ALBERT

Description: Background: Acute Myeloid Leukemia (AML) is the most common acute leukemia in adults in the United States with an incidence of 3 to 5 cases per 100,000 population [Siegel RL, CA Cancer J Clin 2018)]. Even though advances in therapies have increased the survival and improved outcomes in younger population, patients over 65 years of age carry a particularly poor prognosis. Previous results of treatment outcomes in AML have showed significant differences between low- and middle-income countries (LMIC) and high-income countries (HIC). The aim of this study is to assess survival rate for patients with diagnosis of AML in a single center in Colombia, South America. Methods: A retrospective cohort study was conducted at a tertiary referral center in Colombia on patients older than 15 years who were diagnosed with AML between July 2013 and November 2017. All patients were managed based on PETHEMA protocol for AML. Descriptive statistics were used to analyze patient's demographic characteristics. The Kaplan-Meier method was used to assess overall survival (OS) and relapse-free survival (RFS) rates at one and five years. Results: One hundred and seventeen patients were included. Fifty-nine were male (50.42%) and 58 were female (47.6%) with a mean age of 63 years (range 15-95). The most common type of AML based on the French-American-British (FAB) classification was M2 (AML with maturation) in 22.8% of the patients, followed by M1 (AML with no maturation) in 10.5%, and M5 (acute monoblastic leukemia with or without maturation) in 8.8% of the patients; however, classification data was missing in several of the patients (45.6%). OS was 54.6% (CI95% 44.4-63.7) at one year and 19.5% (CI95% 10.3-30.9) at five years. RFS was 91.4% (CI95% 84.0-95.4) at one year and 83.3% (CI95% 73.9-89.5) at five years. Classifying patients by age group, OS was 81.8% (CI95% 68.7-89.7) at one year and 36.5% (CI95%19.6-53.6) at five years for patients younger than 65 years, 22.8% (CI95% 10.8-37.5) at one year and 0% at five years for those between 60 and 80 years, and 19.1% (CI95% 1.4-52.4) at one year and 0% at five years for patients older than 80 years. While median OS for patients who achieved complete response after induction regimen was 35.7 months, it was only 8.9 months for those with either partial response or induction failure (HR 1.03, CI95% 1.01-1.05, P

Description: Introduction Acquired severe aplastic anemia (SAA) is a low frequency hematologic disease associated with significant morbidity and mortality. The destruction by immunological mechanisms of hematopoietic progenitor cells appears to play a fundamental role in the pathophysiology of the disease, therefore, immunosuppressive treatment (IST) is one of the pillars of management. In Colombia and Latin-America there is lack of information about the characteristics of patients with SAA and the effectiveness of IST and other treatments. The main objective of this study was to assess the outcomes of a group of patients treated in different centers in Colombia during the last five years. Materials and methods This is a retrospective observational study, carried out within 6 institutions of 3 Colombian cities (Bogota, Medellín, Bucaramanga) of patients treated from 2013 to 2018. An anonymized database was constructed. All patients diagnosed with SAA and treated with IST as first line of therapy were included. Results We analyzed the data of 37 patients; 22 of them were women. The average age was 37 years old (with a range of 7-68 years). The median time since the onset of the symptoms to the time of diagnosis was 88 days (with a range of 7-655 days). Clastogenic effect of diepoxybutane (DEB) tests were available only in 9 patients (7 of which were positive); Paroxysmal Nocturnal Hemoglobinuria (PNH) clone was detected in 9 of the 27 tested, all of which were under 5%. Mean leukocytes, hemoglobin concentration, and platelets at the moment of diagnosis were 3.090, 8.5 and 22.000. Bacterial infection was the most important clinical manifestation at diagnosis (in 16 of the 37 patients); 19 out of 37 patients had more than 5 red blood cell transfusions before the first treatment. As first line therapy, 25 patients received IST (most by antithymocyte globulin (ATG) of which 10 were treated with rabbit ATG, 12 with horse ATG and 3 combined with Eltrombopag); 4 patients had cyclosporin and prednisone, 2 had allogeneic transplant and 6 received other therapies. Those treated with IST patients, 8 had a complete response (CR) (32%), 6 had partial response (PR) (24%), 8 had no response (32%). 5 received a second course of IST and 3 had CR. 3 patients were lost in follow up. At a mean follow up of 18.7 months (1.7-65), 44% were alive in CR, 26% in PR, 9% were in relapse and 21% died. Causes of death were SAA related infection in 5 patients, transplant related in 1 and non-disease related in 1. Conclusions This is the first multicenter report of SAA treatment in Colombia, it includes children and adults, resulting in a very heterogeneous population. This preliminary information shows that there is a significant delay in the diagnosis and initiation of treatment in patients, most patients have more than 5 transfusions before treatment. This could, in part, explain the apparent low response rates to IST in comparison to that of what have been reported in literature. A larger registry of hematologic pathologies is required so we can confirm these findings, start proposing strategies applicable in our country to achieve better outcomes in these patients and planning clinical trials to answer questions relevant to our population. Disclosures No relevant conflicts of interest to declare.

Description: Background: Survivors of hematopoietic stem cell transplantation (HSCT) are 2 to 4 times more likely to develop cardiovascular diseases, accounting for 2-11% of mortality among long-term survivors. Early diagnosis and treatment of modifiable risk factors, such as arterial hypertension, are imperative in this group of patients. The aim of this study is to evaluate the prevalence and associated factors for arterial hypertension following HSCT in a Colombian population. Methods: A retrospective study was conducted in 220 consecutive adult HSCT recipients who underwent transplantation between 2009 and 2017 at a third level referral center in Colombia. Blood pressure data, from two different measures, were collected at 7 time points: day of mobilization for autologous HSCT (auto-HSCT) and day 0 before infusion for allogeneic HSCT (allo-HSCT), day 7, and months 1, 3, 6 and 12 post-HSCT. Arterial hypertension was defined as a systolic blood pressure 140mmHg and/or a diastolic blood pressure 90 mmHg. Patients with history of arterial hypertension were excluded. Descriptive statistics were used to analyze patient's demographic data. Bivariate and multivariate analyses were performed to assess the association between clinical characteristics and arterial hypertension. Results: One hundred and seventy-one patients were included, with a median age of 45 years (range 18-71). Eighty-nine patients (52.1%) were male. One hundred and fifteen patients (67.3%) underwent auto-HSCT and 56 (32.7%) allo-HSCT. The most common indication for HSCT were lymphomas (39.8%), followed by leukemia (28.6%) and multiple myeloma (23.4%). Thirty-six patients (21.1%) developed arterial hypertension by the end of the first year of follow-up. Prevalence of hypertension at each time point was 2.3% on day 7 post-HSCT, 4.7%, 5.3%, 5.5% and 8.1% at 1, 3, 6 and 12 months respectively. Allo-HSCT (P

Description: Introduction: Autologous hematopoietic stem cell transplantation (auto-HSCT) is a complex medical process that has evolved throughout the years, becoming a potentially curative therapy for many hematologic neoplasms and non-malignant marrow disorders, as well as a clinical option for some autoimmune diseases. During the past decades, HSCT has had important advances in technology and technique, patient supportive care, and conditioning protocols, making it a safer procedure. As a result, patient survival rates continue improving. Nonetheless, it is unclear if these improvements are also seen in developing countries. The aim of the present study is to assess survival rate for patients who underwent auto-HSCT in a Colombian population. Methods: A retrospective cohort study was conducted at a tertiary referral center in Colombia, South America, on patients who underwent auto-HSCT between November 2009 and December 2017. Descriptive statistics were used to analyze patient's demographic characteristics. The Kaplan-Meier method was used to assess overall survival (OS) and relapse-free survival (RFS) rates at 100 days, one year, and five years following auto-HSCT. Results: One hundred and fifty-seven patients were included, with a mean age of 49.54 years (range 14-71). Seventy-nine (50.31%) were men. Classifying patients by age group, 68.7% of the patients (n=108) were in the 20-60 years old group and 28% (n=44) were older than 60 years. The most common indication for auto-HSCT was multiple myeloma (42.7%), followed by non-Hodgkin lymphoma (35%) and Hodgkin lymphoma (13%). Peripheral blood stem cells were the graft source in all patients (100%). High-dose melphalan (MEL 200) was the conditioning regimen administered to patients with diagnosis of multiple myeloma, and BEAM (carmustine, etoposide, cytarabine, and melphalan) to patients with lymphoma. OS was 91.7% (CI95% 86.2-95.1) at 100 days, 81% (CI95% 73.9-86.4) at one year, and 60.9% (CI95% 51.3-69.1) at five years. RFS was 94.9% (CI95% 90-97.4) at 100 days, 86.3% (CI95% 79.7-90.8) at one year, and 70.5% (CI95% 66.6-80.7) at five years. Classifying patients by pre-transplantation disease stage as defined by the EBMT study group, OS for early disease was 85.5% (CI95% 75.6-91.8) at one year and 58.2% (CI95% 43.7-70.2) at 5 years, 88.1% (CI95% 76.5-94.1) at one year and 51.8% (CI95% 33.9-66.9) at 5 years for intermediate stage, and 100% at one year and 42.3% (CI95% 7.3-75.4) at 5 years for advanced disease. The most common cause of death was disease progression. There were 51 deaths (32.48%) post-transplantation, 5.73% (n=9) in the first 100 days, 7.6% (n=12) between 100 days and 1-year, and 18% (n=29) after the first-year post-transplantation. Non-relapse mortality was 3.2% at both 100 days and 5 years. Conclusion: OS and RFS of auto-HSCT were very similar to the outcomes reported in the existing literature mainly assessed in developed countries. The most common cause of death in patients who underwent auto-HSCT was progression of the primary disease, and transplant-related mortality was low. Figure. Figure. Disclosures No relevant conflicts of interest to declare.

Description: Introduction: Allogeneic hematopoietic stem cell transplantation (HCT) is a potentially curative treatment for several malignant and non-malignant hematological diseases. However, sometimes it is challenging to find human leukocyte antigen (HLA)-matched related or unrelated donors, especially in minority populations such as Hispanics. Transplantation of T cell replete HLA haploidentical graft (HaploHCT) followed by a high dose post-transplantation cyclophosphamide (PTCy) to eradicate alloreactive T cells is an option for populations with low donor availability. HaploHCT has emerged as an effective and safe strategy in this population (Luznik L et al. BBMT 2008), but data in Hispanics is scarce. Objective: The aim of our study was to describe the clinical characteristics and assess overall survival at 100 days, 1- and 3-years of patients who underwent haploHCT in two Colombian reference centers. Methods: An observational retrospective study was conducted at two tertiary referral centers in Colombia. Patients who underwent haploHCT at Clinica FOSCAL and Centro Medico Imbanaco between January 2013 and January 2020 were selected. Demographic and clinical characteristics where analyzed using descriptive statistics. The Kaplan-Meier method was used to assess overall survival (OS) rates and the log-rank test was used to compare survival rates between groups. All data were analyzed using R statistical software®. Results: Seventy-six patients were included. Mean age at transplantation was 34 years (range 18-60). Forty-two (57.89%) patients were female. Average body mass index was 19.86kg/m2. The majority of patients (57%) had a pre-transplantation ECOG performance status of 2. The most common indication for haploHCT was acute lymphoblastic leukemia (55.26%), followed by acute myeloid leukemia (23.64%). A sibling was the donor in 69.74% of the cases. Forty-seven (61.84%) patients were ABO-matched group. Peripheral blood stem cells were the graft source in 96% of the patients. The average number of infused CD34+ cells was 11.15 x 106/kg. Fludarabine-melphalan was the most commonly used conditioning regimen (57%), followed by fludarabine-busulfan-thiotepa (39%). Graft-versus-host disease (GVHD) prophylaxis consisted of PTCy (50 mg/kg/day) on days 3 and 4 after HCT and a calcineurin inhibitor plus mycophenolate mofetil from day 5 to day 35 post-HCT. Median time to neutrophil engraftment (neutrophils 〉 0,5x109/L) was 15 days (range 10-33), while platelet engraftment, defined as as the second day of unsupported platelet count of ≥20 × 109, occurred at a median time of 13 days (range 5-38) post-transplantation. On day 28 post-HSCT, 93.4% of the patients had achieved 100% chimerism. OS was 91% (95%CI 84-97.5) at 100 days, 81% (95%CI 72-90) at 1-year, and 77% (95%CI 68-88) at 3-years after HaploHCT. C onclusion: The results of our haploHCT retrospective study in a Hispanic population are comparable to several other cohorts that have reported similar outcomes of haploHCT compared to HLA-matched HCT. The OS rates reported in our study suggest that haploHCT is a viable option in patients without an HLA-matched related or unrelated donor available, especially in populations with lower rates of suitable donors. Acknowledgements: We deeply thank Gonzalo Gutiérrez García, M.D. for his leadership and guidance implementing the haploHCT program in Clinica FOSCAL. Disclosures Peña: Roche: Honoraria. Salazar:Janssen: Honoraria; Novartis: Honoraria. Sandoval-Sus:MorphoSys US: Consultancy; Janssen: Consultancy; Massive Bio: Consultancy; Celgene: Speakers Bureau. Sossa:Novo: Honoraria; Takeda: Honoraria; Astellas: Honoraria; Roche: Honoraria.

Description: Introduction: Myelodysplastic syndromes (MDS) comprise a varied group of clonal myeloid neoplasms characterized by cytopenias and an increased risk of progression to acute myeloid leukemia. Prognosis is variable, but little is known about the clinical features of MDS in the Colombian population. The diverseness of the disease and changes in standardized diagnostic criteria throughout the years have hinder accurate case detection and epidemiologic evaluation of MDS in our population. Objective: The aim of the present study was to determine the clinical characteristics and evaluate the overall survival (OS) of patients with MDS treated at two large referral centers in Colombia. Methods: An observational, retrospective study was conducted at two tertiary care centers in Colombia. Patients diagnosed with MDS at Clinica FOSCAL and Hospital San Jose between June 2013 and June 2019 were selected. Descriptive statistics were used to analyze baseline demographic characteristics and clinical data such as disease classification, risk stratification, and treatment. The Kaplan-Meier method was used to assess overall (OS) at 1, 3 and 5 years. Results: A total of 96 patients were included. Median age at diagnosis was 75 years (range 31-104). Fifty-two (54.2%) patients were male. According to the 2016 World Health Organization classification of MDS, the most commonly diagnosed subtype was MDS with multilineage dysplasia (31.2%), followed by MDS with excess blasts (13.5%); however, 35.4% of patients had an unclassifiable MDS sub-type. Twenty-nine (31.2%) patients were screened for cytogenetic abnormalities, the most common chromosomal abnormalities were deletion in the long arm of chromosome 5 (4.2%) and deletion of 7q (2.1%). Therapy related MDS was diagnosed in 13 (13.5%) patients and secondary MDS associated to pesticides exposure in 2 (2.1%) patients. After stratifying patients by the International Prognostic Scoring System (IPSS), the majority of patients were in the intermediate risk group, with 21 (34.4%) and 16 (26.2%) patients in the intermediate-1 and intermediate-2 categories respectively. Almost 80% of the patients presented one or more comorbidities, the most common was cardiac disease (30.5%). Supportive care with erythropoiesis-stimulating agents was the most common first-line treatment (61.4%), followed by iron chelation therapy (6.2%). Forty-eight (50%) patients were treated with hypomethylating agents (HMA), 43.7% receiving azacytidine and 6.3% decitabine. Among HMA-treated patients, 49.6% were in the intermediate-2 and high-risk IPSS groups. Two patients underwent allogeneic hematopoietic stem cell transplantation. Only patients treated with HMA and cytarabine/idarubicin chemotherapy achieved a complete response (11.5%). OS at one- and five-years post-diagnosis was 73.4% and 40.7% (95%CI 62.4-81.6 and 27.1-53.9) respectively. Patients in the intermediate-2 and high-risk IPSS groups had lower survival rates compared to those in the low and intermediate-1 risk groups. The OS for patients treated with azacytidine was 77.2% (95%CI 60.7-87.5%) at one-year, 43.2% (95%CI 23.9-61.1%) at three-years, and 37.8% (95%CI 19.0-56.5) at five-years after diagnosis. The most common cause of death was infection (51.3%), followed by disease progression (24.3%). Conclusions: The OS of patients with MDS in our study is similar to the reported in the existing literature. Knowing the epidemiology, clinical characteristics, risk stratification, and disease outcomes of MDS patients in our population is crucial to decide the best treatment strategies and improve the clinical outcomes of our patients. Disclosures Sossa: Roche: Honoraria; Astellas: Honoraria; Takeda: Honoraria; Novo: Honoraria. Abello:Dr. Reddy's: Consultancy, Research Funding; Takeda: Honoraria, Research Funding; Amgen: Consultancy, Research Funding; Novartis: Consultancy, Honoraria; Abbvie: Consultancy, Research Funding. Peña:Roche: Honoraria. Salazar:Novartis: Honoraria; Janssen: Honoraria. Sandoval-Sus:Celgene: Speakers Bureau; Massive Bio: Consultancy; Janssen: Consultancy; MorphoSys US: Consultancy.