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129 citation(s) found for "Zhuo, Li".

Environmental impact of single‐use and reusable flexible cystoscopes
Kemble, Jayson , Matlaga, Brian R., Potretzke, Aaron M. , Koo, Kevin , Kemble, Jayson P , Koo, Kevin , Winoker, Jared S. , Patel, Sunil , Su, Zhuo T.

Mayo Clinic

BJU International | December 14, 2022 | Volume: 131 | Issue: 5 | Pages: 617-622

10.1111/bju.15949 | PMID 36515438 Get It

Objectives To compare the carbon footprint and environmental impact of single‐use and reusable flexible cystoscopes. Materials and Methods We analysed the expected clinical lifecycle of single‐use (Ambu aScope™ 4 Cysto) and reusable (Olympus CYF‐V2) flexible cystoscopes, from manufacture to disposal. Performance data on cumulative procedures between repairs and before decommissioning were derived from a high‐volume multispecialty practice. We estimated carbon expenditures per‐case using published data on endoscope manufacturing, energy consumption during transportation and reprocessing, and solid waste disposal. Results A fleet of 16 reusable cystoscopes in service for up to 135 months averaged 207 cases between repairs and 3920 cases per lifecycle. Based on a manufacturing carbon footprint of 11.49 kg CO 2 /kg device for reusable flexible endoscopes and 8.54 kg CO 2 /kg device for single‐use endoscopes, the per‐case manufacturing cost was 1.37 kg CO 2 for single‐use devices and 0.0017 kg CO 2 for reusable devices. The solid mass of single‐use and reusable devices was 0.16 and 0.57 kg, respectively. For reusable devices, the energy consumption of reusable device reprocessing using an automated endoscope reprocessor was 0.20 kg CO 2 , and per‐case costs of device repackaging and repair were 0.005 and 0.02 kg CO 2 , respectively. The total estimated per‐case carbon footprint of single‐use and reusable devices was 2.40 and 0.53 kg CO 2 , respectively, favouring reusable devices. Conclusion In this lifecycle analysis, the environmental impact of reusable flexible cystoscopes is markedly less than single‐use cystoscopes. The primary contributor to the per‐case carbon cost of reusable devices is energy consumption of reprocessing.
Efficacy of CD19 Directed Therapies in Large B-Cell Lymphoma (LBCL) Relapsing after Chimeric Antigen Receptor (CAR) T-Cell Therapy
Khurana, Arushi , Chavez, Julio, Craver, Emily C. , Aditi, Saha, Annunzio, Kaitlin , Isufi, Iris, Fijalka, Andrew, Sandoval‐Sus, Jose , Ivanov, Stanislav , Lin, Yi , Kharfan‐Dabaja, Mohamed A. , Saha, Aditi , Saha, Aditi , Iqbal, Madiha , Rosenthal, Allison , Li, Zhuo , Aditi, Saha, Epperla, Narendranath , Awan, Farrukh T. , Dholaria, Bhagirathbhai , Bhaskar, Shakthi , Maakaron, Joseph E. , Sumransub, Nuttavut

Mayo Clinic

Blood | November 28, 2022 | Volume: 140 | Issue: Supplement 1 | Pages: 10396-10398

10.1182/blood-2022-169689 Get It

Abbreviated Molecular Breast Imaging: Feasibility and Future Considerations
Maimone, Santo , Morozov, Andrey P, Letter, Haley , Robinson, Kristin A. , Wasserman, Martha, Li, Zhuo , Maxwell, Robert W. , Letter, Haley P, Wasserman, Martha C, Maimone, Santo

Mayo Clinic

Journal of Breast Imaging | September 15, 2022 | Volume: 4 | Issue: 6 | Pages: 590-599

10.1093/jbi/wbac060 | PMID 38416994 Get It

Abstract Objective Molecular breast imaging (MBI) is a supplemental screening modality consistently demonstrating incremental cancer detection over mammography alone; however, its lengthy duration may limit widespread utilization. The study purpose was to assess feasibility of an abbreviated MBI protocol, providing readers with mediolateral oblique (MLO) projections only and assessing performance in lesion detection and localization. Methods Retrospective IRB-exempt blinded reader study administered to 5 fellowship-trained breast imaging radiologists. Independent reads performed for 124 screening MBI cases, half abnormal and half negative/normal. Readers determined whether an abnormality was present, side of abnormality, and location of abnormality (medial/lateral). Abnormal cases had confirmatory biopsy or surgical pathology; normal cases had imaging follow-up ensuring true negative results. Sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) were calculated to assess performance. A false negative result indicated that a reader failed to detect abnormal uptake; a false positive result indicated a reader incorrectly called an abnormality for a negative case. Tests for association included chi-square, Fisher-exact, and analysis of variance. Results Mean reader performance for detecting abnormal uptake: sensitivity 96.8%, specificity 98.7%, PPV 98.8%, and NPV 96.9%. Accuracy in localizing lesions to the medial or lateral breast was 100%. There were no associations in reader performance with reader experience, reader technique, lesion morphology, or lesion pathology. Median lesion size was 1.0 cm (range: 0.4–8.0 cm). All readers correctly identified 97.7% (42/43) of lesions with malignant or elevated risk pathology. Conclusion An abbreviated MBI protocol (MLO images only) maintained high accuracy in lesion detection and localization.
Clinical characteristics, prognostic indicators, and survival outcomes in intravascular lymphoma: Mayo Clinic experience (2003–2018)
Seegobin, Karan , Li, Zhuo , Wang, Jing , Jiang, Liuyan , Kuhlman, Justin J. , Menke, David M. , Li, Ke , Kharfan‐Dabaja, Mohamed A. , Ayala, Ernesto , Nowakowski, Grzegorz S. , Johnston, Patrick B. , Thompson, Carrie A. , Ansell, Stephen M. , Alhaj Moustafa, Muhamad, Kuhlman, Justin , Menke, David, Kharfan-Dabaja, Mohamed A , Iqbal, Madiha , Habermann, Thomas , Witzig, T.E. , Thompson, Carrie, Ansell, Stephen M , Moustafa, Muhamad Alhaj , Majeed, Umair , Iqbal, Madiha , Habermann, Thomas M. , Witzig, Thomas E. , Tun, Han W.

Mayo Clinic

American Journal of Hematology | June 17, 2022 | Volume: 97 | Issue: 9 | Pages: 1150-1158

10.1002/ajh.26635 | PMID 35713565 Get It

Abstract Intravascular lymphoma (IVL) is a rare extranodal non‐Hodgkin lymphoma. We performed a retrospective analysis of 55 IVL patients who were treated at our institution 2003–2018. Median age at diagnosis was 68 years, and 64% were males. The most frequent presenting symptoms were skin rash 43% and weight loss 30%. MRI brain on IVL patients with CNS involvement (CNS‐IVL) showed multifocal involvement in 76% (13/17). 89% (17/19) of non‐CNS‐IVL patients with abnormal FDG‐PET had biopsy of an avid lesion resulting in definitive diagnosis. The top diagnostic biopsy site was the bone marrow (45%). 56% had multiorgan involvement. Based on CNS involvement, 36.5% (20/55) had CNS‐IVL and 63.5% (35/55) had non‐CNS‐IVL. CNS‐IVL group consists of clinically isolated CNS involvement (CNS‐only IVL) (22%;12/55) and mixed clinical CNS and peripheral site involvement (M‐IVL) (14.5%; 8/55). Non‐CNS‐IVL group consists of clinically isolated skin involvement (skin‐only IVL) (9%; 5/55) and peripheral IVL with or without skin involvement (P‐IVL); (54.5%; 30/55). Skin involvement was predominantly in the lower extremities. Pathologically, 89% (48/54) were B‐cell IVL. Rituximab + high‐dose methotrexate‐based regimen were used in 75% (12/16) of CNS‐IVL patients and RCHOP in 60% (17/28) of non‐CNS‐IVL patients. Estimated 5‐year progression free survival (PFS) and overall survival (OS) for the entire cohort were 38.6% and 52%, respectively. Skin‐only IVL was associated with excellent survival. Platelet count <150x10 9 /L, age > 60Y, and treatment without Rituximab were poor prognostic factors. Further research is necessary to identify novel therapies.
Abstract 5627: Functional tertiary lymphoid structure (TLS) and outcome in HER2-positive (HER2+) breast cancer in NCCTG N9831 (Alliance)
Chumsri, Saranya , Shachner, Tracy R. , Li, Zhuo , Moreno‐Aspitia, Alvaro , Colón‐Otero, Gerardo , Perez, Edith A. , Thompson, E. A., Knutson, Keith L. , Norton, Nadine , Thompson, E. Aubrey , Nassar, Aziza , Knutson, Keith L.

Mayo Clinic

Cancer Research | June 15, 2022 | Volume: 82 | Issue: 12_Supplement | Pages: 5627-5627

10.1158/1538-7445.am2022-5627 Get It

Abstract Background: Previous studies showed conflicting results regarding association between stromal tumor infiltrating lymphocytes (sTIL) and outcome in HER2+ breast cancer. While sTIL were not associated with outcome in patients (pts) treated with trastuzumab in N9831, immune functions genes are linked to outcome in these pts. TLS is an organized form of ectopic lymphoid aggregates (LA) with secondary lymphoid organ structure. Several studies showed that TLS associates with improved outcome in multiple cancers. However, distinguishing TLS and simple LA is challenging, particularly when germinal center is absent. In this study, we evaluated integrated pathological quantification and genomic data to assess functional TLS. Methods: Pathological evaluation of LA in H&E slides from pts treated in Arm A (chemotherapy alone) and Arm C (chemotherapy with concurrent trastuzumab) in N9831 was performed. NanoString was used to quantify mRNA. Wilcoxon rank sum test, Chi squared test, Kaplan-Meier method and Cox regression model were used to evaluate association between LA and baseline characteristics as well as outcomes. Results: LA was quantified in 1011 pts (526 Arm A, 485 Arm C). Greater number of LA was significantly associated with higher tumor grade, ER/PR negativity and increasing sTIL, but not age, tumor size or lymph node status. Increasing numbers of LA were associated with improved RFS in both arms combined (p 0.028). However, using multivariable Cox regression analysis in each treatment arm, LA (≥ 1 vs 0) was associated with improved RFS only in Arm A (HR 0.6, 95%CI 0.43-0.84, p 0.003) but not Arm C (HR 0.72, 95%CI 0.47-1.1, p 0.134). Further evaluation of expression of TLS-related immune genes including IFNG, ICOSLG, CXCL13, CXCR3, BCL6, IL21R, ICOS, PDCD1, CXCR5, CXCL9, TBX21, CD38, CXCL10, CLXCL11, IL21, CD200 was carried out among 252 pts in Arm C with LA ≥ 1. Among these 16 TLS-related immune genes, as a continuous variable, higher expression of BCL6 (HR 0.61, 95%CI 0.41-0.92, p 0.019) and IL21R (HR 0.78, 95%CI 0.62-0.98, p 0.03) were associated with improved RFS in Arm C pts with LA ≥ 1. However, these genes were not significantly associated with outcome in Arm C pts without LA with BCL6 HR1.07 (95%CI 0.67-1.71, p 0.776) and IL21R HR 0.96 (95%CI 0.71-1.29, p 0.775). Conclusion: Similar to sTIL, greater number of LA was associated with improved outcome in HER2+ pts treated with chemotherapy alone but not chemotherapy in combination with trastuzumab. Using histogenomic integration with the combination of pathological LA and TLS-related immune genes, we identified that pts with functional TLS with LA ≥ 1 and higher expression of BCL6 or IL21R had significantly improved outcome when treated with trastuzumab. Future studies are needed to further confirm these findings. Support: U10 CA180821, U24 CA196171, https://acknowledgments.alliancefound.org; Genentech; Clinicaltrials.gov Id: NCT00005970 Citation Format: Saranya Chumsri, Tracy R. Shachner, Zhuo Li, Nadine Norton, Alvaro Moreno-Aspitia, Gerardo Colon-Otero, Edith A. Perez, E. A. Thompson, Aziza Nassar, Keith L. Knutson. Functional tertiary lymphoid structure (TLS) and outcome in HER2-positive (HER2+) breast cancer in NCCTG N9831 (Alliance) [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2022; 2022 Apr 8-13. Philadelphia (PA): AACR; Cancer Res 2022;82(12_Suppl):Abstract nr 5627.
Abstract 9748: Validation of a Brief Dietary Questionnaire for Use in Clinical Practice: Mini-EAT TM
Kopecky, Stephen L. , Lara-Breitinger, Kyla M , Medina‐Inojosa, José R. , Li, Zhuo , Kunzová, Šárka , Lerman, Amir , López-Jiménez, Francisco

Mayo Clinic

Circulation | April 28, 2022 | Volume: 144 | Issue: Suppl_1 | Pages: No page available

10.1161/circ.144.suppl_1.9748 Get It

Introduction: Limited validated rapid dietary screening tools are available for patient use for actionable goal setting to improve health and reduce cardiovascular risk. The Healthy Index (HEI) Score measures compliance with the 2015-2020 Dietary Guidelines for Americans but requires completion of an extensive food frequency questionnaire (FFQ) to compute, which is time consuming and impractical. Hypothesis: A 19-item dietary survey that assesses consumption of common food groups known to affect health is correlated to the gold standard FFQ and HEI score and can be further reduced without affecting validity. Methods: An evidence-based 19-item Eating Assessment Tool (EAT™) of common food groups was created through literature review and expert consensus. We then conducted a cross-sectional survey of adult patients from a preventive cardiology clinic or cardiac rehabilitation and of healthy volunteers (n=628, mean age= 37 y, 76% women). Participants completed an online 156-item FFQ which was used to calculate the HEI score using standard methods. The association between each EAT™ question and HEI score category was analyzed by Kruskal-Walis test. Linear regression models were used to identify univariable and multivariable predictors for HEI score. The final model of Mini-EAT™ was validated by 5-fold cross validation. Results: The 19-item EAT™ had good correlation with the HEI (r=0.77) and was subsequently reduced to the 8 items independently predictive of the HEI score: fruits, vegetables, whole grains, refined grains, legumes/nuts/seeds, low-fat dairy, high-fat dairy, and sweets consumption, without affecting the predictive ability of the tool (r=0.76). Conclusions: Mini-EAT™ is an 8-item validated brief dietary screener that correlates well with a comprehensive FFQ. Future studies to test the Mini-EAT™’s validity in diverse populations and for development of clinical decision support systems to capture changes over time are needed.
Abstract P3-03-19: Incidence and time to resolution of axillary adenopathy on mammography after COVID-19 vaccination
Robinson, Kristin A. , Advani, Pooja , Gococo-Benore, Denise A. , Qosja, Neda, Mummareddy, Ashita , Ashai, Ahmed M, Wilhelm, Annamaria, Maxwell, Robert W. , Wasserman, Martha, Patel, Neema , Morozov, Andrey P, Chumsri, Saranya , Maimone, Santo , Li, Zhuo

Mayo Clinic

Cancer Research | March 8, 2022 | Volume: 82 | Issue: 4_Supplement | Pages: P3-03-19-P3-03-19

10.1158/1538-7445.sabcs21-p3-03-19 Get It

Abstract Background: This study reports incidence, timing, characteristics, and surveillance imaging of mammographic axillary adenopathy following COVID-19 vaccination. As COVID-19 immunizations continue, with possible booster vaccines upcoming, this study offers timing considerations and potential follow-up recommendations for breast imaging after vaccination. Methods: Retrospective analysis of patients (pts) who received at least one COVID-19 vaccine prior to screening (SM) or diagnostic mammography (DM) at Mayo Clinic Florida between January 15 to May 31, 2021. Vaccine-related information was queried by mammography technologists. Adenopathy was assessed by interpreting radiologists and follow-up studies were collated. Mammogram adenopathy included single enlarged node, multiple enlarged nodes, and adenopathy with soft tissue stranding. Ultrasound adenopathy included mildly prominent nodes with preserved fatty hila to rounded nodes with apparent loss of a fatty hilum. Wilcoxon rank-sum test and Fisher’s exact test were used to compare continuous and categorical variables, respectively. Multivariable logistic regression model was used to evaluate the association between days from vaccine and adenopathy. Results: Of 2349 pts, 34 (1.4%) had adenopathy (DM=6; SM=28) and 3 (0.1%) were symptomatic. Presence of axillary symptoms was associated with abnormal imaging (p&lt;0.001) with an odds ratio of 33 in multivariable model. Median time after vaccine for pts with adenopathy was significantly shorter at 14 days compared to 33 days for pts without adenopathy (p&lt;0.001). Incidence of adenopathy decreased as days from vaccine increased (3.4% for 0-14 days, 2.1% for 15-28 days, and 0.4% for &gt; 28 days, p&lt;0.001). After adjusting for being symptomatic, days from vaccine still had a significant impact on finding mammographic adenopathy (for each day after vaccine, OR=0.96, p&lt;0.001). No significant difference was seen based on age (p=0.66), vaccine brand (p=0.66), vaccine dose (p=0.18). ROC analysis to identify a cutoff value for presence/absence of adenopathy was 0.74 (95% CI 0.67-0.81) at 22.5 days following vaccination. Additional imaging with mammogram and/or ultrasound was requested for 31 pts. These included no follow-up (n=4, 12.9%), repeat ultrasound with or without mammogram in 1-3 months (n=26, 83.9%), and biopsy (n=1, 3.2%, pt with ipsilateral breast cancer with negative results, presumably vaccine induced). To date, all pts who underwent surveillance imaging demonstrated normalization of lymph node appearance. The median time for abnormal imaging related to adenopathy to return to BI-RADS 1 or 2 was 84 (range 13-157) days. Conclusion: The incidence of COVID-19 vaccine-induced adenopathy in this study (1.4%) appeared to be lower than self-reported axillary swelling in COVID-19 vaccine trials (16%) but is still higher than the reported incidence of adenopathy on an otherwise normal SM (0.02-0.04%). The incidence of adenopathy decreased significantly over time and was not present in most pts 28 days after the vaccine. In patients with abnormal adenopathy, followup imaging showed resolution of vaccine-induced adenopathy in most patients by 3 months. Adenopathy(N=34)No Adenopathy (N=2315)P valueAge0.66N342314Median (Range)63.5 (35.0, 83.0)64.0 (30.0, 94.0)Q1, Q351.5, 72.555.0, 71.0Exam type&lt;0.001DM6 (13.3%)39 (86.7%)SM28 (1.2%)2276 (98.8%)Symptomatic&lt;0.001Missing032Yes3 (23.1%)10 (76.9%)No31 (1.3%)2273 (98.7%)Vaccine brand0.66Missing119mRNA-127319 (1.7%)1117 (98.3%)BNT162b214 (1.2%)1138 (98.8%)Other0 (0.0%)41 (100.0%)Vaccine dose0.18Missing0181st9 (2.2%)409 (97.8%)2nd25 (1.3%)1888 (98.7%)Days from vaccine&lt;0.001Median (Range)14.0 (1.0, 91.0)33.0 (0.0, 239.0)Q1, Q38.2, 20.816.0, 61.0Days from Vaccine&lt;0.0010-1418 (3.4%)519 (96.6%)15-2811 (2.1%)513 (97.9%)&gt;285 (0.4%)1283 (99.6%) Citation Format: Kristin Robinson, Santo Maimone, Pooja P Advani, Zhuo Li, Denise Gococo-Benore, Neda Qosja, Ashita Mummareddy, Ahmed M Ashai, Annamaria Wilhelm, Robert Maxwell, Martha Wasserman, Neema Patel, Andrey Morozov, Saranya Chumsri. Incidence and time to resolution of axillary adenopathy on mammography after COVID-19 vaccination [abstract]. In: Proceedings of the 2021 San Antonio Breast Cancer Symposium; 2021 Dec 7-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2022;82(4 Suppl):Abstract nr P3-03-19.
Development of a Preliminary Question Prompt List as a Communication Tool for Adults With Achalasia
Zhuo, Justin , Clarke, John O. , Gyawali, C. Prakash , Hawn, Mary T. , Hwang, Joo Ha , Katzka, David A. , Massey, Benson T. , Patel, Dhyanesh A. , Savarino, Edoardo , Smout, A. J. P. M. , Tatum, Roger P. , Vela, Marcelo F. , Zaninotto, Giovanni, Kamal, A. N. , Clarke, J , Gyawali, C P , Savarino, Edoardo , Triadafilopoulos, George , Bredenoord, Albert J. , Fass, Ronnie , Kahrilas, Peter J. , Low, Donald E. , Penagini, Roberto , Roman, Sabine , Swanström, Lee L. , Kamal, Afrin N.

Mayo Clinic

Journal of Clinical Gastroenterology | February 18, 2022 | Volume: 57 | Issue: 2 | Pages: 159-164

10.1097/mcg.0000000000001671 | PMID 35180150 Get It

Background: Question prompt lists (QPLs) are structured sets of disease-specific questions that enhance patient-physician communication by encouraging patients to ask questions during consultations. Aim: The aim of this study was to develop a preliminary achalasia-specific QPL created by esophageal experts. Methods: The QPL content was derived through a modified Delphi method consisting of 2 rounds. In round 1, experts provided 5 answers to the prompts “What general questions should patients ask when given a new diagnosis of achalasia” and “What questions do I not hear patients asking, but given my expertise, I believe they should be asking?” In round 2, experts rated questions on a 5-point Likert scale. Questions considered “essential” or “important” were accepted into the QPL. Feedback regarding the QPL was obtained in a pilot study wherein patients received the QPL before their consultation and completed surveys afterwards. Results: Nineteen esophageal experts participated in both rounds. Of 148 questions from round 1, 124 (83.8%) were accepted into the QPL. These were further reduced to 56 questions to minimize redundancy. Questions were categorized into 6 themes: “What is achalasia,” “Risks with achalasia,” “Symptom management in achalasia,” “Treatment of achalasia,” “Risk of reflux after treatment,” and “Follow-up after treatment.” Nineteen patients participated in the pilot, most of whom agreed that the QPL was helpful (84.2%) and recommended its wider use (84.2%). Conclusions: This is the first QPL developed specifically for adults with achalasia. Although well-received in a small pilot, follow-up studies will incorporate additional patient feedback to further refine the QPL content and assess its usability, acceptability, and feasibility.
Histologic acute graft pyelonephritis after kidney transplantation: Incidence, clinical characteristics, risk factors, and association with graft loss
Powers, H. R. , Hellinger, Walter C. , Cortese, Cherise , Elrefaei, Mohamed , Khouzam, Samir , Spiegel, Matthew R. , Li, Zhuo , Wadei, Hani M. , Powers, Harry R , Spiegel, Matthew, Wadei, Hani M

Mayo Clinic

Transplant Infectious Disease | January 26, 2022 | Volume: 24 | Issue: 2 | Pages: No page available

10.1111/tid.13801 | PMID 35080081 Get It

AbstractBackgroundHistologic acute graft pyelonephritis (HAGPN) after kidney transplantation (KT) has been assessed less frequently than urinary tract infections (UTIs) or clinical acute graft pyelonephritis. Risk factors for HAGPN, its association with graft loss, and measures that might prevent it are not known.MethodsWe performed a retrospective review of HAGPN cases identified from KT occurring between January 2008 and December 2017 at our institution. We compared the HAGPN cases to a randomly selected control group of KTs to identify risk factors using univariate and multivariate Cox regression models. The association between HAGPN and graft loss was also assessed, similarly.ResultsHAGPN was identified in 46 of 1391 patients (cumulative incidence, 5% [95% CI, 3%–7%]) undergoing KT at a single center from January 2008 through December 2017 (median time to diagnosis, 241 days after KT; interquartile range, 122–755 days). Indications for biopsy were follow‐up of treated rejection (n = 20 [43%]), KT protocol biopsy (n = 19 [41%]), and acute kidney injury (n = 7 [15%]). Histologic rejection, UTI, and asymptomatic bacteriuria (ASB) were present in 23 (50%), 9 (20%), and 16 (35%). Multivariate Cox proportional hazards models comparing KT recipients with or without HAGPN (n = 46 and n = 138, respectively) showed that HAGPN was associated with urologic complication by day 30, delayed graft function, previous UTI or ASB, and a history of rejection. In the univariate and multivariate analyses, HAGPN was associated with an increased risk of graft loss.ConclusionHAGPN is an infrequent, unanticipated, and clinically significant complication of KT.
A Calcineurin Inhibitor Free Graft Versus Host Disease (GVHD) Prophylaxis for Patients Undergoing Matched Related (MRD) and Matched Unrelated Donor (MUD) Allogeneic Hematopoietic Cell Transplant (Allo-HCT)
Nieto, Felipe Andres Mendieta, Brannick, Kaitlyn M., Foran, James M. , Kharfan‐Dabaja, Mohamed A. , Ayala, Ernesto , Iqbal, Madiha , Nieto, Felipe A. Mendieta, Li, Zhuo , Murthy, Hemant S. , Roy, Vivek

Mayo Clinic

Blood | November 23, 2021 | Volume: 138 | Issue: Supplement 1 | Pages: 3893-3893

10.1182/blood-2021-151845 Get It

Abstract Introduction Post-transplantation cyclophosphamide (PTCy) and calcineurin inhibitor (CNI) based GVHD prophylaxis has shown lower rates of acute and chronic GVHD when compared with the traditional prophylaxis of calcineurin inhibitor (CNI) and methotrexate (MTX) in matched donor (related and unrelated) allo-HCT. The combination of PTCy with sirolimus as a calcineurin inhibitor-free GVHD prophylaxis has shown promising results with cumulative rates of grade II-IV acute and chronic GVHD in the range of 15-27% and 20-27% respectively in patients undergoing matched and haploidentical allo-HCT. We report a single center, nonrandomized comparison of patients undergoing matched donor allo-HCT receiving PTCy in combination with sirolimus (PTCy/Siro) with those receiving the standard GVHD prophylaxis of tacrolimus and MTX (Tac/MTX). Methods One hundred and sixteen consecutive patients who had undergone a MRD or MUD allo-HCT between January 2018 to January 2021 and received either PTCy with sirolimus or tacrolimus with methotrexate as GVHD prophylaxis regimens were eligible for inclusion. The selection of PTCy with sirolimus or tacrolimus with methotrexate as GVHD prophylaxis regimen was based on physician choice. Primary endpoints were cumulative incidence of acute (grade II to IV) and chronic GVHD. Secondary endpoints were a) neutrophil and platelet engraftment; b) overall survival (OS); c) non-relapse mortality (NRM); d) relapse; e) clinical infections and f) time to immunosuppression (IS) withdrawal. Kaplan-Meier method was used to estimate 1-year and 2-year freedom from long term adverse events, including chronic GVHD, relapse, NRM and OS. All tests were two-sided with alpha level set at 0.05 for statistical significance. Results Out of a total of 116 patients undergoing MRD and MUD allo-HCT, 29 received PTCy/Siro and 87 Tac/MTX. Baseline characteristics were similar between the two arms except patients in PTCy/Siro were younger with median of 48 (range: 24-69) years vs. 61 (range: 20-73) years (p=0.004) in Tac/MTX. There was difference in primary indication for allo-HCT between the two arms with non-hodgkin lymphoma (NHL) being the most common in PTCy/Siro and acute myeloid leukemia (AML) in the Tac/MTX group. Patients receiving PTCy/Siro had a significantly higher median CD3 day 100 chimerism at 100 (90-100) vs. 90 (40-100) % (&lt;0.001) and a significantly shorter median time to IS withdrawal at 138 (37-312) vs 232(66-1120) days for patients receiving Tac/MTX. There was no difference between the two arms for length of hospital stay and time to neutrophil engraftment, but PTCy/Siro had a significantly longer median time for platelet engraftment at 17.5 (12-74) vs.14 (11-38) days (p= 0.001). No significant difference was observed between the two arms for incidence of grade II to IV acute GVHD, grade III to IV acute GVHD, steroid refractory acute GVHD or clinical infections (Table 1). After a median follow up of 1.1 (range: 0-1.8) years, patients receiving PTCy/Siro were significantly less likely to have chronic GVHD with 2-year freedom from GVHD of 75% (95%CI: 58-98%) vs 20% (95%CI 10-40%), p=0.005 (Figure 1). There was no difference between the two arms for OS, disease relapse or non-relapse mortality (Table 2). Conclusion In this study, the combination of PTCy/Siro is associated with a significantly lower risk of chronic GVHD when compared against the traditional GVHD prophylaxis of CNI and methotrexate, despite significantly earlier IS withdrawal. Other long-term outcomes of interest remained comparable between the two arms. Chronic GVHD contributes to significant morbidity and mortality in patients undergoing allo-HCT. Newer strategies to limit the impact of chronic GVHD are needed. The results of our study warrant validation in a large, multicenter, randomized prospective trial. Figure 1 Figure 1. Disclosures Murthy: CRISPR Therapeutics: Research Funding. Foran: gamida: Honoraria; takeda: Research Funding; novartis: Honoraria; trillium: Research Funding; boehringer ingelheim: Research Funding; OncLive: Honoraria; abbvie: Research Funding; certara: Honoraria; sanofi aventis: Honoraria; syros: Honoraria; taiho: Honoraria; revolution medicine: Honoraria; bms: Honoraria; servier: Honoraria; pfizer: Honoraria; actinium: Research Funding; aptose: Research Funding; kura: Research Funding; h3bioscience: Research Funding; aprea: Research Funding; sellas: Research Funding; stemline: Research Funding.