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605 citation(s) found for "Ibrahim, A".

Current Status and Future Perspectives on the Internet of Things in Oncology
Muhsen, Ibrahim N. , Rasheed, Omar W. , Habib, Eiad , Alsaad, Rakan, Maghrabi, Mohannad K., Sicker, Douglas , Wood, William A. , Beg, Muhammad S., Sung, Anthony D. , Hashmi, Shahrukh K. , Muhsen, Ibrahim N , Wood, William A , Sung, Anthony D , Rahman, Md. Abdur

Hematology/Oncology and Stem Cell Therapy | October 19, 2021 | Volume: 16 | Issue: 2 | Pages: 102-109

10.1016/j.hemonc.2021.09.003 | PMID 34687614 Get It

The Internet of Things (IoT) has penetrated many aspects of everyday human life. The use of IoT in healthcare has been expanding over the past few years. In this review, we highlighted the current applications of IoT in the medical literature, along with the challenges and opportunities. IoT use mainly involves sensors and wearables, with potential applications in improving the quality of life, personal health monitoring, and diagnosis of diseases. Our literature review highlights that the current main application studied in the literature is physical activity tracking. In addition, we discuss the current technologies that would help IoT-enabled devices achieve safe, quick, and meaningful data transfer. These technologies include machine learning/artificial intelligence, 5G, and blockchain. Data on current IoT-enabled devices are still limited, and future research should address these devices’ effect on patients’ outcomes and the methods by which their integration in healthcare will avoid increasing costs.
Psychological Distress, Fear, and Coping Strategies among Citizens and Residents in Saudi Arabia During the COVID-19 Pandemic
AlQurashi, Alaa , Mahmud, Ilias , Islam, Sheikh Mohammed Shariful , Almustanyir, Sami , Maklad, Ahmed Essam , AlSarraj, Ahmad, Mughaiss, Lujain Nedhal, Ahmed, Ahmed Ali, Barry, Mazin , Alabdan, Lulwah Ibrahim, Alif, Sheikh Mohammad , Sultana, Farhana , Salehin, Masudus , Banik, Biswajit , Rahman, Muhammad Aziz , Islam, Sheikh Mohammed Shariful , Alif, Sheikh M , Rahman, Muhammad Aziz , Alharbi, Talal Ali F. , Alharbi, Rayan Jafnan , Al‐Tawfiq, Jaffar A. , Ghozy, Sherief , Cross, Wendy M

No container title available | October 12, 2021 | Volume: No volume available | Issue: No issue available | Pages: No page available

10.21203/rs.3.rs-887072/v1 Get It

Abstract Background: COVID-19 caused the worst international public health crisis, accompanied by major global economic downturns, mass-scale job losses, which impacted on the psychosocial wellbeing of the worldwide population. This study examined factors associated with psychosocial distress, fear of COVID-19 and coping strategies amongst the general population in Saudi Arabia.Methods: A cross-sectional study was conducted using an anonymous online questionnaire. Multivariate logistic regressions were used; Adjusted Odds Ratio (AOR) with 95% Confidence Intervals (CIs) was reported.Results: Among 803 participants, 70 %(n=556), were females and the median age was 27 years; 35% (n=278), were frontline or essential service workers; 24% (n=195), reported comorbid conditions including mental health illness. Factors associated with moderate to high levels of psychological distress were: youth (18 - 29 years) (AOR 3.35, 95% CIs 2.06 - 5.44), females (2.59, 1.60 - 4.19), non-Saudi nationals (2.17, 1.11 - 4.26), change in employment (2.9, 1.73 - 4.87), negative financial impact (2.14, 1.29-3.56), having comorbidities (2.67, 1.47 - 4.87), and current smoking (2.87, 1.55 - 5.33). Being ex-smokers (3.72, 1.14 - 12.14) and change in employment (3.42, 1.91 - 6.11) were associated with higher levels of fear of COVID-19. People whose financial situation was impacted and who had contact with known/suspected cases (1.63, 1.12-2.38) had low medium to high resilient coping.Conclusions: People in Saudi Arabia were at a higher risk of psychosocial distress and fear along with low resilience during the COVID-19 pandemic, warranting urgent attention from healthcare providers and policymakers, to provide specific mental health support strategies for their wellbeing currently and to avoid a post-pandemic mental health crisis.
Antiplatelet therapy and outcome in COVID-19: the Health Outcome Predictive Evaluation Registry
Santoro, Francesco , Núñez‐Gil, Iván J. , Vitale, Enrica , Viana‐Llamas, María C. , Reche-Martínez, Begoña, Romero-Pareja, Rodolfo, Guzman, Gisela Feltez, Rozas, Inmaculada Fernández, Uribarri, Aitor , Becerra‐Muñoz, Víctor Manuel , Alfonso‐Rodríguez, Emilio , García-Aguado, Marcos, Huang, Jia , Ortega-Armas, María Elizabeth , Prieto, Juan Fortunato García, Mulet, Alba , Raposeiras‐Roubín, Sergio , Mendez, Jorge Luis Jativa , Paeres, Carolina Espejo, Albarrán, Adrián Rodríguez, Marı́n, Francisco , Akın, İbrahim , Cortese, Bernardo , Macaya, Carlos , Nuñez-Gil, Ivan Javier , Corral Rubio, Eva Maria , Raposeiras-Roubin, Sergio , Guerra, Federico , Akin, Ibrahim , Cortese, Bernardo , Ramakrishna, Harish , Brunetti, Natale Daniele , Santoro, Francesco , Marín, Francisco , Viana-Llamas, María C , Becerra-Muñoz, Víctor , Uribarri, Aitor , Guzmãn, Gisela Feltes, Ugo, Fabrizio , Bianco, Matteo , Fernández‐Ortíz, Antonio

Heart | October 5, 2021 | Volume: 108 | Issue: 2 | Pages: 130-136

10.1136/heartjnl-2021-319552 | PMID 34611045 Get It

Background Standard therapy for COVID-19 is continuously evolving. Autopsy studies showed high prevalence of platelet-fibrin-rich microthrombi in several organs. The aim of the study was therefore to evaluate the safety and efficacy of antiplatelet therapy (APT) in hospitalised patients with COVID-19 and its impact on survival. Methods 7824 consecutive patients with COVID-19 were enrolled in a multicentre international prospective registry (Health Outcome Predictive Evaluation-COVID-19 Registry). Clinical data and in-hospital complications were recorded. Data on APT, including aspirin and other antiplatelet drugs, were obtained for each patient. Results During hospitalisation, 730 (9%) patients received single APT (93%, n=680) or dual APT (7%, n=50). Patients treated with APT were older (74±12 years vs 63±17 years, p<0.01), more frequently male (68% vs 57%, p<0.01) and had higher prevalence of diabetes (39% vs 16%, p<0.01). Patients treated with APT showed no differences in terms of in-hospital mortality (18% vs 19%, p=0.64), need for invasive ventilation (8.7% vs 8.5%, p=0.88), embolic events (2.9% vs 2.5% p=0.34) and bleeding (2.1% vs 2.4%, p=0.43), but had shorter duration of mechanical ventilation (8±5 days vs 11±7 days, p=0.01); however, when comparing patients with APT versus no APT and no anticoagulation therapy, APT was associated with lower mortality rates (log-rank p<0.01, relative risk 0.79, 95% CI 0.70 to 0.94). On multivariable analysis, in-hospital APT was associated with lower mortality risk (relative risk 0.39, 95% CI 0.32 to 0.48, p<0.01). Conclusions APT during hospitalisation for COVID-19 could be associated with lower mortality risk and shorter duration of mechanical ventilation, without increased risk of bleeding. Trial registration number NCT04334291.
Haploidentical vs sibling, unrelated, or cord blood hematopoietic cell transplantation for acute lymphoblastic leukemia
Wieduwilt, Matthew J. , Metheny, Leland , Zhang, Mei‐Jie , Wang, Hailin , Estrada‐Merly, Noel, Marks, David I. , Al‐Homsi, A. Samer, Muffly, Lori , Chao, Nelson J. , Rizzieri, David A. , Gadalla, Shahinaz M. , Cairo, Mitchell S. , Gore, Steven D. , Patel, Sagar S. , Michelis, Fotios V. , Inamoto, Yoshihiro , Copelan, Edward A. , Palmisiano, Neil , Kharfan‐Dabaja, Mohamed A. , Ganguly, Siddhartha , Bredeson, Christopher , Ballen, Karen K. , Martino, Rodrigo , Wirk, Baldeep , Aljurf, Mahmoud , Bashey, Asad, Murthy, Hemant S. , Farhadfar, Nosha , Liu, Hongtao , Abdel‐Azim, Hisham , Solh, Melhem , Seftel, Matthew D. , Poel, Marjolein van der , Kamble, Rammurti T., Munker, Reinhold , Cahn, Jean‐Yves , Freytes, César O. , Krem, Maxwell M. , Winestone, Lena E. , Nathan, Sunita , Verdonck, Leo F. , Sharma, Akshay , Ringdén, Olle , Černý, Jan , Choe, Hannah , Seo, Sachiko , Baxter‐Lowe, Lee Ann , Hildebrandt, Gerhard , Litzow, Mark R. , Abid, Muhammad Bilal , Weisdorf, Daniel J. , Saber, Wael , Chao, Nelson , Rizzieri, David A , Gadalla, Shahinaz M , Bhatt, Vijaya Raj , Patel, Sagar , Michelis, Fotios V , Kharfan-Dabaja, Mohamed A , Savani, Bipin N , Martino, Rodrigo , Bacher, Ulrike , Liu, Hongtao , Waller, Edmund K , McGuirk, Joseph , Krem, Maxwell M , Winestone, Lena E , Olsson, Richard F , Sharma, Akshay , Ringden, Olov , Friend, Brian D , Cerny, Jan , Chhabra, Saurabh , Nishihori, Taiga , Seo, Sachiko , George, Biju , Baxter-Lowe, Lee Ann , Hildebrandt, Gerhard C , de Lima, Marcos , Litzow, Mark R. , Hourigan, Christopher S , Weisdorf, Dan , Murthy, Hemant S , Muffly, Lori , Abid, Muhammad Bilal , Gale, Robert Peter , Mussetti, Alberto , Bhatt, Vijaya Raj , Badawy, Sherif M. , Lazarus, Hillard M. , Díaz, Miguel Ángel , Cassaday, Ryan D. , Savani, Bipin N. , Yared, Jean A. , Aldoss, Ibrahim , Waller, Edmund K. , Grunwald, Michael R. , Liesveld, Jane L. , McGuirk, Joseph P. , Lee, Jong Wook , Gergis, Usama , Olsson, Richard F. , Chhabra, Saurabh , Nishihori, Taiga , Lima, Marcos de , Kebriaei, Partow , Hourigan, Christopher S.

Blood Advances | September 21, 2021 | Volume: 6 | Issue: 1 | Pages: 339-357

10.1182/bloodadvances.2021004916 | PMID 34547770 Get It

Abstract The role of haploidentical hematopoietic cell transplantation (HCT) using posttransplant cyclophosphamide (PTCy) for acute lymphoblastic leukemia (ALL) is being defined. We performed a retrospective, multivariable analysis comparing outcomes of HCT approaches by donor for adults with ALL in remission. The primary objective was to compare overall survival (OS) among haploidentical HCTs using PTCy and HLA-matched sibling donor (MSD), 8/8 HLA-matched unrelated donor (MUD), 7 /8 HLA-MUD, or umbilical cord blood (UCB) HCT. Comparing haploidentical HCT to MSD HCT, we found that OS, leukemia-free survival (LFS), nonrelapse mortality (NRM), relapse, and acute graft-versus-host disease (aGVHD) were not different but chronic GVHD (cGVHD) was higher in MSD HCT. Compared with MUD HCT, OS, LFS, and relapse were not different, but MUD HCT had increased NRM (hazard ratio [HR], 1.42; P = .02), grade 3 to 4 aGVHD (HR, 1.59; P = .005), and cGVHD. Compared with 7/8 UD HCT, LFS and relapse were not different, but 7/8 UD HCT had worse OS (HR, 1.38; P = .01) and increased NRM (HR, 2.13; P ≤ .001), grade 3 to 4 aGVHD (HR, 1.86; P = .003), and cGVHD (HR, 1.72; P ≤ .001). Compared with UCB HCT, late OS, late LFS, relapse, and cGVHD were not different but UCB HCT had worse early OS (≤18 months; HR, 1.93; P &lt; .001), worse early LFS (HR, 1.40; P = .007) and increased incidences of NRM (HR, 2.08; P &lt; .001) and grade 3 to 4 aGVHD (HR, 1.97; P &lt; .001). Haploidentical HCT using PTCy showed no difference in survival but less GVHD compared with traditional MSD and MUD HCT and is the preferred alternative donor HCT option for adults with ALL in complete remission.
Comparison of the real‐world effectiveness of vertical versus lateral functional hemispherotomy techniques for pediatric drug‐resistant epilepsy: A post hoc analysis of the HOPS study
Fallah, Aria , Lewis, Evan , Ibrahim, George M. , Tseng, Chi‐Hong , Harris, William B., Chen, Jia‐Shu , Lin, Kao‐Min, Cai, Lixin , Liu, Qingzhu , Lin, Jiuluan , Mathern, Gary W. , Smyth, Matthew D. , O’Neill, Brent R., Dudley, Roy , Ragheb, John , Bhatia, Sanjiv, Delev, Daniel , Ramantani, Georgia , Zentner, Josef , Dorfer, Christian , Feucht, Martha , Czech, Thomas , Bollo, Robert J. , Issabekov, Galymzhan , Zhu, Hongwei , Connolly, Mary , Steinbok, Paul , Zhang, Kai , Weiner, Howard L. , Lapalme‐Remis, Samuel , Tripathi, Manjari , Chandra, P. Sarat , Hader, Walter , Wang, Feng‐Peng , Champagne, Pierre‐Olivier , Brunette‐Clément, Tristan , Budke, Marcelo , Pérez-Jiménez, María Ángeles, Raftopoulos, Christian , Finet, Patrice, Michel, Pauline, Schaller, Karl , Malone, Christian Cantillano, Pociecha, Juan , Chamorro, Noelia, Muro, Valeria L., Lehe, Marec von , Vieker, Silvia, Oluigbo, Chima , Gaillard, William D. , Al‐Khateeb, Mashael, Alotaibi, Faisal , Krayenbühl, Niklaus , Bolton, Jeffrey , Weil, Alexander G. , Cai, Li-Xin , Ramantani, Georgia , Dorfer, Christian , Feucht, Martha , Wong-Kisiel, Lily, Tripathi, Manjari , Sarat Chandra, Poodipedi , von Lehe, Marec , Gaillard, William D , Weil, Alexander G , Fallah, Aria , Chen, Jia-Shu , Oluigbo, Chima O , Kola, Olivia , Zhou, Wen-Jing , Wang, Anthony , Zhang, Jianguo , Hidalgo, Eveline Teresa , Wong‐Kisiel, Lily C. , Wang, Feng‐Peng, Yao, Yi , Guo, Qiang , Li, Shao‐Chun, Stienen, Martin Nikolaus , Baro, Valentina , Pearl, Phillip L.

Epilepsia | September 12, 2021 | Volume: 62 | Issue: 11 | Pages: 2707-2718

10.1111/epi.17021 | PMID 34510448 Get It

AbstractObjectiveThis study was undertaken to determine whether the vertical parasagittal approach or the lateral peri‐insular/peri‐Sylvian approach to hemispheric surgery is the superior technique in achieving long‐term seizure freedom.MethodsWe conducted a post hoc subgroup analysis of the HOPS (Hemispheric Surgery Outcome Prediction Scale) study, an international, multicenter, retrospective cohort study that identified predictors of seizure freedom through logistic regression modeling. Only patients undergoing vertical parasagittal, lateral peri‐insular/peri‐Sylvian, or lateral trans‐Sylvian hemispherotomy were included in this post hoc analysis. Differences in seizure freedom rates were assessed using a time‐to‐event method and calculated using the Kaplan–Meier survival method.ResultsData for 672 participants across 23 centers were collected on the specific hemispherotomy approach. Of these, 72 (10.7%) underwent vertical parasagittal hemispherotomy and 600 (89.3%) underwent lateral peri‐insular/peri‐Sylvian or trans‐Sylvian hemispherotomy. Seizure freedom was obtained in 62.4% (95% confidence interval [CI] = 53.5%–70.2%) of the entire cohort at 10‐year follow‐up. Seizure freedom was 88.8% (95% CI = 78.9%–94.3%) at 1‐year follow‐up and persisted at 85.5% (95% CI = 74.7%–92.0%) across 5‐ and 10‐year follow‐up in the vertical subgroup. In contrast, seizure freedom decreased from 89.2% (95% CI = 86.3%–91.5%) at 1‐year to 72.1% (95% CI = 66.9%–76.7%) at 5‐year to 57.2% (95% CI = 46.6%–66.4%) at 10‐year follow‐up for the lateral subgroup. Log‐rank test found that vertical hemispherotomy was associated with durable seizure‐free progression compared to the lateral approach (p = .01). Patients undergoing the lateral hemispherotomy technique had a shorter time‐to‐seizure recurrence (hazard ratio = 2.56, 95% CI = 1.08–6.04, p = .03) and increased seizure recurrence odds (odds ratio = 3.67, 95% CI = 1.05–12.86, p = .04) compared to those undergoing the vertical hemispherotomy technique.SignificanceThis pilot study demonstrated more durable seizure freedom of the vertical technique compared to lateral hemispherotomy techniques. Further studies, such as prospective expertise‐based observational studies or a randomized clinical trial, are required to determine whether a vertical approach to hemispheric surgery provides superior long‐term seizure outcomes.
North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition Position Paper on the Diagnosis and Management of Pediatric Acute Liver Failure
Squires, James E., Alonso, Estella M., Ibrahim, Samar H., Kasper, Vania, Kehar, Mohit, Martinez, Mercedes, Squires, Robert H., Ibrahim, Samar H. , Squires, James E. , Kehar, Mohit , Ibrahim, Samar H , Squires, James E , Alonso, Estella M., Ibrahim, Samar H., Kasper, Vania, Martinez, Mercedes, Squires, Robert H.

Journal of Pediatric Gastroenterology and Nutrition | August 4, 2021 | Volume: 74 | Issue: 1 | Pages: 138-158

10.1097/mpg.0000000000003268 | PMID 34347674 Get It

ABSTRACT Pediatric acute liver failure (PALF) is a rare, rapidly progressive clinical syndrome with significant morbidity and mortality. The phenotype of PALF manifests as abrupt onset liver dysfunction, which can be brought via disparate etiology. Management is reliant upon intensive clinical care and support, often provided by the collaborative efforts of hepatologists, critical care specialists, and liver transplant surgeons. The construction of an age‐based diagnostic approach, the identification of a potential underlying cause, and the prompt implementation of appropriate therapy can be lifesaving; however, the dynamic and rapidly progressive nature of PALF also demands that diagnostic inquiries be paired with monitoring strategies for the recognition and treatment of common complications of PALF. Although liver transplantation can provide a potential life‐saving therapeutic option, the ability to confidently determine the certainness that liver transplant is needed for an individual child has been hampered by a lack of adequately tested clinical decision support tools and accurate predictive models. Given the accelerated progress in understanding PALF, we will provide clinical guidance to pediatric gastroenterologists and other pediatric providers caring for children with PALF by presenting the most recent advances in diagnosis, management, pathophysiology, and associated outcomes.
Impact of Atrial Fibrillation on Outcome in Takotsubo Syndrome: Data From the International Takotsubo Registry
El‐Battrawy, Ibrahim , Cammann, Victoria L. , Szawan, Konrad A. , Vece, Davide Di , Rossi, Aurelio, Wischnewsky, Manfred , Hermes‐Laufer, Julia , Gili, Sebastiano , Citro, Rodolfo , Franke, Jennifer , Meder, Benjamin , Knorr, Maike, Heiner, Susanne, Burgdorf, Christof , Kherad, Behrouz , Tschöpe, Carsten , Sarcon, Annahita, Shinbane, Jerold S., Rajan, Lawrence, Michels, Guido, Pfister, Roman , Cuneo, Alessandro , Jacobshagen, Claudius, Karakas, Mahir , Köenig, Wolfgang , Pott, Alexander , Meyer, Philippe , Arroja, José David , Banning, Adrian , Cuculi, Florim , Fischer, Thomas, Vasankari, Tuija , Napp, L. Christian , Budnik, Monika , Dworakowski, Rafał , MacCarthy, Philip , Osswald, Stefan , Galiuto, Leonarda , Chan, Christina , Bridgman, Paul , Beug, Daniel , Gilyarova, Ekaterina, Gilyarov, Mikhail , Kozel, Martin , Winchester, David E. , Ukena, Christian , Carrilho‐Ferreira, Pedro , Hauck, Christian , Paolini, Carla , Bilato, Claudio , Kobayashi, Yoshio, Rihal, Charanjit S. , Liu, Kan , Bianco, Matteo , Jörg, Lucas, Rickli, Hans , Böhm, Michael , Pinto, Fausto J. , Widimský, Petr , Felix, Stephan B. , Opolski, Grzegorz , Rottbauer, Wolfgang , Pieske, Burkert , Katus, Hugo A. , Münzel, Thomas , Crea, Filippo , Lüscher, Thomas F. , Duru, Fırat , Borggrefe, Martin, Ghadri, Jelena R. , Akın, İbrahim , Templin, Christian , Crea, Filippo , Citro, Rodolfo , El-Battrawy, Ibrahim , Duru, Firat , Tschöpe, Carsten , Koenig, Wolfgang , Meyer, Philippe , Banning, Adrian , Gilyarov, Mikhail , Ukena, Christian , Bilato, Claudio , Bianco, Matteo , Kato, Ken , Bossone, Eduardo , Neuhaus, Michael, Jaguszewski, Miłosz , Noutsias, Michel , D’Ascenzo, Fabrizio , Dichtl, Wolfgang , Kobza, Richard , Airaksinen, Juhani , Kaiser, Christoph A. , Delmas, Clément , Lairez, Olivier , Shilova, Alexandra S. , Toušek, Petr , Gałuszka, Jan , Poglajen, Gregor , Prasad, Abhiram , Rihal, Charanjit S. , Schulze, Paul Christian , Pestana, Gonçalo , Nguyen, Thanh Ha Tuan , Maier, Lars S. , Braun-Dullaeus, Ruediger Christian , Hasenfuß, Gerd , Schunkert, Heribert , Thiele, Hölger , Bauersachs, Johann , Horowitz, John D. , Mario, Carlo Di , Bax, Jeroen J. , Ruschitzka, Frank T.

Journal of the American Heart Association | July 28, 2021 | Volume: 10 | Issue: 15 | Pages: No page available

10.1161/jaha.119.014059 | PMID 34315238 Get It

Background Atrial fibrillation (AF) is a major risk factor for mortality. The prevalence, clinical correlates, and prognostic impact of AF in Takotsubo syndrome (TTS) have not yet been investigated in a large patient cohort. This study aimed to investigate the prevalence, clinical correlates, and prognostic impact of AF in patients with TTS. Methods and Results Patients with TTS were enrolled from the International Takotsubo Registry, which is a multinational network with 26 participating centers in Europe and the United States. Patients were dichotomized according to the presence or absence of AF at the time of admission. Of 1584 patients with TTS, 112 (7.1%) had AF. The mean age was higher ( P <0.001), and there were fewer women ( P =0.046) in the AF than in the non‐AF group. Left ventricular ejection fraction was significantly lower ( P =0.001), and cardiogenic shock was more often observed ( P <0.001) in the AF group. Both in‐hospital ( P <0.001) and long‐term mortality ( P <0.001) were higher in the AF group. Multivariable Cox regression analysis revealed that AF was independently associated with higher long‐term mortality (hazard ratio, 2.31; 95% CI, 1.50–3.55; P <0.001). Among patients with AF on admission, 42% had no known history of AF before the acute TTS event, and such patients had comparable in‐hospital and long‐term outcomes compared with those with a history of AF. Conclusions In patients presenting with TTS, AF on admission is significantly associated with increased in‐hospital and long‐term mortality rates. Whether antiarrhythmics and/or cardioversion are beneficial in TTS with AF should thus be tested in a future trial. Registration URL: https://www.clinicaltrials.gov ; Unique identifier: NCT01947621.
Echocardiography, lung ultrasound, and cardiac magnetic resonance findings in COVID‐19: A systematic review
Barssoum, Kirolos , Victor, Varun , Kumar, Ashish , Mubasher, Mahmood , Hassib, Mohab, Magdi, Mohamed, Renjithlal, Sarathlal, Abdelazeem, Mohamed , Shariff, Mariam , Idemudia, Osarenren , Ibrahim, Mounir , Mohamed, Amr , Patel, Harsh , Diab, Mohamed , Szeles, Andras , Ibrahim, Fadi , Jha, Roshan Kumar , Akula, Navya, Nanda, Navin C. , Kumar, Ashish , Kumar, Ashish , Shariff, Mariam , Chowdhury, Medhat , Salem, Ahmad, Thakkar, Samarthkumar , Kalra, Ankur

Echocardiography | July 8, 2021 | Volume: No volume available | Issue: No issue available | Pages: No page available

10.1111/echo.15152 | PMID 34236091 Get It

Idecabtagene vicleucel (ide-cel, bb2121), a BCMA-directed CAR T cell therapy, in relapsed and refractory multiple myeloma: Updated KarMMa results.
Anderson, Larry D. , Munshi, Nikhil C. , Shah, Nina , Delforge, Michel, Huang, Liping , Campbell, Timothy , Hege, Kristen , Investigators, on behalf of the KarMMa Study, Anderson, Larry D , Jagannath, Sundar , Berdeja, Jesús G. , Lonial, Sagar , Raje, Noopur , Siegel, David S. , Lin, Yi , Oriol, Albert , Moreau, Philippe , Yakoub‐Agha, Ibrahim , Petrocca, Fabio , Patel, Payal , Miguel, Jesús F. San , Investigators, on behalf of the KarMMa Study

Journal of Clinical Oncology | June 2, 2021 | Volume: 39 | Issue: 15_suppl | Pages: 8016-8016

10.1200/jco.2021.39.15_suppl.8016 Get It

8016 Background: Patients (pts) with RRMM previously exposed to immunomodulatory agents, proteasome inhibitors (PIs), and CD38 antibodies (mAbs) have poor outcomes with subsequent treatments. Ide-cel, a BCMA-directed CAR T cell therapy, showed frequent, deep, and durable responses in heavily pretreated pts with RRMM in the pivotal KarMMa trial (Munshi NC, et al. J Clin Oncol 2020;38[suppl 15]. Abstract 8503). Here, we present updated data. Methods: Pts with ≥ 3 prior regimens (including immunomodulatory agent, PI, and CD38 mAb) and refractory to their last regimen per IMWG criteria were eligible (NCT03361748). Pts received 150─450 × 106 CAR+ T cells (target dose range) after 3 days of lymphodepletion (cyclophosphamide 300 mg/m2 + fludarabine 30 mg/m2). Endpoints included overall response rate (ORR; primary) and complete response (CR) rate (key secondary). Additional secondary endpoints included progression-free survival (PFS), overall survival (OS), and safety. Results: KarMMa enrolled 140 pts, and 128 received ide-cel. Pts had a median age of 61 years and a median of 6 (range, 3-16) prior regimens; 84% were triple-class refractory, and 26% were penta-class refractory (lenalidomide, pomalidomide, bortezomib, carfilzomib, and daratumumab). Most pts (88%) had bridging therapy. Median follow-up was 15.4 mo (data cutoff, 7 Apr 2020). ORR was 73% and median PFS was 8.8 mo in all treated pts; both increased with higher dose (Table). At the highest target dose (450 × 106 CAR+ T cells), the ORR was 81%, the CR rate was 39%, and the median PFS increased to 12.2 months with longer follow-up. Responses were observed in all subgroups including difficult-to-treat subsets (eg, extramedullary disease [ORR, 70%], high tumor burden [71%], and R-ISS stage III disease [48%]). OS continues to mature and the median has not been reached; the 15-month event-free rate for OS was 71%. Cytopenias (97%) and cytokine release syndrome (CRS; 84%) were the most common any-grade toxicities. CRS was mostly grade 1/2; 5 pts (4%) had grade 3, 1 had grade 4 (at 300 × 106), and 1 had grade 5 (at 300 × 106). Investigator-identified neurotoxicity was reported in 23 pts (18%); 4 pts (3%) had grade 3 and 0 had grade ≥ 4. Tocilizumab was used in 67 and 3 pts with CRS and neurotoxicity, respectively. Conclusions: Updated results from the KarMMa trial continue to demonstrate deep, durable responses with ide-cel in heavily pretreated pts with RRMM. Efficacy and safety reflect prior reports and support a favorable clinical benefit-risk profile for ide-cel across the target dose range. Clinical trial information: NCT03361748. [Table: see text]
Evaluation of intra-tumoral (IT) SD-101 and pembrolizumab (Pb) in combination with paclitaxel (P) followed by AC in high-risk HER2-negative (HER2-) stage II/III breast cancer: Results from the I-SPY 2 trial.
Chien, A. Jo , Ewing, Cheryl Ann, Campbell, Michael J. , Albain, Kathy S. , Stringer-Reasor, Erica , Church, An , Clark, Amy S. , Nanda, Rita, Berry, Donald A. , Soliman, Hatem Hussein , Boughey, Judy C. , Rugo, Hope S. , Wallace, Anne M. , Kalinsky, Kevin M. , Elias, Anthony , Mitri, Zahi Ibrahim , Thomas, Alexandra , Yau, Christina , Esserman, Laura J.

Journal of Clinical Oncology | June 1, 2021 | Volume: 39 | Issue: 15_suppl | Pages: 508-508

10.1200/jco.2021.39.15_suppl.508 Get It

508 Background: I-SPY 2 is a multicenter, phase 2 trial using response-adaptive randomization within molecular subtypes defined by receptor status and MammaPrint (MP) risk to evaluate novel agents as neoadjuvant therapy for women with high-risk breast cancer. SD-101 is an investigational Toll-like receptor 9 (TLR9) agonist CpG-C class oligodeoxynucleotide that stimulates the production of IFN-α and interleukin (IL)-12, functional maturation of plasmacytoid dendritic cells, and production of cytotoxic antibodies. IT SD-101 was combined with systemic anti-PD-1 antibody Pb to investigate the antitumor and immunologic activity of this novel immunotherapeutic strategy. Methods: Women with tumors ≥ 2.5cm were eligible for screening. Only pts (pts) with HER2- disease were eligible for this treatment. Treatment included weekly P x 12 in combination with IT SD-101 2 mg/ml (1 ml for T2 tumors, 2 ml for >T3 tumors) weekly x 4, then q3 weeks x 2, and IV Pb q3 weeks x 4, followed by doxorubicin/cyclophosphamide (AC) q2-3 weeks x 4 (SD-101+Pembro 4). Pts in the control arm received weekly P x 12 followed by AC q2-3 weeks x 4. The I-SPY 2 methods have been previously published. This investigational arm was eligible for graduation (>85% chance of success in a 300-person phase 3 neoadjuvant trial) in 3 of 10 pre-defined signatures: HER2-, hormone receptor (HR)+/HER2- and HR-/HER2-. Results: 75 pts were randomized and evaluable in SD-101+Pembro 4 treatment arm. The control arm included 329 historical controls enrolled since April 2010. The study arm was stopped due to maximal patient accrual. Pt characteristics were balanced; 56% HR+, 44% HR-. The probability that SD-101+Pembro4 was superior to control exceeded 97% for all eligible tumor signatures, but did not reach the threshold for graduation in any of the signatures. However, it is notable that the rate of pCR/Residual Cancer Burden 1 (RCB1) in the HR+/HER2- signature was 51%. Preliminary safety events for SD-101+Pembro 4 include increased rates of fever, neutropenia, febrile neutropenia, transaminitis, and immune-related events, including adrenal insufficiency. Conclusions: The SD-101+Pembro 4 regimen was active but did not meet the pre-specified threshold for graduation in I-SPY 2. pCR/RCB 1 analysis suggests improved response in the HR+/HER-negative signature compared to control. The clinical significance of these findings needs to be weighed against the potential risk of immune-related toxicities. Clinical trial information: NCT01042379. [Table: see text]