11 results on '"Luz del Carmen Tarín Arzaga"'
Search Results
2. A Tale of Two Centers: Access to Private Care Improves Outcomes in Allogeneic Transplant Recipients
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Anna Cecilia Rodríguez-Zuñiga, David Gómez-Almaguer, Gerardo A De la rosa-Flores, César Homero Gutiérrez-Aguirre, Luz del Carmen Tarín Arzaga, Felipe Soto-Lanza, Elías Eugenio González López, Olga Graciela Cantu Rodriguez, Perla R. Colunga-Pedraza, Andrés Gómez-De León, and Xitlaly Judith Gonzalez Leal
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Transplantation ,Immunology ,Molecular Medicine ,Immunology and Allergy ,Cell Biology ,Hematology ,Biochemistry - Abstract
Introduction Allogeneic bone marrow transplantation (BMT) is a potentially curative treatment for many hematological diseases. However, lack of availability of specialized centers and high costs limit access to the procedure in low and middle income countries. Previous research has shown that Latin-American patients with hematological malignancies have worse outcomes when treated in public health systems compared to patients treated in the private setting. Healthcare in Mexico is provided by three systems: the private sector (financed by a private insurance or out of pocket), social security (government-run health systems) and a public system (partially funded by the government), where the most vulnerable population is treated. To date, disparities in outcomes of BMT between patients in public and private health systems have not been widely studied. Objectives Primary: to determine the impact of access to private healthcare in BMT recipients by comparing the outcomes of patients treated in two centers that are led by a single team. Secondary objectives were to determine differences in the overall treatment population and transplantation strategies in each context. Patients and Methods We performed a retrospective analysis of consecutive patients aged 15 and older who underwent BMT regardless of diagnosis form 2015-2021 in two Institutions: 1) A private hematology practice treating insured patients in conventional BMT units similar to those in high-income countries (Private) and 2) A public academic institution where an outpatient transplant strategy is common in the context of significant limitations in access to quality supportive care and high-cost medications (Public). Both programs are led by the same team of hematologists following similar transplant strategies with the salient features being the frequent use of peripheral blood stem cells, chemotherapy-based conditioning regimens, and the preferred use of haploidentical donors vs. matched unrelated donors. We excluded second transplants from this analysis and patients who received them were censored at the time of infusion. We compared baseline characteristics, overall survival (OS), event free survival (EFS), non-relapse mortality (NRM), and the incidence of GVHD in the two different treatment systems. Results A total of 219 patients underwent BMT from January 2015 to June 2021, n=166 (76%) were performed in the Public setting, and n=53 (24%) in the Private setting. Patients in the Private group were older, with a higher proportion of high/very high disease risk index (DRI), hematopoietic cell comorbidity index (HCT-CI) and more frequent use of myeloablative conditioning (Table 1). A similar proportion haploidentical donor grafts were performed (61 vs 57%) with a single matched unrelated donor transplant in the Private center. Median follow-up was 9.7 (0.2-71), and 10.3 (0.7-67.6) months, for Public and Private centers respectively (p=0.38). Median time to neutrophil and platelet engraftment were similar. Seventy patients (42%) in Public, and 15 patients (28%) in Private groups relapsed (p=0.049), with a median time to relapse of 17.5 vs. 47.6 months (p Conclusion Patients who undergo BMT in the public health system are at risk for significantly worse outcomes when compared to patients cared for in private systems even if a similar strategy is followed and are led by the same team. Figure 1 Figure 1. Disclosures González López: AMGEN: Honoraria; JANSSEN: Honoraria. Gomez-Almaguer: Janssen: Honoraria, Speakers Bureau; Takeda: Honoraria, Speakers Bureau; Bristol-Myers-Squibb: Honoraria, Speakers Bureau; Roche: Honoraria, Speakers Bureau. Gomez-De Leon: ASH: Research Funding; Abbvie: Honoraria; Sanofi: Honoraria; Novartis: Honoraria.
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- 2022
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3. Romiplostim, Low-Dose Rituximab and High-Dose Dexamethasone Combination in Newly Diagnosed Immune Thrombocytopenia: Another 'Total Therapy' Pilot Study
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César Homero Gutiérrez-Aguirre, Ana Varela-Constantino, Fernando De La Garza, Olga Graciela Cantu Rodriguez, David Gómez-Almaguer, Perla R. Colunga-Pedraza, Luz del Carmen Tarín Arzaga, Mónica Bustillos Muñoz, Gerardo A De la rosa-Flores, Andrés Gómez-De León, Eliezer Tomas Gomez Gomez, and Edgar Ulises Coronado-Alejandro
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medicine.medical_specialty ,Romiplostim ,High dose dexamethasone ,business.industry ,Immunology ,Low dose ,Cell Biology ,Hematology ,Newly diagnosed ,Biochemistry ,Gastroenterology ,Immune thrombocytopenia ,Internal medicine ,medicine ,Rituximab ,business ,medicine.drug - Abstract
Background: Primary immune thrombocytopenia (ITP) is an acquired autoimmune disorder that results from accelerating platelet clearance, destruction, and production. Front-line therapy for newly diagnosed ITP includes corticosteroids, intravenous immune globulin, or anti-D immunoglobulin. However, after these single-agent therapies, relapses will occur in half of patients. We previously reported the safety, feasibility, and efficacy of the combination of dexamethasone, low-dose rituximab, and the thrombopoietin receptor agonist (TPO-Ra) eltrombopag as front-line treatment in newly diagnosed ITP. Romiplostim, another TPO-Ra is approved by the FDA for patients with chronic ITP. However, the safety, tolerability, and efficacy of romiplostim combined with low-dose rituximab, and high-dose dexamethasone in newly diagnosed ITP remain unknown. Objective: Our primary objectives were safety, and tolerability. Secondary objectives were initial response and relapse incidence. Methods: An open-label, single-arm study was performed in Hospital Universitario "Dr. José Eleuterio González" in Monterrey, Mexico (Clinical trials.gov NCT04588194). Eligible patients were newly diagnosed ITP patients, treatment-naïve, ≥18 years, with a platelet count ≤30×10 9/L. Patients were excluded if they had an active infection, pregnancy, or malignant disease. The treatment regimen was romiplostim (2 mcg/kg weekly, four doses), low-dose rituximab (100 mg weekly, four doses) and high-dose dexamethasone (40 mg PO, days 1-4). Dexamethasone was allowed up to 3 cycles. Partial (PR) and complete responses (CR) were defined as an increase in platelet counts ≥30×10 9/L (at least a doubling of the baseline count) and ≥100×10 9/L, respectively. Results: We included ten consecutive patients. The median age was 34.5 years (range, 17-63). Seven patients were men (70%). The median platelet account at diagnosis was 6x10 9/L (range 0-23), and median follow-up was 180 days (range 30-270). The median number of romiplostim doses was 3.5 (range 1-4), and three (30%) patients required dose adjustment due to thrombocytosis. All but one patient achieved response (CR or PR) at a median of 7 days (range 7-28). Five patients (50%) achieved CR at 28 days of treatment, and four patients (40%) PR. No significant adverse effects have occurred during treatment; one patient presented grade 1 myalgia and the other a grade 2 soft tissue infection. Five patients (50%) relapsed during follow-up. Recently, four (40%) patients remain in CR and three (30%) in PR. Conclusion: The combination of romiplostim, low-dose rituximab, and high-dose dexamethasone was safe and effective. This "total therapy" approach was associated with minimum side effects and rapid initial response. Prospective validation in a larger sample is needed. Figure 1 Figure 1. Disclosures Gomez-Almaguer: Janssen: Honoraria, Speakers Bureau; Roche: Honoraria, Speakers Bureau; Bristol-Myers-Squibb: Honoraria, Speakers Bureau; Takeda: Honoraria, Speakers Bureau. OffLabel Disclosure: Romiplostim in firs-line therapy for immune thrombocytopenia
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- 2021
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4. Real World Outcomes in Latin-American Patients with Multiple Myeloma Under 40 Years Old
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Paola Ochoa, Ariel Corzo, Sebastian Yantorno, Yarely Itzayana García-Navarrete, Hernán López-Vidal, Alicia Molina, Ines Reyes, Henry Idrobo, Cecilia Beltran, Pilar Papilco, Pilar León, Vanesa Fernandez, Marcela Espinoza, Luz del Carmen Tarín Arzaga, Claudia Shanley, Camila Peña, Lina Gaviria, Pablo Soto, Antonio Cruz-Mora, Gabriel La Rocca, Veronica Verri, Alicia Henao-Uribe, Rocío Osorio, Patricio Duarte, Daniela Cardemil, Humberto Martinez-Cordero, Sergio Lopresti, Guillermina Remaggi, Virginia Abello, Guillermo Quintero, Mauricio Chandia, Yahveth Cantero-Fortiz, Vivianne Torres, Omar Cantú-Martínez, Virginia Bove, Javier Schulz, Rigoberto Gomez, David Gómez-Almaguer, Sergio Orlando, Juan José García García, Macarena Alejandra Roa Salinas, Dorotea Fantl, Guillermo J. Ruiz-Argüelles, Brenner Sabando, Jhoanna Ramirez, Soledad Zabaljauregui, Natalia Schutz, Fiorella Villano, Sandra Aranda, Carolina Contreras, Domingo Saavedra, Javiera Donoso, Monica Osuna Pérez, Claudia Sossa, Carmen Gloria Vergara, Christine Rojas, Francisca M. Ramirez Aspiazu, Eloisa Riva, Luis Quiroga, and Alex Mite
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Oncology ,medicine.medical_specialty ,biology ,business.industry ,Anemia ,education ,Immunology ,Cell Biology ,Hematology ,medicine.disease ,Biochemistry ,Chemotherapy regimen ,Immunoglobulin G ,Transplantation ,Internal medicine ,biology.protein ,medicine ,Vocal cord dysfunction ,Plasmacytoma ,business ,health care economics and organizations ,Survival analysis ,Multiple myeloma - Abstract
Background Multiple myeloma (MM) is a heterogeneous disease that is most frequently diagnosed in the elderly. Therefore, data on clinical characteristics and outcomes in the young population are scarce and it is recognized that it remains incurable even in this group of patients. We present here the outcomes of patients under 40 years old cohort in Latin-American countries. On behalf of GELAMM (Grupo de Estudio Latino-Americano de Mieloma Múltiple). Methods Retrospective international multicenter cohort study. We analyzed MM patients under 40 years old who received treatment in 6 Latin-American countries, between 2010 and 2018. Demographics and disease features were analyzed using descriptive statics. We examined treatment characteristics and response rates. The overall survival (OS) of the entire cohort was analyzed using Kaplan-Meier curves. Results Eighty-six patients of 6 countries were analyzed (Table1). The mean age was 35.4 years old, and 60% were male. The most frequent monoclonal component type was IgG followed by light chain MM. Risk determined by ISS was distributed in almost equal percentages. The most frequent cytogenetic alteration was the t (4;14) that was found in four patients out of 25 evaluated. The missing data were greater than 70%. Skeleton-related events were the most frequent clinical feature, followed by anemia and renal failure. Plasmacytomas and fractures were present in more than 20 percent of cases. With regard to treatment, VCD / CyBorD was the most used regimen, followed by VTD. The overall response rate (ORR) was 63%. Fifty-three patients received high dose therapy and autologous stem cell transplantation (62%). Only 8% received post-transplant consolidation, and 45% received maintenance therapy. The median OS of the entire cohort was 45 months, and a plateau in the survival curve was not observed, suggesting that patients continue relapsing over the time. Conclusion In this Latin American multicenter study, we found that the young population with MM has similar presentation characteristics to those of elderly patients. A significant amount of information is lost regarding the risk characterization, especially in regard with cytogenetics. With respect to treatment, less than half of the patients achieve very good partial response or better. It is striking that more than a third of this young patients did not access to high doses of chemotherapy and bone marrow transplantation. Maintenance therapy is offered to less than half patients. The median OS is lower than in other series of patients younger than 40 years, even than in the elderly cohorts. Prospective multicentric studies are required to elucidate the behavior of the disease in this group of patients. Disclosures Peña: Pfizer: Membership on an entity's Board of Directors or advisory committees; Janssen: Other: Congress inscription and flights; Biotoscana: Other: Congress inscription and flights; Novartis: Other: Congress inscription and flights; Tecnofarma: Other: Congress inscription and flights; Roche: Other: Congress inscription and flights. Rojas:Novartis: Membership on an entity's Board of Directors or advisory committees; Pfeizer: Membership on an entity's Board of Directors or advisory committees; Abbvie: Membership on an entity's Board of Directors or advisory committees; Roche: Membership on an entity's Board of Directors or advisory committees. Abello:Takeda: Other: Participation in advisory board meeting. Gomez-Almaguer:Takeda: Consultancy, Speakers Bureau; Celgene: Consultancy, Speakers Bureau; Amgen: Consultancy, Speakers Bureau; Janssen: Consultancy, Speakers Bureau; Teva: Consultancy, Speakers Bureau.
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- 2019
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5. Contributions to Global Hematology from Low and Middle-Income Countries: Insights from ASH 2018
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Perla R. Colunga Pedraza, David Gómez-De León, Emmanuel Bugarin-Estrada, Luz del Carmen Tarín Arzaga, David Gómez-Almaguer, Andrés Gómez-De León, and Lillian Sung
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Low and middle income countries ,Immunology ,Development economics ,Economics ,Developing country ,Cell Biology ,Hematology ,China ,Biochemistry - Abstract
Background. Establishing research capacity in low and middle-income countries (LMIC) is key for improving health systems and implementing actionable programs through evidence-based assessments. Few studies have analyzed hematology research capacity in LMICs. The American Society of Hematology (ASH) annual meeting is the largest hematology event where peer-reviewed contributions from researchers worldwide are selected for presentation based on scientific merit. Therefore, it can provide a useful snapshot of the current status of hematology research in a single point in time. For this reason, we analyzed abstracts presented at the 2018 ASH annual meeting (ASH18) with a focus on those from authors working in a LMIC. Objective. To describe the proportion of abstracts presented at ASH18 from an LMIC and analyze their characteristics as a surrogate for academic contributions to global hematology. Methods. We reviewed all abstracts presented at ASH18 in an oral presentation or poster form published online in the supplemental edition of Blood 2018;132 (Suppl 1). LMICs were selected according to the World Bank classification including countries or territories with a gross national income Results. A total of 4,871 abstracts presented at ASH 2018, with 1,026 oral presentations and 3,845 posters were available online. Among them, 510 abstracts (10.5%) had a contributing author from an institution in an LMIC, corresponding to 92 (9%) of all oral presentations and 418 (10.9%) of all posters (Figure 1). LMIC-only contributions represented 4.7% of all abstracts (n=229). The most common LMIC of origin for LMIC-only contributions was China with 133 (58.1%) (Figure 1). Most abstracts were clinical and multicentric in nature (62 and 70.2%, respectively), and in 42.5% of them a COI was reported. Clinical trials reflected 19% of all LMIC contributions. In 31.9% of cases the first author was affiliated to an institution in a HIC. Mixed LMIC/HIC contributions had significantly more COIs and industry sponsors than those from LMIC-only institutions (Table 1). When comparing between oral vs poster LMIC presentations, works selected for an oral presentation were significantly more clinical and multicentric, had a higher proportion of clinical trials, more COIs and identified industry sponsors (Table 2). Conclusions. LMICs, where more than 80% of the world population resides, were responsible for only a small fraction of contributions to ASH18, half of them representing a form of international collaboration, with a high number of COI disclosures. Disclosures Gomez-Almaguer: Amgen: Consultancy, Speakers Bureau; Janssen: Consultancy, Speakers Bureau; Teva: Consultancy, Speakers Bureau; Takeda: Consultancy, Speakers Bureau; Celgene: Consultancy, Speakers Bureau.
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- 2019
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6. Unequal Outcomes in Transplant Eligible Patients with Multiple Myeloma in Latin America: Differences between Public and Private Centers
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Guillermo J. Ruiz-Argüelles, Christine Rojas, Henry Idrobo, Vivianne Torres, Jhoanna Ramirez, Soledad Zabaljauregui, Carlos Cristóbal Medina García, Brener Sabando, Raimundo Gazitua, Francisca M. Ramirez Aspiazu, Vanesa Fernandez, Carolina Contreras, Patricio Duarte, Virginia Bove, Sergio Orlando, Rigoberto Gomez, Sergio Lopresti, Guillermo Quintero, Omar Cantú-Martínez, Pilar Papilco, Antonio Cruz-Mora, Camila Peña, Lina Gaviria, Paola Ochoa, Claudia Sossa, Virginia Abello, Alicia Molina, Ines Reyes, Claudia Shanley, Kenny Galvez, Luis Quiroga, Alex Mite, Pilar León, Daniela Cardemil, Javier Schulz, Marcela Espinoza, Luz del Carmen Tarín Arzaga, Sandra Aranda, Pablo Soto, Alicia Henao-Uribe, Gabriel La Rocca, Mauricio Chandia, Dorotea Fantl, Yarely Itzayana García-Navarrete, Ariel Corzo, Sebastian Yantorno, Natalia Schutz, Fiorella Villano, Domingo Saavedra, Javiera Donoso, Monica Osuna Pérez, Guillermina Remaggi, Yahveth Cantero-Fortiz, Eloisa Riva, Hernán López-Vidal, Cecilia Beltran, Carmen Gloria Vergara, Macarena Roa, Veronica Verri, Rocío Osorio, and David Gómez-Almaguer
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Pediatrics ,medicine.medical_specialty ,business.industry ,Proportional hazards model ,Immunology ,Gold standard ,Cell Biology ,Hematology ,medicine.disease ,Biochemistry ,Transplantation ,Median follow-up ,medicine ,Progression-free survival ,business ,Survival analysis ,Multiple myeloma ,Cohort study - Abstract
Background Multiple myeloma (MM) is a frequent hematologic malignancy. The current gold standard frontline strategy includes a proteasome inhibitor (PI)-based induction, followed by autologous stem cell transplant (ASCT). Access to novel drugs in Latin America (LA) is limited. ASCT is available in most countries, but real access to it is highly heterogeneous. Data regarding patients´ outcomes in candidates to ASCT in the region is scarce. The aim of this study was to describe clinical characteristics and outcomes of MM transplant eligible patients in LA countries. Material and Methods Retrospective international multicenter cohort study. Consecutive MM transplant- eligible patients diagnosed between 2010 and 2018 from participating centers in Chile, Argentina, Ecuador, Mexico, Colombia, and Uruguay were included. Data were collected from clinical records in a standardized report form. We analyzed clinical characteristics at diagnosis and frontline therapy outcomes, including ASCT. Transplant-eligible patients were defined as fit patients younger than 66 years old. Active MM and response to treatment were defined according to current IMWG criteria. Inclusion criteria: 1.- Patients with newly diagnosed active MM between 2010 and 2018. 2.- Older than 18 years, and younger than 66 years. 3- Candidates for ASCT according to the evaluation of the attending physician Exclusion criteria: 1- Lack of minimum data in the clinical history 2- Plasma cell leukemia, AL amyloidosis or solitary plasmacytoma. 3- HIV infection 4-No consent and/or Ethics Committee approvals. Statistical analysis A descriptive statistic has been done. Comparisons of characteristics between groups was made usingT-student, Chi2 or ANOVA, as appropriate. Survival analysis was performed using Kaplan-Meier curves. Comparisons of survival between groups were made by the logarithmic recording method and the calculations of the risk relationships by Cox regression. Statistical analysis was performed by using STATA 13. Results We included 1293 patients in the study, 363 from Chile, 395 from Argentina, 209 from Colombia, 45 from Ecuador, 151 from Mexico, and 130 from Uruguay. The main characteristics at diagnosis and therapeutic strategies are shown in Table 1. Optimal response (sCR, CR and VGPR) was achieved in 38% of the patients in the cyclophosphamide, bortezomib, and dexamethasone (CyBorD) group, in 46% in the bortezomib, thalidomide, and dexamethasone (VTD) group, and in 36% in the cyclophosphamide, thalidomide, and dexamethasone (CTD) group, the 3 main induction regimens used. Only 53% of patients finally received ASCT. Significant differences were found between both groups, private and public institutions, regarding burden of symptoms, ISS staging, access to PI based induction, ASCT completion and adequate maintenance, with patients from the latter being more symptomatic, and receiving suboptimal therapy. FISH analysis was performed in less than 50% of patients, both in the public and private setting. With a median follow up of 34 months (range 1-113), median overall survival (OS) was 86 months. The 5-year progression free survival (PFS) was 38% and 5- year overall survival (OS) was 64%. When comparing public vs private settings, 5 year OS was 45% vs 80%, with a median OS of 56 months vs not reached, respectively (P In the multivariable analysis renal failure (p=0.03), achieving less than VGPR response (p Conclusion This is the largest report on transplant eligible patients with MM in LA. Great inequities are shown between public and private health systems. Survival in transplant-eligible patients is lower than that described in other regions. Only one third of patients had FISH performed. This means that very few patients are treated with a risk-based induction in LA. Patients in the public setting are diagnosed with a more symptomatic disease, probably due to a late diagnosis. OS is significantly worse in the public setting. This might be explained by the significant differences in access to PI-based induction, ASCT and maintenance between private and public institutions, with patients from the latter receiving suboptimal frontline therapy and maintenance. Reasons for 47% of potential candidates not being transplanted merit further analysis. Table 1 Disclosures Peña: Novartis: Other: Congress inscription and flights; Tecnofarma: Other: Congress inscription and flights; Roche: Other: Congress inscription and flights; Biotoscana: Other: Congress inscription and flights; Janssen: Other: Congress inscription and flights; Pfizer: Membership on an entity's Board of Directors or advisory committees. Rojas:Roche: Membership on an entity's Board of Directors or advisory committees; Novartis: Membership on an entity's Board of Directors or advisory committees; Pfeizer: Membership on an entity's Board of Directors or advisory committees; Abbvie: Membership on an entity's Board of Directors or advisory committees. Abello:Takeda: Other: Participation in advisory board meeting. Gomez-Almaguer:Amgen: Consultancy, Speakers Bureau; Janssen: Consultancy, Speakers Bureau; Teva: Consultancy, Speakers Bureau; Takeda: Consultancy, Speakers Bureau; Celgene: Consultancy, Speakers Bureau.
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- 2019
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7. Aspicular Bone Marrow Aspiration: A Common, but Not a Minor Problem
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Olga Graciela Cantu Rodriguez, David Gómez-Almaguer, Jose Angel Hawing, Luz del Carmen Tarín Arzaga, Consuelo Mancias, and Andrés Gómez-De León
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medicine.medical_specialty ,business.industry ,Immunology ,Cell Biology ,Hematology ,Hematologic Neoplasms ,Aspirations (Psychology) ,medicine.disease ,Biochemistry ,Surgery ,Patient referral ,Pulmonary aspiration ,medicine.anatomical_structure ,Endotracheal aspiration ,Platelet Count measurement ,Medicine ,Bone marrow ,business - Abstract
Bone marrow (BM) aspiration plays an important role in hematologic malignancies diagnosis. Access and cost of diagnostic flow cytometry remains a problem in low and middle-income countries. In this context, morphological diagnosis by BM smear often represents the only means to rapidly diagnose our patients. Therefore, in this context obtaining the highest quality sample possible during the procedure is paramount. Despite being a well-known problem, evidence-based recommendations to improve BM aspirate quality are few, with studies evaluating factors associated with poor quality samples lacking. Objectives To determine factors associated with poor quality BM aspirates defined by an aspicular or hemodiluted sample in a hematology referral center. Materials and methods We conducted a retrospective study in our University Hospital and analyzed the BM smear samples stored in our center performed from October 2014 to December 2018. We collected and analyzed data based on diagnosis, age, gender, recent chemotherapy, and the variables of a complete blood count performed just before each BM aspiration. The quality of the BM smear was defined in any of the following: aspicular (without spicules), pauciaspicular (1-3 spicules), spicular (> 3 spicules), defining aspicular BM smear as non-diagnostic samples. Univariate analysis was performed looking for diferences between operators (in a 3-year residency program). In the other hand, in the multivariate analysis we seek to reveal the factors associated with obtaining hemodiluted (aspicular) bone marrow aspirate-smears. Results A total of 1,073 BM aspirates were evaluated. Hematology fellows performed 97% of BM aspirates; the remaining 3% were performed by attending physicians. In our analysis, 301 aspirates were aspicular, constituting 28.1% of the total number of aspirate smears. Most BM aspirates were performed for a diagnostic evaluation (66.3%) with the rest of the procedures for subsequent hematologic malignancy response assessments. In the univariate analysis, no differences were observed between operators. In a multivariate analysis the presence of an age >65 years (OR 3.1, 95% CI 2.3 to 4.1) and hemoglobin Conclusions We found no differences between operators, emphasizing that there are other factors to consider in addition to a correct BM aspiration technique or operator experience. We believe this is crucial to recognize, especially in developing countries where morphological diagnosis remains the only means for the diagnosis or response evaluation of our patients. BM aspirate sample quality is multifactorial, being age and hemoglobin important factors. In addition, obtaining aspicular or hemodiluted samples represents not only a diagnostic challenge, but also delays the treatment of our patients. Disclosures Gomez-Almaguer: Celgene: Consultancy, Speakers Bureau; Takeda: Consultancy, Speakers Bureau; Teva: Consultancy, Speakers Bureau; Amgen: Consultancy, Speakers Bureau; Janssen: Consultancy, Speakers Bureau.
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- 2019
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8. Cytokine Release Syndrome after Peripheral Blood T-Cell Replete Haploidentical Transplantation Is Not Prevented By Dexamethasone and Limits Its Full-Outpatient Conduction
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Luz del Carmen Tarín Arzaga, Julia Esther Colunga Pedraza, Emmanuel Bugarin Estrada, Olga Graciela Cantu Rodriguez, David Gómez-Almaguer, Perla R. Colunga Pedraza, Andrés Gómez-De León, Cesar Homero Gutierrez Aguirre, José Miguel Yañez Reyes, and Paola Santana-Hernandez
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Cyclophosphamide ,business.industry ,medicine.medical_treatment ,Immunology ,Cell Biology ,Hematology ,Hematopoietic stem cell transplantation ,medicine.disease ,Biochemistry ,Tacrolimus ,Transplantation ,Cytokine release syndrome ,Graft-versus-host disease ,Cytokine ,otorhinolaryngologic diseases ,medicine ,business ,Dexamethasone ,medicine.drug - Abstract
Introduction: Our center has implemented an outpatient-based peripheral blood haploidentical HSCT (haplo-HSCT) program since 2012. Cytokine release syndrome (CRS) associated with T-cell replete haplo-HSCT is characterized by fever and high levels of inflammatory cytokines with symptom onset typically occurring early after cell infusion, coinciding with maximal in vivo T-cell expansion. In this study, we report our analysis of CRS development after T cell-replete haplo-HSCT after using prophylactic dexamethasone and focusing on the impact of CRS on hospitalization and transplant outcomes in our outpatient program. Methods: In this retrospective study, adult patients undergoing a T-cell replete haplo-HSCT at our transplant center between January 2016-2018 were included. CRS was defined and graded using the criteria described by Lee et. al. Conditioning was based on fludarabine 25 mg/m2/day (day -5 to -3), cyclophosphamide 350 mg/m2/day (day -5 to -3), and oral melphalan 50-100 mg/m2 (day -2 to -1). For graft-versus-host disease (GVHD) prophylaxis we used post-transplant cyclophosphamide (PTCy) 50 mg/kg on days +3 and +4 as well as mycophenolate mofetil and either cyclosporine or tacrolimus starting on day +5. All patients received dexamethasone 8 mg IV on day 0 to +2 as prophylaxis against CRS. Disease-risk index (DRI) and HCT-Comorbidity Index (HCT-CI) were calculated based on established definitions. The primary objective was to evaluate the incidence of CRS with dexamethasone prophylaxis during an outpatient-based peripheral blood haplo-HSCT. Secondary objectives were to describe factors associated with CRS and to determine the impact of CRS on transplant outcomes and hospitalizations. Results: There were 42 patients included; the median age was 32.5 years (range, 16-66). The median DRI score was 3 (range, 1-4). The most common underlying diagnosis was acute lymphoblastic leukemia (n=14, 33%), followed by acute myeloid leukemia (n=8, 19%), and lymphoma (n=7, 16.6%). Conditioning was myeloablative (n=33, 79%) or reduced-intensity (n=9, 21%). Thirty patients (71.4%) developed CRS. CRS severity was grade 1-2 in 28 patients (66.7%) and grade 3 in 2 patients (4.8%). Median day of onset occurred on day +2 (range 0-4) and usually resolved after PTCy on day +5 (range, 1-11). The incidence of CRS was not associated with recipient age, number of CD34+ cells infused, DRI score, baseline HCT-CI score, and conditioning intensity. Time to neutrophil and platelet engraftment was not different in patients with CRS compared with patients without. Hospitalization was required in 36 cases (87%) while 6 patients (13%) were followed in a fully-outpatient basis, including 2 patients with grade 1 CRS. The median length of hospitalization was 13 days (range, 0-50) for patients with CRS and 8 days for patients without CRS (range, 0-44). The most common signs and symptoms besides fever were gastrointestinal manifestations (36.6%), hypoxemia (30%), fluid-responsive hypotension (16%) while 2 patients required vasopressors. Conclusion: The completely ambulatory conduct of haplo-HSCT was limited by the development of CRS. However, even in patients who developed CRS median length of hospitalization was short. CRS was common despite dexamethasone prophylaxis although most CRS were of grade 1 or 2. None of the factors evaluated were associated with CRS development in this context, and CRS did not influence time to engraftment, cumulative incidence of acute or chronic GVHD. New strategies are required to prevent CRS and prevent hospitalizations associated with haplo-HSCT. Disclosures Gomez-Almaguer: AbbVie: Consultancy; Novartis: Consultancy.
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- 2018
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9. Supplementation with Selenium As Prevention for the Development of Mucositis in Patients Undergoing HSCT. Results of a Pilot Study
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Cesar Homero Gutierrez Aguirre, Consuelo Mancias, Miguel Herrera-Rojas, Olga Graciela Cantu Rodriguez, Luz del Carmen Tarín Arzaga, Jose Angel Hawing, David Gómez-Almaguer, Andrés Gómez-De León, and Lourdes Garza-Ocañas
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medicine.medical_specialty ,Weight measurement scales ,business.industry ,medicine.medical_treatment ,Immunology ,Head and neck tumors ,Cancer therapy ,chemistry.chemical_element ,Cell Biology ,Hematology ,Hematopoietic stem cell transplantation ,medicine.disease ,Biochemistry ,chemistry ,Internal medicine ,medicine ,Mucositis ,In patient ,Allogeneic hematopoietic stem cell transplant ,business ,Selenium - Abstract
Introduction: Numerous clinical trials have been conducted in order to reduce or prevent the appearance of mucositis in patients undergoing cancer treatment and some of these have appeared in the clinical guidelines as recommendations (Keefe,DM Cancer 2007). However, to date no molecule has been shown to prevent appearance of this kind of lesions. Selenium, a trace element in the organism, cofactor of multiple biological processes, has been used previously for mucositis chemoprevention in head and neck tumors. We conducted a study to know if selenium supplementation has an impact on the development of mucositis. Objective: We aim to know the impact of Selenium in patients undergoing hematopoietic stem cell transplantation, in the presentation and duration of mucositis comparing against placebo. Methods: We performed a double blind clinical trial in a single center pilot study approved by our ethics committee. All patients candidates for autologous or allogeneic HSCT above 18 years were submitted for our study previous informed consent by our institution. Patients were randomized into one of two arms: a) selenium methionine, b) placebo. Previously randomized, patients were administered supplementation with oral selenium methionine at a dose of 400mcg/day or placebo starting 7 days prior transplantion. We determined a baseline measurement of serum and urinary selenium. Subsequent measurements were made each week for a total of 28 days. Evaluations were made with validated SMAQ questionnaires which also included scales of mucositis severity, using the WHO mucositis scale. All of them performed by an observer blinded to what supplementation were being administered to each patient. Results: We have recruited a total of 31 patients, of whom 16 were allogeneic and 15 autologous. We observed that 38.7% developed some degree of mucositis, most of them on the allogeneic arm (10 patients). Selenium consumption arm was associated with a median decrease of 32% (1.9 vs 2.8) in the WHO scale in the severity of mucositis compared to the placebo arm (p=0.046), however we didn't find difference in mucositis resolution time between groups (p=0.162). On the other hand, selenium supplementation was associated with shorter platelet engraftment time (p=0.041), without any significant difference in neutrophil engraftment time. With a follow up of 112 days, there are no difference about mortality or other analized variables. Conclusions: Supplementation with selenium was associated with a slight decrease in the severity of mucositis in comparison with placebo. Without any relevant findings in relation to mortality or other variables analized. Disclosures Gomez-Almaguer: Novartis: Consultancy; AbbVie: Consultancy. Herrera-Rojas:Janssen: Employment.
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- 2018
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10. Newly Diagnosed Pernicious Anemia Can be Treated with a Single Megadose of Cobalamin. Results of a Pilot Trial
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David Gómez-Almaguer, Oscar Marquez-Pinedo, Andrés Gómez-De León, Cesar Homero Gutierrez Aguirre, Paola Santana-Hernandez, Luz del Carmen Tarín Arzaga, Olga Graciela Cantu Rodriguez, Diana E Garcia-Camarillo, César Cantú, and Perla R. Colunga Pedraza
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medicine.medical_specialty ,medicine.diagnostic_test ,business.industry ,Immunology ,Complete blood count ,Cell Biology ,Hematology ,medicine.disease ,Biochemistry ,Cobalamin ,Gastroenterology ,chemistry.chemical_compound ,chemistry ,Internal medicine ,Medicine ,Vitamin B12 ,Intramuscular injection ,business ,Multivitamin ,Mean corpuscular volume ,Complete Hematologic Response ,pernicious anemia - Abstract
Introduction: Pernicious anemia is the leading cause of vitamin B12 deficiency worldwide, caused by an autoimmune reaction against parietal cells in the gastric mucosa leading to B12 absorption impairment. The treatment of pernicious anemia is based on replacement of cobalamin, oral and sublingual routes have been described nevertheless its absorption is erratic. The recommended schedules for vitamin B12 replacement is an intramuscular injection of 1000μg every other day for 1 to 2 weeks followed by weekly injections for a month and then tapered to once a month indefinitely (Green.Blood 2017;129(19):2603-2611). Such an approach can limit treatment adherence for patients in a resource-poor setting and may be unnecessary. Furthermore, the toxicity of cobalamin is minimal, while the benefit of larger doses is unknown. Objective: We aim to demonstrate that a single mega-dose intramuscular (IM) injection of a multivitamin formulation is sufficient to achieve and maintain a complete hematologic response for a six-month period. Methods: We performed a single center pilot study approved by our ethics committee and registered in Clinicaltrials.gov (NCT03372447). All patients with newly diagnosed, untreated pernicious anemia ≥18 years were included after written informed consent was obtained. A single IM dose of a multivitamin formulation consisting on cobalamin 10,000 μg, thiamin 100 mg, and pyridoxine 50 mg was administered. Complete blood count (CBC) was performed at 15 and 30 days and monthly thereafter for a total of six months. Partial response (PR) was considered when Hb ≥10g/dl, Normal WBC, PLT ≥100x103/μL, Complete response (CR) was defined as Hb ≥12g/dl, normal WBC and PLT. Our primary outcome was normalization of CBC (CR) at 6 months. As secondary outcomes we evaluated safety and measured levels of methylmalonic acid (MMA), homocysteine (HCY) and B12 levels (B12L) at diagnosis, three and six months after treatment. Results: Eight patients have been enrolled (5 men and 3 women), median age was 58 years (range 25-77). None had neurological symptoms at presentation. Median laboratory values at diagnosis were Hb 5.9 g/dL (range 3.9-10.7), mean corpuscular volume 113.2 fL (range 94.6-122.9), WBC 2.68x103/μL (range 1.26-6.08), PLT 93x103/μL (range 9.75-156,000), lactic dehydrogenase 3082IU/L (range 439-9840), B12L 85 pg/ml (range 83-90), HCY 154.09 μmol/L (range 83.7-182.44), MMA 24435 nmol/L (range 5175-99500). By day 30 all patients achieved PR. At the end of the third month, 100% of patients reached a CR regarding Hb and WBC while 88% of patients reached a complete PLT response. Median Hb increment at 1 month and 3 months was 6.15g/dl (range 3.1-7.74) and 1.8g/dl (range 0.4-3.7) respectively. The difference between Hb concentration at all time-points was statistically significant (ANOVA; p=0.002) particularly in the first 15 days (p=0.025), while post hoc testing revealed that increments in Hb after the second-week post-treatment were not (p>0.05). Until now, 4/8 patients have completed the primary outcome and all of them have maintained CR and normal levels of HCY and B12L without further cobalamin doses, only one patient had an asymptomatic increase of MMA. No adverse events following the administration of multivitamin preparation were documented. Conclusions: A single dose of a 10,000μg B12 multivitamin was safe and tolerated. Thus far all patients have achieved and maintained a response for at least six months. This simplified single cobalamin administration is an effective option for the treatment of pernicious anemia. Disclosures Gomez-Almaguer: AbbVie: Consultancy; Novartis: Consultancy.
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- 2018
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11. [Is it possible to cure a patient with mycosis fungoides? A case report]
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Victor Antonio, Guillermo-Villanueva, Guillermo J, Ruiz-Delgado, Luz, del Carmen Tarín-Arzaga, and David, Gómez-Almaguer
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Adult ,Mycosis Fungoides ,Skin Neoplasms ,Remission Induction ,Hematopoietic Stem Cell Transplantation ,Humans ,Female - Abstract
Sezary syndrome (SS) and mycosis fungoides (MF) are a group of non Hodgkin lymphomas that originate from T-lymphocytes and involve mostly the skin. These entities are generally non treatable and patient prognosis remains poor even with the advent of current treatment schedules. Complete remissions are seldom observed. For this reason, bone marrow transplant has been used as a treatment option. The high mortality associated with this procedure has turned reduced intensity conditioning stem cell transplant into a treatment option. This case study illustrates how stem cell transplant offers complete remission of this type of lymphomas.
- Published
- 2007
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