Associação Brasileira de Hematologia, Hemoterapia e Terapia Celular Consensus on genetically modified cells. III: anti-CD19 CAR-T cell therapy for patients with non-Hodgkin lymphoma.

The treatment and evolution of B-cell non-Hodgkin lymphoma (B-NHL) has undergone important changes in the last years with the emergence of targeted therapies, such as monoclonal antibodies, small molecules, antibody-drug conjugates, and bispecific antibodies. Nevertheless, a significant portion of patients remains refractory or relapsed (R/R) to the new therapeutic modalities, representing thus an unmet medical need. The use of CAR-T cells for the treatment of B-NHL patients has shown to be a promising therapy with impressive results in patients with R/R disease. The expectations are as high as the imminent approval of CAR-T cell therapy in Brazil, which it is expected to impact the prognosis of R/R B-NHL. The aim of this manuscript is to offer a consensus of specialists in the field of onco-hematology and cellular therapy, working in Brazil and United States, in order to discuss and offer recommendations in the present setting of the use of CAR-T cells for patients with B-NHL.

Brazilian Nutritional Consensus in Hematopoietic Stem Cell Transplantation: Adults.

The nutritional status of patients submitted to hematopoietic stem cell transplant is considered an independent risk factor, which may influence on quality of life and tolerance to the proposed treatment. The impairment of nutritional status during hematopoietic stem cell transplant occurs mainly due to the adverse effects resulting from conditioning to which the patient is subjected. Therefore, adequate nutritional evaluation and follow-up during hematopoietic stem cell transplant are essential. To emphasize the importance of nutritional status and body composition during treatment, as well as the main characteristics related to the nutritional assessment of the patient, the Brazilian Consensus on Nutrition in Hematopoietic Stem Cell Transplant: Adults was prepared, aiming to standardize and update Nutritional Therapy in this area. Dietitians, nutrition physicians and hematologists from 15 Brazilian centers thar are references in hematopoietic stem cell transplant took part.

Brazilian Nutritional Consensus in Hematopoietic Stem Cell Transplantation: Adults / Consenso Brasileiro de Nutrição em Transplante de Células-Tronco Hematopoiéticas: Adultos

ABSTRACT The nutritional status of patients submitted to hematopoietic stem cell transplant is considered an independent risk factor, which may influence on quality of life and tolerance to the proposed treatment. The impairment of nutritional status during hematopoietic stem cell transplant occurs mainly due to the adverse effects resulting from conditioning to which the patient is subjected. Therefore, adequate nutritional evaluation and follow-up during hematopoietic stem cell transplant are essential. To emphasize the importance of nutritional status and body composition during treatment, as well as the main characteristics related to the nutritional assessment of the patient, the Brazilian Consensus on Nutrition in Hematopoietic Stem Cell Transplant: Adults was prepared, aiming to standardize and update Nutritional Therapy in this area. Dietitians, nutrition physicians and hematologists from 15 Brazilian centers thar are references in hematopoietic stem cell transplant took part.

RESUMO O estado nutricional do paciente submetido ao transplante de células-tronco hematopoéticas é considerado fator de risco independente, podendo influenciar na qualidade de vida e na tolerância ao tratamento proposto. O comprometimento do estado nutricional durante o transplante de células-tronco hematopoéticas ocorre principalmente devido aos efeitos adversos decorrentes do condicionamento ao qual o paciente é submetido. Desta forma, a adequada avaliação nutricional e o acompanhamento durante o transplante de células-tronco hematopoéticas tornam-se imprescindíveis. Com o objetivo de salientar a importância do estado nutricional e da composição corporal durante o tratamento, bem como as principais características relacionadas à avaliação nutricional do paciente, o Consenso Brasileiro de Nutrição em Transplante de Células-Tronco Hematopoiéticas: Adulto foi elaborado visando uniformizar e atualizar a Terapia Nutricional nesta área. Com a participação de nutricionistas, nutrólogos e hematologistas de 15 centros brasileiros referências em transplante de células-tronco hematopoéticas

Translation, Cross-Cultural Adaptation, and Validation of the Lee Chronic Graft-versus-Host Disease Symptom Scale in a Brazilian Population.

The Lee Chronic Graft-versus-Host Disease (GVHD) Symptom Scale is a patient-reported instrument developed and validated in English to measure the symptoms and functional impact of cGVHD. This tool has not yet been validated in a Latin American population, however. The Brazil-Seattle Chronic GVHD Consortium conducted a multicenter study at 5 Brazilian institutions to validate the Lee cGVHD Symptom Scale in adults with cGVHD. Study objectives included the translation and validation of the instrument in Brazilian Portuguese and evaluation of the correlation with other quality of life (QoL) tools, including the Medical Outcomes Study Short Form 36 (SF-36) and Functional Assessment of Chronic Illness Therapy with Bone Marrow Transplant subscale (FACT-BMT). Translation and validation were done according to the American Association of Orthopedic Surgeons Outcome Committee guidelines. Spearman's correlation coefficient was used to measure construct validity. Reliability was assessed using Cronbach's α and intraclass correlation coefficients. Between April 2011 and August 2012, 47 patients with cGVHD based on the 2005 National Institutes of Health criteria (29 males [62%], 18 females [38%]; median age, 48 years; range, 23 to 69 years) were enrolled in this study. The reliability of the Lee cGVHD Symptom Scale was adequate (Cronbach's α = 0.62 to 0.83). The correlations between similar domains of the Lee cGVHD Symptom Scale, SF-36, and FACT-BMT were moderate to high. Our data indicate that the Brazilian Portuguese version of the Lee cGVHD Symptom Scale is valid and reliable and can be used in clinical trials of cGVHD in Brazil.

Survival and graft-versus-host disease in patients receiving peripheral stem cell compared to bone marrow transplantation from HLA-matched related donor: retrospective analysis of 334 consecutive patients.

OBJECTIVES: The objective of this study was to compare the major transplant outcomes between patients receiving hematopoietic stem cell transplantation (HSCT) from bone marrow (BM) or peripheral blood stem cells (PBSC). METHODS: All consecutive HSCT patients using BM or PBSC from an HLA-matched related donors for haematological malignancies after high intensity conditioning at seven Brazilian transplant centres between January 2008 and December 2009 were retrospectively evaluated. RESULTS: In the study period, 334 patients were treated in the centres and included in the evaluation. The cumulative incidence of grades II-IV and III-IV acute graft-versus-host disease (GVHD) at one year was 36.7% and 9.7% for BM recipients and 34.4% and 15.1% for PBSC recipients, respectively (not statistically different). The cumulative incidence of chronic GVHD at three years was 53.7% and 79.8% (HR 1.93; 95% CI 1.38-2.69, P < 0.001) for BM and PBSC, respectively. Median overall survival was 2.85 and 2.39 years for BM and PBSC recipients, respectively (HR 1.19; 95% CI, 0.84-1.68, P = 0.34). CONCLUSIONS: Our results confirm previous findings of increased chronic GVHD incidence in patients receiving PBSC when compared to patients receiving BM as the graft source in HSCT. Acute GVHD incidence, progression-free survival and overall survival were not different between the groups.

Peripheral blood stem cell yield calculated using preapheresis absolute CD34+ cell count, peripheral blood volume processed, and donor body weight accurately predicts actual yield at multiple centers.

BACKGROUND: Accurate prediction of stem cell yield is important for planning leukapheresis procedures. A formula has been published (Pierelli et al., Vox Sang 2006;91:126-34) to estimate the CD34+ dose collected on the first day of leukapheresis that was based on the preapheresis peripheral blood (PB) CD34+ counts, the blood volume processed, and the donor's weight. The aim of this study was to assess the predictive value of this formula. STUDY DESIGN AND METHODS: Data were retrospectively collected on 1126 consecutive PB stem cell harvests conducted at five institutions. Information on age, sex, diagnosis, weight, preapheresis absolute peripheral CD34+ count, total blood volume processed, and CD34+ cells harvested per kilogram of body weight on the first day of apheresis was collected. RESULTS: Among donors at least 18 years old, Pearson's correlation coefficient (r) between actual yield (AY) and predicted yield (PY) was 0.76. To characterize this correlation, AY and PY were classified as being within the conventionally acceptable CD34+ doses (>2 × 10(6) -5 × 10(6) cells/kg), below this range (≤2 × 10(6) cells/kg), or above it (>5 × 10(6) cells/kg). The positive predictive value (PPV) of PY was estimated considering the distribution of AY as the "gold standard." PPV was relatively high for PY of more than 5 × 10(6) cells/kg (85%), moderate for PY of not more than 2 × 10(6) cells/kg (72%), and low for PY more than 2 × 10(6) to 5 × 10(6) cells/kg (56%). A consistent pattern was observed within institutions. CONCLUSION: The formula of Pierelli et al. is associated with a PPV that is high, moderate, and relatively low for the corresponding predicted CD34+ doses.