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INTRODUCTION: RTXM83, a biosimilar of rituximab, was approved after physicochemical, functional, non-clinical, and clinical studies demonstrated their similarity; these studies included RTXM83-AC-01-11, a multicentric double-blind international prospective pivotal study. Long-term data on biosimilars can potentially elucidate their clinical robustness and facilitate their broader adoption. METHODS: In this retrospective observational study, we analyzed a dataset from a Brazilian cohort previously randomized in the RTXM83-AC-01-11 study followed by the assessment of long-term outcomes in an observational extension phase from randomization in the RTXM83-AC-01-11 study to the last recorded evaluation. Patients with diffuse large B cell lymphoma (DLBCL) received either reference rituximab (R) or RTXM83 plus cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) as adjuvant treatment. RESULTS: The median follow-up period was 77.0 months. Patients with initial DLBCL stages III and IV comprised 50% of the R-CHOP group and 40% of the biosimilar group. Five (18.5%) patients, including two RTXM83-CHOP-treated and three R-CHOP-treated individuals, experienced late adverse events (AEs) of interest. No new safety signs were established. At the final assessment, the progression-free survival (PFS) rates were 93.3% and 50.0% in the RTXM83-CHOP and R-CHOP groups, respectively. Median PFS was not achieved in the RTXM83-CHOP group, which was 40.5 months in the R-CHOP group. The overall survival (OS) rates were 100% and 66.7% in the RTXM83-CHOP and R-CHOP groups, respectively. The median OS was not reached in any group. CONCLUSION: This study demonstrated the long-term safety and effectiveness of RTXM83 in treating DLBCL; outcomes comparable to those of the reference product and potentially improved access to treatment have been indicated. However, further research with more diverse patient groups can validate these findings and advocate the broader adoption of biosimilars in cancer care. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04928573. June 16, 2021, "retrospectively registered".

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The preoperative clinical and laboratory evaluations of the patient is an essential step to ensure the safety and success of any surgical procedure. This assessment aims to identify any underlying medical conditions and risk factors and determine suitability for surgery. With this step, the medical team can adapt the care plan to meet each patient's specific needs, increasing the chances of a successful procedure. Good clinical assessment and comprehensive laboratory testing, when integrated into a Patient Blood Management approach, are invaluable in promoting safety of care, reducing transfusion risks, improving surgical outcomes, and optimizing resource utilization. This approach not only elevates the quality of care, but is also aligned with evidence-based practice and patient-centered principles, making it an essential component of the perioperative process.

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Managing coagulation disorders and potential bleeding risks, especially in the context of anticoagulant medications, is of immense value both clinically and prior to surgery. Coagulation disorders can lead to bleeding complications, affecting patient safety and surgical outcomes. The use of Patient Blood Management protocols offers a comprehensive, evidence-based approach that effectively addresses these challenges. The problem is to find a delicate balance between preventing thromboembolic events (blood clots) and reducing the risk of bleeding. Anticoagulant medications, although crucial to preventing clot formation, can increase the potential for bleeding during surgical procedures. Patient blood management protocols aim to optimize patient outcomes by minimizing blood loss and unnecessary transfusions.

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Managing anemia before surgery is extremely important as it is a clinical condition that can significantly increase surgical risk and affect patient outcomes. Anemia is characterized by a reduction in the number of red blood cells or hemoglobin levels leading to a lower oxygen-carrying capacity of the blood. Proper treatment requires a multifaceted approach to ensure patients are in the best possible condition for surgery and to minimize potential complications. The challenge is recognizing anemia early and implementing a timely intervention to correct it. Anemic patients are more susceptible to surgical complications such as increased infection rates, slower wound healing and increased risk of cardiovascular events during and after surgery. Additionally, anemia can exacerbate existing medical conditions, causing greater strain on organs and organ systems. To correct anemia and optimize patient outcomes, several essential measures must be taken with the most common being identifying and correcting iron deficiency.

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Oral surgical procedures are a great challenge in cancer patients, especially those with pancytopenia, given the risk of both hemorrhage and opportunistic infection. Thus, we report herein a case of a patient with refractory acute myeloid leukemia, severe pancytopenia, and some episodes of febrile neutropenia, who presented asymptomatic, bilateral lesions on the tongue, requiring excisional biopsy. Considering the high risk of bleeding, surgical intervention was proposed with a high-power laser (HPL) at the bedside. There was no considerable bleeding and stitches were not needed. Within 48 h postoperatively, the patient reported neither pain nor further bleeding and her tongue presented normal function. The patient was under a follow-up period of about 8 months, with no lesion relapse. The HPL seems to be of great value for preventing excessive bleeding and late infection in patients with pancytopenia submitted to minor oral surgeries.

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In the COVID-19 scenario, patients undergoing hematopoietic stem cell transplantation (HSCT) infected with SARS-CoV-2 may have an increased risk of death. Through a national multicenter study, we aimed to describe the impact of COVID-19 on the survival of HSCT recipients in Brazil. Eighty-six patients with a confirmed diagnosis of SARS-CoV-2 (92% by RT-PCR) were included. There were 24 children and 62 adults receiving an autologous (n = 25) and allogeneic (n = 61) HSCT for malignant (n = 72) and non-malignant (n = 14) disorders. Twenty-six patients died, (10 on autologous (38%) and 16 patients (62%) on allogeneic group). The estimated overall survival (OS) at day 40 was 69%. Adults had decreased OS compared to children (66% vs 79%, p = 0.03). The severity of symptoms at the time of diagnosis, ECOG score, laboratory tests (C-reactive protein, urea values) were higher in patients who died (p < 0.05). In conclusion, HSCT recipients infected with SARS-CoV-2 have a high mortality rate mainly in adults and patients with critical initial COVID-19 presentation. These findings show the fragility of HSCT recipients with SARS-CoV-2 infection. Therefore, the importance of adherence to preventive measures is evident, in addition to prioritizing the vaccination of family members and the HSCT team.

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Background: Patients with hematological disease are 15 times more likely to develop sepsis than the general population. The patient with hematological disease and, mainly, those undergoing hematopoietic stem cell transplantation (HSCT), develop a severe secondary humoral immunodeficiency, with low serum levels of IgM, which may take more than a year to be restored. Materials and Methods: This is a retrospective, controlled and observational study that analyzed 51 patients with underlying hematological disease, who were diagnosed with sepsis or septic shock during the study period, to evaluate whether IgM-rich Ig replacement decreases the 30-day mortality. Results: Of the 51 patients, 35 patients received IgM-rich immunoglobulin (group A) and 16 (31%) received conventional therapy. Eleven (69%) patients in the control group were alive after 30 days compared to 11 (34%) patients in the intervention group, p= 0.013. Conclusion: There are no apparent benefits in the use of IgM-rich immunoglobulin in septic patients with hematological disease.

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Acute Lymphoblastic Leukemia is a very aggressive malignant disorder of lymphoid cells in adults, with recurrence (30 to 60% of the cases) after the initial treatment. Until this moment, there is no gold standard therapy for the treatment of adult patients with acute relapsed/refractory lymphoblastic leukemia. In this case report, we describe two cases of relapsed leukemia: one of lymphocytic leukemia B and one of trilineage leukemia, which presented a satisfactory response to treatment with Bortezomib associated with Vincristine, Dexamethasone, and Bendamustine.

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Hematopoietic stem cell transplantation (HSCT) has been used to treat many malignant and nonmalignant hematologic conditions; however, the use of HSCT in patients who refuse blood transfusions has rarely been described in the literature, and no data have been published concerning haploidentical HSCT without the use of blood products. The aim of this study is to describe the experience of a Brazilian group in performing 21 HSCTs without the use of blood components in the first 100 days after transplantation, which is the period corresponding to the greatest risk of toxicity for this procedure. We developed 21 HSCTs without transfusion support in 19 patients admitted to 2 Brazilian transplantation centers. The patients were subjected to stem cell mobilization and different conditioning regimens. No mortality related to the procedure occurred among the transplant recipients. The global survival rate after 100 days, which is the period related to the immediate toxicity of HSCT, was 94.7%, and the median duration of follow-up was 980 days, with an overall survival rate of 68.4%. Thus, refusal of blood transfusion is not an absolute contraindication for HSCT. This therapy is feasible in specific situations when the patient clearly expresses a desire to avoid blood transfusions and when favorable clinical conditions are achievable with strict, specialized medical monitoring.

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