Cost of Treating Cutaneous T-Cell Lymphoma in Spain: Analysis of MICADOS Study Data by Disease Stage. / Evaluación de los costes asociados a la enfermedad de pacientes con linfoma cutáneo de células T en España: análisis en función del estadio clínico (estudio MICADOS).

BACKGROUND AND OBJECTIVE: The cost of treating cutaneous T-cell lymphoma (CTCL) in Spain is unknown. With the advent of new treatments, it is more important than ever to gain an accurate picture of the true costs involved. The MICADOS study had 2 primary objectives: 1)to evaluate the impact of CTCL on patient quality of life, and 2)to evaluate the costs associated with the disease. This article reports the results of the cost analysis. METHODS: We estimated the cost of treating CTCL over a period of 1year from the perspective of the Spanish National Health System. Twenty-three dermatologists and hematologists from 15 public hospitals analyzed data for adult patients with mycosis fungoides (MF) or Sézary syndrome (SS). RESULTS: A total of 141 patients (57.4% male) with a mean age of 63.6 years (95%CI: 61.4-65.7 years) were included. The mean direct annual cost of treating CTCL was €34,214 per patient. The corresponding costs by stage were €11,952.47 for stageI disease, €23,506.21 for stageII disease, €38,771.81 for stageIII disease, and €72,748.84 for stageIV disease. The total direct annual cost of treating MF/SS in public hospitals in Spain was estimated at €78,301,171; stageI disease accounted for 81% of all costs, stageII for 7%, and stagesIII andIV for 6% each. CONCLUSIONS: The MICADOS study offers an accurate picture of the direct cost of treating CTCL in patients with MF/SS in Spain and shows that costs vary significantly according to disease stage. Patient-borne and indirect costs should be analyzed in future studies.

[Translated article] Cost of Treating Cutaneous T-Cell Lymphoma in Spain: Analysis of MICADOS Study Data by Disease Stage.

BACKGROUND AND OBJECTIVE: The cost of treating cutaneous T-cell lymphoma (CTCL) in Spain is unknown. With the advent of new treatments, it is more important than ever to gain an accurate picture of the true costs involved. The MICADOS study had 2 primary objectives: 1)to evaluate the impact of CTCL on patient quality of life, and 2)to evaluate the costs associated with the disease. This article reports the results of the cost analysis. METHODS: We estimated the cost of treating CTCL over a period of 1year from the perspective of the Spanish National Health System. Twenty-three dermatologists and hematologists from 15 public hospitals analyzed data for adult patients with mycosis fungoides (MF) or Sézary syndrome (SS). RESULTS: A total of 141 patients (57.4% male) with a mean age of 63.6 years (95%CI: 61.4-65.7 years) were included. The mean direct annual cost of treating CTCL was €34,214 per patient. The corresponding costs by stage were €11,952.47 for stageI disease, €23,506.21 for stageII disease, €38,771.81 for stageIII disease, and €72,748.84 for stageIV disease. The total direct annual cost of treating MF/SS in public hospitals in Spain was estimated at €78,301,171; stageI disease accounted for 81% of all costs, stageII for 7%, and stagesIII andIV for 6% each. CONCLUSIONS: The MICADOS study offers an accurate picture of the direct cost of treating CTCL in patients with MF/SS in Spain and shows that costs vary significantly according to disease stage. Patient-borne and indirect costs should be analyzed in future studies.

Autologous stem cell transplantation (ASCT) in patients with mantle cell lymphoma: a retrospective study of the Spanish lymphoma group (GELTAMO).

Guidelines recommend autologous stem cell transplantation (ASCT) consolidation in first complete or partial response after regimens including rituximab (R) and high-dose AraC (HDAC), but its use beyond that response is questioned. We present a retrospective analysis of 268 patients with MCL who received ASCT. With a median follow-up for survival patients of 54 months, progression-free survival and overall survival for the whole series were 38 and 74 months, respectively, and for patients transplanted in first CR 49 and 97 months, respectively. Patients without CR before transplant were analyzed separately, those who achieved CR after transplantation had better PFS (48 vs 0.03 months, p < 0.001) and OS (92 vs 16 months, p < 0.001) than the remaining. In univariate analysis, first CR at transplant (p = 0.01) and prior rituximab (p = 0.02) were the variables associated with PFS. For OS, the same variables resulted significant (p = 0.03 and p < 0.001, respectively). In multivariate analysis, only the status at transplant (first CR) remained significant. This retrospective study concludes that ASCT consolidation in first CR induces high survival rates. In other stages of disease, the need of ASCT as consolidation may be questioned.

[Efficacy of parenteral glutamine in patients undergoing bone marrow transplantation]. / Eficacia de la glutamina parenteral en pacientes sometidos a trasplante autólogo de médula ósea.

INTRODUCTION: Autologous bone marrow transplant (ABMT) represents a high metabolic stress. Glutamine has proven to be effective in severe catabolic states, although there are controversial studies. OBJECTIVES: To assess the effect of parenteral nutrition (PN) therapy supplemented with glutamine on the occurrence of mucositis and mean hospital stay in patients submitted to ABMT. METHODS: Retrospective study of patients submitted to ABMT between 2006 and 2009. In 2008, one vial of L-alanyl-L-glutamine (20 g) was added by protocol to the PN formulations of these patients. Thirteen clinical charts since that date (glutamine group) and 13 previous charts (control group) were randomly selected (n = 26). We compared the degree of mucositis and hospital stay in both groups. In the subgroup of glutamine-treated patients, we compare the glutamine dose in the patients developing some degree of mucositis with that of those not having this complication. RESULTS: Mean hospital stay: 27.8 ± 7.4 days (control group) vs. 20.3 ± 5.3 days (glutamine group) (p = 0.01). The severity of mucositis was lower in the glutaminetreated group (p = 0.02). The weight-adjusted dose of L-alanyl-L-glutamine in the patients not developing mucositis was higher than in the other ones (0.32 vs. 0.24 g/kg/day; p = 0.02). CONCLUSIONS: Glutamine supplementation reduces the degree of mucositis and hospital stay in patients submitted to autologous bone marrow transplantation. The degree of mucositis is lower in the subgroup of patients receiving higher doses of glutamine.

Eficacia de la glutamina parenteral en pacientes sometidos a trasplante autólogo de médula ósea / Efficacy of parenteral glutamine in patients undergoing bone marrow transplantation

Introducción: El Trasplante Autólogo de Médula Ósea(TASPE) conlleva un alto estrés metabólico. La glutamina es considerada se ha mostrado eficaz en estados catabólicos severos, aunque hay estudios contradictorios. Objetivos: Valorar el efecto del tratamiento con nutrición parenteral (NP) suplementada con glutamina en el desarrollo de mucositis y en la estancia media hospitalaria en pacientes sometidos a TASPE. Metodología: Estudio retrospectivo de pacientes con TASPE efectuados entre 2006 y 2009. En 2008 se introdujo de forma protocolizada la adición de 1 vial de L-alanil-L-glutamina (20 g) en las fórmulas de NP de dichos pacientes. Se seleccionaron aleatoriamente 13 historias apartir de dicha fecha (grupo glutamina) y 13 historias anteriores (grupo control) (n = 26). Se comparó el grado de mucositis y la estancia hospitalaria en los dos grupos. En el subgrupo de pacientes tratados con glutamina, se comparó la dosis de glutamina que recibieron los pacientes que desarrollaron algún grado mucositis con aquellos que no presentaron dicha complicación. Resultados: Estancia media: 27,8 ± 7,4 días (grupo control) vs 20,3 ± 5,3 días (grupo glutamina) (p = 0,01). La gravedad de la mucositis fue menor en el grupo glutamina (p = 0,02). La dosis de L-alanail-L-glutamina ajustada por peso en los pacientes que no desarrollaron mucositis fue mayor que en los que la desarrollaron (0,32 vs 0,24g/kg/día; p = 0,02).Conclusiones: La suplementación con glutamina reduce el grado de mucositis y la estancia hospitalaria en pacientes sometidos a transplante autólogo de médula ósea. El grado de mucositis es menor en el subgrupo de pacientes que reciben dosis más elevadas de glutamina (AU)

Introduction: Autologous bone marrow transplant(ABMT) represents a high metabolic stress. Glutamine has proven to be effective in severe catabolic states, although there are controversial studies. Objectives: To assess the effect of parenteral nutrition(PN) therapy supplemented with glutamine on the occurrence of mucositis and mean hospital stay in patients submitted to ABMT. Methods: Retrospective study of patients submitted to ABMT between 2006 and 2009. In 2008, one vial of Lalanyl-L-glutamine (20 g) was added by protocol to the PN formulations of these patients. Thirteen clinical charts since that date (glutamine group) and 13 previous charts (control group) were randomly selected (n = 26).We compared the degree of mucositis and hospital stay in both groups. In the subgroup of glutamine-treated patients, we compare the glutamine dose in the patients developing some degree of mucositis with that of those not having this complication. Results: Mean hospital stay: 27.8 ± 7.4 days (control group) vs. 20.3 ± 5.3 days (glutamine group) (p = 0.01).The severity of mucositis was lower in the glutamine treated group (p = 0.02). The weight-adjusted dose of Lalanyl-L-glutamine in the patients not developing mucositis was higher than in the other ones (0.32 vs. 0.24g/kg/day; p = 0.02). Conclusions: Glutamine supplementation reduces the degree of mucositis and hospital stay in patients submitted to autologous bone marrow transplantation. The degree of mucositis is lower in the subgroup of patients receiving higher doses of glutamine (AU)

Hematopoietic cell transplantation using plasma and DMSO without HES, with non-programmed freezing by immersion in a methanol bath: results in 213 cases.

A simplified cryopreservation method for bone marrow (BM) and peripheral blood progenitor cells (PBPC) was utilized in hematopoietic cell transplantation of 213 patients with hematological or solid neoplasms after ablative chemotherapy (187 with peripheral blood progenitor cells and 26 with bone marrow). Cells were cryopreserved, after addition of autologous fresh plasma with DMSO, without HES, by freezing to -80 degrees C in a methanol bath and non-programmed freezer. For the patients autotransplanted with PBPC, the median period necessary for recovery of more than 0.5 x 10(9)/l granulocytes was 11 days (range 6-44), and 15 (8-204) days were required to obtain more than 20 x 10(9)/l platelets. For the patients autotransplanted with BM, the median period necessary to recover >0.5 x 10(9)/l granulocytes was 12 days (range 9-33), and 24 (12-57) days to obtain more than 20 x 10(9)/l platelets. These results support this method as being very effective in achieving high-quality cryopreservation. The procedure, which uses a non-programmed freezer, simplifies and reduces enormously the cost of the technical measures currently in use, enabling its adoption in almost any clinical oncological institution.

Single-centre experience of peripheral blood stem cell transplantation using cryopreservation by immersion in a methanol bath.

A simplified method to remove and cryopreserve peripheral blood stem cells (PBSC) was utilised to restore the bone marrow in 31 patients with haematological or solid neoplasms after ablative chemotherapy. Mobilization was performed with subcutaneous G-CSF, starting 4 days before the first PBSC harvest and continuing to the last day of harvest. Cryopreservation was carried out by freezing cells to -80 degrees C after addition of autologous fresh plasma with DMSO, in a methanol bath and non-programmed freezer. The PBSC were reinfused in all cases. The mean quantity of CD34 cell (x 10(6)/kg) infused was 6.5 +/- 6.7. The mean number of procedures needed to harvest an appropriate number of PBSC was 3.6 +/- 1.3. The mean times necessary to recover more than 0.5 x 10(9)/l granulocytes were 11 +/- 4 (8-30) days and 23 +/- 13 (8-55) days to obtain more than 20 x 10(9)/l platelets. These results confirm our method as very effective in achieving a high-quality harvest, and it was used in paediatric and adult patients without problems. This procedure, using a non-programmed freezer, simplifies and reduces enormously the cost of the technical measures currently used, enabling their adoption in almost any clinical oncological institution.

[Severe hemolytic anemia caused by anti-AB in renal transplantation with minor ABO incompatibility]. / Anemia hemolítica grave por anti-AB en trasplante renal con incompatibilidad menor ABO.

A 54 year-old woman subjected to renal transplant with minor ABO incompatibility developed clinically severe anti-AB haemolytic anaemia. On the 13th day after transplantation the patient had: haemoglobin, 7.5 g/dL, unconjugated bilirubin, 393 mumol/L (23 mg/dL), and undetectable haptoglobin levels. Positive direct antihuman globulin test was found, and an IgG antibody capable of binding complement and with anti-AB specificity was found upon studying the eluate. Immunosuppressive therapy improved the clinical picture, although antibodies could still be detected one month later. Clinically significant immune haemolysis after renal transplantation appears in about 10-15% of those cases having antibodies against the host's antigens. The peak red-cell destruction is seen one to two weeks after grafting, and haemolytic signs may last for about three weeks. Although self-limited, this condition may achieve high severity. The duration and severity of haemolysis depend upon the density of antigen sites on the surface of the host's red-cells, his secretor trait, the presence or absence of complement activation and the immunosuppressive therapy including cyclosporin. Several cases of anti-A and anti-B specificity have been reported, but anti-AB specificity had not been previously found; this fact is probably related to the scarce interest paid to its search thus far.