Brian, Vanderheide, Jnh, Dennis, Brittany , Hendricks, Lisa, Reyes-Rodriguez, Clemente, Wolf, Valerie, Coyne, Kasey, Kravarusic, Jelena, Fronczyk, Evelyn, Herrmann, Stefanie, Penn, Samsam C., Blevins, Thomas , Casaubon, Luis, Espinosa, Valerie, Pandit, Keta, Perez, Jennifer, Stewart, Ana, Assir, Courtney, Fields, Cory, Kruger, Davida , Estrada, Kathleen, Jones, J. Kimberly, Mukhashen, Shereen, Corker, Natalie, Hunter, Heather, Layton, Paula, Brown, Sue A. , Afreen, Samina , Dhillon, Jasmeen, Emory, Emma, Fulkerson, David, Fuller, Morgan, Holmes, Viola, Kollar, Laura, Toole, Elyse, Levister, Camilla, O’Malley, Grenye , Ipek, Aslihan, Alabi, Denise, Ellis, Emily, Hassan, Shaziah, Ogyaadu, Selassie, Tamarez, Denisa, Weinstock, Ruth S. , Stone, Sheri , Bzdick, Suzan, Agostini, Lynn, Bulger, Jane , Wolpert, Howard , Atakov-Castillo, Astrid , Sullivan, Asya, Aia, Corinne, Brouillard, Elizabeth, Driscoll, Marsha, Lapier, Heather, Payra, Sherryl, Vancer, Louise, Averkiou, Xenia, Baran, Jesica, Holod, Rosanna, Litvicov, Patrisia, Mandava, Patali, Swinton, Sydney, Khakpour, Dori , Broyles, Frances E. , Marks, Sheryl, Mitchell, Tina, Hairston, Babette, Costello, Reilly, Curtis, Stella, Kamimoto, Jorge Jo, Peleckis, Amy J. , Sultan, Rahaf , Dalton-Bakes, Cornelia, Bourne, Patricia, Haidar, Ahmad, Pasqua, Melissa, Tardio, Vanessa , Moore, Adelyn, Kemp, Gabrielle, Raskin, Philip, Jordan, L.F., Shao, Baomei, DoNguyen, Trang, Meeks, Tram, Phan, Michael , Lesniak, Amanda, Becerra, Mario, Bellini, Natalie J. , Denallo, Erica, Lewis, Claudia , Tribout, Jerry, Tribout, Megan, DiFrancesco, Kathryn, Phillips, Kylie, Raghinaru, Dan, Campos, Tiffany, Morrell, Beth, Oduah, Vanessa, Cardenas-Villamil, Gabriela, Morales, Amanda, Murphy, Carlos, Strayer, Heidi, Spanbauer, Charles , Kollman, Craig, Sasson-Katchalski, Ravid, Piquette, Nicole, Wheatcroft, Alex, WHITE, KIRSTIN N., Carmelo, KC, Janicek, Robert, Gabrielson, Deanna, Mercado, Kevin, Beck, Roy W , Group*, 2IQP Study, Smith, Joshua W. , Christensen, Rochelle, Malone, Joann, Pasquel, Francisco J. , Tajrishi, Farbod Zahedi , Arroyo, Lizda Guerrero, Dean, Ariel, Howard, Matthew, Vander-Heide, Jesse, Ahn, David , Aleppo, Grazia , Fields, Cory, Layton, Paula, Oliveri, Mary Clancy , Levy, Carol J. , Agostini, Lynn, Steenkamp, Devin W , Spaic, Tamara , Liu, Selina , Marks, Sheryl, Mitchell, Tina, Costello, Reilly, Curtis, Stella, Rickels, Michael R. , Bourne, Patricia, Tsoukas, Michael A. , Pasqua, Melissa-Rosina , Moore, Adelyn, Kemp, Gabrielle, Meeks, Tram, Phan, Michael, Hatipoğlu, Betül , Lesniak, Amanda, Howard, Quiana , DiFrancesco, Kathryn, Raghinaru, Dan, Morrell, Beth, Morales, Amanda, Kanapka, Lauren , Le, Van

Mayo Clinic

Diabetes Care | December 5, 2025 | Volume: 49 | Issue: 2 | Pages: e18-e20

10.2337/dc25-2059 | PMID 41348329 Get It

Updates in antithrombotic therapy in coronary and peripheral artery disease
Pollak, Amy W., Pollak, Amy West

Mayo Clinic

Hematology | December 5, 2025 | Volume: 2025 | Issue: 1 | Pages: 34-38

10.1182/hematology.2025000684 | PMID 41348008 Get It

Abstract Atherosclerotic cardiovascular disease (ASCVD) encompasses a spectrum of vascular conditions, including coronary artery disease (CAD) and lower extremity peripheral artery disease (PAD), which frequently coexist. In the setting of ASCVD, there is a common underlying pathophysiology for acute ischemic events related to platelet activation and thrombin generation. The scope of this review focuses on the role of dual-pathway inhibition, the approach combining antiplatelet and antithrombotic therapy, for improvement in cardiovascular outcomes in patients with ASCVD. To determine which patients with CAD and PAD may benefit from dual-pathway inhibition, a brief overview of clinical presentations for both stable CAD and the spectrum of lower extremity PAD is outlined.
Progression of disease within 36 months (POD36) of starting first-line targeted therapy independently predicts poor overall survival in patients with chronic lymphocytic leukemia (CLL)
Hampel, Paul J. , Leis, José F., Koehler, Amber B. , Bailen, Rachel, Coddington, Catherine, Behnken, Amy, Schwager, Susan M., Hanson, Curtis A. , Mendoza, Cinthya, Rabe, Kari G. , Maurer, Matthew J. , Wang, Yucai , Kenderian, Saad S. , Muchtar, Eli , Roeker, Lindsey E. , Tsang, Mazie , Hilal, Talal , Parrondo, Ricardo D , Coddington, Catherine, Braggio, Esteban , Shi, Min , Slager, Susan L. , Kay, Neil E. , Parikh, Sameer A.

Mayo Clinic

Blood | December 5, 2025 | Volume: 146 | Issue: Supplement 1 | Pages: 5667-5667

10.1182/blood-2025-5667 Get It

Abstract BACKGROUND Early disease progression within 24 months following chemoimmunotherapy (CIT) is an established adverse prognostic factor for overall survival (OS) in patients (pts) with indolent non-Hodgkin lymphomas. Initially reported in pts with follicular lymphoma, progression of disease (PD) within 24 months in pts with CLL treated with CIT (occurring in ~1-out-of-4 pts) is also associated with inferior OS. The prognostic utility of early event status in pts with CLL treated with targeted therapies is unknown. Recently, we reported worse than expected outcomes with BCL2 inhibitor (BCL2i) treatments in an international cohort of pts with covalent BTK inhibitor (BTKi)-resistant, CIT-naïve CLL. We hypothesize that early disease progression on first-line (1L) targeted agent treatment will identify additional pts with high-risk disease beyond conventional prognostics in the current era. METHODS We identified pts in the Mayo Clinic CLL Database with the following 1L treatments a) BTKi (+/- anti-CD20 monoclonal antibody [CD20mAb]); b) BCL2i + CD20mAb; c) BTKi + BCL2i +/- CD20mAb. PD was defined by a) new or progressive lymphadenopathy or splenomegaly; and/or b) ≥ 50% increase from nadir absolute lymphocyte count (ALC) with persistent (&gt;2 months), and otherwise unexplained ALC ≥ 10x109/L; and/or c) Richter transformation. Logistic regression model evaluated association between clinical factors and POD36 status. OS in pts with PD within 36 months of 1L start (POD36) was evaluated and compared to those without early PD (non-POD36) with analyses: a) starting from time of PD (POD36) and starting from 3 years after 1L initiation (non-POD36); and b) Kaplan-Meier landmark analysis amongst pts alive 3 years post 1L initiation. Cox regression analyses compared a) OS from POD36 by groups and b) OS from 1L treatment with POD36 as a time-dependent covariate. RESULTS A total of 787 pts with CLL initiated 1L targeted therapy (n=538 [68%] BTKi +/- CD20mAb; n=151 [19%] BCL2i + CD20mAb; n=98 [13%] BTKi + BCL2i +/- CD20mAb. The median age at 1L start was 67 years (range 26-92 years), and 67% of pts were male. Among pts with complete CLL-IPI data (n=519), 44% and 15% had high- and very high-risk CLL-IPI risk scores, respectively. Specific pre-1L treatment disease characteristics included TP53 disruption (del17p or TP53 mutation) in 120/639 (19%), del11q in 103/634 (16%), unmutated IGHV in 406/591 (69%), complex karyotype (≥3 clonal structural or numerical abnormalities on karyotype) in 70/273 (26%), and positive CD49d expression in 229/449 (46%). The median pre-treatment beta-2-microglobulin level was 3.3 mcg/mL (range 1.2-24.4 mcg/mL). The median follow-up from 1L start was 50 months (95% CI 46-54 months). 496 pts met criteria for defining POD36 status; 72 (15%) had PD, and 424 did not. TP53 disruption (OR 2.9; 95% CI 1.5-5.7, P=0.001) was associated with POD36 on univariate analysis; complex karyotype, unmutated IGHV status, elevated serum lactate dehydrogenase level, age, sex, and inclusion of CD20mAb were not associated with POD36 status. Median OS from the time of determination of POD36 status was not reached. OS was significantly shorter after POD36 compared to non-POD36 pts (HR 3.5; 95%CI 2.1-6.0, P&lt;0.0001), with 4-year OS estimates of 65% and 88%, respectively. When assessed by landmark analysis at the 3-year timepoint following 1L start (n=50 POD36), OS was also shorter in pts with POD36 compared to non-POD36 pts (HR 3.5; 95%CI 1.8-6.8, P=0.0002). In the overall cohort (n=787), when evaluating OS from 1L treatment with POD36 as a time-dependent covariate, POD36 status was associated with an increased risk of death (HR 4.3; 95% CI 2.6-7.1, P&lt;0.0001) on univariable analysis; and remained an independent marker of shorter OS in multivariable analyses after adjusting for age, sex, TP53 disruption status, and IGHV status (HR 4.2; 95% CI 2.1-8.4, P&lt;0.0001). CONCLUSIONMost pts achieved durable CLL disease control with 1L targeted treatments, and early PD occurs much less frequently than previously reported with CIT. However, among pts who receive 1L targeted therapies for CLL, PD within 36 months is associated with a ~4-fold higher risk of death. These results, if validated in larger data sets, will provide a practical measure for identifying a high-risk subgroup of pts in need of novel treatment strategies in future trials.
Pirtobrutinib versus usual care for patients with richter transformation of chronic lymphocytic leukemia: Inverse probability of treatment weighting-based analysis of BRUIN trial and mayo observational cohort
Hampel, Paul J. , Schwager, Susan M., Hanson, Curtis A. , King, Rebecca, Zepeda, Cinthya Mendoza, Koehler, Amber B. , Behnken, Amy, Coddington, Catherine, Wang, Yucai , Rabe, Kari G. , Roeker, Lindsey E. , Zhou, Jihao , Atallah‐Yunes, Suheil Albert , Shi, Min , Kenderian, Saad S. , Muchtar, Eli , Kay, Neil E. , Coddington, Catherine, Slager, Susan L. , Parikh, Sameer A.

Mayo Clinic

Blood | December 5, 2025 | Volume: 146 | Issue: Supplement 1 | Pages: 5673-5673

10.1182/blood-2025-5673 Get It

Abstract Introduction: Pirtobrutinib, a highly selective non-covalent BTK inhibitor, demonstrated encouraging efficacy in Richter transformation (RT) of chronic lymphocytic leukemia (CLL) in the BRUIN trial (Wierda et al, Lancet Haematology, 2024). However, a control arm was not included in this phase 1/2 trial, and how pirtobrutinib compares to usual care is unknown. To address this gap of knowledge, we sought to compare efficacy outcomes in BRUIN to that in a control cohort consisting of RT patients treated with usual care at Mayo Clinic. Methods: The study was approved by the Mayo Clinic IRB. Patient-level data from BRUIN (n=79; investigator-assessed) were obtained from the study sponsor. Patients with histologically confirmed RT (large B-cell lymphoma) who received at least one line of therapy (n=230) were identified from the Mayo Clinic CLL Database. Multivariable logistic regression was employed to calculate propensity scores for baseline covariates (ie, age at RT treatment line, number of prior lines of CLL treatment [truncated at 3], number of prior lines of RT treatment [truncated at 3], and LDH). For each Mayo patient, propensity scores for each line of RT therapy were calculated, and the line with the highest propensity score was chosen as the index RT treatment line. Using the inverse probability treatment weighting (IPTW) methodology, individual weights were computed, and standardized mean differences (SMDs) were examined for each of the unadjusted and weighted baseline covariates to ensure that balance was obtained between BRUIN cases and Mayo controls. Overall survival (OS; the primary endpoint) and progression-free survival (PFS) were analyzed using unweighted and weighted Cox proportional hazards models. Unweighted and weighted overall response rates (ORRs) and complete response (CR) rates were analyzed using logistic regression. Results: The final analysis dataset contained 79 BRUIN cases (median age 67 [range 26-95], 66% male) and 204 Mayo controls (median age 69 [range 30-89], 74% male). The BRUIN cohort had more patients with ECOG PS ≥1 (61% vs 40%, p=0.001) and elevated LDH (81% vs 63%, p=0.003) than the Mayo cohort. The proportion of patients with TP53 aberration was not statistically different in both cohorts (57% vs. 44%, p=0.15). The index line of RT treatment in the Mayo cohort included chemoimmunotherapy (n=167, 80%) and novel agent-based therapy (eg, cBTKi, venetoclax, PI3Ki, immune checkpoint inhibitor, etc; n=42, 20%). Median lines of prior CLL therapy were 2 (IQR 1-4) vs 1 (IQR 0-3) in the BRUIN and Mayo cohorts, respectively; median lines of prior RT therapy were 2 (IQR 1-2) vs 0 (IQR 0-2). The SMDs of the weighted baseline factors met pre-determined criteria (-0.25≤SMD≤0.25), indicating that balance between the two cohorts was achieved. The median follow-up was 18.3 months (range 0.7-32.9) in the BRUIN cohort and 122.8 months (range 0-280.2) in the Mayo cohort. The unweighted median OS was 12.5 months (95% CI 7.0-20.6) in the BRUIN cohort and 5.7 months (95% CI 3.9-10.7) in the Mayo cohort. The unweighted HR was 0.76 (95% CI 0.54-1.07, p=0.12). After IPTW, the weighted HR was 0.63 (95% CI 0.50-0.78, p&lt;0.001), significantly favoring the BRUIN cohort. The unweighted median PFS was 3.6 months (95% CI 2.8-5.1) in the BRUIN cohort and 3.1 months (95% CI 2.5-4.3) in the Mayo cohort. The unweighted HR was 0.98 (95%CI 0.72-1.34, p=0.92). After IPTW, the weighted HR was 0.78 (95% CI 0.64-0.95, p=0.01), again favoring the BRUIN cohort. Response was evaluable/available in 69 patients in BRUIN and 182 patients in Mayo cohort. The unweighted ORR was 58% vs 53% in BRUIN and Mayo cohorts, respectively (OR=0.83, 95% CI 0.47-1.45, p=0.51), and the CR rate was 16% vs 36% (OR=2.94, 95% CI 1.43-5.88, p=0.003). After IPTW, the weighted OR was 0.65 (95% CI 0.45-0.93, p=0.02) for ORR, favoring the BRUIN cohort, and 1.89 (95%CI 1.23-2.86, p=0.02) for CR rate, favoring the Mayo cohort. Conclusions: This individual patient-level IPTW-based analysis demonstrated that single agent pirtobrutinib is associated with improved OS, PFS, and ORR compared to usual care in patients with RT. These results support the choice of pirtobrutinib over traditional therapies for RT. Although these results are encouraging, the durability of response to pirtobrutinib remains suboptimal. Ongoing trials and other future research will evaluate the efficacy of pirtobrutinib in combination with other treatments in this setting.
Survival after first relapse of pediatric B-ALL differs by insurance type: A real-world analysis from the recall-1 study
Lind, Katherine , Berry, Abigale, Liu, Hongyan , Nguyen, Gabriella, Bhojwani, Deepa, Quigg, Troy C. , Maude, Shannon L. , Shah, Nirali, Al-Mulla, Abdulla , Ahmed, Ibrahim , Beck, Jill C., Bhatla, Deepika, Briscoe, Eliza, Chu, Roland, Davis, Laurie , Drinkwine, Jennifer, Elias, Anna , Elo, Lyannette, Eom, Elizabeth, Faulk, Kelly , Goode, Erin , Hamill, Darcy, Hammoud, Miza Salim, Hinson, Ashley , Kinoshita, Hannah , Kohorst, Mira A. , Krieger, Elizabeth , Lee‐Miller, Cathy , Milner, Jordan , Moore‐Higgs, Giselle J., Murphy, Lindsey , Murphy, Megan , Patel, Hiren P. , Prosser-Dombrowski, Alexandra, Rahrig, April , Saraf, Amanda J. , Shoag, Jamie , Symons, Heather J. , Tastet, Nicholas, Thomas, Stephanie , Thornock, Molly, Vasanna, Smitha Hosahalli, Vasco, Alejandra Escobar, Weisnicht, Allison , Zarnegar‐Lumley, Sara , Elgarten, Caitlin W. , Li, Yimei , Rubinstein, Jeremy , Fabrizio, Vanessa A , Hall, Anurekha G. , Bhojwani, Deepa , Shah, Nirali N , Ortega, Maria, Briscoe, Eliza, Dolan, J. Gregory , Hoover, Alex , McNerney, Kevin Owen , Moskop, Amy , Murphy, Megan, Patel, Hiren, Pfeiffer, Thomas , Rahim, Mahvish Qureshi , Toner, Keri , Winestone, Lena E. , Myers, Regina M.

Mayo Clinic

Blood | December 5, 2025 | Volume: 146 | Issue: Supplement 1 | Pages: 6292-6292

10.1182/blood-2025-6292 Get It

Abstract BACKGROUND Children exposed to poverty during frontline therapy for B-lymphoblastic leukemia (B-ALL) experience inferior overall survival (OS), higher relapse rates, and earlier relapse than their peers. Real-world data describing treatment patterns and survival after relapse of B-ALL are lacking and, as a result, the impact of poverty following relapse remains poorly understood. This study evaluated the association of poverty exposure, proxied by insurance status, with post-relapse survival and explored potential explanatory mechanisms, including disease biology and therapy utilization. METHODS Data from Retrospective Study of Contemporary Approaches to First Relapse in B-ALL (ReCALL-1), a multicenter retrospective cohort study of patients &lt; 30 years old with first relapse of B-ALL from 2018-2022, were used. The primary exposure was poverty, proxied by insurance status at relapse, categorized as any private insurance (poverty unexposed), public-only insurance (poverty exposed), no insurance, or unknown; the latter two were not included in comparative analyses due to low numbers. The primary outcome was OS. Secondary outcomes included measurable residual disease (MRD)-negative second complete remission (CR2), relapse after CR2, non-relapse mortality (NRM), with relapse treated as a competing risk, and receipt of cellular and immunotherapies. RESULTS Among 462 patients from 31 U.S. institutions, 41% had private insurance, 47% public-only insurance, 2% no insurance, and 10% unknown. Compared to privately insured patients, those with public insurance were more likely to be Hispanic (56% vs 19%, p&lt;0.001) and have non-English preferred language (30% vs 6%, p&lt;0.001). Non-Hispanic Black patients comprised 9% of those with public insurance and 5% of those with private insurance. Disease characteristics that differed by insurance status at relapse included: Ph-like cytogenetics, more common in publicly insured (23% vs 11%, p=0.002), and infant ALL, more common in privately insured patients (10% vs 5%, p=0.06). Publicly insured patients were more likely to have experienced major organ toxicity during frontline therapy (32% vs 18%, p=0.002) and very early relapse (&lt;18m from diagnosis: 43% vs 32%, p=0.07). Other demographic and disease characteristics, including relapse site and cytomolecular features, were similar by insurance status. With a median follow-up of 51 months from relapse, 4-year OS differed by insurance (log-rank p=0.02): 72% for private vs 56% for public insurance. After adjusting for race/ethnicity and language, public insurance increased the hazard of death by 65% (aHR 1.65 95% CI 1.13-2.42, p=0.004). The association remained, but was attenuated, when unbalanced disease characteristics (time to relapse, infant ALL, Ph-like cytogenetics, prior organ dysfunction) were included (aHR 1.47, 95% CI 1.00-2.16, p=0.05). Rates of MRD-negative CR2 were similar (85% public vs 87% private). However, point estimates suggested publicly insured patients had more relapse after CR2 (44% vs 37%, p=0.42) and higher 4-year NRM (16% vs 10%, Gray's test p=0.12), though neither were significant. Treatment choices for first relapse did not differ by insurance status. Utilization of intensive reinduction (91% vs 95% for public vs private, p=0.18) and clinical trial enrollment (22% for both) were similar. Receipt of cellular therapies did not significantly differ by public vs private insurance: Chimeric Antigen Receptor-T cells (CAR-T: 38% vs 34%, p=0.41), hematopoietic cell transplant (HCT: 42% vs 47%, p=0.32). Use of blinatumomab trended higher in those with private insurance (36% vs 45%, p=0.07), and inotuzumab was similar (11% for both, p=0.87). Median time from relapse to CAR-T or HCT was comparable (to CAR-T 102 vs 100 days, to HCT 117 vs 114 days). CONCLUSION This is the first study to demonstrate differential survival by insurance type, a proxy for poverty exposure, after first relapse of B-ALL. In this large multicenter, real-world cohort, patients with public insurance had worse OS after relapse than those with private insurance. The survival disparity existed independent of other SDOH factors. Adjustment for known high-risk disease features only partially accounted for the observed differences in OS. In contrast, rates of MRD-negative CR2 and receipt of CAR-T and HCT were comparable across insurance types. These findings highlight the urgent need to identify effective interventions that will ensure equitable outcomes after relapse.