559 results on '"Baggott, Christina"'
Search Results
2. Tisagenlecleucel utilisation and outcomes across refractory, first relapse and multiply relapsed B-cell acute lymphoblastic leukemia: a retrospective analysis of real-world patterns.
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Barsan, Valentin, Li, Yimei, Prabhu, Snehit, Baggott, Christina, Nguyen, Khanh, Pacenta, Holly, Phillips, Christine, Rossoff, Jenna, Stefanski, Heather, Talano, Julie-An, Moskop, Amy, Baumeister, Susanne, Verneris, Michael, Myers, Gary, Karras, Nicole, Cooper, Stacy, Qayed, Muna, Satwani, Prakash, Krupski, Christa, Keating, Amy, Fabrizio, Vanessa, Chinnabhandar, Vasant, Kunicki, Michael, Curran, Kevin, Mackall, Crystal, Laetsch, Theodore, Schultz, Liora, and Hermiston, Michelle
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CAR T cells ,CD19 CAR T cells ,Commercial CAR ,First relapse ,Immunotherapy ,Pediatric oncology ,Real-world analysis ,Tisagenlecleucel - Abstract
BACKGROUND: Tisagenlecleucel was approved by the Food and Drug Administration (FDA) in 2017 for refractory B-cell acute lymphoblastic leukemia (B-ALL) and B-ALL in ≥2nd relapse. Outcomes of patients receiving commercial tisagenlecleucel upon 1st relapse have yet to be established. We aimed to report real-world tisagenlecleucel utilisation patterns and outcomes across indications, specifically including patients treated in 1st relapse, an indication omitted from formal FDA approval. METHODS: We conducted a retrospective analysis of real-world tisagenlecleucel utilisation patterns across 185 children and young adults treated between August 30, 2017 and March 6, 2020 from centres participating in the Pediatric Real-World CAR Consortium (PRWCC), within the United States. We described definitions of refractory B-ALL used in the real-world setting and categorised patients by reported Chimeric Antigen Receptor (CAR) T-cell indication, including refractory, 1st relapse and ≥2nd relapse B-ALL. We analysed baseline patient characteristics and post-tisagenlecleucel outcomes across defined cohorts. FINDINGS: Thirty-six percent (n = 67) of our cohort received tisagenlecleucel following 1st relapse. Of 66 evaluable patients, 56 (85%, 95% CI 74-92%) achieved morphologic complete response. Overall-survival (OS) and event-free survival (EFS) at 1-year were 69%, (95% CI 58-82%) and 49%, (95% CI 37-64%), respectively, with survival outcomes statistically comparable to remaining patients (OS; p = 0.14, EFS; p = 0.39). Notably, toxicity was increased in this cohort, warranting further study. Interestingly, of 30 patients treated for upfront refractory disease, 23 (77%, 95% CI 58-90%) had flow cytometry and/or next-generation sequencing (NGS) minimum residual disease (MRD)-only disease at the end of induction, not meeting the historic morphologic definition of refractory. INTERPRETATION: Our findings suggested that tisagenlecleucel response and survival rates overlap across patients treated with upfront refractory B-ALL, B-ALL ≥2nd relapse and B-ALL in 1st relapse. We additionally highlighted that definitions of refractory B-ALL are evolving beyond morphologic measures of residual disease. FUNDING: St. Baldricks/Stand Up 2 Cancer, Parker Institute for Cancer Immunotherapy, Virginia and D.K. Ludwig Fund for Cancer Research.
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- 2023
3. HLH-like toxicities predict poor survival following use of tisagenlecleucel in children and young adults with B-ALL
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McNerney, Kevin Owen, Lim, Stephanie Si, Ishikawa, Kyle, Dreyzin, Alexandra, Vatsayan, Anant, Chen, John J, Baggott, Christina, Prabhu, Snehit, Pacenta, Holly L, Phillips, Christine L, Rossoff, Jenna, Stefanski, Heather E, Talano, Julie-An, Moskop, Amy, Verneris, Michael R, Myers, Doug, Karras, Nicole A, Brown, Patrick A, Bonifant, Challice L, Qayed, Muna, Hermiston, Michelle L, Satwani, Prakash, Krupski, Christa, Keating, Amy K, Baumeister, Susanne HC, Fabrizio, Vanessa A, Chinnabhandar, Vasant, Egeler, Emily, Mavroukakis, Sharon, Curran, Kevin J, Mackall, Crystal L, Laetsch, Theodore W, and Schultz, Liora M
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Biomedical and Clinical Sciences ,Clinical Sciences ,Hematology ,Pediatric ,Rare Diseases ,Humans ,Child ,Young Adult ,Lymphohistiocytosis ,Hemophagocytic ,Retrospective Studies ,Receptors ,Antigen ,T-Cell ,Receptors ,Chimeric Antigen ,Precursor B-Cell Lymphoblastic Leukemia-Lymphoma ,Burkitt Lymphoma ,Chronic Disease ,Cardiovascular medicine and haematology - Abstract
Chimeric antigen receptor-associated hemophagocytic lymphohistiocytosis (HLH)-like toxicities (LTs) involving hyperferritinemia, multiorgan dysfunction, coagulopathy, and/or hemophagocytosis are described as occurring in a subset of patients with cytokine release syndrome (CRS). Case series report poor outcomes for those with B-cell acute lymphoblastic leukemia (B-ALL) who develop HLH-LTs, although larger outcomes analyses of children and young adults (CAYAs) with B-ALL who develop these toxicities after the administration of commercially available tisagenlecleucel are not described. Using a multi-institutional database of 185 CAYAs with B-ALL, we conducted a retrospective cohort study including groups that developed HLH-LTs, high-grade (HG) CRS without HLH-LTs, or no to low-grade (NLG) CRS without HLH-LTs. Primary objectives included characterizing the incidence, outcomes, and preinfusion factors associated with HLH-LTs. Among 185 CAYAs infused with tisagenlecleucel, 26 (14.1%) met the criteria for HLH-LTs. One-year overall survival and relapse-free survival were 25.7% and 4.7%, respectively, in those with HLH-LTs compared with 80.1% and 57.6%, respectively, in those without. In multivariable analysis for death, meeting criteria for HLH-LTs carried a hazard ratio of 4.61 (95% confidence interval, 2.41-8.83), controlling for disease burden, age, and sex. Patients who developed HLH-LTs had higher pretisagenlecleucel disease burden, ferritin, and C-reactive protein levels and lower platelet and absolute neutrophil counts than patients with HG- or NLG-CRS without HLH-LTs. Overall, CAYAs with B-ALL who developed HLH-LTs after tisagenlecleucel experienced high rates of relapse and nonrelapse mortality, indicating the urgent need for further investigations into prevention and optimal management of patients who develop HLH-LTs after tisagenlecleucel.
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- 2023
4. Higher doses of tisagenlecleucel associate with improved outcomes: a report from the pediatric real-world CAR consortium
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Stefanski, Heather, Eaton, Anne, Baggott, Christina, Rossoff, Jenna, Verneris, Michael R, Keating, Amy K, Prabhu, Snehit, Pacenta, Holly L, Phillips, Christine L, Talano, Julie-An, Moskop, Amy, Margossian, Steven P, Myers, Gary Doug, Karras, Nicole A, Brown, Patrick A, Qayed, Muna, Hermiston, Michelle L, Satwani, Prakash, Krupski, Christa, Wilcox, Rachel, rabik, cara A, Fabrizio, Vanessa A, Chinnabhandar, Vasant, Goksenin, A Yasemin, Egeler, Emily, Mavroukakis, Sharon, Curran, Kevin J, Mackall, Crystal L, Laetsch, Theodore W, and Schultz, Liora M
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Rare Diseases ,Pediatric ,Pediatric Cancer ,Cancer ,Pediatric Research Initiative ,Childhood Leukemia ,Hematology ,Clinical Research ,United States ,Humans ,Child ,Adult ,Retrospective Studies ,Receptors ,Antigen ,T-Cell ,Precursor Cell Lymphoblastic Leukemia-Lymphoma ,T-Lymphocytes ,Recurrence ,Chronic Disease - Abstract
Remarkable complete response rates have been shown with tisagenlecleucel, a chimeric antigen receptor (CAR) T-cell therapy targeting CD19, in patients up to age 26 years with refractory/relapsed B-cell acute lymphoblastic leukemia; it is US Food and Drug Administration approved for this indication. Currently, patients receive a single dose of tisagenlecleucel across a wide dose range of 0.2 to 5.0 × 106 and 0.1 to 2.5 × 108 CAR T cells per kg for patients ≤50 and >50 kg, respectively. The effect of cell dose on survival and remission is not yet well established. Our primary goal was to determine if CAR T-cell dose affects overall survival (OS), event-free survival (EFS), or relapse-free-survival (RFS) in tisagenlecleucel recipients. Retrospective data were collected from Pediatric Real World CAR Consortium member institutions and included 185 patients infused with commercial tisagenlecleucel. The median dose of viable transduced CAR T cells was 1.7 × 106 CAR T cells per kg. To assess the impact of cell dose, we divided responders into dose quartiles: 0.134 to 1.300 × 106 (n = 48 [27%]), 1.301 to 1.700 × 106 (n = 46 [26%]), 1.701 to 2.400 × 106 (n = 43 [24%]), and 2.401 to 5.100 × 106 (n = 43 [24%]). OS, EFS, and RFS were improved in patients who received higher doses of tisagenlecleucel (P = .031, .0079, and .0045, respectively). Higher doses of tisagenlecleucel were not associated with increased toxicity. Because the current tisagenlecleucel package insert dose range remains broad, this work has implications in regard to targeting higher cell doses, within the approved dose range, to optimize patients' potential for long-standing remission.
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- 2023
5. Outcomes After Nonresponse and Relapse Post-Tisagenlecleucel in Children, Adolescents, and Young Adults With B-Cell Acute Lymphoblastic Leukemia.
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Schultz, Liora, Eaton, Anne, Baggott, Christina, Rossoff, Jenna, Prabhu, Snehit, Keating, Amy, Krupski, Christa, Pacenta, Holly, Philips, Christine, Talano, Julie-An, Moskop, Amy, Baumeister, Susanne, Myers, Gary, Karras, Nicole, Brown, Patrick, Qayed, Muna, Satwani, Prakash, Wilcox, Rachel, Rabik, Cara, Fabrizio, Vanessa, Chinnabhandar, Vasant, Kunicki, Michael, Mavroukakis, Sharon, Egeler, Emily, Li, Yimei, Mackall, Crystal, Curran, Kevin, Verneris, Michael, Laetsch, Theodore, Stefanski, Heather, and Hermiston, Michelle
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Humans ,Child ,Young Adult ,Adolescent ,Retrospective Studies ,Receptors ,Antigen ,T-Cell ,Precursor B-Cell Lymphoblastic Leukemia-Lymphoma ,Immunotherapy ,Adoptive ,Recurrence ,Antigens ,CD19 ,Chronic Disease - Abstract
PURPOSE: Nonresponse and relapse after CD19-chimeric antigen receptor (CAR) T-cell therapy continue to challenge survival outcomes. Phase II landmark data from the ELIANA trial demonstrated nonresponse and relapse rates of 14.5% and 28%, respectively, whereas use in the real-world setting showed nonresponse and relapse rates of 15% and 37%. Outcome analyses describing fate after post-CAR nonresponse and relapse remain limited. Here, we aim to establish survival outcomes after nonresponse and both CD19+ and CD19- relapses and explore treatment variables associated with inferior survival. METHODS: We conducted a retrospective multi-institutional study of 80 children and young adults with B-cell acute lymphoblastic leukemia experiencing nonresponse (n = 23) or relapse (n = 57) after tisagenlecleucel. We analyze associations between baseline characteristics and these outcomes and establish survival rates and salvage approaches. RESULTS: The overall survival (OS) at 12 months was 19% across nonresponders (n = 23; 95% CI, 7 to 50). Ninety-five percent of patients with nonresponse had high preinfusion disease burden. Among 156 morphologic responders, the cumulative incidence of relapse was 37% (95% CI, 30 to 47) at 12 months (CD19+; 21% [15 to 29], CD19-; 16% [11 to 24], median follow-up; 380 days). Across 57 patients experiencing relapse, the OS was 52% (95% CI, 38 to 71) at 12 months after time of relapse. Notably, CD19- relapse was associated with significantly decreased OS as compared with patients who relapsed with conserved CD19 expression (CD19- 12-month OS; 30% [14 to 66], CD19+ 12-month OS; 68% [49 to 92], P = .0068). Inotuzumab, CAR reinfusion, and chemotherapy were used as postrelapse salvage therapy with greatest frequency, yet high variability in treatment sequencing and responses limits efficacy analysis across salvage approaches. CONCLUSION: We describe poor survival across patients experiencing nonresponse to tisagenlecleucel. In the post-tisagenlecleucel relapse setting, patients can be salvaged; however, CD19- relapse is distinctly associated with decreased survival outcomes.
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- 2023
6. Mediport use as an acceptable standard for CAR T cell infusion.
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Eylon, Maya, Prabhu, Snehit, John, Samuel, King, Maxwell, Bhatt, Dhruv, Curran, Kevin, Erickson, Courtney, Karras, Nicole, Phillips, Christine, Satwani, Prakash, Southworth, Erica, Baumeister, Susanne, Talano, Julie-An, MacMillan, Margaret, Rossoff, Jenna, Bonifant, Challice, Myers, Gary, Rouce, Rayne, Toner, Keri, Driscoll, Timothy, Katsanis, Emmanuel, Salzberg, Dana, Capitini, Christian, Pacenta, Holly, Pfeiffer, Thomas, Shah, Niketa, Huynh, Van, Skiles, Jodi, Fraint, Ellen, McNerney, Kevin, Quigg, Troy, Krueger, Joerg, Ligon, John, Fabrizio, Vanessa, Baggott, Christina, Laetsch, Theodore, Schultz, Liora, Hermiston, Michelle, De Oliveira, Satiro, and Schiff, Deborah
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cancer ,chimeric antigen receptor T cell ,immune cell engineering ,immunotherapy ,implanted catheter ,mediport - Abstract
INTRODUCTION: Mediport use as a clinical option for the administration of chimeric antigen receptor T cell (CAR T cell) therapy in patients with B-cell malignancies has yet to be standardized. Concern for mediport dislodgement, cell infiltration, and ineffective therapy delivery to systemic circulation has resulted in variable practice with intravenous administration of CAR T cell therapy. With CAR T cell commercialization, it is important to establish practice standards for CAR T cell delivery. We conducted a study to establish usage patterns of mediports in the clinical setting and provide a standard of care recommendation for mediport use as an acceptable form of access for CAR T cell infusions. METHODS: In this retrospective cohort study, data on mediport use and infiltration rate was collected from a survey across 34 medical centers in the Pediatric Real-World CAR Consortium, capturing 504 CAR T cell infusion routes across 489 patients. Data represents the largest, and to our knowledge sole, report on clinical CAR T cell infusion practice patterns since FDA approval and CAR T cell commercialization in 2017. RESULTS: Across 34 sites, all reported tunneled central venous catheters, including Broviac® and Hickman® catheters, as accepted standard venous options for CAR T cell infusion. Use of mediports as a standard clinical practice was reported in 29 of 34 sites (85%). Of 489 evaluable patients with reported route of CAR T cell infusion, 184 patients were infused using mediports, with no reported incidences of CAR T cell infiltration. DISCUSSION/CONCLUSION: Based on current clinical practice, mediports are a commonly utilized form of access for CAR T cell therapy administration. These findings support the safe practice of mediport usage as an accepted standard line option for CAR T cell infusion.
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- 2023
7. Initial Evaluation of an Electronic Symptom Diary for Adolescents with Cancer
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Baggott, Christina, Gibson, Faith, Coll, Beatriz, Kletter, Richard, Zeltzer, Paul, and Miaskowski, Christine
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Medicine ,Computer applications to medicine. Medical informatics ,R858-859.7 - Abstract
BackgroundThe delivery of optimal care depends on accurate communication between patients and clinicians regarding untoward symptoms. Documentation of patients’ symptoms necessitates reliance on memory, which is often imprecise. We developed an electronic diary (eDiary) for adolescents and young adults (AYAs) with cancer to record symptoms. ObjectiveThe purpose of this paper is to describe the utility of an eDiary designed for AYAs with cancer, including dependability of the mobile application, the reasons for any missing recorded data, patients’ adherence rates to daily symptom queries, and patients’ perceptions of the usefulness and acceptability of symptom data collection via mobile phones. MethodsOur team developed an electronic symptom diary based on interviews conducted with AYAs with cancer and their clinicians. This diary included daily severity ratings of pain, nausea, vomiting, fatigue, and sleep. The occurrence of other selected physical sequelae was assessed daily. Additionally, patients selected descriptors of their mood. A 3-week trial of the eDiary was conducted with 10 AYA cancer patients. Mobile phones with service plans were loaned to patients who were instructed to report their symptoms daily. Patients completed a brief questionnaire and were interviewed to elicit their perceptions of the eDiary and any technical difficulties encountered. ResultsOverall adherence to daily symptom reports exceeded 90%. Young people experienced few technical difficulties and reported benefit from daily symptom reports. Symptom occurrence rates were high and considerable inter- and intra-patient variability was noted in symptom and mood reports. ConclusionsWe demonstrated the utility of an eDiary that may contribute insight into patients’ symptom patterns to promote effective symptom management.
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- 2012
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8. Real-World Use of Tisagenlecleucel in Infant Acute Lymphoblastic Leukemia
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Moskop, Amy, Pommert, Lauren, Baggott, Christina, Prabhu, Snehit, Pacenta, Holly L, Phillips, Christine L, Rossoff, Jenna, Stefanski, Heather, Talano, Julie-An, Margossian, Steven P, Verneris, Michael R, Myers, Gary Doug, Karras, Nicole A, Brown, Patrick A, Qayed, Muna, Hermiston, Michelle L, Satwani, Prakash, Krupski, Christa, Keating, Amy K, Wilcox, Rachel, Rabik, Cara A, Fabrizio, Vanessa A, Chinnabhandar, Vasant, Goksenin, A Yasemin, Curran, Kevin J, Mackall, Crystal L, Laetsch, Theodore W, Guest, Erin M, Breese, Erin H, and Schultz, Liora M
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Pediatric Research Initiative ,Cancer ,Pediatric Cancer ,Biotechnology ,Stem Cell Research ,Immunization ,Vaccine Related ,Childhood Leukemia ,Orphan Drug ,Rare Diseases ,Clinical Research ,Hematology ,Pediatric ,Evaluation of treatments and therapeutic interventions ,6.1 Pharmaceuticals ,5.2 Cellular and gene therapies ,Development of treatments and therapeutic interventions ,5.1 Pharmaceuticals ,Antigens ,CD19 ,Child ,Humans ,Precursor Cell Lymphoblastic Leukemia-Lymphoma ,Receptors ,Antigen ,T-Cell ,Receptors ,Chimeric Antigen ,Retrospective Studies ,United States - Abstract
Infants with B-cell acute lymphoblastic leukemia (B-ALL) have poor outcomes because of chemotherapy resistance leading to high relapse rates. Tisagenlecleucel, a CD19-directed chimeric antigen receptor T-cell (CART) therapy, is US Food and Drug Administration approved for relapsed or refractory B-ALL in patients ≤25 years; however, the safety and efficacy of this therapy in young patients is largely unknown because children M1 marrow) were refractory to this therapy (n = 5). Overall, tisagenlecleucel was tolerable in this population, with only 3 patients experiencing ≥grade 3 cytokine release syndrome. No neurotoxicity was reported. This is the largest report of tisagenlecleucel use in infant B-ALL and shows that this therapy is safe and can be effective in this population. Incorporating this novel immunotherapy into the treatment of infant B-ALL offers a promising therapy for a highly aggressive leukemia.
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- 2022
9. Symptom management care pathway adaptation process and specific adaptation decisions
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Vettese, Emily, Sherani, Farha, King, Allison A., Yu, Lolie, Aftandilian, Catherine, Baggott, Christina, Agarwal, Vibhuti, Nagasubramanian, Ramamoorthy, Kelly, Kara M., Freyer, David R., Orgel, Etan, Bradfield, Scott M., Kyono, Wade, Roth, Michael, Klesges, Lisa M., Beauchemin, Melissa, Grimes, Allison, Tomlinson, George, Dupuis, L. Lee, and Sung, Lillian
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- 2023
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10. Optimal fludarabine lymphodepletion is associated with improved outcomes following CAR T-cell Therapy
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Fabrizio, Vanessa A, Boelens, Jaap Jan, Mauguen, Audrey, Baggott, Christina, Prabhu, Snehit, Egeler, Emily, Mavroukakis, Sharon, Pacenta, Holly L, Phillips, Christine L, Rossoff, Jenna, Stefanski, Heather, Talano, Julie-An An, Moskop, Amy, Margossian, Steven P, Verneris, Michael R, Myers, Gary Doug, Karras, Nicole A, Brown, Patrick A, Qayed, Muna, Hermiston, Michelle L, Satwani, Prakash, Krupski, Christa, Keating, Amy K, Wilcox, Rachel, Rabik, Cara A, Chinnabhandar, Vasant, Kunicki, Michael, Goksenin, A Yasemin, Mackall, Crystal L, Laetsch, Theodore W, Schultz, Liora M, and Curran, Kevin J
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Pediatric Cancer ,Transplantation ,Hematology ,Human Genome ,Cancer ,Clinical Research ,Pediatric ,Genetics ,6.1 Pharmaceuticals ,Evaluation of treatments and therapeutic interventions ,Good Health and Well Being ,Adolescent ,Adult ,Child ,Child ,Preschool ,Humans ,Immunotherapy ,Adoptive ,Infant ,Prospective Studies ,Recurrence ,Retrospective Studies ,Vidarabine ,Young Adult - Abstract
Chimeric antigen receptor (CAR) T cells provide a therapeutic option in hematologic malignancies. However, treatment failure after initial response approaches 50%. In allogeneic hematopoietic cell transplantation, optimal fludarabine exposure improves immune reconstitution, resulting in lower nonrelapse mortality and increased survival. We hypothesized that optimal fludarabine exposure in lymphodepleting chemotherapy before CAR T-cell therapy would improve outcomes. In a retrospective analysis of patients with relapsed/refractory B-cell acute lymphoblastic leukemia undergoing CAR T-cell (tisagenlecleucel) infusion after cyclophosphamide/fludarabine lymphodepleting chemotherapy, we estimated fludarabine exposure as area under the curve (AUC; mg × h/L) using a validated population pharmacokinetic (PK) model. Fludarabine exposure was related to overall survival (OS), cumulative incidence of relapse (CIR), and a composite end point (loss of B-cell aplasia [BCA] or relapse). Eligible patients (n = 152) had a median age of 12.5 years (range,
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- 2022
11. Disease Burden Affects Outcomes in Pediatric and Young Adult B-Cell Lymphoblastic Leukemia After Commercial Tisagenlecleucel: A Pediatric Real-World Chimeric Antigen Receptor Consortium Report
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Schultz, Liora M, Baggott, Christina, Prabhu, Snehit, Pacenta, Holly L, Phillips, Christine L, Rossoff, Jenna, Stefanski, Heather E, Talano, Julie-An, Moskop, Amy, Margossian, Steven P, Verneris, Michael R, Myers, Gary Douglas, Karras, Nicole A, Brown, Patrick A, Qayed, Muna, Hermiston, Michelle, Satwani, Prakash, Krupski, Christa, Keating, Amy K, Wilcox, Rachel, Rabik, Cara A, Fabrizio, Vanessa A, Rouce, Rayne H, Chinnabhandar, Vasant, Kunicki, Michael, Barsan, Valentin V, Goksenin, A Yasemin, Li, Yimei, Mavroukakis, Sharon, Egeler, Emily, Curran, Kevin J, Mackall, Crystal L, and Laetsch, Theodore W
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Pediatric Research Initiative ,Clinical Research ,Rare Diseases ,Cancer ,Pediatric ,Hematology ,Childhood Leukemia ,Pediatric Cancer ,Orphan Drug ,6.1 Pharmaceuticals ,Evaluation of treatments and therapeutic interventions ,Adolescent ,Child ,Cost of Illness ,Humans ,Immunotherapy ,Adoptive ,Leukemia ,Lymphocytic ,Chronic ,B-Cell ,Precursor Cell Lymphoblastic Leukemia-Lymphoma ,Receptors ,Antigen ,T-Cell ,Receptors ,Chimeric Antigen ,Retrospective Studies ,Young Adult ,Clinical Sciences ,Oncology and Carcinogenesis ,Oncology & Carcinogenesis - Abstract
PurposeTisagenlecleucel is a CD19-specific chimeric antigen receptor T-cell therapy, US Food and Drug Administration-approved for children, adolescents, and young adults (CAYA) with relapsed and/or refractory (RR) B-cell acute lymphoblastic leukemia (B-ALL). The US Food and Drug Administration registration for tisagenlecleucel was based on a complete response (CR) rate of 81%, 12-month overall survival (OS) of 76%, and event-free survival (EFS) of 50%. We report clinical outcomes and analyze covariates of outcomes after commercial tisagenlecleucel.MethodsWe conducted a retrospective, multi-institutional study of CAYA with RR B-ALL across 15 US institutions, who underwent leukapheresis shipment to Novartis for commercial tisagenlecleucel. A total of 200 patients were included in an intent-to-treat response analysis, and 185 infused patients were analyzed for survival and toxicity.ResultsIntent-to-treat analysis demonstrates a 79% morphologic CR rate (95% CI, 72 to 84). The infused cohort had an 85% CR (95% CI, 79 to 89) and 12-month OS of 72% and EFS of 50%, with 335 days of median follow-up. Notably, 48% of patients had low-disease burden (< 5% bone marrow lymphoblasts, no CNS3, or other extramedullary disease), or undetectable disease, pretisagenlecleucel. Univariate and multivariate analyses associate high-disease burden (HB, ≥ 5% bone marrow lymphoblasts, CNS3, or non-CNS extramedullary) with inferior outcomes, with a 12-month OS of 58% and EFS of 31% compared with low-disease burden (OS; 85%, EFS; 70%) and undetectable disease (OS; 95%, EFS; 72%; P < .0001 for OS and EFS). Grade ≥ 3 cytokine release syndrome and neurotoxicity rates were 21% and 7% overall and 35% and 9% in patients with HB, respectively.ConclusionCommercial tisagenlecleucel in CAYA RR B-ALL demonstrates efficacy and tolerability. This first analysis of commercial tisagenlecleucel stratified by disease burden identifies HB preinfusion to associate with inferior OS and EFS and increased toxicity.
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- 2022
12. Tisagenlecleucel Outcomes in Relapsed/Refractory Extramedullary ALL: A Pediatric Real World CAR Consortium Report.
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Fabrizio, Vanessa A, Phillips, Christine L, Lane, Adam, Baggott, Christina, Prabhu, Snehit, Egeler, Emily, Mavroukakis, Sharon, Pacenta, Holly L, Rossoff, Jenna, Stefanski, Heather, Talano, Julie-An An, Moskop, Amy, Margossian, Steven P, Verneris, Michael R, Myers, Gary Doug, Karras, Nicole A, Brown, Patrick A, Qayed, Muna, Hermiston, Michelle L, Satwani, Prakash, Krupski, Christa, Keating, Amy K, Wilcox, Rachel, Rabik, Cara A, Chinnabhandar, Vasant, Kunicki, Michael, Goksenin, A Yasemin, Curran, Kevin J, Mackall, Crystal L, Laetsch, Theodore W, and Schultz, Liora M
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Clinical Research ,Rare Diseases ,Pediatric ,Pediatric Cancer ,Childhood Leukemia ,Neurosciences ,Hematology ,Cancer ,Child ,Humans ,Immunotherapy ,Adoptive ,Precursor Cell Lymphoblastic Leukemia-Lymphoma ,Receptors ,Antigen ,T-Cell ,Recurrence ,Retrospective Studies - Abstract
Chimeric antigen receptor (CAR) T cells have transformed the therapeutic options for relapsed/refractory (R/R) B-cell acute lymphoblastic leukemia. Data for CAR therapy in extramedullary (EM) involvement are limited. Retrospective data were abstracted from the Pediatric Real World CAR Consortium (PRWCC) of 184 infused patients from 15 US institutions. Response (complete response) rate, overall survival (OS), relapse-free survival (RFS), and duration of B-cell aplasia (BCA) in patients referred for tisagenlecleucel with EM disease (both central nervous system (CNS)3 and non-CNS EM) were compared with bone marrow (BM) only. Patients with CNS disease were further stratified for comparison. Outcomes are reported on 55 patients with EM disease before CAR therapy (CNS3, n = 40; non-CNS EM, n = 15). The median age at infusion in the CNS cohort was 10 years (range,
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- 2022
13. HLH-like toxicities predict poor survival after the use of tisagenlecleucel in children and young adults with B-ALL
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McNerney, Kevin O., Si Lim, Stephanie J., Ishikawa, Kyle, Dreyzin, Alexandra, Vatsayan, Anant, Chen, John J., Baggott, Christina, Prabhu, Snehit, Pacenta, Holly L., Philips, Christine, Rossoff, Jenna, Stefanski, Heather E., Talano, Julie-An, Moskop, Amy, Verneris, Michael, Myers, Doug, Karras, Nicole A., Brown, Patrick, Bonifant, Challice L., Qayed, Muna, Hermiston, Michelle, Satwani, Prakash, Krupski, Christa, Keating, Amy K., Baumeister, Susanne H. C., Fabrizio, Vanessa A., Chinnabhandar, Vasant, Egeler, Emily, Mavroukakis, Sharon, Curran, Kevin J., Mackall, Crystal L., Laetsch, Theodore W., and Schultz, Liora M.
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- 2023
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14. Higher doses of tisagenlecleucel are associated with improved outcomes: a report from the pediatric real-world CAR consortium
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Stefanski, Heather E., Eaton, Anne, Baggott, Christina, Rossoff, Jenna, Verneris, Michael R., Prabhu, Snehit, Pacenta, Holly L., Phillips, Christine L., Talano, Julie-An, Moskop, Amy, Margossian, Steven P., Myers, Gary Douglas, Karras, Nicole A., Brown, Patrick A., Qayed, Muna, Hermiston, Michelle, Satwani, Prakash, Krupski, M. Christa, Keating, Amy K., Wilcox, Rachel, Rabik, Cara A., Fabrizio, Vanessa A., Chinnabhandar, Vasant, Goksenin, A. Yasemin, Curran, Kevin J., Mackall, Crystal L., Laetsch, Theodore W., and Schultz, Liora M.
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- 2023
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15. DIGIPREDICT: physiological, behavioural and environmental predictors of asthma attacks—a prospective observational study using digital markers and artificial intelligence—study protocol
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Chan, Amy Hai Yan, primary, Te Ao, Braden, additional, Baggott, Christina, additional, Cavadino, Alana, additional, Eikholt, Amber A, additional, Harwood, Matire, additional, Hikaka, Joanna, additional, Gibbs, Dianna, additional, Hudson, Mariana, additional, Mirza, Farhaan, additional, Naeem, Muhammed Asif, additional, Semprini, Ruth, additional, Chang, Catherina L, additional, Tsang, Kevin C H, additional, Shah, Syed Ahmar, additional, Jeremiah, Aron, additional, Abeysinghe, Binu Nisal, additional, Roy, Rajshri, additional, Wall, Clare, additional, Wood, Lisa, additional, Dalziel, Stuart, additional, Pinnock, Hilary, additional, van Boven, Job F M, additional, Roop, Partha, additional, and Harrison, Jeff, additional
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- 2024
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16. GD2-CAR T cell therapy for H3K27M-mutated diffuse midline gliomas
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Majzner, Robbie G., Ramakrishna, Sneha, Yeom, Kristen W., Patel, Shabnum, Chinnasamy, Harshini, Schultz, Liora M., Richards, Rebecca M., Jiang, Li, Barsan, Valentin, Mancusi, Rebecca, Geraghty, Anna C., Good, Zinaida, Mochizuki, Aaron Y., Gillespie, Shawn M., Toland, Angus Martin Shaw, Mahdi, Jasia, Reschke, Agnes, Nie, Esther H., Chau, Isabelle J., Rotiroti, Maria Caterina, Mount, Christopher W., Baggott, Christina, Mavroukakis, Sharon, Egeler, Emily, Moon, Jennifer, Erickson, Courtney, Green, Sean, Kunicki, Michael, Fujimoto, Michelle, Ehlinger, Zach, Reynolds, Warren, Kurra, Sreevidya, Warren, Katherine E., Prabhu, Snehit, Vogel, Hannes, Rasmussen, Lindsey, Cornell, Timothy T., Partap, Sonia, Fisher, Paul G., Campen, Cynthia J., Filbin, Mariella G., Grant, Gerald, Sahaf, Bita, Davis, Kara L., Feldman, Steven A., Mackall, Crystal L., and Monje, Michelle
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- 2022
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17. Optimal fludarabine lymphodepletion is associated with improved outcomes after CAR T-cell therapy
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Fabrizio, Vanessa A., Boelens, Jaap Jan, Mauguen, Audrey, Baggott, Christina, Prabhu, Snehit, Egeler, Emily, Mavroukakis, Sharon, Pacenta, Holly, Phillips, Christine L., Rossoff, Jenna, Stefanski, Heather E., Talano, Julie-An, Moskop, Amy, Margossian, Steven P., Verneris, Michael R., Myers, Gary Douglas, Karras, Nicole A., Brown, Patrick A., Qayed, Muna, Hermiston, Michelle, Satwani, Prakash, Krupski, Christa, Keating, Amy K., Wilcox, Rachel, Rabik, Cara A., Chinnabhandar, Vasant, Kunicki, Michael, Goksenin, A. Yasemin, Mackall, Crystal L., Laetsch, Theodore W., Schultz, Liora M., and Curran, Kevin J.
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- 2022
- Full Text
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18. Case report: sub-clinical extramedullary B-ALL in the setting of relapse following targeted therapy.
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Johns, Claire, Erickson, Courtney, Jacobs, Ashley, Moon, Jennifer, Baggott, Christina, Dagher, Regina, Nadel, Helen, Balagtas, Jay, Aftandilian, Catherine, Ramakrishna, Sneha, Lacayo, Norman, Davis, Kara L., Stieglitz, Elliot, and Schultz, Liora
- Abstract
Standard testing for disease evaluation in B-cell acute lymphoblastic leukemia (B-ALL) includes examination of the bone marrow and cerebrospinal fluid. Radiographic or functional imaging are indicated when clinical signs of non-CNS extramedullary disease are present but are not standard in the relapsed/refractory setting. We describe two cases of patients with relapsed/refractory BALL with prior exposure to blinatumomab and/or inotuzumab ozogamicin presenting for CAR-T cell treatment. Both patients were thought to only have minimal residual disease (MRD) at the pre-CAR disease assessment, with MRD of 6,648 (0.66%) and 100 (0.01%) cells per million cells, respectively, as measured by next-generation sequencing (NGS) in their bone marrows. Both patients for distinct reasons unrelated to non-CNS extra-medullary (EM) symptoms had PETMRIs prior to lymphodepletion and CAR T cell infusion. In both cases patients were found to have significant bulky subclinical EM disease that required changes in clinical management. In the newly-emergent era of antigen-targeted immunotherapy, it is foundational that incidence and relapse patterns following targeted therapy are well-understood. Herein we contribute to a growing body of literature addressing this fundamental clinical gap and highlight a future role for formal prospective imaging studies to better establish response, toxicity and relapse patterns following CAR-T cell therapy in EM B-ALL. [ABSTRACT FROM AUTHOR]
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- 2024
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19. Real World Outcomes for AYA Patients with Relapsed/Refractory B-Cell ALL Receiving CD19-Directed CAR T-Cell Therapy
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Lust, Hannah, primary, Roloff, Gregory, additional, Schultz, Liora Michal, additional, Muffly, Lori S, additional, Krugman, Jessica, additional, Aldoss, Ibrahim, additional, Kwon, Soyang, additional, Kubiak, Michal, additional, Lee, Catherine J., additional, Cassaday, Ryan D., additional, Shah, Bijal D., additional, Baggott, Christina, additional, Kopmar, Noam E., additional, Bradshaw, Danielle, additional, Schwartz, Marc, additional, Tracy, Sean, additional, Mukherjee, Akash, additional, Ladha, Abdullah, additional, Yaghmour, George, additional, Advani, Anjali S., additional, Stefan, Maryann, additional, Kota, Vamsi, additional, Veeraputhiran, Muthu, additional, Stock, Wendy, additional, Rossoff, Jenna, additional, Qayed, Muna, additional, Talano, Julie A, additional, Curran, Kevin J., additional, Phillips, Christine L, additional, Karras, Nicole, additional, Fabrizio, Vanessa A., additional, Baumeister, Susanne H.C., additional, Cooper, Stacy, additional, Hermiston, Michelle, additional, Satwani, Prakash, additional, Macmillan, Margaret, additional, John, Samuel, additional, and Faramand, Rawan G, additional
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- 2024
- Full Text
- View/download PDF
20. Establishing Costs for Commercial Chimeric Antigen Receptor T-Cell (Tisagenlecleucel; Kymriah) in Children and Young Adult B-Cell Acute Lymphoblastic Leukemia: A Merged Analysis from the Pediatric Real-World CAR Consortium (PRWCC) and Pediatric Health Information System (PHIS)
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Satwani, Prakash, primary, Chao, Karen, additional, Lopez-Garcia, Maria, additional, Hall, Matt, additional, Jin, Zhezhen, additional, Winestone, Lena E., additional, Friedman, Danielle, additional, Phelan, Rachel, additional, Baggott, Christina, additional, John, Samuel, additional, Pacenta, Holly L, additional, Laetsch, Theodore W, additional, Phillips, Christine L, additional, Verneris, Michael R., additional, Fabrizio, Vanessa A., additional, Keating, Amy K., additional, Talano, Julie A, additional, Moskop, Amy, additional, Baumeister, Susanne H.C., additional, Qayed, Muna, additional, Myers, Doug, additional, Hall, Erin M., additional, Prabhu, Snehit, additional, Nguyen, Khanh, additional, Mackall, Crystal L., additional, Lin, John Kent, additional, Goldhaber-Fiebert, Jeremy, additional, and Schultz, Liora Michal, additional
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- 2024
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- View/download PDF
21. Risk Factors for Hematotoxicity Following Tisagenlecleucel for Pediatric B-Acute Lymphoblastic Leukemia
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McNerney, Kevin Owen, primary, Fabrizio, Vanessa A., additional, Talleur, Aimee C., additional, Lim, Stephanie Si, additional, Dreyzin, Alexandra, additional, Baggott, Christina, additional, Vatsayan, Anant, additional, Prabhu, Snehit, additional, Rossoff, Jenna, additional, Pacenta, Holly L, additional, Phillips, Christine L, additional, Talano, Julie A, additional, Moskop, Amy, additional, Verneris, Michael R., additional, Myers, Doug, additional, Karras, Nicole, additional, Bonifant, Challice L, additional, Qayed, Muna, additional, Hermiston, Michelle, additional, Satwani, Prakash, additional, Krupski, Christa, additional, Keating, Amy K., additional, Baumeister, Susanne H.C., additional, Chinnabhandar, Vasant, additional, Egeler, Emily, additional, Mavroukakis, Sharon, additional, Curran, Kevin J., additional, Mackall, Crystal L., additional, Laetsch, Theodore W, additional, Schultz, Liora Michal, additional, and Naik, Swati, additional
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- 2024
- Full Text
- View/download PDF
22. Technology to Support the Care of Children and Adolescents with Cancer
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Baggott, Christina, Jibb, Lindsay, Parker, Roses, Stinson, Jennifer, Linder, Lauri, Reaman, Gregory H., Series Editor, Smith, Franklin O., Series Editor, Hinds, Pamela S., editor, and Linder, Lauri, editor
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- 2020
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23. Practice Preferences for Consolidative Hematopoietic Stem Cell Transplantation Following Tisagenlecleucel in Children and Young Adults with B Cell Acute Lymphoblastic Leukemia
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McNerney, Kevin O., Moskop, Amy, Winestone, Lena E., Baggott, Christina, Talano, Julie-An, Schiff, Deborah, Rossoff, Jenna, Modi, Arunkumar, Verneris, Michael R., Laetsch, Theodore W., and Schultz, Liora
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- 2024
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- View/download PDF
24. Clinical practice guideline for the prevention of oral and oropharyngeal mucositis in pediatric cancer and hematopoietic stem cell transplant patients: 2021 update
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Patel, Priya, Robinson, Paula D., Baggott, Christina, Gibson, Paul, Ljungman, Gustaf, Massey, Nicholas, Ottaviani, Guilia, Phillips, Robert, Revon-Rivière, Gabriel, Treister, Nathaniel, White, Marie, Cabral, Sandra, Dupuis, Lee, and Sung, Lillian
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- 2021
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25. Feeling scared or worried self-report in children receiving cancer treatments using the Symptom Screening in Pediatrics Tool (SSPedi)
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Hyslop, Shannon, Tomlinson, Deborah, Baggott, Christina, Dix, David, Gibson, Paul, Johnston, Donna L., Orsey, Andrea D., Portwine, Carol, Price, Vicky, Vanan, Magimairajan, Kuczynski, Susan, Spiegler, Brenda, Tomlinson, George A., Dupuis, L. Lee, and Sung, Lillian
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- 2021
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- View/download PDF
26. Predictive value of blood eosinophils and exhaled nitric oxide in adults with mild asthma: a prespecified subgroup analysis of an open-label, parallel-group, randomised controlled trial
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Corin, Andrew, Helm, Colin, Poudel, Bhuwan, Sheahan, Davitt, Sheahan, Pamela, Bennett, Miriam, Chang, Caterina, Ellis, Hollie, Hancox, Bob, Hopping, Sandra, Tuffery, Christine, Ramsahai, James Michael, Simpson, Jodie, Wark, Peter, Aliani, Maria, Genco, Maddalena, Capozzolo, Alberto, Carone, Mauro, Maini, Elisa, Mancin, Jenny, Meriggi, Antonio, Perfetti, Luca, Cherubino, Francesca, Spanevello, Antonio, Visca, Dina, Zampogna, Elisabetta, Baggott, Christina, Beasley, Richard, Braithwaite, Irene, Eathorne, Allie, Ebmeier, Stefan, Fingleton, James, Hardy, Jo, Holliday, Mark, Houghton, Claire, Oldfield, Karen, Pilcher, Janine, Sabbagh, Donah, Semprini, Alex, Williams, Mathew, Harrison, Tim, Shaw, Karen, Mackisack, Summer, Montgomery, Barney, Autridge, Karen, Joseph, Joanna, Moon, Stella, Quinn, Dean, Millar-Coote, Dean, Reid, Jim, Bellini, Federico, Marchi, Martina, Morandi, Luca, Padovani, Marianna, Papi, Alberto, Scalet, Daniela, Borg, Katie, Connolly, Clare, Gittins, Anna, Hynes, Gareth, Jeffers, Helen, Pavord, Ian, Shrimanker, Rahul, Foxley, Gloria, Guevara-Rattray, Elyse, Milne, Stephen, Reddel, Helen, Toelle, Brett, Pavord, Ian D, Reddel, Helen K, Hancox, Robert J, and Weatherall, Mark
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- 2020
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27. Do You Know My Child? Continuity of Nursing Care in the Pediatric Intensive Care Unit
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Baird, Jennifer, Rehm, Roberta S, Hinds, Pamela S, Baggott, Christina, and Davies, Betty
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Health Services and Systems ,Nursing ,Health Sciences ,Pediatric ,Clinical Research ,7.1 Individual care needs ,Management of diseases and conditions ,Adolescent ,Adult ,Attitude of Health Personnel ,Child ,Child ,Preschool ,Chronic Disease ,Continuity of Patient Care ,Critical Care ,Female ,Grounded Theory ,Hospitalization ,Humans ,Infant ,Infant ,Newborn ,Intensive Care Units ,Pediatric ,Male ,Middle Aged ,Nurse-Patient Relations ,Nursing Staff ,Parents ,Young Adult ,child ,pediatric intensive care unit ,continuity of care ,chronic illness ,Midwifery - Abstract
BackgroundParents of children with complex, chronic conditions report a desire for continuity of care, but relatively little is known about the ways in which nursing continuity of care occurs and the extent to which it is delivered in the inpatient setting.ObjectivesThe objective of this analysis, which arose from a study on best practices in parent/nurse interactions in the pediatric intensive care unit (PICU), was to explore the delivery of continuity of nursing care in the PICU from the perspective of both parents and nurses.MethodsA qualitative, grounded theory study using situational analysis was conducted with seven parents and 12 nurse participants from a single PICU. Data sources included in-depth interviews, observation, and organizational written materials. Data were coded and analyzed using memoing and situational and positional maps to highlight emerging themes, context, and positions within the data.ResultsParents repeatedly endorsed a desire for continuity of nursing care, wanting to ensure that the bedside nurse valued their child as an individual and understood the complexities of the child's care regimen. Nurses understood this need but faced both contextual and personal challenges to achieving continuity, including fluctuations in staffing needs, training demands, fear of emotional entanglement, and concern for missed learning opportunities.DiscussionContinuity of nursing care is highly valued by parents of children with complex chronic condition in the PICU, but significant barriers to optimal delivery exist within the current critical care environment. Mechanisms for supporting nurses to deliver continuity of care are needed, as are alternative ways to help parents feel that all nurses caring for their child have the knowledge necessary to deliver safe and compassionate care.
- Published
- 2016
28. Establishing Costs for Commercial Chimeric Antigen Receptor T-Cell (Tisagenlecleucel; Kymriah) in Children and Young Adult B-Cell Acute Lymphoblastic Leukemia; A Merged Analysis from the Prwcc and PHIS
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Satwani, Prakash, primary, Chao, Karen, additional, Lopez-Garcia, Maria, additional, Hall, Matt, additional, Jin, Zhezhen, additional, Winestone, Lena E, additional, Friedman, Danielle Novetsky, additional, Phelan, Rachel, additional, Baggott, Christina, additional, John, Samuel, additional, Pacenta, Holly L., additional, Laetsch, Theodore W., additional, Phillips, Christine L, additional, Verneris, Michael R, additional, Fabrizio, Vanessa A., additional, Keating, Amy, additional, Talano, Julie-An, additional, Moskop, Amy, additional, Baumeister, Susanne H.C., additional, Qayed, Muna, additional, Myers, Doug Douglas, additional, Hall, Erin Marie, additional, Prabhu, Snehit, additional, Nguyen, Khanh, additional, Carr, Casey A, additional, Mackall, Crystal L., additional, Lin, John K, additional, Goldhaber-Fiebert, Jeremy, additional, and Schultz, Liora Michal, additional
- Published
- 2023
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- View/download PDF
29. Cytokine gene variations associated with trait and state anxiety in oncology patients and their family caregivers.
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Miaskowski, Christine, Cataldo, Janine K, Baggott, Christina R, West, Claudia, Dunn, Laura B, Dhruva, Anand, Merriman, John D, Langford, Dale J, Kober, Kord M, Paul, Steven M, Cooper, Bruce A, and Aouizerat, Bradley E
- Subjects
Humans ,Neoplasms ,Cytokines ,Severity of Illness Index ,Regression Analysis ,Anxiety ,Age Distribution ,Sex Distribution ,Genotype ,Phenotype ,Aged ,Middle Aged ,Caregivers ,Female ,Male ,Genetic Variation ,Behavioral and Social Science ,Cancer ,Genetics ,Mental Health ,Biotechnology ,2.1 Biological and endogenous factors ,Aetiology ,Radiation therapy ,Single nucleotide polymorphism ,Family caregiver ,Trait anxiety ,State anxiety ,Medical and Health Sciences ,Psychology and Cognitive Sciences ,Oncology & Carcinogenesis - Abstract
PurposeAnxiety is common among cancer patients and their family caregivers (FCs) and is associated with poorer outcomes. Recently, associations between inflammation and anxiety were identified. However, the relationship between variations in cytokine genes and anxiety warrants investigation. Therefore, phenotypic and genotypic characteristics associated with trait and state anxiety were evaluated in a sample of 167 oncology patients with breast, prostate, lung, or brain cancer and 85 of their FCs.MethodsUsing multiple regression analyses, the associations between participants' demographic and clinical characteristics as well as variations in cytokine genes and trait and state anxiety were evaluated.ResultsIn the bivariate analyses, a number of phenotypic characteristics were associated with both trait and state anxiety (e.g., age, functional status). However, some associations were specific only to trait anxiety (e.g., number of comorbid conditions) or state anxiety (e.g., participation with a FC). Variations in three cytokine genes (i.e., interleukin (IL) 1 beta, IL1 receptor 2 (IL1R2), nuclear factor kappa beta 2 (NFKB2)) were associated with trait anxiety, and variations in two genes (i.e., IL1R2, tumor necrosis factor alpha (TNFA)) were associated with state anxiety.ConclusionsThese findings suggest that both trait and state anxiety need to be assessed in oncology patients and their FCs. Furthermore, variations in cytokine genes may contribute to higher levels of anxiety in oncology patients and their FCs.
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- 2015
30. Cytokine gene associations with self-report ratings of morning and evening fatigue in oncology patients and their family caregivers.
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Cooper, Bruce, Paul, Steven, West, Claudia, Langford, Dale, Merriman, John, Baggott, Christina, Miaskowski, Christine, Aouizerat, Bradley, Lee, Kathryn, Leutwyler, Heather, Cataldo, Janine, Dunn, Laura, Ritchie, Christine, Dhruva, Anand, Dodd, Marylin, Wara, William, and Kober, Kord
- Subjects
breast cancer ,cytokines ,evening fatigue ,genetics ,interleukin 4 ,morning fatigue ,tumor necrosis factor alpha ,Caregivers ,Cytokines ,Fatigue ,Female ,Genetic Association Studies ,Genetic Markers ,Haplotypes ,Humans ,Male ,Middle Aged ,Neoplasms ,Phenotype ,Polymorphism ,Genetic ,Polymorphism ,Single Nucleotide ,Regression Analysis ,Time - Abstract
The purpose of this study was to evaluate for differences in variations in pro- and anti-inflammatory cytokine genes between participants who were classified as having low and high levels of morning and evening fatigue and to evaluate for differences in phenotypic characteristics between these two groups. In a sample of 167 oncology outpatients with breast, prostate, lung, or brain cancer and 85 of their family caregivers, growth mixture modeling was used to identify latent classes of individuals based on ratings of morning and evening fatigue obtained prior to, during, and for 4 months following completion of radiation therapy. Differences in single nucleotide polymorphisms and haplotypes in 15 cytokine genes were evaluated between the latent classes. Multiple logistic regression was used to assess the effect of phenotypic and genotypic characteristics on morning and evening fatigue class membership. Associations were found between morning fatigue and number of comorbidities as well as variations in tumor necrosis factor alpha (TNFA) rs1800629 and rs3093662. Evening fatigue was associated with caring for children at home and variations in interleukin 4 (IL4) rs2243248 and TNFA rs2229094. Younger age and lower performance status were associated with both morning and evening fatigue. These findings suggest that inflammatory mediators are associated with the development of morning and evening fatigue. However, because different phenotypic characteristics and genomic markers are associated with diurnal variations in fatigue, morning and evening fatigue may be distinct but related symptoms.
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- 2015
31. Cytokine gene associations with self-report ratings of morning and evening fatigue in oncology patients and their family caregivers.
- Author
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Dhruva, Anand, Aouizerat, Bradley E, Cooper, Bruce, Paul, Steven M, Dodd, Marylin, West, Claudia, Wara, William, Lee, Kathryn, Dunn, Laura B, Langford, Dale J, Merriman, John D, Baggott, Christina, Cataldo, Janine, Ritchie, Christine, Kober, Kord M, Leutwyler, Heather, and Miaskowski, Christine
- Subjects
Humans ,Neoplasms ,Fatigue ,Genetic Markers ,Cytokines ,Regression Analysis ,Haplotypes ,Phenotype ,Polymorphism ,Genetic ,Polymorphism ,Single Nucleotide ,Time ,Middle Aged ,Caregivers ,Female ,Male ,Genetic Association Studies ,breast cancer ,cytokines ,evening fatigue ,genetics ,interleukin 4 ,morning fatigue ,tumor necrosis factor alpha ,Clinical Research ,Cancer ,Genetics ,Aging ,2.1 Biological and endogenous factors ,Aetiology ,Nursing - Abstract
The purpose of this study was to evaluate for differences in variations in pro- and anti-inflammatory cytokine genes between participants who were classified as having low and high levels of morning and evening fatigue and to evaluate for differences in phenotypic characteristics between these two groups. In a sample of 167 oncology outpatients with breast, prostate, lung, or brain cancer and 85 of their family caregivers, growth mixture modeling was used to identify latent classes of individuals based on ratings of morning and evening fatigue obtained prior to, during, and for 4 months following completion of radiation therapy. Differences in single nucleotide polymorphisms and haplotypes in 15 cytokine genes were evaluated between the latent classes. Multiple logistic regression was used to assess the effect of phenotypic and genotypic characteristics on morning and evening fatigue class membership. Associations were found between morning fatigue and number of comorbidities as well as variations in tumor necrosis factor alpha (TNFA) rs1800629 and rs3093662. Evening fatigue was associated with caring for children at home and variations in interleukin 4 (IL4) rs2243248 and TNFA rs2229094. Younger age and lower performance status were associated with both morning and evening fatigue. These findings suggest that inflammatory mediators are associated with the development of morning and evening fatigue. However, because different phenotypic characteristics and genomic markers are associated with diurnal variations in fatigue, morning and evening fatigue may be distinct but related symptoms.
- Published
- 2015
32. What Impact Do Hospital and Unit-Based Rules Have Upon Patient and Family-Centered Care in the Pediatric Intensive Care Unit?
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Baird, Jennifer, Davies, Betty, Hinds, Pamela S, Baggott, Christina, and Rehm, Roberta S
- Subjects
Health Services and Systems ,Nursing ,Health Sciences ,Pediatric ,Clinical Research ,Patient Safety ,Management of diseases and conditions ,Health and social care services research ,7.1 Individual care needs ,8.1 Organisation and delivery of services ,Good Health and Well Being ,Adolescent ,Adult ,Child ,Child ,Preschool ,Chronic Disease ,Female ,Health Impact Assessment ,Hospitals ,Teaching ,Humans ,Infant ,Intensive Care Units ,Pediatric ,Long-Term Care ,Male ,Middle Aged ,Needs Assessment ,Outcome Assessment ,Health Care ,Patient-Centered Care ,Professional-Family Relations ,Qualitative Research ,Risk Assessment ,Severity of Illness Index ,Patient and family-centered care ,Pediatric intensive care unit ,Children with complex chronic conditions ,Paediatrics and Reproductive Medicine ,Paediatrics - Abstract
Patient and family-centered care (PFCC) is the foundation for pediatric healthcare. The existence of hospital rules can, however, impact the extent to which PFCC is delivered. This qualitative, grounded theory study identified the existence of explicit and implicit rules in a pediatric intensive care unit, all of which negatively affected the family's ability to receive care that was attentive to their needs. The rules also placed the registered nurse in the challenging position of serving as rule enforcer and facilitator of PFCC. Further work is needed to explore how to adapt the hospital environment to better meet families' needs.
- Published
- 2015
33. Real-world use of tisagenlecleucel in children and young adults with relapsed or refractory B-cell lymphomas
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Bender, Jonathan D., Damodharan, Sudarshawn, Capitini, Christian M., Moskop, Amy, Toner, Keri, Vatsayan, Anant, Talano, Julie-An, Baggott, Christina, Schiff, Deborah, Katsanis, Emmanuel, Modi, Arunkumar J., Quigg, Troy C., Raikar, Sunil S., Schultz, Liora M., and Pommert, Lauren
- Published
- 2024
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34. Refinement of the symptom screening in pediatrics tool (SSPedi).
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Baggott, Christina, O'Sullivan, C, Dupuis, LL, Gibson, P, Johnston, DL, Portwine, C, Spiegler, B, Kuczynski, S, Tomlinson, D, and de, S
- Abstract
BACKGROUND: Objective was to evaluate and refine a new instrument for paediatric cancer symptom screening named the Symptom Screening in Pediatrics Tool (SSPedi). METHODS: Respondents were children 8-18 years of age undergoing active cancer treatment and p
- Published
- 2014
35. Identification of patient subgroups and risk factors for persistent arm/shoulder pain following breast cancer surgery
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Miaskowski, Christine, Paul, Steven M, Cooper, Bruce, West, Claudia, Levine, Jon D, Elboim, Charles, Hamolsky, Deborah, Abrams, Gary, Luce, Judith, Dhruva, Anand, Langford, Dale J, Merriman, John D, Kober, Kord, Baggott, Christina, Leutwyler, Heather, and Aouizerat, Bradley E
- Subjects
Health Services and Systems ,Biomedical and Clinical Sciences ,Clinical Sciences ,Health Sciences ,Breast Cancer ,Clinical Research ,Patient Safety ,Cancer ,Chronic Pain ,Pain Research ,Rehabilitation ,Musculoskeletal ,Activities of Daily Living ,Arm ,Breast Neoplasms ,California ,Female ,Hand Strength ,Humans ,Longitudinal Studies ,Mastectomy ,Middle Aged ,Pain Measurement ,Pain ,Postoperative ,Prevalence ,Prospective Studies ,Quality of Life ,Range of Motion ,Articular ,Risk Factors ,Shoulder Pain ,Surveys and Questionnaires ,Arm pain ,Shoulder pain ,Persistent postsurgical pain ,Risk factors ,Breast cancer surgery ,Growth mixture modeling ,Latent class analysis ,Chronic pain ,Nursing ,Oncology and Carcinogenesis ,Oncology and carcinogenesis ,Health services and systems - Abstract
PurposeIn this prospective, longitudinal study, we extend our findings on persistent breast pain in patients (n = 398) following breast cancer surgery and evaluate the prevalence and characteristics of persistent pain in the arm/shoulder. In addition, differences in the severity of common symptoms and quality of life outcomes measured prior to surgery, among the arm pain classes, were evaluated.Methods and samplePatients were recruited from Breast Care Centers located in a Comprehensive Cancer Center, two public hospitals, and four community practices. Patients were assessed prior to and monthly for six months following breast cancer surgery.ResultsUsing growth mixture modeling, patients were classified into no (41.6%), mild (23.6%), and moderate (34.8%) arm pain classes based on ratings of worst arm/shoulder pain. Compared to the no pain class, patients in the moderate pain class were significantly younger, had a higher body mass index, and were more likely to report preoperative breast pain and swelling in the affected breast. In addition, patients in the moderate pain class reported higher levels of depression, anxiety, and sleep disturbance than the no pain class.ConclusionsFindings suggest that approximately 35% of women experience persistent levels of moderate arm/shoulder pain in the first six months following breast cancer surgery. Moderate arm/shoulder pain is associated with clinically meaningful decrements in functional status and quality of life.
- Published
- 2014
36. Preliminary evidence of an association between an interleukin 6 promoter polymorphism and self-reported attentional function in oncology patients and their family caregivers.
- Author
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Merriman, John, Aouizerat, Bradley, Langford, Dale, Cooper, Bruce, Baggott, Christina, Cataldo, Janine, Dhruva, Anand, Dunn, Laura, West, Claudia, Paul, Steven, Ritchie, Christine, Swift, Patrick, and Miaskowski, Christine
- Subjects
attention ,cancer ,cytokines ,genetic association studies ,inflammation ,radiotherapy ,Aged ,Attention ,Caregivers ,Family ,Female ,Humans ,Interleukin-6 ,Male ,Middle Aged ,Neoplasms ,Polymorphism ,Single Nucleotide ,Promoter Regions ,Genetic - Abstract
Subgroups of individuals may be at greater risk of cytokine-induced changes in attentional function. The purposes of this study were to identify subgroups of individuals with distinct trajectories of attentional function and evaluate for phenotypic and genotypic (i.e., cytokine gene polymorphisms) differences among these subgroups. Self-reported attentional function was evaluated in 252 participants (167 oncology patients and 85 family caregivers) using the Attentional Function Index before radiation therapy and at six additional assessments over 6 months. Three latent classes of attentional function were identified using growth mixture modeling: moderate (36.5%), moderate-to-high (48.0%), and high (15.5%) attentional function. Participants in the moderate class were significantly younger, with more comorbidities and lower functional status, than those in the other two classes. However, only functional status remained significant in multivariable models. Included in the genetic association analyses were 92 single nucleotide polymorphisms (SNPs) among 15 candidate genes. Additive, dominant, and recessive genetic models were assessed for each SNP. Controlling for functional status, only Interleukin 6 (IL6) rs1800795 remained a significant genotypic predictor of class membership in multivariable models. Each additional copy of the rare G allele was associated with a 4-fold increase in the odds of belonging to the lower attentional function class (95% confidence interval: [1.78, 8.92]; p = .001). Findings provide preliminary evidence of subgroups of individuals with distinct trajectories of attentional function and of a genetic association with an IL6 promoter polymorphism.
- Published
- 2014
37. Cytokine candidate genes predict the development of secondary lymphedema following breast cancer surgery.
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West, Claudia, Elboim, Charles, Paul, Steven, Cooper, Bruce, Leung, Geraldine, Schmidt, Brian, Merriman, John, Langford, Dale, Smoot, Betty, Miaskowski, Christine, Abrams, Gary, Baggott, Christina, Aouizerat, Bradley, Leutwyler, Heather, Neuhaus, John, Dhruva, Anand, and Kober, Kord
- Subjects
Adult ,Aged ,Breast Neoplasms ,Cytokines ,Electric Impedance ,Female ,Genetic Predisposition to Disease ,Genotype ,Humans ,Lymphedema ,Mastectomy ,Middle Aged ,Oligonucleotide Array Sequence Analysis ,Polymorphism ,Single Nucleotide ,Surveys and Questionnaires - Abstract
BACKGROUND: Lymphedema (LE) is a frequent complication following breast cancer treatment. While progress is being made in the identification of phenotypic risk factors for the development of LE, little information is available on the molecular characterization of LE. The purpose of this study was to determine if variations in pro- and anti-inflammatory cytokine genes were associated with LE following breast cancer treatment. METHODS AND RESULTS: Breast cancer patients completed a number of self-report questionnaires. LE was evaluated using bioimpedance spectroscopy. Genotyping was done using a custom genotyping array. No differences were found between patients with (n=155) and without LE (n=387) for the majority of the demographic and clinical characteristics. Patients with LE had a significantly higher body mass index, more advanced disease, and a higher number of lymph nodes removed. Genetic associations were identified for three genes (i.e., interleukin (IL4) 4 (rs2227284), IL 10 (rs1518111), and nuclear kappa factor beta 2 (NFKB2 (rs1056890)) associated with inflammatory responses. CONCLUSIONS: These genetic associations suggest a role for a number of pro- and anti-inflammatory genes in the development of LE following breast cancer treatment.
- Published
- 2014
38. Variations in potassium channel genes are associated with breast pain in women prior to breast cancer surgery.
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Langford, Dale J, West, Claudia, Elboim, Charles, Cooper, Bruce A, Abrams, Gary, Paul, Steven M, Schmidt, Brian L, Levine, Jon D, Merriman, John D, Dhruva, Anand, Neuhaus, John, Leutwyler, Heather, Baggott, Christina, Sullivan, Carmen Ward, Aouizerat, Bradley E, and Miaskowski, Christine
- Subjects
Humans ,Breast Neoplasms ,Pain ,Genetic Predisposition to Disease ,Potassium Channels ,Regression Analysis ,Genotype ,Polymorphism ,Single Nucleotide ,Adult ,Aged ,Middle Aged ,Female ,Young Adult ,Genetic Association Studies ,breast cancer ,breast pain ,candidate genes ,potassium channel genes ,preoperative pain ,Genetics ,Neurosciences ,Genetic Testing ,Pain Research ,Patient Safety ,Breast Cancer ,Clinical Research ,Cancer ,Chronic Pain ,Aetiology ,2.1 Biological and endogenous factors ,Clinical Sciences ,Neurology & Neurosurgery - Abstract
Preoperative breast pain in women with breast cancer may result from a number of causes. Previous work from our team found that breast pain occurred in 28.2% of women (n = 398) who were about to undergo breast cancer surgery. The occurrence of preoperative breast pain was associated with a number of demographic and clinical characteristics, as well as variation in two cytokine genes. Given that ion channels regulate excitability of sensory neurons, we hypothesized that variations in potassium channel genes would be associated with preoperative breast pain in these patients. Therefore, in this study, we evaluated for associations between single-nucleotide polymorphisms and inferred haplotypes among 10 potassium channel genes and the occurrence of preoperative breast pain in patients scheduled to undergo breast cancer surgery. Multivariable logistic regression analyses were used to identify those genetic variations that were associated with the occurrence of preoperative breast pain while controlling for age and genomic estimates of and self-reported race/ethnicity. Variations in four potassium channel genes: (1) potassium voltage-gated channel, delayed rectifier, subfamily S, member 1 (KCNS1); (2) potassium inwardly rectifying channel, subfamily J, member 3 (KCNJ3); (3) KCNJ6; and (4) potassium channel, subfamily K, member 9 (KCNK9) were associated with the occurrence of breast pain. Findings from this study warrant replication in an independent sample of women who report breast pain following one or more breast biopsies.
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- 2014
39. Association between an interleukin 1 receptor, type I promoter polymorphism and self-reported attentional function in women with breast cancer
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Merriman, John D, Aouizerat, Bradley E, Cataldo, Janine K, Dunn, Laura, Cooper, Bruce A, West, Claudia, Paul, Steven M, Baggott, Christina R, Dhruva, Anand, Kober, Kord, Langford, Dale J, Leutwyler, Heather, Ritchie, Christine S, Abrams, Gary, Dodd, Marylin, Elboim, Charles, Hamolsky, Deborah, Melisko, Michelle, and Miaskowski, Christine
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Biomedical and Clinical Sciences ,Immunology ,Clinical Research ,Genetics ,Women's Health ,Cancer ,Aging ,Breast Cancer ,Behavioral and Social Science ,Aetiology ,2.1 Biological and endogenous factors ,Alleles ,Attention ,Breast Neoplasms ,Demography ,Female ,Genetic Association Studies ,Genetic Predisposition to Disease ,Heterozygote ,Homozygote ,Humans ,Logistic Models ,Middle Aged ,Models ,Biological ,Phenotype ,Polymorphism ,Single Nucleotide ,Promoter Regions ,Genetic ,Receptors ,Interleukin-1 Type I ,Self Report ,Breast cancer ,Inflammation ,Cytokine genes ,Interleukin 1 receptor ,type I ,AFI ,AIMs ,Attentional Function Index ,BIC ,BLRT ,BMI ,Bayesian information criterion ,CI ,CNS ,DNA ,GMM ,KPS ,Karnofsky Performance Status ,LD ,MAF ,OR ,SCQ ,SNP ,Self-administered Comorbidity Questionnaire ,VLMR ,Vuong-Lo-Mendell-Rubin likelihood ratio test ,ancestry informative markers ,body mass index ,bootstrapped likelihood ratio test ,central nervous system ,confidence interval ,deoxyribonucleic acid ,growth mixture modeling ,linkage disequilibrium ,minor allele frequency ,odds ratio ,single nucleotide polymorphism ,Biochemistry and Cell Biology - Abstract
Subgroups of patients with breast cancer may be at greater risk for cytokine-induced changes in cognitive function after diagnosis and during treatment. The purposes of this study were to identify subgroups of patients with distinct trajectories of attentional function and evaluate for phenotypic and genotypic (i.e., cytokine gene polymorphisms) predictors of subgroup membership. Self-reported attentional function was evaluated in 397 patients with breast cancer using the Attentional Function Index before surgery and for six months after surgery (i.e., seven time points). Using growth mixture modeling, three attentional function latent classes were identified: High (41.6%), Moderate (25.4%), and Low-moderate (33.0%). Patients in the Low-moderate class were significantly younger than those in the High class, with more comorbidities and lower functional status than the other two classes. No differences were found among the classes in years of education, race/ethnicity, or other clinical characteristics. DNA was recovered from 302 patients' samples. Eighty-two single nucleotide polymorphisms among 15 candidate genes were included in the genetic association analyses. After controlling for age, comorbidities, functional status, and population stratification due to race/ethnicity, IL1R1 rs949963 remained a significant genotypic predictor of class membership in the multivariable model. Carrying the rare "A" allele (i.e., GA+AA) was associated with a twofold increase in the odds of belonging to a lower attentional function class (OR: 1.98; 95% CI: 1.18, 3.30; p=.009). Findings provide evidence of subgroups of women with breast cancer who report distinct trajectories of attentional function and of a genetic association between subgroup membership and an IL1R1 promoter polymorphism.
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- 2014
40. Associations Between Cytokine Gene Variations and Severe Persistent Breast Pain in Women Following Breast Cancer Surgery
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Stephens, Kimberly, Cooper, Bruce A, West, Claudia, Paul, Steven M, Baggott, Christina R, Merriman, John D, Dhruva, Anand, Kober, Kord M, Langford, Dale J, Leutwyler, Heather, Luce, Judith A, Schmidt, Brian L, Abrams, Gary M, Elboim, Charles, Hamolsky, Deborah, Levine, Jon D, Miaskowski, Christine, and Aouizerat, Bradley E
- Subjects
Biomedical and Clinical Sciences ,Neurosciences ,Clinical Sciences ,Health Sciences ,Cancer ,Chronic Pain ,Breast Cancer ,Genetics ,Pain Research ,Aetiology ,2.1 Biological and endogenous factors ,Breast ,Breast Neoplasms ,Cytokines ,Female ,Genotyping Techniques ,Haplotypes ,Humans ,Interleukin-10 ,Linkage Disequilibrium ,Logistic Models ,Longitudinal Studies ,Mastectomy ,Middle Aged ,Pain Measurement ,Pain ,Postoperative ,Phenotype ,Polymorphism ,Single Nucleotide ,Receptors ,Interleukin-1 Type II ,Severity of Illness Index ,Surveys and Questionnaires ,polymorphism ,breast cancer surgery ,candidate genes ,persistent pain ,Medical and Health Sciences ,Psychology and Cognitive Sciences ,Anesthesiology ,Clinical sciences ,Epidemiology - Abstract
UnlabelledPersistent pain following breast cancer surgery is a significant clinical problem. Although immune mechanisms may play a role in the development and maintenance of persistent pain, few studies have evaluated for associations between persistent breast pain following breast cancer surgery and variations in cytokine genes. In this study, associations between previously identified extreme persistent breast pain phenotypes (ie, no pain vs severe pain) and single nucleotide polymorphisms (SNPs) spanning 15 cytokine genes were evaluated. In unadjusted analyses, the frequency of 13 SNPs and 3 haplotypes in 7 genes differed significantly between the no pain and severe pain classes. After adjustment for preoperative breast pain and the severity of average postoperative pain, 1 SNP (ie, interleukin [IL] 1 receptor 2 rs11674595) and 1 haplotype (ie, IL10 haplotype A8) were associated with pain group membership. These findings suggest a role for cytokine gene polymorphisms in the development of persistent breast pain following breast cancer surgery.PerspectiveThis study evaluated for associations between cytokine gene variations and the severity of persistent breast pain in women following breast cancer surgery. Variations in 2 cytokine genes were associated with severe breast pain. The results suggest that cytokines play a role in the development of persistent postsurgical pain.
- Published
- 2014
41. Mediport use as an acceptable standard for CAR T cell infusion
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Eylon, Maya, primary, Prabhu, Snehit, additional, John, Samuel, additional, King, Maxwell J. M., additional, Bhatt, Dhruv, additional, Curran, Kevin J., additional, Erickson, Courtney, additional, Karras, Nicole A., additional, Phillips, Christine L., additional, Satwani, Prakash, additional, Hermiston, Michelle, additional, Southworth, Erica, additional, Baumeister, Susanne H. C., additional, Talano, Julie-An, additional, MacMillan, Margaret L., additional, Rossoff, Jenna, additional, Bonifant, Challice L., additional, Myers, Gary Doug, additional, Rouce, Rayne H., additional, Toner, Keri, additional, Driscoll, Timothy A., additional, Katsanis, Emmanuel, additional, Salzberg, Dana B., additional, Schiff, Deborah, additional, De Oliveira, Satiro N., additional, Capitini, Christian M., additional, Pacenta, Holly L., additional, Pfeiffer, Thomas, additional, Shah, Niketa C., additional, Huynh, Van, additional, Skiles, Jodi L., additional, Fraint, Ellen, additional, McNerney, Kevin O., additional, Quigg, Troy C., additional, Krueger, Joerg, additional, Ligon, John A., additional, Fabrizio, Vanessa A., additional, Baggott, Christina, additional, Laetsch, Theodore W., additional, and Schultz, Liora M., additional
- Published
- 2023
- Full Text
- View/download PDF
42. Practice Preferences for Consolidative Hematopoietic Stem Cell Transplantation Following Tisagenlecleucel in Children and Young Adults with B Cell Acute Lymphoblastic Leukemia
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McNerney, Kevin O., primary, Moskop, Amy, additional, Winestone, Lena E., additional, Baggott, Christina, additional, Talano, Julie-An, additional, Schiff, Deborah, additional, Rossoff, Jenna, additional, Modi, Arunkumar, additional, Verneris, Michael R., additional, Laetsch, Theodore W., additional, and Schultz, Liora, additional
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- 2023
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- View/download PDF
43. Differences in morning and evening fatigue in oncology patients and their family caregivers.
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Cooper, Bruce, Paul, Steven, West, Claudia, Langford, Dale, Merriman, John, Miaskowski, Christine, Baggott, Christina, Aouizerat, Bradley, Lee, Kathryn, Leutwyler, Heather, Cataldo, Janine, Dunn, Laura, Ritchie, Christine, Dhruva, Anand, Dodd, Marylin, Wara, William, and Kober, Kord
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Cancer treatment ,Diurnal variability ,Evening fatigue ,Fatigue ,Growth mixture modeling ,Latent class analysis ,Morning fatigue ,Radiation therapy ,Adult ,Age Factors ,Aged ,Ambulatory Care ,Ambulatory Care Facilities ,Analysis of Variance ,Cancer Care Facilities ,Caregivers ,Chi-Square Distribution ,Circadian Rhythm ,Fatigue ,Female ,Humans ,Longitudinal Studies ,Male ,Middle Aged ,Neoplasms ,Risk Assessment ,Severity of Illness Index ,Sex Factors - Abstract
PURPOSE OF THE RESEARCH: To identify distinct latent classes of individuals based on ratings of morning and evening fatigue; evaluate for differences in phenotypic characteristics, as well as symptom and quality of life scores, among these latent classes; and evaluate for an overlap in morning and evening fatigue class membership. PATIENTS AND METHODS: In a sample of 167 oncology outpatients and 85 of their FCs, growth mixture modeling was used to identify distinct latent classes based on ratings of morning and evening fatigue obtained before, during, and after radiation therapy. Analyses of variance and Chi Square analyses were used to evaluate for differences among the morning and evening fatigue latent classes. RESULTS: Three distinct latent classes for morning fatigue were identified. Participants in the High Morning Fatigue class (47%) were younger and had lower functional status. Three distinct latent classes for evening fatigue were identified. Participants in the High Evening Fatigue class (61%) were younger, more likely to be female, more likely to have children at home, and more likely to be a FC. Only 10.3% of participants were classified in both the Very Low Morning and Low Evening Fatigue classes and 41.3% were classified in both the High Morning and High Evening Fatigue classes. CONCLUSIONS: Different characteristics were associated with morning and evening fatigue, which suggests that morning and evening fatigue may be distinct but related symptoms. Additional research is needed to elucidate the mechanisms that may underlie diurnal variability in fatigue.
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- 2013
44. Differences in morning and evening fatigue in oncology patients and their family caregivers.
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Dhruva, Anand, Aouizerat, Bradley E, Cooper, Bruce, Paul, Steven M, Dodd, Marylin, West, Claudia, Wara, William, Lee, Kathryn, Dunn, Laura B, Langford, Dale J, Merriman, John D, Baggott, Christina, Cataldo, Janine, Ritchie, Christine, Kober, Kord, Leutwyler, Heather, and Miaskowski, Christine
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Humans ,Neoplasms ,Fatigue ,Ambulatory Care ,Severity of Illness Index ,Analysis of Variance ,Risk Assessment ,Chi-Square Distribution ,Longitudinal Studies ,Age Factors ,Sex Factors ,Circadian Rhythm ,Adult ,Aged ,Middle Aged ,Caregivers ,Ambulatory Care Facilities ,Cancer Care Facilities ,Female ,Male ,Cancer treatment ,Diurnal variability ,Evening fatigue ,Growth mixture modeling ,Latent class analysis ,Morning fatigue ,Radiation therapy ,Cancer ,Nursing ,Oncology and Carcinogenesis - Abstract
Purpose of the researchTo identify distinct latent classes of individuals based on ratings of morning and evening fatigue; evaluate for differences in phenotypic characteristics, as well as symptom and quality of life scores, among these latent classes; and evaluate for an overlap in morning and evening fatigue class membership.Patients and methodsIn a sample of 167 oncology outpatients and 85 of their FCs, growth mixture modeling was used to identify distinct latent classes based on ratings of morning and evening fatigue obtained before, during, and after radiation therapy. Analyses of variance and Chi Square analyses were used to evaluate for differences among the morning and evening fatigue latent classes.ResultsThree distinct latent classes for morning fatigue were identified. Participants in the High Morning Fatigue class (47%) were younger and had lower functional status. Three distinct latent classes for evening fatigue were identified. Participants in the High Evening Fatigue class (61%) were younger, more likely to be female, more likely to have children at home, and more likely to be a FC. Only 10.3% of participants were classified in both the Very Low Morning and Low Evening Fatigue classes and 41.3% were classified in both the High Morning and High Evening Fatigue classes.ConclusionsDifferent characteristics were associated with morning and evening fatigue, which suggests that morning and evening fatigue may be distinct but related symptoms. Additional research is needed to elucidate the mechanisms that may underlie diurnal variability in fatigue.
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- 2013
45. Validation of the Children's International Mucositis Evaluation Scale (ChIMES) in paediatric cancer and SCT.
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Baggott, Christina, Jacobs, S, Agarwal, R, Hesser, T, Schechter, T, Judd, P, Tomlinson, D, Beyene, J, and Sung, L
- Abstract
Objectives were to describe the reliability and validity of a new paediatric-specific mucositis scale, the Children's International Mucositis Evaluation Scale (ChIMES).In a multi-centre prospective study, children aged 0 to ≤18 years were eligible if they
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- 2013
46. Cytokine gene variation is associated with depressive symptom trajectories in oncology patients and family caregivers.
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Dunn, Laura, Aouizerat, Bradley, Langford, Dale, Cooper, Bruce, Dhruva, Anand, Cataldo, Janine, Baggott, Christina, Merriman, John, Dodd, Marylin, West, Claudia, Paul, Steven, and Miaskowski, Christine
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Adult ,Age Distribution ,Aged ,California ,Caregivers ,Cohort Studies ,Comorbidity ,Cytokines ,Depression ,Female ,Follow-Up Studies ,Genetic Predisposition to Disease ,Genetic Variation ,Genotype ,Humans ,Incidence ,Logistic Models ,Male ,Medical Oncology ,Middle Aged ,Multivariate Analysis ,Neoplasms ,Phenotype ,Polymorphism ,Single Nucleotide ,Severity of Illness Index ,Sex Distribution - Abstract
PURPOSE: Depressive symptoms are common in cancer patients and their family caregivers (FCs). While these symptoms are characterized by substantial interindividual variability, the factors that predict this variability remain largely unknown. This study sought to confirm latent classes of oncology patients and FCs with distinct depressive symptom trajectories and to examine differences in phenotypic and genotypic characteristics among these classes. METHOD: Among 167 oncology outpatients with breast, prostate, lung, or brain cancer and 85 of their FCs, growth mixture modeling (GMM) was used to identify latent classes of individuals based on Center for Epidemiological Studies-Depression (CES-D) scores obtained prior to, during, and for four months following completion of radiation therapy. One hundred four single nucleotide polymorphisms (SNPs) and haplotypes in 15 candidate cytokine genes were interrogated for differences between the two largest latent classes. Multivariate logistic regression analyses assessed effects of phenotypic and genotypic characteristics on class membership. RESULTS: Four latent classes were confirmed: Resilient (56.3%), Subsyndromal (32.5%), Delayed (5.2%), and Peak (6.0%). Participants who were younger, female, non-white, and who reported higher baseline trait and state anxiety were more likely to be in the Subsyndromal, Delayed, or Peak groups. Variation in three cytokine genes (i.e., interleukin 1 receptor 2 [IL1R2], IL10, tumor necrosis factor alpha [TNFA]), age, and performance status predicted membership in the Resilient versus Subsyndromal classes. CONCLUSIONS: Findings confirm the four latent classes of depressive symptom trajectories previously identified in a sample of breast cancer patients. Variations in cytokine genes may influence variability in depressive symptom trajectories.
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- 2013
47. Severely bothersome fatigue in children and adolescents with cancer and hematopoietic stem cell transplant recipients
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Tomlinson, Deborah, Baggott, Christina, Dix, David, Gibson, Paul, Hyslop, Shannon, Johnston, Donna L., Orsey, Andrea, Portwine, Carol, Price, Victoria, Vanan, Magimairajan, Kuczynski, Susan, Spiegler, Brenda, Tomlinson, George A., Dupuis, L. Lee, and Sung, Lillian
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- 2019
- Full Text
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48. Taste changes in children with cancer and hematopoietic stem cell transplant recipients
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Loves, Robyn, Tomlinson, Deborah, Baggott, Christina, Dix, David, Gibson, Paul, Hyslop, Shannon, Johnston, Donna L., Orsey, Andrea D., Portwine, Carol, Price, Victoria, Schechter, Tal, Vanan, Magimairajan, Kuczynski, Susan, Spiegler, Brenda, Tomlinson, George A., Dupuis, L. Lee, and Sung, Lillian
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- 2019
- Full Text
- View/download PDF
49. Identification of patient subgroups and risk factors for persistent breast pain following breast cancer surgery.
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Cooper, Bruce, Paul, Steven, West, Claudia, Langford, Dale, Hamolsky, Deborah, Schmidt, Brian, Merriman, John, Miaskowski, Christine, Abrams, Gary, Baggott, Christina, Aouizerat, Bradley, Neuhaus, John, Cataldo, Janine, Dunn, Laura, Levine, Jon, Dhruva, Anand, and Dodd, Marylin
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Adult ,Aged ,Breast Neoplasms ,Female ,Humans ,Longitudinal Studies ,Mastodynia ,Middle Aged ,Pain Measurement ,Pain ,Postoperative ,Prospective Studies ,Risk Factors ,Surveys and Questionnaires - Abstract
UNLABELLED: Study purposes were to determine the prevalence of persistent pain in the breast; characterize distinct persistent pain classes using growth mixture modeling; and evaluate for differences among these pain classes in demographic, preoperative, intraoperative, and postoperative characteristics. In addition, differences in the severity of common symptoms and quality of life outcomes measured prior to surgery, among the pain classes, were evaluated. Patients (n = 398) were recruited prior to surgery and followed for 6 months. Using growth mixture modeling, patients were classified into no (31.7%), mild (43.4%), moderate (13.3%), and severe (11.6%) pain groups based on ratings of worst breast pain. Differences in a number of demographic, preoperative, intraoperative, and postoperative characteristics differentiated among the pain classes. In addition, patients in the moderate and severe pain classes reported higher preoperative levels of depression, anxiety, and sleep disturbance than the no pain class. Findings suggest that approximately 25% of women experience significant and persistent levels of breast pain in the first 6 months following breast cancer surgery. PERSPECTIVE: Persistent pain is a significant problem for 25% of women following surgery for breast cancer. Severe breast pain is associated with clinically meaningful decrements in functional status and quality of life.
- Published
- 2012
50. Identification of patient subgroups and risk factors for persistent breast pain following breast cancer surgery.
- Author
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Miaskowski, Christine, Cooper, Bruce, Paul, Steven M, West, Claudia, Langford, Dale, Levine, Jon D, Abrams, Gary, Hamolsky, Deborah, Dunn, Laura, Dodd, Marylin, Neuhaus, John, Baggott, Christina, Dhruva, Anand, Schmidt, Brian, Cataldo, Janine, Merriman, John, and Aouizerat, Bradley E
- Subjects
Humans ,Breast Neoplasms ,Pain ,Postoperative ,Pain Measurement ,Risk Factors ,Longitudinal Studies ,Prospective Studies ,Adult ,Aged ,Middle Aged ,Female ,Mastodynia ,Surveys and Questionnaires ,Breast Cancer ,Rehabilitation ,Cancer ,Chronic Pain ,Clinical Research ,Pain Research ,Patient Safety ,Breast pain ,persistent postsurgical pain ,risk factors ,breast cancer surgery ,growth mixture modeling ,latent class analysis ,Medical and Health Sciences ,Psychology and Cognitive Sciences ,Anesthesiology - Abstract
UnlabelledStudy purposes were to determine the prevalence of persistent pain in the breast; characterize distinct persistent pain classes using growth mixture modeling; and evaluate for differences among these pain classes in demographic, preoperative, intraoperative, and postoperative characteristics. In addition, differences in the severity of common symptoms and quality of life outcomes measured prior to surgery, among the pain classes, were evaluated. Patients (n = 398) were recruited prior to surgery and followed for 6 months. Using growth mixture modeling, patients were classified into no (31.7%), mild (43.4%), moderate (13.3%), and severe (11.6%) pain groups based on ratings of worst breast pain. Differences in a number of demographic, preoperative, intraoperative, and postoperative characteristics differentiated among the pain classes. In addition, patients in the moderate and severe pain classes reported higher preoperative levels of depression, anxiety, and sleep disturbance than the no pain class. Findings suggest that approximately 25% of women experience significant and persistent levels of breast pain in the first 6 months following breast cancer surgery.PerspectivePersistent pain is a significant problem for 25% of women following surgery for breast cancer. Severe breast pain is associated with clinically meaningful decrements in functional status and quality of life.
- Published
- 2012
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