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Patients with multiple myeloma (MM) have an increased risk for severe infections due to both the disease and anti-myeloma therapies. During the COVID-19 pandemic, case series of MM patients have demonstrated a poor outcome in those who required hospitalization due to COVID-19, and there are few data regarding those managed out of hospitals or risk factors for hospitalization. In Brazil, where the scenario is of restricted resources to treat MM patients and large numbers of COVID-19 cases and related death, the outcome can be even worse. Objective: To assess risk factors and outcomes of COVID-19 in Brazilian patients with MM. This retrospective case series investigated 81 MM patients with documented COVID-19, managed in and out-hospital, from 8 states, representing 4 of 5 regions in Brazil. This study has been conducted by "Grupo Brasileiro de Mieloma" (GBRAM), and the present analyses included cases from April 2020 to July 2021. Clinical features and risk factors were analyzed with the severity of COVID-19 and outcomes (hospital admissions, intensive care unit (ICU) admission, ventilatory support, and death). The frequency of MM treatment modification due to COVID-19 was also accessed. There were 81 MM patients (male 50%; median age 63 years; and ISS III at diagnosis 25%) diagnosed with COVID-19. At least one comorbidity was present in 47 (58%) patients: most frequently hypertension and diabetes (56% and 27%). Twenty-eight (35%) patients had more than one comorbidity. At COVID episode, 21 (26%) patients had an active disease or progression disease, and 40% received at least two prior lines of treatment. COVID-19 management required hospitalization in 49 (61%), ventilatory support in 30 (40%) and ICU in 28 (35%). Hospitalization was associated with age (p=0.008), presence of comorbidity (p=0.02), hypertension (p=0.02), presence of fever (p=0.005) and low respiratory symptoms (p=0.003). Ventilatory support was more frequent in patients with cardiac disease (p=0.05), receiving immunomodulatory (p=0.03), or monoclonal drugs (p=0.006). Patients receiving corticosteroids (p=0.02), immunomodulatory (p=0.06), or monoclonal drugs (p=0.06) in MM treatment had a higher frequency of ICU admission. By adjusted multivariate analysis, age, the clinical presentation with fever and low respiratory symptoms (p In this series, COVID-19 MM patients had a very high frequency of hospitalization, ventilatory support requirement, ICU admission, and deaths due to COVID-19. Although not associated with increased mortality, prior therapy drug classes were associated with severity of manifestation in our series. We also observed a high frequency of MM treatment delay in recovered patients, and the post-COVID clinical impact should be more explored. The high mortality observed reinforces the importance of preventing COVID-19, such as social distancing, wearing masks, and vaccination. Disclosures De Queiroz Crusoe: Janssen: Research Funding. Hungria: Takeda: Honoraria; Amgen, BMS, Celgene, Janssen: Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: Support for attending meetings/travel ; Abbvie: Honoraria; Sanofi: Honoraria, Other: Support for attending meetings/travel .

Introduction: Diffuse large B-cell lymphoma (DLBCL) is the most frequent lymphoid malignancy, representing 30-40% of all non-Hodgkin's lymphomas (NHLs). They comprise a group of aggressive and heterogeneous neoplasms in terms of clinical presentation, response to therapy and prognosis. The OCT-1 gene is a member of the homodomain-POU family of transcriptional regulators of B-lymphoid differentiation. OCT-1 acts by controlling the expression of specific B-cell genes, such as BCL-2, a potent inhibitor of apoptosis that is essential for the differentiation of B-cells in the germinal center. These genes can be expressed in DLBCL, but the role of BCL-2 in its prognosis has been contradictory and the prognostic impact of the OCT-1 gene has not yet been tested in this lymphoma. Methods: In this observational, retrospective, single-center study, we investigated the prognostic impact of BCL-2 and OCT-1 gene expression in Brazilian patients with DLCBL treated with immunopolychemotherapy R-CHOP in a real-world context. The BCL-2 and OCT-1 genes were assessed in 78.5% (77/98) DLBCL patients, and the RNA for quantitative real-time PCR (qRT-PCR) was isolated from formalin-fixed and paraffin-embedded (FFPE) samples. The values obtained for gene expression were transformed into categorical variables according to their medians (6.27 for BCL-2 and 24.5 for OCT-1). The association between clinical and laboratory variables and results of gene expression was verified by the Fischer test. Overall survival (OS) and progression-free survival (PFS) were estimated using the Kaplan-Meier method. Univariate analysis was performed using Cox's bivariate regression method and multivariate analysis using Cox multiple regression methodology. Results: The median age of the cohort was 54.5 years (15-84), 50% (49/98) were male, 49.4% (38/77) and 51.4% (40/77) showed expression of OCT-1 and BCL- 2 ≥ median, respectively. The clinical characteristics of the 98 Brazilian patients with DLBCL that comprised our cohort are summarized in Table 1. The overall response rate (ORR) in all patients was 68.4% (67/98), 65.3% (64/98) showed a complete response (CR), and 3.1% (3/98) showed partial response (PR), while 6.1% (6/98) were primary refractory. With a median follow-up of 3.77 years (95% CI: 3.2-4.1), the median overall survival (OS) was 5.43 years (95% CI: 2.2-NR) and the median progression-free survival (PFS) was 5.15 years (95% CI: 2.9-NR). The 5-year OS and PFS was 54.2% (42.2% -64.8%) and 52.0% (40.1-62.6%), respectively. In the univariate analysis OCT-1 ≥ median was associated with shortened OS (HR: 2.45, 95% CI: 1.21-4.96, p = 0.013) and PFS (HR: 2.27, 95% CI: 1.14-4.51, p = 0.019). Overexpression of BCL-2 was associated with worse PFS (HR: 2.00, 95% CI: 1.02-3.95, p = 0.043). Subgroup analysis showed that OCT-1 overexpression predominated in elderly individuals (≥ 60 years) in a statistically significant mode (29/38 cases - 76.3%, p = 0.029). It was also observed that overexpression of OCT-1 was associated with worse OS in the high-risk adjusted International Prognostic Index (aIPI) subgroup (p = 0.048) - Figure 1, and worse PFS in patients ≥ 60 years old (p = 0.025) - Figure 2. In the multivariate analysis, overexpression of OCT-1 was associated with poor PFS (HR: 2.22, 95% CI: 1.06-4.76, p = 0.035). Conclusion: In this study, we demonstrated that overexpression of the OCT-1 gene was an independent prognostic factor associated with adverse outcomes in Brazilian patients with DLCBL. We also show that in patients with unfavorable risk, such as the elderly and those with intermediate-high and high-risk IPI, overexpression of OCT-1 contributed to the identification of a very high-risk clinical-molecular subgroup, where the results with standard R-CHOP therapy are unsatisfactory, and they may benefit from intensified therapeutic strategies. Our results are preliminary and need to be validated in subsequent studies of prospective nature and with an expanded sample. Disclosures No relevant conflicts of interest to declare.

Introduction:Adult T cell Leukemia/Lymphoma (ATLL) is a mature T-Cell-neoplasm related to human T-cell lymphotropic virus type 1 (HTLV-1) infection that shows variable clinical presentation and adverse prognosis with shorter overall survival (OS) when compared to other peripheral T-cell lymphomas (PTCL). Previous epidemiological studies estimated cumulative incidence in endemic regions around the world. In Brazil, mainly due to its vast dimension, data collection has limitations and is subject to bias. In April 2015 theBrazilianT-cell longitudinal project initiative was launched. One of the primary purposes was the collection of epidemiological and clinical data from the most frequent subtypes of newly diagnosed PTCL. Among them, 41 cases of ATLL were recorded. Objectives:The aim of this study is to describe clinical features, frequency and overall survival (OS) of 41 cases of ATLL registered in the ongoingBrazilianT-Cell Project. Methods:This is an ambispective observational study design collecting baseline characteristics, clinical features including date of diagnosis, clinical subtypes, B symptoms, performance status, Ann-Arbor staging, HTLV-1 status, number of sites, nodal and extra nodal presentation and types of skin lesions, peripheral blood counts and biochemical tests, front-line treatment and best response after first-line treatment. REDcap Platform has been used to collect and store data and for descriptive analysis the IBM-SPSS version 24 was applied. Kaplan-Meier method estimated the OS, whereas Log-Rank tests to compare its curves. OS period was calculated from diagnosis date until death or last seen date, and event was death by any cause. Results:Out of 281 cases of PTCL registered so far, 41 were ATLL cases. The median age was 50 years (34-88), 25 (64%) female; a higher incidence of lymphoma subtype was observed (46%), followed by acute (29%), chronic (17%) and smoldering (8%). Most of the patients (85%) had advanced-stage disease (III-IV, Ann-Arbor) and 56% had B symptoms (Table 1); 73% received chemotherapy with anthracycline-based regimens (46.5% CHOEP; 33.5% CHOP; 20% others) whereas 17% were managed with immunotherapy and antiviral therapy. The overall response rate was 30%; no response or progression 46%; stable disease 9% and 15% no data available yet (Table 2). Median follow-up was 13 months and 25 months for 41% of alive patients. Two year OS was 39% (95%CI: 23-55%) (Figure 1). Smoldering and Chronic subtypes showed better OS when compared with acute and lymphoma (100% smoldering, 86% chronic; 30% lymphoma type and 13% acuteP=0.04) (Figure 2). The multivariate Cox Regression analysis found male gender (HR 10.9 95%CI: 3.0-39.7, P Discussion:ATLL prognosis remains poor regardless of the type of treatment regimen and may be associated with the high incidence of lymphoma and acute subtypes, as well as advanced stage disease presentation. Despite the high number of cases seen in southeastern region of Brazil, it is important to emphasize there are still limited data from other regions. Albeit the sample size is small, these findings confirmed literature review data so far, with poor overall survival in a short time and gender and albumin as predictors of OS in the multivariate analysis. Conclusion:This study highlights the poor prognosis associated with ATLL. Moreover, it seems relevant to expand this study to all Brazilian regions. Hence, the need for early diagnosis and new treatment strategies, able to reduce mortality is warranted, that could possibly change the nature and spectrum of disease. Disclosures Federico: Spectrum:Consultancy, Membership on an entity's Board of Directors or advisory committees;Sandoz:Consultancy, Membership on an entity's Board of Directors or advisory committees;Cephalon/Teva:Research Funding;Mundipharma s.r.l.:Research Funding;Celgene:Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding;Millennium/Takeda:Research Funding;Roche:Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding;Takeda:Consultancy, Membership on an entity's Board of Directors or advisory committees.

Introduction: An epidemiological database is an important tool to characterize the population disease distribution, long-term effects of the diseases, impact of evolving treatments, to identify adverse events (AE) and their possible mitigation and to improve the healthcare system. Another important reason to create a database is to rapidly identify, recruit and enroll individuals for research activities. Based on these, the Brazilian Multiple Myeloma Study Group (GBRAM) developed an electronic database platform with the intention of prospectively registering the MM cases diagnosed at Brazilian healthcare services. Methods: This is a prospective, multicenter, open, epidemiological study, based on an electronic system register. Patients diagnosed with MM after January 1, 2018 have been included. The eligibility criteria were: intent-to-treat (ITT) MM patients, aged over 18 years and under care in any healthcare system (private, public and academic). All clinical and laboratory data, prognostic profiling, treatment patterns and responses, AE and survival were compiled. The data were analyzed with the NCSS® 2020 software. This project is registered in the Brazilian study platform control (Plataforma Brasil) linked to federal health authorities by the number CAAE-05340918.3.1001.8098. Results: To date, 1,113 patients at 44 reference centers were included. The median age was 64 (25 -96) years and 578 (52%) were male. According to the ECOG performance status: 0 = 185 (16.5%), 1 = 257 (23.2%), 2 = 144 (13%), 3 = 105 (9.5%), 4 = 62 (5.5%) and the not available data (NA) = 359 (32.3%). The ISS 1, 2, and 3 were 219 (19.7%), 286 (25.7%) and 406 (36.5%), respectively, the NA being 202 (18.1%). MM isotypes were 524 (47.1%) IgG, 202 (18.2%) IgA, 192 (17.2%) free-light chain, 4 (0.5%) IgM, 7 (0.8%) biclonal, 9 (0.7%) non-secretor and 175 (15.5%) NA. Regarding the treatment backbone, 427 (38.4%) patients received immunomodulators (IMID- thalidomide), 277 (20.4%), proteasome inhibitors (PI-bortezomib), 84 (7.6%), the combination of PI + IMID, 72 (6.6%), combinations with anti-CD38 monoclonal antibody (Daratumumab) and 253 (27%), other treatments. Based on the ITT analysis of 1003 cases, 636 (63.4%) patients were planned for bone marrow transplantation (BMT) and 367 (36.6%) were ineligible. After a median follow-up of 14.0 months, 150 (23.6%) of the planned patients had undergone the procedure, 284 (44.7%) had not yet been submitted and 202 (31.7%) had NA data. The overall survival (OS) was 80.9% for the total group at 20 months, 73.5% for ineligible and 95.5% for eligible. There was a significant improvement in eligible patients who had performed BMT, as compared to those who had not, HR 0.15 (0.09 - 0.26), p < 0.0001. A total of 142 deaths (12.8%) occurred, 51 (36%) of them being during the first 180 days. Discussion: Due to the lack of a reliable national register and the undoubtable need for a better understanding of MM for the development of public health and patient support measures, GBRAM has developed and built an electronic platform. This epidemiological study prospectively enrolled patients diagnosed since January 2018 and is of a nationwide scope. To date, 1,113 new cases were included. Despite the short follow-up, this analysis has identified differences in survival, comparing ISS stratifications and whether a BMT was performed or not. Conclusion: This project demonstrates the feasibility and importance of electronic platforms in the compilation of MM populational data for a better understanding of the clinical characteristics, treatment patterns and outcomes in the real world, permitting a clearer perception of local issues and thus, addressing possible improvement in public healthcare policy, such as the improvement of BMT access. Disclosures De Queiroz Crusoe: Janssen: Research Funding. Aranha:Janssen: Honoraria, Membership on an entity's Board of Directors or advisory committees; Ache Pharmaceutics: Honoraria.

Background While rituximab revolutionized outcomes in DLBCL, little is known regarding survival improvements at population level beyond the introduction of rituximab. The advent of novel agents, improvements in supportive care and expansion of autologous hematopoietic cell transplantation (auto-HCT) to older individuals may have improved survival of DLBCL patients. We hypothesized that outcomes for patients diagnosed with DLBCL in the U.S. has continued to improve in recent years and intended to measure improvements and identify possible disparities by comparing survival of DLBCL between two consecutive post-rituximab eras. Methods We used the population-based SEER-18 registry to calculate the incidence and relative survival rates (RSR) of DLBCL in the U.S. for two consecutive eras since broad availability of rituximab in upfront DLBCL treatment, 2002-2007 (era-1, early years after adoption of rituximab) and 2008-2013 (era-2, availability of novel agents, broader use of auto-HCT and improvement in supportive care). We included adult patients with microscopically confirmed DLBCL as first malignant neoplasm regardless of histologic subtype and survival follow up to the end of 2015. Results There were a total of 56,625 DLBCL patients diagnosed between 2002 and 2013, of which 27,306 patients were diagnosed during era-1 and 29,319 during era-2. Median follow up of survivors was 125 months in era-1 and 53 months in era-2. The median age at diagnosis was 66 years with slight male predominance in both the eras. There were no differences in age, gender, race/ethnicity and stage characteristics. There was a slight decline in incidence of DLBCL (era-1 vs. era-2), 8.11 (95% CI=8.01-8.2) vs. 7.82 (95% CI=7.73-7.91) cases per 100,000 persons (P Conclusions There has been limited improvement in the survival of adult patients with DLBCL beyond the introduction of rituximab, highlighting the need for experimental therapies and calling for the incorporation of novel therapies earlier in treatment, especially for high-risk cases. Disclosures Costa: Sanofi: Honoraria; Celgene: Honoraria, Research Funding; Karyopharm: Research Funding; Janssen: Research Funding; Amgen: Honoraria, Research Funding; BMS: Research Funding; Abbvie: Research Funding.

Introduction: The association between classical Hodgkin's Lymphoma (cHL) and tumor Epstein-Barr virus (EBV) status is well established. However, the presence of EBV within Hodgkin/Reed-Sternberg (HRS) cells and its prognosis remains controversial, with conflicting findings from studies of various regions of the world. It is considered essential to deepen the understanding of the pathogenic role of EBV in cHL and its impact in prognosis. Methods: We assessed the correlation between EBV presence in HRS and outcomes in a cohort of Brazilian patients with cHL. EBV positivity was determined by in situ hybridization (ISH) for EBV-encoded RNA (EBER) and immunohistochemistry (IMH) for viral latent membrane protein (LMP-1). All cases were histologically confirmed by an expert hematopathologist who also performed the assays for EBV identification. We examined the prognostic impact of EBV status in 29 patients with cHL. The prognostic factors by IPS (International Prognostic Score) for patients with advanced stage and the risk factors by GHSG (German Hodgkin Study Group) for patients with limited stage were correlated with EBV status tumor cells. For associations between the presence of EBV and other categorical variables, we applied Chi-square or Fisher's exact tests. For describe the effect size (ES) measures for chi-square, we used Cramér's V (V) and odds ratios (OR) with the respective 95% Confidence Intervals (CIs). To evaluate the correlation between all methods of identification of EBV status and among evaluators in histological classification, we applied the Kappa test (K), which measures the degree of agreement these assessments. Differences in OS (overall survival) and EFS (event-free survival) Kaplan-Meier survival curves between EBV-positive and EBV-negative patients were compared statistically using the log-rank test. To evaluate the impact of EBV status on event-free survival controlling for prognostic factors and unfavorable risks, we applied Cox proportional hazards regression to determine hazards ratios (HR) and associated the respective 95% CIs. Multivariate analyses included variables significant at p ≤ 0.15 in univariate models. Results: The mean age at diagnosis was 33 years. Sixty-five percent of the patients had the Nodular Sclerosis histologic subtype and 62,1% had Ann Arbor stage I or II disease at diagnosis. According to GHSG, 88,3% of early-stage patients were classified with unfavorable risk (at least one risk factor) at diagnosis. Compared to advanced-stage patients, 81,9% were considered with favorable IPS (< 4 prognostic factors) at diagnosis. HRS cells were EBV-positive in 37.9% of cases. EBV-positive cHL cases were more frequent in patients ≥ 45 years (71,4% vs. 27,3%, p =0,07). Mixed cellularity (MC) histology subtype was more common in EBV-related tumor cells (p= 0,02) and its effect-size index was medium. The correlation between all methods of identification of EBV status was 96,5% (p< 0,001; K=0.93). The correlation among evaluators in histological classification was 89,6% (p< 0,001; K=0.79). In univariate analysis, age, stage, histologic subtype, nodal involvement, extranodal disease, sex, bulky disease, laboratory data were not associated with adverse EFS (p>0,05). EBV-positive HL seemed to have better EFS than EBV-negative HL (log-rank test, p = 0,07). Cox proportional hazards model confirmed that EBV-positive tumor status and prognosis factors did not impact HL outcome. Conclusions: Despite EBV status in HRS cells not being associated with adverse prognostic factors and not influencing the overall and event-free survivals, the presence of EBV was linked to MC subtype, showing possible implication in histological subtype and worse prognosis. Disclosures Costa: Sanofi: Honoraria, Research Funding.

Introduction: To evaluate a new enhanced IPI proposed by the National Comprehensive Cancer Network (NCCN-IPI) in DLBCL patients, we compared the international prognostic index (IPI), R-IPI and NCCN-IPI in DLBCL patients treated with rituximab, cyclophosphamide, hidroxydaunorubicin, vincristine and prednisone (R-CHOP). Methods: From June 2008 to November 2011 we retrospectively evaluated 146 DLBCL patients treated with R-CHOP-21 referred for cancer treatment in a single university institution in Brazil. Patient's clinical data were assessed to calculate the IPI, R-IPI and NCCN-IPI. Results: Patient's median age was 58.9 years (range 16 – 86); 85 (57.8%) were female. According to IPI, risk categories were low (n=41, 28.1%), low-intermediate (n=43, 29.5%), high-intermediate (n=37, 25.3%) and high (n=25, 17.1%). Using R-IPI, risk categories were very good (n=19, 13%), good (n=65, 44.5%) and poor (n=62, 42.5%). According to NCCN-IPI, risk categories were low (n=12, 8.2%), low-intermediate (n=52, 35.6%), high-intermediate (n=62, 42.5%) and high (n=20, 13.7%). At 30 months (median follow up 17.7 months - range 0.6-58.2 months) the overall survival (OS) was 75.5%. The progression-free survival (PFS) at a median follow-up of 16.3 months (range 0.6-52.4) was 68.3% for all patients. Using IPI, the OS at 30 months did not differ between low and low-intermediate risk patients (96.8% vs. 82.2%; p=0.136); however, it was higher than the OS of high-intermediate risk (n=37; 96.8% vs 74.1% p=0.11) and high-risk (n=25; 96.8% vs 41% p < 0.001) patients (Figure 1). The NCCN-IPI demonstrated significant differences in OS (p < 0,001) and PFS (p Figure 1: OS and PFS according to International Prognostic Index (IPI) Figure 1:. OS and PFS according to International Prognostic Index (IPI) Figure 2: OS and PFS according to NCCN-IPI Figure 2:. OS and PFS according to NCCN-IPI Figure 3 Figure 3. Conclusion: In our study the NCCN-IPI, but not the IPI or R-IPI was able to discriminate a high-risk group of DLBCL patients treated with R-CHOP with worse OS. Disclosures No relevant conflicts of interest to declare.

Background: Diffuse large B-cell lymphoma (DLBCL) is the most common subtype of non-Hodgkin lymphoma (NHL) in our institution (49.5%). The World Health Organization (WHO) classification recognizes several subtypes of DLBCL based on morphology, immunohistochemistry (IHC) and molecular analysis. A half of patients remain incurable with standard strategy with anti-CD20 monoclonal antibody (rituximab) and anthracycline-based chemotherapy. Therefore, it is necessary to identify high risk patients to try to improve their prognosis. In the pre-rituximab era, the best way to identify this high-risk group was based on International Prognostic Index (IPI) and more recently on molecular aspects that characterizesthe gene signature of the malignant cell. Patients with gene expression profile similarto normal cells from germinal center (GC) showed better prognosis than those with B-cells activated signature. Correspondentsalgorithms based in IHC were also proposed and that proposed by Hans is the most commonly used.However, these prognostic indicators have been questioned in the rituximab era. On the other hand, currently,the positron emission tomography with 18 F-fluodeoxyglucose (PET 18 F-FDG) has been recommended at diagnosis and at the endof treatment to improve accuracy of staging and response evaluation. Even though some studies have shown improvement on survival in patients with negative PET after 2-3 cycles of R-CHOP it impact as a prognostic factor in DLBCL remains controversial. Objective: This study was proposed to investigate the association between interim PET (iPET) and cellular origin of DLBCL using Hans' algorithm as prognosis in patients treated with R-CHOP. Methods: Were analyzed prospectively 146 DLBCL patients treated with R-CHOP 21.The 18 F-FDG PET was performed after 2 cycles of R-CHOP and at the end of treatment in 105 patients. DLBCL was classified asGC and NGC subtype by IHC using Hans's algorithm . Results: The median age of GC-DLBCL (52.7 years) was lower than NGC-DLBCL (59.4 years) (p=0.021) and in patients with negative iPET (52.7 years) versus positive iPET (59.4 years) (p=0.031). Bulky disease was more common in GC-DLBCL (p=0.008). The overall survival (OS) at 30 months for GC-DLBCL was 100% for patients with negative iPET and 70,4% for patients with positive iPET (p=0.063) (Figure 1). Progression-free survival (PFS) at 30 months was 100% for GC-DLBCL and iPET negative and 64,3% for GC-DLBCLand iPET positive (p=0.02) (Figure 2). Conclusion: We concluded that iPET and cell origin determination by Hans's immunohistochemical algorithm was able to identify a subgroup of very good prognosis showing GC origin and negative iPET. However, our results should be confirmed in others studies. Figure 1: Analysis of overall survival in patients with GC-DLBCL according to positivity of iPET. Figure 1:. Analysis of overall survival in patients with GC-DLBCL according to positivity of iPET. Figure 2: Analysis of progression-free survival in patients with GC-DLBCL according to positivity of iPET. Figure 2:. Analysis of progression-free survival in patients with GC-DLBCL according to positivity of iPET. Disclosures No relevant conflicts of interest to declare.

Abstract 5096 Background Deferasirox is a once-daily oral iron chelator with established dose-dependent efficacy for treating transfusional iron overload. The retrospective multicenter Brazilian trial included patients (pts) from 14 sites of 10 states with a variety of transfusion-dependent anemias and was designed to evaluate the efficacy and safety of fixed starting doses of deferasirox based on transfusion history, with subsequent dose titration based on serum ferritin (SF) trends. Data were available from 105 eligible pts at 6 months of treatment and 73 pts from 1-year follow-up period. Methods Pts (aged ≥ 2 yrs) had transfusion-dependent anemia with a history of multiple transfusions (>20 transfusions) and/or SF levels ≥ 1000 ng/mL and serum creatinine level < the upper limit of normal (ULN). Deferasirox starting dose was 10-30mg/kg/day depending on transfusion requirements and subsequent dose adjustments of 5-10 mg/Kg/day (range 0–35 mg/kg/d) were done every 3 months based on changes in SF and safety parameters. Efficacy was assessed monthly by measuring change from baseline in SF levels. Safety was evaluated on a monthly basis according to the incidence and type of adverse events and measurement of laboratory parameters, including serum creatinine and liver enzyme levels. Results 105 pts (40 M, 65 F; mean age 25.0±16.6 yrs) were enrolled; 46% (n=48) aged 40 units of red blood cell (RBC); 71.5% (n=75) were on regular RBC transfusion, 56% of the pts required < 2 RBC units/month and 44% between 2 and 4 RBC units/month. Only 63% (n=66) had received prior chelation therapy: deferoxamine (DFO; 51.4%) or DFO/deferiprone combination (11.4%). Sixty-four (61%) pts started on 20 mg/kg/d and 41(39%) > 20-30 mg/kg/d, 15.2% of pts had dose increases at a median of 24 weeks after treatment initiation. Mean ± SD SF levels (μg/L) did significantly reduce at 6 months and 12 months compared to baseline (BL) [from 3132.14 ± 2237.47 to 2784.25 ± 1969.7 at 6 months (p=0.0001) and 2327.46 ± 1873.8 at 12 months (p=0.005)]. The proportion of patients with SF levels < 2000, 2000-3000 and > 3000 μg/L from BL to 6 and 12 months by percentage of patients changed from 36% to 47.5% and 52%; from 26% to 26.5% and 24.5%; from 38% to 26% and 23%, respectively. No patient discontinued the treatment. No death was reported by the investigators during the study. The most common drug-related (investigator-assessed) AEs were mild, transient diarrhea (n=15; 14.3%), rash (n=5; 4.7%), nausea (n=9; 8.5%) and headache (n=6; 5.7%). Seven pts (6.6%) had serum creatinine value >33% above BL on two consecutive visits, 3 (2.8%) of whom had creatinine increases above the ULN; there were no progressive increases or renal failure. Eleven (10.5%) pts had an increase in alanine aminotransferase < 5x ULN but no one experience increases ≥ 5x ULN; levels were already elevated in all of them. Conclusions This first multicenter Brazilian study confirms deferasirox efficacy in achieving a reduction of iron load across a wide range of pts with transfusion-related iron overload. It also supports the clinical approach to fixed starting dose of deferasirox based on iron intake from ongoing blood transfusions and current iron burden with subsequent individual dose titration every 3 months according to SF trends and safety markers. Deferasirox was generally well tolerated in pediatric and adult pts with a safety profile consistent with data from previous clinical trials. The availability of deferasirox as a once-daily oral iron chelator would potentially facilitate improved compliance, and thereby reduce morbidity and mortality from iron overload. Disclosures No relevant conflicts of interest to declare.