Roxanne Nelson

Post-transplantation cyclophosphamide may help decrease the rate of nonrelapse mortality and graft-versus-host disease (GVHD) in patients who have undergone allogeneic blood or marrow transplantation, according to new findings published in Biology of Blood and Marrow Transplantation.

Even though it is a potentially curative option for patients with poor-risk hematologic malignancies, allogeneic blood or marrow transplantation (alloBMT) has not been commonly used in multiple myeloma because of its association with high nonrelapse mortality and high relapse rates. However, the use of post-transplantation cyclophosphamide (PTCy) in this study led to low rates of both acute and chronic GVHD, which translated to low rates of nonrelapse mortality and maintenance of long-term remissions in a subset of patients with multiple myeloma treated at Johns Hopkins Hospital, Baltimore.

“The favorable toxicity profile of alloBMT using PTCy in patients with MM offers the potential to further explore the use of post-transplantation strategies to improve disease control,” wrote Nilanjan Ghosh, MD, of the Levine Cancer Institute, Charlotte, N.C., and his colleagues.

The researchers examined outcomes of 39 patients with multiple myeloma who underwent bone marrow or peripheral blood alloBMT from HLA-matched related/unrelated or haploidentical related donors after either myeloablative or nonmyeloablative conditioning.

Patients who underwent myeloablative conditioning received PTCy 50 mg/kg per day (given intravenously on days 3 and 4 after alloBMT) as GVHD prophylaxis, while those who received nonmyeloablative conditioning received PTCy (same dose and schedule) and additional immunosuppression with mycophenolate mofetil 15 mg/kg (orally two to three times daily, up to 1,000 mg/dose on days 4-35 after transplantation).

At a median follow-up of 10.3 years following alloBMT, 23% of the cohort remained alive and without any evidence of disease. The median overall survival was 4.4 years. The 5-year survival probability was 49% (95% confidence interval, 32%-67%) and 10-year survival probability was 43% (95% CI, 29%-62%).

Following transplantation, 10 (26%) patients achieved a complete response, 8 (21%) had a very good partial response, 6 (15%) had a partial response, and 15 (38%) had progressive disease, the investigators reported (Biol Blood Marrow Transplant. 2017 Nov;23[11]:1903-9).

Among the 36 patients with evidence of donor engraftment, the cumulative incidences of grade 2-4 and grade 3 and 4 acute GVHD were 0.41 (95% CI, 0.25-0.57) and 0.08 (95% CI, 0.01-0.16), respectively. For chronic GVHD, the cumulative incidence was 0.13 (95% CI, 0.02-0.23), and the median time to development was 109 days after alloBMT.

The median progression-free survival was 12 months (95% CI, 7.6-40), and the estimated cumulative incidence of relapse was 0.46 (95% CI, 0.3-0.62) at 1 year and 0.56 (95% CI, 0.41-0.72) at 2 years.

In univariate analysis, achievement of a complete response following alloBMT correlated with overall survival. Factors such as the intensity of the alloBMT conditioning regimen, stem cell source, age, and disease response before alloBMT did not appear to impact overall survival.

“Given the low incidence of GVHD and [nonrelapse mortality] in our study, it is possible that post-transplantation maintenance therapies can be used to improve diseases control,” Dr. Ghosh and his associates wrote. “Emerging data suggest that many anticancer agents may be more active after alloBMT than before transplantation.”

The study was funded in part by grants from the National Institutes of Health. The researchers reported having no relevant financial disclosures.

Post-transplantation cyclophosphamide may help decrease the rate of nonrelapse mortality and graft-versus-host disease (GVHD) in patients who have undergone allogeneic blood or marrow transplantation, according to new findings published in Biology of Blood and Marrow Transplantation.

Even though it is a potentially curative option for patients with poor-risk hematologic malignancies, allogeneic blood or marrow transplantation (alloBMT) has not been commonly used in multiple myeloma because of its association with high nonrelapse mortality and high relapse rates. However, the use of post-transplantation cyclophosphamide (PTCy) in this study led to low rates of both acute and chronic GVHD, which translated to low rates of nonrelapse mortality and maintenance of long-term remissions in a subset of patients with multiple myeloma treated at Johns Hopkins Hospital, Baltimore.

“The favorable toxicity profile of alloBMT using PTCy in patients with MM offers the potential to further explore the use of post-transplantation strategies to improve disease control,” wrote Nilanjan Ghosh, MD, of the Levine Cancer Institute, Charlotte, N.C., and his colleagues.

The researchers examined outcomes of 39 patients with multiple myeloma who underwent bone marrow or peripheral blood alloBMT from HLA-matched related/unrelated or haploidentical related donors after either myeloablative or nonmyeloablative conditioning.

Patients who underwent myeloablative conditioning received PTCy 50 mg/kg per day (given intravenously on days 3 and 4 after alloBMT) as GVHD prophylaxis, while those who received nonmyeloablative conditioning received PTCy (same dose and schedule) and additional immunosuppression with mycophenolate mofetil 15 mg/kg (orally two to three times daily, up to 1,000 mg/dose on days 4-35 after transplantation).

At a median follow-up of 10.3 years following alloBMT, 23% of the cohort remained alive and without any evidence of disease. The median overall survival was 4.4 years. The 5-year survival probability was 49% (95% confidence interval, 32%-67%) and 10-year survival probability was 43% (95% CI, 29%-62%).

Following transplantation, 10 (26%) patients achieved a complete response, 8 (21%) had a very good partial response, 6 (15%) had a partial response, and 15 (38%) had progressive disease, the investigators reported (Biol Blood Marrow Transplant. 2017 Nov;23[11]:1903-9).

Among the 36 patients with evidence of donor engraftment, the cumulative incidences of grade 2-4 and grade 3 and 4 acute GVHD were 0.41 (95% CI, 0.25-0.57) and 0.08 (95% CI, 0.01-0.16), respectively. For chronic GVHD, the cumulative incidence was 0.13 (95% CI, 0.02-0.23), and the median time to development was 109 days after alloBMT.

The median progression-free survival was 12 months (95% CI, 7.6-40), and the estimated cumulative incidence of relapse was 0.46 (95% CI, 0.3-0.62) at 1 year and 0.56 (95% CI, 0.41-0.72) at 2 years.

In univariate analysis, achievement of a complete response following alloBMT correlated with overall survival. Factors such as the intensity of the alloBMT conditioning regimen, stem cell source, age, and disease response before alloBMT did not appear to impact overall survival.

“Given the low incidence of GVHD and [nonrelapse mortality] in our study, it is possible that post-transplantation maintenance therapies can be used to improve diseases control,” Dr. Ghosh and his associates wrote. “Emerging data suggest that many anticancer agents may be more active after alloBMT than before transplantation.”

The study was funded in part by grants from the National Institutes of Health. The researchers reported having no relevant financial disclosures.

Post-transplantation cyclophosphamide may help decrease the rate of nonrelapse mortality and graft-versus-host disease (GVHD) in patients who have undergone allogeneic blood or marrow transplantation, according to new findings published in Biology of Blood and Marrow Transplantation.

Even though it is a potentially curative option for patients with poor-risk hematologic malignancies, allogeneic blood or marrow transplantation (alloBMT) has not been commonly used in multiple myeloma because of its association with high nonrelapse mortality and high relapse rates. However, the use of post-transplantation cyclophosphamide (PTCy) in this study led to low rates of both acute and chronic GVHD, which translated to low rates of nonrelapse mortality and maintenance of long-term remissions in a subset of patients with multiple myeloma treated at Johns Hopkins Hospital, Baltimore.

“The favorable toxicity profile of alloBMT using PTCy in patients with MM offers the potential to further explore the use of post-transplantation strategies to improve disease control,” wrote Nilanjan Ghosh, MD, of the Levine Cancer Institute, Charlotte, N.C., and his colleagues.

The researchers examined outcomes of 39 patients with multiple myeloma who underwent bone marrow or peripheral blood alloBMT from HLA-matched related/unrelated or haploidentical related donors after either myeloablative or nonmyeloablative conditioning.

Patients who underwent myeloablative conditioning received PTCy 50 mg/kg per day (given intravenously on days 3 and 4 after alloBMT) as GVHD prophylaxis, while those who received nonmyeloablative conditioning received PTCy (same dose and schedule) and additional immunosuppression with mycophenolate mofetil 15 mg/kg (orally two to three times daily, up to 1,000 mg/dose on days 4-35 after transplantation).

At a median follow-up of 10.3 years following alloBMT, 23% of the cohort remained alive and without any evidence of disease. The median overall survival was 4.4 years. The 5-year survival probability was 49% (95% confidence interval, 32%-67%) and 10-year survival probability was 43% (95% CI, 29%-62%).

Following transplantation, 10 (26%) patients achieved a complete response, 8 (21%) had a very good partial response, 6 (15%) had a partial response, and 15 (38%) had progressive disease, the investigators reported (Biol Blood Marrow Transplant. 2017 Nov;23[11]:1903-9).

Among the 36 patients with evidence of donor engraftment, the cumulative incidences of grade 2-4 and grade 3 and 4 acute GVHD were 0.41 (95% CI, 0.25-0.57) and 0.08 (95% CI, 0.01-0.16), respectively. For chronic GVHD, the cumulative incidence was 0.13 (95% CI, 0.02-0.23), and the median time to development was 109 days after alloBMT.

The median progression-free survival was 12 months (95% CI, 7.6-40), and the estimated cumulative incidence of relapse was 0.46 (95% CI, 0.3-0.62) at 1 year and 0.56 (95% CI, 0.41-0.72) at 2 years.

In univariate analysis, achievement of a complete response following alloBMT correlated with overall survival. Factors such as the intensity of the alloBMT conditioning regimen, stem cell source, age, and disease response before alloBMT did not appear to impact overall survival.

“Given the low incidence of GVHD and [nonrelapse mortality] in our study, it is possible that post-transplantation maintenance therapies can be used to improve diseases control,” Dr. Ghosh and his associates wrote. “Emerging data suggest that many anticancer agents may be more active after alloBMT than before transplantation.”

The study was funded in part by grants from the National Institutes of Health. The researchers reported having no relevant financial disclosures.

SAN DIEGO – The method of manufacturing can markedly influence the interaction of products containing red blood cells and lung cells, according to research presented at the annual meeting of the American Association of Blood Banks.

Compared with other RBC products, those derived from apheresis significantly increased pulmonary cell interleukin (IL)–6 and IL-8 production, and this was further exacerbated by cell stretching. Conversely, red cell–filtered products appeared to be the least likely to cause cell injury.

“Several studies have shown that red blood cell transfusion is associated with acute lung injury, and transfusion induces leakage in ICU patients,” said lead study author Mathijs Wirtz, MD, of the Academic Medical Center, Amsterdam.

ICU patients who did not receive any transfusions had significantly lower leakage than those who were transfused. “There also seems to be a synergy between transfusion and mechanical ventilation,” Dr. Wirtz said.

Studies have also shown that there are differences in the prevalence of transfusion-related acute lung injury, when comparing Europe to the United States. Storage and manufacturing methods do differ between Europe and the United States, Dr. Wirtz noted. “This led to our hypothesis that lung injury inflicted by red blood cell transfusion is influenced by manufacturing methods.”

In this study, Dr. Wirtz and his colleagues investigated the response of pulmonary cells to the different methods of manufacturing RBC products. Using type A or B blood obtained from eight donors, a variety of RBC products were manufactured for the study, including whole-blood filtered, red-cell filtered, apheresis derived, and whole-blood derived.

For measuring thrombin generation and analyzing extracellular vesicles (EV), supernatants were prepared after 4-5 days of storage for fresh and 41-42 days for stored. The researchers selected A549 type II alveolar cells to seed onto flexible membranes, which were then incubated with RBC supernatant also stretched 25% using a cell stretcher.

After 24 hours, the production of IL-8 and IL-6 was measured.

Both fresh and stored supernatants that were derived from apheresis significantly increased the production of IL-6 and IL-8 in pulmonary cells, compared with nonincubated controls and most of the other RBC products. The production of IL-6 and IL-8 was exacerbated by cell stretching.

Average IL-6 production in nonstretched cells was 91 pg/mL for fresh and 87 pg/mL for expired (P less than .05 vs. control and other RBC products). For stretched cells, it was 130 pg/mL and 150 pg/mL (P less than .05 vs. control). For controls, mean nonstretched and stretched production was 21 pg/mL and 85 pg/mL.

Mean IL-8 production in nonstretched cells was 2,100 pg/mL for fresh and 1,900 pg/mL for stored (P less than .05 vs. control and other RBC products). For stretched cells, the means were 4,100 pg/mL for fresh and 5,200 pg/mL for stored (P less than .05 vs. control).

The average nonstretched and stretched control IL-8 production was 1,200 pg/mL for fresh and 4,300 pg/mL for stored.

Products derived from apheresis also demonstrated a significantly higher ability to generate thrombin, compared with other RBC products, and a significantly increased number of RBC-derived EVs, compared with filtered red cell and whole blood–derived products (P less than .05).

However, incubated stretched cells from stored whole blood–filtered products had higher IL-8 production (16,000 pg/mL), compared with other products and stretched controls. The lowest mean levels of IL-6 were observed in supernatants derived from red cell–filtered products (nonstretched fresh and expired, 12 pg/mL and 8 pg/mL; stretched, 40 pg/mL and 36 pg/mL) and they did not appear to activate pulmonary cells. Levels of EVs were also low, compared with other blood products.

“We can conclude that manufacturing methods contribute to the differences in inducing lung injury, and especially the apheresis-derived products, which induced the most consistent injury in our model,” Dr. Wirtz said. “The red cell–filtered products appeared to be the safest.”

Dr. Wirtz had no disclosures.

[email protected]

SAN DIEGO – The method of manufacturing can markedly influence the interaction of products containing red blood cells and lung cells, according to research presented at the annual meeting of the American Association of Blood Banks.

Compared with other RBC products, those derived from apheresis significantly increased pulmonary cell interleukin (IL)–6 and IL-8 production, and this was further exacerbated by cell stretching. Conversely, red cell–filtered products appeared to be the least likely to cause cell injury.

“Several studies have shown that red blood cell transfusion is associated with acute lung injury, and transfusion induces leakage in ICU patients,” said lead study author Mathijs Wirtz, MD, of the Academic Medical Center, Amsterdam.

ICU patients who did not receive any transfusions had significantly lower leakage than those who were transfused. “There also seems to be a synergy between transfusion and mechanical ventilation,” Dr. Wirtz said.

Studies have also shown that there are differences in the prevalence of transfusion-related acute lung injury, when comparing Europe to the United States. Storage and manufacturing methods do differ between Europe and the United States, Dr. Wirtz noted. “This led to our hypothesis that lung injury inflicted by red blood cell transfusion is influenced by manufacturing methods.”

In this study, Dr. Wirtz and his colleagues investigated the response of pulmonary cells to the different methods of manufacturing RBC products. Using type A or B blood obtained from eight donors, a variety of RBC products were manufactured for the study, including whole-blood filtered, red-cell filtered, apheresis derived, and whole-blood derived.

For measuring thrombin generation and analyzing extracellular vesicles (EV), supernatants were prepared after 4-5 days of storage for fresh and 41-42 days for stored. The researchers selected A549 type II alveolar cells to seed onto flexible membranes, which were then incubated with RBC supernatant also stretched 25% using a cell stretcher.

After 24 hours, the production of IL-8 and IL-6 was measured.

Both fresh and stored supernatants that were derived from apheresis significantly increased the production of IL-6 and IL-8 in pulmonary cells, compared with nonincubated controls and most of the other RBC products. The production of IL-6 and IL-8 was exacerbated by cell stretching.

Average IL-6 production in nonstretched cells was 91 pg/mL for fresh and 87 pg/mL for expired (P less than .05 vs. control and other RBC products). For stretched cells, it was 130 pg/mL and 150 pg/mL (P less than .05 vs. control). For controls, mean nonstretched and stretched production was 21 pg/mL and 85 pg/mL.

Mean IL-8 production in nonstretched cells was 2,100 pg/mL for fresh and 1,900 pg/mL for stored (P less than .05 vs. control and other RBC products). For stretched cells, the means were 4,100 pg/mL for fresh and 5,200 pg/mL for stored (P less than .05 vs. control).

The average nonstretched and stretched control IL-8 production was 1,200 pg/mL for fresh and 4,300 pg/mL for stored.

Products derived from apheresis also demonstrated a significantly higher ability to generate thrombin, compared with other RBC products, and a significantly increased number of RBC-derived EVs, compared with filtered red cell and whole blood–derived products (P less than .05).

However, incubated stretched cells from stored whole blood–filtered products had higher IL-8 production (16,000 pg/mL), compared with other products and stretched controls. The lowest mean levels of IL-6 were observed in supernatants derived from red cell–filtered products (nonstretched fresh and expired, 12 pg/mL and 8 pg/mL; stretched, 40 pg/mL and 36 pg/mL) and they did not appear to activate pulmonary cells. Levels of EVs were also low, compared with other blood products.

“We can conclude that manufacturing methods contribute to the differences in inducing lung injury, and especially the apheresis-derived products, which induced the most consistent injury in our model,” Dr. Wirtz said. “The red cell–filtered products appeared to be the safest.”

Dr. Wirtz had no disclosures.

[email protected]

SAN DIEGO – The method of manufacturing can markedly influence the interaction of products containing red blood cells and lung cells, according to research presented at the annual meeting of the American Association of Blood Banks.

Compared with other RBC products, those derived from apheresis significantly increased pulmonary cell interleukin (IL)–6 and IL-8 production, and this was further exacerbated by cell stretching. Conversely, red cell–filtered products appeared to be the least likely to cause cell injury.

“Several studies have shown that red blood cell transfusion is associated with acute lung injury, and transfusion induces leakage in ICU patients,” said lead study author Mathijs Wirtz, MD, of the Academic Medical Center, Amsterdam.

ICU patients who did not receive any transfusions had significantly lower leakage than those who were transfused. “There also seems to be a synergy between transfusion and mechanical ventilation,” Dr. Wirtz said.

Studies have also shown that there are differences in the prevalence of transfusion-related acute lung injury, when comparing Europe to the United States. Storage and manufacturing methods do differ between Europe and the United States, Dr. Wirtz noted. “This led to our hypothesis that lung injury inflicted by red blood cell transfusion is influenced by manufacturing methods.”

In this study, Dr. Wirtz and his colleagues investigated the response of pulmonary cells to the different methods of manufacturing RBC products. Using type A or B blood obtained from eight donors, a variety of RBC products were manufactured for the study, including whole-blood filtered, red-cell filtered, apheresis derived, and whole-blood derived.

For measuring thrombin generation and analyzing extracellular vesicles (EV), supernatants were prepared after 4-5 days of storage for fresh and 41-42 days for stored. The researchers selected A549 type II alveolar cells to seed onto flexible membranes, which were then incubated with RBC supernatant also stretched 25% using a cell stretcher.

After 24 hours, the production of IL-8 and IL-6 was measured.

Both fresh and stored supernatants that were derived from apheresis significantly increased the production of IL-6 and IL-8 in pulmonary cells, compared with nonincubated controls and most of the other RBC products. The production of IL-6 and IL-8 was exacerbated by cell stretching.

Average IL-6 production in nonstretched cells was 91 pg/mL for fresh and 87 pg/mL for expired (P less than .05 vs. control and other RBC products). For stretched cells, it was 130 pg/mL and 150 pg/mL (P less than .05 vs. control). For controls, mean nonstretched and stretched production was 21 pg/mL and 85 pg/mL.

Mean IL-8 production in nonstretched cells was 2,100 pg/mL for fresh and 1,900 pg/mL for stored (P less than .05 vs. control and other RBC products). For stretched cells, the means were 4,100 pg/mL for fresh and 5,200 pg/mL for stored (P less than .05 vs. control).

The average nonstretched and stretched control IL-8 production was 1,200 pg/mL for fresh and 4,300 pg/mL for stored.

Products derived from apheresis also demonstrated a significantly higher ability to generate thrombin, compared with other RBC products, and a significantly increased number of RBC-derived EVs, compared with filtered red cell and whole blood–derived products (P less than .05).

However, incubated stretched cells from stored whole blood–filtered products had higher IL-8 production (16,000 pg/mL), compared with other products and stretched controls. The lowest mean levels of IL-6 were observed in supernatants derived from red cell–filtered products (nonstretched fresh and expired, 12 pg/mL and 8 pg/mL; stretched, 40 pg/mL and 36 pg/mL) and they did not appear to activate pulmonary cells. Levels of EVs were also low, compared with other blood products.

“We can conclude that manufacturing methods contribute to the differences in inducing lung injury, and especially the apheresis-derived products, which induced the most consistent injury in our model,” Dr. Wirtz said. “The red cell–filtered products appeared to be the safest.”

Dr. Wirtz had no disclosures.

[email protected]

Perioperative blood transfusion (PBT) is associated with poorer outcomes among patients who underwent nephrectomy for renal cell carcinoma (RCC), according to a retrospective review of 1,159 patients.

Using multivariate analysis and controlling for potential confounders such as clinical and pathologic features, receipt of PBT was associated with significantly increased risk of tumor recurrence (HR = 2, P = .02, metastatic progression (HR = 2.5, P = .007), and death from RCC (HR = 2.5, P = .02).

Tomasz Gierygowski/Thinkstock

Perioperative blood transfusion (PBT) is associated with poorer outcomes among patients who underwent nephrectomy for renal cell carcinoma (RCC), according to a retrospective review of 1,159 patients.

Using multivariate analysis and controlling for potential confounders such as clinical and pathologic features, receipt of PBT was associated with significantly increased risk of tumor recurrence (HR = 2, P = .02, metastatic progression (HR = 2.5, P = .007), and death from RCC (HR = 2.5, P = .02).

Tomasz Gierygowski/Thinkstock

Perioperative blood transfusion (PBT) is associated with poorer outcomes among patients who underwent nephrectomy for renal cell carcinoma (RCC), according to a retrospective review of 1,159 patients.

Using multivariate analysis and controlling for potential confounders such as clinical and pathologic features, receipt of PBT was associated with significantly increased risk of tumor recurrence (HR = 2, P = .02, metastatic progression (HR = 2.5, P = .007), and death from RCC (HR = 2.5, P = .02).

Tomasz Gierygowski/Thinkstock

Event-free survival at 24 months (EFS24) is predictive of survival in patients with peripheral T-cell lymphomas (PTCLs), according to new findings published in the Journal of Clinical Oncology.

Patients who were event free 2 years after diagnosis had a more favorable outcome, compared with those who relapsed within that time period. Some patients who remained event free for 24 months were potentially cured; conversely, events within 2 years were associated with an early death in almost all of those patients.

“Thus, EFS24 is a dichotomous end point that allows individualized risk prediction in patients with PTCL and can help inform patient counseling, biomarker discovery, clinical trial design, and precision medicine approaches,” wrote Matthew J. Maurer, MS, of the Mayo Clinic, Rochester, MN, and his coauthors (J Clin Oncol. 2017 Oct 26. doi: 10.1200/JCO.2017.73.8195).

PTCL is an uncommon and heterogeneous group of non-Hodgkin lymphomas that carry a very poor prognosis; most systemic cases are treated with anthracycline-based combination chemotherapy. Previous studies have reported that achieving EFS24 is predictive of excellent long-term outcomes, independent of baseline prognostic factors.

In this study Mr. Maurer and his coauthors assessed the association between EFS24 and overall survival in 775 patients with newly systemic PTCL who were diagnosed during 2000-2012 and received treatment with curative intent.

Among the entire cohort, 36% of patients achieved EFS24 while 64% did not, and the median overall survival following progression within that 2-year time period was 4.9 months (95% confidence interval, 3.8-5.9 months). The 5-year overall survival in the group that relapsed was 11%, with a standardized mortality ratio of 46.4 (95% CI, 41.8-51.3).

Conversely, among patients with EFS24, the median overall survival was not reached, and the 5-year overall survival was 78% (95% CI, 73%-84%). In this group, the 5-year risk of subsequent lymphoma relapse was 23%, and survival following a late relapse was generally poor (median of 10.3 months; 95% CI, 5.7-19.1 months). The best outcomes after achieving EFS24 were observed among patients aged 60 years or younger: These patients had a 5-year overall survival of 91%.

“The use of a dichotomous end point that allows individualized risk prediction is particularly important in rare diseases such as PTCL, where limited numbers of patients may make formal surrogate end point analysis difficult,” wrote the authors.

The study was supported by grants from the National Cancer Institute, the Terry Fox Research Institute, and the BC Cancer Foundation. Dr. Maurer reported research funding from Kite Pharma and Celgene, and several of the coauthors reported relationships with industry.

Event-free survival at 24 months (EFS24) is predictive of survival in patients with peripheral T-cell lymphomas (PTCLs), according to new findings published in the Journal of Clinical Oncology.

Patients who were event free 2 years after diagnosis had a more favorable outcome, compared with those who relapsed within that time period. Some patients who remained event free for 24 months were potentially cured; conversely, events within 2 years were associated with an early death in almost all of those patients.

“Thus, EFS24 is a dichotomous end point that allows individualized risk prediction in patients with PTCL and can help inform patient counseling, biomarker discovery, clinical trial design, and precision medicine approaches,” wrote Matthew J. Maurer, MS, of the Mayo Clinic, Rochester, MN, and his coauthors (J Clin Oncol. 2017 Oct 26. doi: 10.1200/JCO.2017.73.8195).

PTCL is an uncommon and heterogeneous group of non-Hodgkin lymphomas that carry a very poor prognosis; most systemic cases are treated with anthracycline-based combination chemotherapy. Previous studies have reported that achieving EFS24 is predictive of excellent long-term outcomes, independent of baseline prognostic factors.

In this study Mr. Maurer and his coauthors assessed the association between EFS24 and overall survival in 775 patients with newly systemic PTCL who were diagnosed during 2000-2012 and received treatment with curative intent.

Among the entire cohort, 36% of patients achieved EFS24 while 64% did not, and the median overall survival following progression within that 2-year time period was 4.9 months (95% confidence interval, 3.8-5.9 months). The 5-year overall survival in the group that relapsed was 11%, with a standardized mortality ratio of 46.4 (95% CI, 41.8-51.3).

Conversely, among patients with EFS24, the median overall survival was not reached, and the 5-year overall survival was 78% (95% CI, 73%-84%). In this group, the 5-year risk of subsequent lymphoma relapse was 23%, and survival following a late relapse was generally poor (median of 10.3 months; 95% CI, 5.7-19.1 months). The best outcomes after achieving EFS24 were observed among patients aged 60 years or younger: These patients had a 5-year overall survival of 91%.

“The use of a dichotomous end point that allows individualized risk prediction is particularly important in rare diseases such as PTCL, where limited numbers of patients may make formal surrogate end point analysis difficult,” wrote the authors.

The study was supported by grants from the National Cancer Institute, the Terry Fox Research Institute, and the BC Cancer Foundation. Dr. Maurer reported research funding from Kite Pharma and Celgene, and several of the coauthors reported relationships with industry.

Event-free survival at 24 months (EFS24) is predictive of survival in patients with peripheral T-cell lymphomas (PTCLs), according to new findings published in the Journal of Clinical Oncology.

Patients who were event free 2 years after diagnosis had a more favorable outcome, compared with those who relapsed within that time period. Some patients who remained event free for 24 months were potentially cured; conversely, events within 2 years were associated with an early death in almost all of those patients.

“Thus, EFS24 is a dichotomous end point that allows individualized risk prediction in patients with PTCL and can help inform patient counseling, biomarker discovery, clinical trial design, and precision medicine approaches,” wrote Matthew J. Maurer, MS, of the Mayo Clinic, Rochester, MN, and his coauthors (J Clin Oncol. 2017 Oct 26. doi: 10.1200/JCO.2017.73.8195).

PTCL is an uncommon and heterogeneous group of non-Hodgkin lymphomas that carry a very poor prognosis; most systemic cases are treated with anthracycline-based combination chemotherapy. Previous studies have reported that achieving EFS24 is predictive of excellent long-term outcomes, independent of baseline prognostic factors.

In this study Mr. Maurer and his coauthors assessed the association between EFS24 and overall survival in 775 patients with newly systemic PTCL who were diagnosed during 2000-2012 and received treatment with curative intent.

Among the entire cohort, 36% of patients achieved EFS24 while 64% did not, and the median overall survival following progression within that 2-year time period was 4.9 months (95% confidence interval, 3.8-5.9 months). The 5-year overall survival in the group that relapsed was 11%, with a standardized mortality ratio of 46.4 (95% CI, 41.8-51.3).

Conversely, among patients with EFS24, the median overall survival was not reached, and the 5-year overall survival was 78% (95% CI, 73%-84%). In this group, the 5-year risk of subsequent lymphoma relapse was 23%, and survival following a late relapse was generally poor (median of 10.3 months; 95% CI, 5.7-19.1 months). The best outcomes after achieving EFS24 were observed among patients aged 60 years or younger: These patients had a 5-year overall survival of 91%.

“The use of a dichotomous end point that allows individualized risk prediction is particularly important in rare diseases such as PTCL, where limited numbers of patients may make formal surrogate end point analysis difficult,” wrote the authors.

The study was supported by grants from the National Cancer Institute, the Terry Fox Research Institute, and the BC Cancer Foundation. Dr. Maurer reported research funding from Kite Pharma and Celgene, and several of the coauthors reported relationships with industry.

SAN DIEGO – Cold stored leukoreduced apheresis platelets in platelet additive solution were effective for controlling bleeding in a small study of patients undergoing complex cardiothoracic surgery, according to findings presented at the annual meeting of the American Association of Blood Banks.

The volume of postoperative bleeding was significantly lower among patients who received cold stored platelets compared with those who received standard room temperature storage platelets. Thromboembolic events did not differ between the two groups, nor did measures of coagulation at varying time points. Platelet counts and blood usage were also similar in the two groups. The study was small, however, and further studies are needed to confirm the findings.

“These patients are undergoing major surgery and are at high risk in every aspect,” said Torunn Oveland Apelseth, MD, PhD, of the Laboratory of Clinical Biochemistry, Haukeland (Norway) University Hospital. “They are at high risk for bleeding, at high risk for thromboembolic events and high blood usage, and there is a need for optimized blood components.”

There has been debate over the use of cold stored platelets, she noted. While storage at 4° C shortens platelet circulation time, some research shows that cold stored platelets have better hemostatic function.

In this study, one patient cohort was transfused with leukoreduced apheresis platelets stored at 4° C in platelet additive solution for up to 7 days under constant agitation, while the other group received platelets stored at standard room temperature. The study endpoints were comparisons between the two groups of postoperative bleeding, total blood usage, and laboratory measures of coagulation and blood cell counts within the first postoperative day. Thromboembolic events in the 28 days after surgery were also evaluated.

The study evaluated 17 patients who received cold stored platelets and 22 who received room temperature storage platelets. Patient demographics for the two groups were similar – as were their international normalized ratios, activated partial thromboplastin times, and fibrinogen levels – before surgery, immediately after heparin reversal, and the morning following the procedure.

Platelet counts and hemoglobin levels also did not significantly differ between groups.

As measured by chest drain output after chest closure, patients who received cold stored platelets had a significantly lower median amount of bleeding in the postoperative period compared with patients given room temperature storage platelets: 576 mL vs. 838 mL. Average chest drain output after chest closure was 594 mL in those who did not receive any transfusions.

Thromboembolic events occurred in 3 patients (18%) who received cold stored platelets and 7 (31%) of those given room temperature storage platelets. The difference was not statistically significant. In addition, blood usage – platelets, red blood cells, and solvent/detergent-treated pooled plasma – was similar for the two cohorts.

“There were also no differences in the number of thromboembolic episodes or length of stay in ICU,” said Dr. Apelseth, who recommended larger studies to explore the use of use of cold stored platelet transfusion in the critical care setting.

SAN DIEGO – Cold stored leukoreduced apheresis platelets in platelet additive solution were effective for controlling bleeding in a small study of patients undergoing complex cardiothoracic surgery, according to findings presented at the annual meeting of the American Association of Blood Banks.

The volume of postoperative bleeding was significantly lower among patients who received cold stored platelets compared with those who received standard room temperature storage platelets. Thromboembolic events did not differ between the two groups, nor did measures of coagulation at varying time points. Platelet counts and blood usage were also similar in the two groups. The study was small, however, and further studies are needed to confirm the findings.

“These patients are undergoing major surgery and are at high risk in every aspect,” said Torunn Oveland Apelseth, MD, PhD, of the Laboratory of Clinical Biochemistry, Haukeland (Norway) University Hospital. “They are at high risk for bleeding, at high risk for thromboembolic events and high blood usage, and there is a need for optimized blood components.”

There has been debate over the use of cold stored platelets, she noted. While storage at 4° C shortens platelet circulation time, some research shows that cold stored platelets have better hemostatic function.

In this study, one patient cohort was transfused with leukoreduced apheresis platelets stored at 4° C in platelet additive solution for up to 7 days under constant agitation, while the other group received platelets stored at standard room temperature. The study endpoints were comparisons between the two groups of postoperative bleeding, total blood usage, and laboratory measures of coagulation and blood cell counts within the first postoperative day. Thromboembolic events in the 28 days after surgery were also evaluated.

The study evaluated 17 patients who received cold stored platelets and 22 who received room temperature storage platelets. Patient demographics for the two groups were similar – as were their international normalized ratios, activated partial thromboplastin times, and fibrinogen levels – before surgery, immediately after heparin reversal, and the morning following the procedure.

Platelet counts and hemoglobin levels also did not significantly differ between groups.

As measured by chest drain output after chest closure, patients who received cold stored platelets had a significantly lower median amount of bleeding in the postoperative period compared with patients given room temperature storage platelets: 576 mL vs. 838 mL. Average chest drain output after chest closure was 594 mL in those who did not receive any transfusions.

Thromboembolic events occurred in 3 patients (18%) who received cold stored platelets and 7 (31%) of those given room temperature storage platelets. The difference was not statistically significant. In addition, blood usage – platelets, red blood cells, and solvent/detergent-treated pooled plasma – was similar for the two cohorts.

“There were also no differences in the number of thromboembolic episodes or length of stay in ICU,” said Dr. Apelseth, who recommended larger studies to explore the use of use of cold stored platelet transfusion in the critical care setting.

SAN DIEGO – Cold stored leukoreduced apheresis platelets in platelet additive solution were effective for controlling bleeding in a small study of patients undergoing complex cardiothoracic surgery, according to findings presented at the annual meeting of the American Association of Blood Banks.

The volume of postoperative bleeding was significantly lower among patients who received cold stored platelets compared with those who received standard room temperature storage platelets. Thromboembolic events did not differ between the two groups, nor did measures of coagulation at varying time points. Platelet counts and blood usage were also similar in the two groups. The study was small, however, and further studies are needed to confirm the findings.

“These patients are undergoing major surgery and are at high risk in every aspect,” said Torunn Oveland Apelseth, MD, PhD, of the Laboratory of Clinical Biochemistry, Haukeland (Norway) University Hospital. “They are at high risk for bleeding, at high risk for thromboembolic events and high blood usage, and there is a need for optimized blood components.”

There has been debate over the use of cold stored platelets, she noted. While storage at 4° C shortens platelet circulation time, some research shows that cold stored platelets have better hemostatic function.

In this study, one patient cohort was transfused with leukoreduced apheresis platelets stored at 4° C in platelet additive solution for up to 7 days under constant agitation, while the other group received platelets stored at standard room temperature. The study endpoints were comparisons between the two groups of postoperative bleeding, total blood usage, and laboratory measures of coagulation and blood cell counts within the first postoperative day. Thromboembolic events in the 28 days after surgery were also evaluated.

The study evaluated 17 patients who received cold stored platelets and 22 who received room temperature storage platelets. Patient demographics for the two groups were similar – as were their international normalized ratios, activated partial thromboplastin times, and fibrinogen levels – before surgery, immediately after heparin reversal, and the morning following the procedure.

Platelet counts and hemoglobin levels also did not significantly differ between groups.

As measured by chest drain output after chest closure, patients who received cold stored platelets had a significantly lower median amount of bleeding in the postoperative period compared with patients given room temperature storage platelets: 576 mL vs. 838 mL. Average chest drain output after chest closure was 594 mL in those who did not receive any transfusions.

Thromboembolic events occurred in 3 patients (18%) who received cold stored platelets and 7 (31%) of those given room temperature storage platelets. The difference was not statistically significant. In addition, blood usage – platelets, red blood cells, and solvent/detergent-treated pooled plasma – was similar for the two cohorts.

“There were also no differences in the number of thromboembolic episodes or length of stay in ICU,” said Dr. Apelseth, who recommended larger studies to explore the use of use of cold stored platelet transfusion in the critical care setting.

SAN DIEGO – The rate of citrate reactions was nearly 7% in over 80,000 apheresis procedures involving nearly 15,000 donors, and risk increased with the level of citrate exposure, based on data presented from Héma-Québec, Montreal, presented at the annual meeting of the American Association of Blood Banks.

Vasovagal reactions were seen in 2.5% of procedures, and reactions with loss of consciousness occurred in 0.1%, reported Pierre Robillard, MD, of McGill University and Héma-Québec.

The fairly high rates of adverse reactions speak to the importance of taking preventive measures in donors undergoing apheresis, he said. Hypocalcemia and other citrate-induced abnormalities can affect neuromuscular and cardiac function. Most reactions are mild dysesthesias, but tetany, seizures, and cardiac arrhythmias can occur. Prophylactic oral or intravenous calcium supplements can correct decreased ionized calcium levels and manage the symptoms of hypocalcemia, which are especially likely in procedures involving platelet collection.

Donor exposure to citrate can vary depending on the type and length of the specific apheresis procedure as well as the type of system used, he said. The risk for vasovagal reactions also varies with the type of procedure performed and the use of volume replacement.

Dr. Robillard and his colleagues examined the severity of all cases of donor complications reported to Héma-Québec, beginning in October 2015. A Trima Accel system by Terumo BCT was used for single and double red blood cell collection, single and double platelets, platelets plus plasma, platelets plus red blood cells, platelets plus red blood cells plus plasma, double platelets plus red blood cells, and double platelets plus plasma. Plasma for fractionation was collected with a PCS®2 Plasma Collection System by Haemonetics.

During the study period, 80,409 apheresis procedures were conducted, involving 14,742 donors. Within this cohort, 5,447 (6.8%) had citrate reactions; 2,006 (2.5%) had vasovagal reactions without loss of consciousness, and 77 (0.1%) had vasovagal reactions with loss of consciousness.

Three quarters of the donors (74%) were male, and rates of citrate reactions were higher in men than in women (7% vs. 6%, P less than .001). There was a linear association between level of citrate exposure and citrate reactions rates (P less than .001).

“Vasovagal reactions were four times higher for female donors than for males, with or without loss of consciousness, and this difference was statistically significant,” said Dr. Robillard. Vasovagal reactions were higher in first-time donors.

The rate of vasovagal reactions without loss of consciousness was 6.2% in women and 1.6% in men, (P less than .001). Vasovagal reactions with loss of consciousness affected 0.22% of women and 0.06% of men (P less than .001).

The rates of citrate reactions were similar at all ages, but the rates of vasovagal reactions declined with age; the rates were 6.1% in patients aged 18-22 years and 1% among those over age 70.

SAN DIEGO – The rate of citrate reactions was nearly 7% in over 80,000 apheresis procedures involving nearly 15,000 donors, and risk increased with the level of citrate exposure, based on data presented from Héma-Québec, Montreal, presented at the annual meeting of the American Association of Blood Banks.

Vasovagal reactions were seen in 2.5% of procedures, and reactions with loss of consciousness occurred in 0.1%, reported Pierre Robillard, MD, of McGill University and Héma-Québec.

The fairly high rates of adverse reactions speak to the importance of taking preventive measures in donors undergoing apheresis, he said. Hypocalcemia and other citrate-induced abnormalities can affect neuromuscular and cardiac function. Most reactions are mild dysesthesias, but tetany, seizures, and cardiac arrhythmias can occur. Prophylactic oral or intravenous calcium supplements can correct decreased ionized calcium levels and manage the symptoms of hypocalcemia, which are especially likely in procedures involving platelet collection.

Donor exposure to citrate can vary depending on the type and length of the specific apheresis procedure as well as the type of system used, he said. The risk for vasovagal reactions also varies with the type of procedure performed and the use of volume replacement.

Dr. Robillard and his colleagues examined the severity of all cases of donor complications reported to Héma-Québec, beginning in October 2015. A Trima Accel system by Terumo BCT was used for single and double red blood cell collection, single and double platelets, platelets plus plasma, platelets plus red blood cells, platelets plus red blood cells plus plasma, double platelets plus red blood cells, and double platelets plus plasma. Plasma for fractionation was collected with a PCS®2 Plasma Collection System by Haemonetics.

During the study period, 80,409 apheresis procedures were conducted, involving 14,742 donors. Within this cohort, 5,447 (6.8%) had citrate reactions; 2,006 (2.5%) had vasovagal reactions without loss of consciousness, and 77 (0.1%) had vasovagal reactions with loss of consciousness.

Three quarters of the donors (74%) were male, and rates of citrate reactions were higher in men than in women (7% vs. 6%, P less than .001). There was a linear association between level of citrate exposure and citrate reactions rates (P less than .001).

“Vasovagal reactions were four times higher for female donors than for males, with or without loss of consciousness, and this difference was statistically significant,” said Dr. Robillard. Vasovagal reactions were higher in first-time donors.

The rate of vasovagal reactions without loss of consciousness was 6.2% in women and 1.6% in men, (P less than .001). Vasovagal reactions with loss of consciousness affected 0.22% of women and 0.06% of men (P less than .001).

The rates of citrate reactions were similar at all ages, but the rates of vasovagal reactions declined with age; the rates were 6.1% in patients aged 18-22 years and 1% among those over age 70.

SAN DIEGO – The rate of citrate reactions was nearly 7% in over 80,000 apheresis procedures involving nearly 15,000 donors, and risk increased with the level of citrate exposure, based on data presented from Héma-Québec, Montreal, presented at the annual meeting of the American Association of Blood Banks.

Vasovagal reactions were seen in 2.5% of procedures, and reactions with loss of consciousness occurred in 0.1%, reported Pierre Robillard, MD, of McGill University and Héma-Québec.

The fairly high rates of adverse reactions speak to the importance of taking preventive measures in donors undergoing apheresis, he said. Hypocalcemia and other citrate-induced abnormalities can affect neuromuscular and cardiac function. Most reactions are mild dysesthesias, but tetany, seizures, and cardiac arrhythmias can occur. Prophylactic oral or intravenous calcium supplements can correct decreased ionized calcium levels and manage the symptoms of hypocalcemia, which are especially likely in procedures involving platelet collection.

Donor exposure to citrate can vary depending on the type and length of the specific apheresis procedure as well as the type of system used, he said. The risk for vasovagal reactions also varies with the type of procedure performed and the use of volume replacement.

Dr. Robillard and his colleagues examined the severity of all cases of donor complications reported to Héma-Québec, beginning in October 2015. A Trima Accel system by Terumo BCT was used for single and double red blood cell collection, single and double platelets, platelets plus plasma, platelets plus red blood cells, platelets plus red blood cells plus plasma, double platelets plus red blood cells, and double platelets plus plasma. Plasma for fractionation was collected with a PCS®2 Plasma Collection System by Haemonetics.

During the study period, 80,409 apheresis procedures were conducted, involving 14,742 donors. Within this cohort, 5,447 (6.8%) had citrate reactions; 2,006 (2.5%) had vasovagal reactions without loss of consciousness, and 77 (0.1%) had vasovagal reactions with loss of consciousness.

Three quarters of the donors (74%) were male, and rates of citrate reactions were higher in men than in women (7% vs. 6%, P less than .001). There was a linear association between level of citrate exposure and citrate reactions rates (P less than .001).

“Vasovagal reactions were four times higher for female donors than for males, with or without loss of consciousness, and this difference was statistically significant,” said Dr. Robillard. Vasovagal reactions were higher in first-time donors.

The rate of vasovagal reactions without loss of consciousness was 6.2% in women and 1.6% in men, (P less than .001). Vasovagal reactions with loss of consciousness affected 0.22% of women and 0.06% of men (P less than .001).

The rates of citrate reactions were similar at all ages, but the rates of vasovagal reactions declined with age; the rates were 6.1% in patients aged 18-22 years and 1% among those over age 70.

SAN DIEGO – Tattoos are rapidly moving into mainstream America, and as more states regulate tattoo facilities, persons with tattoos can be blood donors without compromising patient safety, Mary Townsend of Blood Systems Inc. reported at the annual meeting of the American Association of Blood Banks.

“Two big states – Arizona and California – were added to the list of approved states, and we had a gain of 2,216 donors in California during a 3-month period and a gain of 4,035 donors in Arizona over 4 months,” Ms. Townsend said.

Both the AABB and the Food and Drug Administration require a 12-month deferral of donors after they have received tattoos using nonsterile needles or reusable ink. The FDA’s current 2015 guidance also states that tattooed donors can give plasma as soon as the inked area has healed if they reside in a state with applied inspections and licenses for tattoo facilities, and if a sterile needle and ink were used.

Blood Systems monitors state regulations to see if they require tattoo establishments to be licensed and require the use of sterile needles and non-reusable ink. To be considered an approved state, the regulations have to be statewide, covering all jurisdictions.

In the study, Ms. Townsend and her colleagues compared the rates of donors who were deferred before and after Arizona and California were added to the list of approved states, to determine the potential gain in donors with changes in state tattoo licensing regulations.

They analyzed blood centers in California and Arizona before and after implementation of state tattoo regulations, and also screened individuals who had received tattoos in those states with the question: “In the past 12 months have you had a tattoo?” and if the answer was ‘yes,’ if the tattoo was applied by a state regulated facility.

For California, they compared two periods – 3 months before regulations were implemented (February to April of 2015) and 3 months after (February to April of 2016) regulations were implemented. For Arizona, they selected a 4-month period (December 2015 to March 2016) and 4 months afterward (December 2016 to March 2017).

A higher proportion of donors who came to centers to donate blood admitted to having gotten a tattoo within the last 12 months in the postregulatory period in both states. The increase in donors occurred immediately following the addition of both states to the Acceptable States List. Accepted donors increased 13-fold in California and 3-fold in Arizona. The absolute number of accepted donors with tattoos rose from 13 to 567 in California and from 151 to 1,496 in Arizona, which represented an annual potential gain of 2,216 and 4,035 additional blood donations.

For blood donors who received a tattoo in a regulated state, blood donations were reviewed for the presence of infectious disease markers including HIV, hepatitis B, and hepatitis C. All donors who had received a tattoo in a regulated state tested negative for HIV, HBV, and HCV.

“Roughly one in three people (in the United States) have a tattoo and, of those, about 70% have more than one tattoo. The bottom line is that 45 million Americans have at least one tattoo,” she said. As state regulations adhere to guidelines regarding tattoos and blood donation, the pool of donors increases.

SAN DIEGO – Tattoos are rapidly moving into mainstream America, and as more states regulate tattoo facilities, persons with tattoos can be blood donors without compromising patient safety, Mary Townsend of Blood Systems Inc. reported at the annual meeting of the American Association of Blood Banks.

“Two big states – Arizona and California – were added to the list of approved states, and we had a gain of 2,216 donors in California during a 3-month period and a gain of 4,035 donors in Arizona over 4 months,” Ms. Townsend said.

Both the AABB and the Food and Drug Administration require a 12-month deferral of donors after they have received tattoos using nonsterile needles or reusable ink. The FDA’s current 2015 guidance also states that tattooed donors can give plasma as soon as the inked area has healed if they reside in a state with applied inspections and licenses for tattoo facilities, and if a sterile needle and ink were used.

Blood Systems monitors state regulations to see if they require tattoo establishments to be licensed and require the use of sterile needles and non-reusable ink. To be considered an approved state, the regulations have to be statewide, covering all jurisdictions.

In the study, Ms. Townsend and her colleagues compared the rates of donors who were deferred before and after Arizona and California were added to the list of approved states, to determine the potential gain in donors with changes in state tattoo licensing regulations.

They analyzed blood centers in California and Arizona before and after implementation of state tattoo regulations, and also screened individuals who had received tattoos in those states with the question: “In the past 12 months have you had a tattoo?” and if the answer was ‘yes,’ if the tattoo was applied by a state regulated facility.

For California, they compared two periods – 3 months before regulations were implemented (February to April of 2015) and 3 months after (February to April of 2016) regulations were implemented. For Arizona, they selected a 4-month period (December 2015 to March 2016) and 4 months afterward (December 2016 to March 2017).

A higher proportion of donors who came to centers to donate blood admitted to having gotten a tattoo within the last 12 months in the postregulatory period in both states. The increase in donors occurred immediately following the addition of both states to the Acceptable States List. Accepted donors increased 13-fold in California and 3-fold in Arizona. The absolute number of accepted donors with tattoos rose from 13 to 567 in California and from 151 to 1,496 in Arizona, which represented an annual potential gain of 2,216 and 4,035 additional blood donations.

For blood donors who received a tattoo in a regulated state, blood donations were reviewed for the presence of infectious disease markers including HIV, hepatitis B, and hepatitis C. All donors who had received a tattoo in a regulated state tested negative for HIV, HBV, and HCV.

“Roughly one in three people (in the United States) have a tattoo and, of those, about 70% have more than one tattoo. The bottom line is that 45 million Americans have at least one tattoo,” she said. As state regulations adhere to guidelines regarding tattoos and blood donation, the pool of donors increases.

SAN DIEGO – Tattoos are rapidly moving into mainstream America, and as more states regulate tattoo facilities, persons with tattoos can be blood donors without compromising patient safety, Mary Townsend of Blood Systems Inc. reported at the annual meeting of the American Association of Blood Banks.

“Two big states – Arizona and California – were added to the list of approved states, and we had a gain of 2,216 donors in California during a 3-month period and a gain of 4,035 donors in Arizona over 4 months,” Ms. Townsend said.

Both the AABB and the Food and Drug Administration require a 12-month deferral of donors after they have received tattoos using nonsterile needles or reusable ink. The FDA’s current 2015 guidance also states that tattooed donors can give plasma as soon as the inked area has healed if they reside in a state with applied inspections and licenses for tattoo facilities, and if a sterile needle and ink were used.

Blood Systems monitors state regulations to see if they require tattoo establishments to be licensed and require the use of sterile needles and non-reusable ink. To be considered an approved state, the regulations have to be statewide, covering all jurisdictions.

In the study, Ms. Townsend and her colleagues compared the rates of donors who were deferred before and after Arizona and California were added to the list of approved states, to determine the potential gain in donors with changes in state tattoo licensing regulations.

They analyzed blood centers in California and Arizona before and after implementation of state tattoo regulations, and also screened individuals who had received tattoos in those states with the question: “In the past 12 months have you had a tattoo?” and if the answer was ‘yes,’ if the tattoo was applied by a state regulated facility.

For California, they compared two periods – 3 months before regulations were implemented (February to April of 2015) and 3 months after (February to April of 2016) regulations were implemented. For Arizona, they selected a 4-month period (December 2015 to March 2016) and 4 months afterward (December 2016 to March 2017).

A higher proportion of donors who came to centers to donate blood admitted to having gotten a tattoo within the last 12 months in the postregulatory period in both states. The increase in donors occurred immediately following the addition of both states to the Acceptable States List. Accepted donors increased 13-fold in California and 3-fold in Arizona. The absolute number of accepted donors with tattoos rose from 13 to 567 in California and from 151 to 1,496 in Arizona, which represented an annual potential gain of 2,216 and 4,035 additional blood donations.

For blood donors who received a tattoo in a regulated state, blood donations were reviewed for the presence of infectious disease markers including HIV, hepatitis B, and hepatitis C. All donors who had received a tattoo in a regulated state tested negative for HIV, HBV, and HCV.

“Roughly one in three people (in the United States) have a tattoo and, of those, about 70% have more than one tattoo. The bottom line is that 45 million Americans have at least one tattoo,” she said. As state regulations adhere to guidelines regarding tattoos and blood donation, the pool of donors increases.

SAN DIEGO – It’s still too early to assess the impact of new guidelines for blood donation by men who have had sex with men, Brian S. Custer, PhD, MPH, of Blood Systems Research Institute, San Francisco, said at the annual meeting of the American Association of Blood Banks.

In 2015, the U.S. Food and Drug Administration lifted its lifetime ban on blood donations by men who have sex with men (MSM) and changed it to a 1-year deferral policy. Based on this new guidance, many U.S. blood centers moved from an indefinite deferral for any man who reported having had sex with a man since 1977 to a 1-year deferral from last sexual contact with a man.

blueskyline/Thinkstock

SAN DIEGO – It’s still too early to assess the impact of new guidelines for blood donation by men who have had sex with men, Brian S. Custer, PhD, MPH, of Blood Systems Research Institute, San Francisco, said at the annual meeting of the American Association of Blood Banks.

In 2015, the U.S. Food and Drug Administration lifted its lifetime ban on blood donations by men who have sex with men (MSM) and changed it to a 1-year deferral policy. Based on this new guidance, many U.S. blood centers moved from an indefinite deferral for any man who reported having had sex with a man since 1977 to a 1-year deferral from last sexual contact with a man.

blueskyline/Thinkstock

SAN DIEGO – It’s still too early to assess the impact of new guidelines for blood donation by men who have had sex with men, Brian S. Custer, PhD, MPH, of Blood Systems Research Institute, San Francisco, said at the annual meeting of the American Association of Blood Banks.

In 2015, the U.S. Food and Drug Administration lifted its lifetime ban on blood donations by men who have sex with men (MSM) and changed it to a 1-year deferral policy. Based on this new guidance, many U.S. blood centers moved from an indefinite deferral for any man who reported having had sex with a man since 1977 to a 1-year deferral from last sexual contact with a man.

blueskyline/Thinkstock

SAN DIEGO – Transgender male blood donors may have been pregnant at some point, an issue that can be missed at the time of blood donation. If HLA testing is not performed in these cases, male blood recipients can potentially be placed at risk.

In study results presented at the annual meeting of the American Association of Blood Banks, 3% of transgender males who were identified as such reported a prior history of pregnancy. Importantly, this pregnancy history may not be divulged unless transgender males are asked “female” questions, said Kathleen M. Grima, MD, executive medical officer at the American Red Cross and medical director of the blood bank at the Brooklyn Hospital Center, New York.

Several studies have suggested that blood from ever-pregnant female donors can present increased risks to male recipients. Research also has suggested that antibodies or other immune system factors that women develop when pregnant could trigger transfusion-related acute lung injury (TRALI), a serious inflammatory reaction that can result in death, in male blood-transfusion recipients.

For this reason, it is important to have pregnancy histories from blood donors, and obtaining those histories from transgender males “presents a challenge for blood centers,” she said. “At our center, when a donor requests a gender change from female to male, an HLA test is requested for the next donation.” But as first-time donors are qualified based on their stated gender, transgender donors who have been pregnant will not be identified unless they volunteer the information or are asked about their pregnancy history.

The AABB recommends that a facility can perform HLA testing on all apheresis plasma donors and all whole blood donors whose units are intended for production into plasma components or, as an alternative, obtain a pregnancy history from all female donors and perform HLA typing only on women with a history of one or more full-term pregnancies.

Dr. Grima explained that, prior to the implementation of the Food and Drug Administration’s “final rule” on requirements for blood and blood components, blood centers asked donors to identify their birth gender to determine eligibility. If gender had changed, the donor was then asked to answer both the male and female questions. The FDA’s final rule now allows blood centers to accept the donor’s stated gender and eligibility can be determined based on that gender.

Dr. Grima and her colleagues conducted a review to determine the number of transgender males who were actively donating with a large blood center and to assess the risk of failing to ask a transgender male donor about pregnancy.

From 2013 to 2015, there were 121 female donors who had changed their gender to male and 60 male donors who had changed their gender to female. Of this group, seven (6%) transgender male donors (female at birth) stated at one of their donations that they had a pregnancy history; three were apheresis donors who had been tested for HLA antibodies (one was positive and two negative). The other four were whole blood donors and had not been tested.

After 2016, donors self-identified their gender, and 326 had requested a gender change from female to male. Of this group, 5 (1.5%) answered yes to pregnancy questions, 56 said no, and 265 did not respond.

“In our system, if a donor identifies as a male, then they only see male questions,” she pointed out. The center subsequently added in a test for HLA antibodies, and 101 donors were tested. Of this group, 13 (13%) tested positive; 2 had answered yes to pregnancy, 4 answered no, and 7 did not respond to the pregnancy question.

Combining the two cohorts, there were 447 transgender males who were identified; 12 (3%) responded yes to pregnancy, and 5 (1%) tested positive for HLA antibodies.

“We are continuing to add the HLA test,” said Dr. Grima. “I’m not sure this is the best [approach], but we will see over time.”

But if a donor comes in for the first time or identifies as a male or transgender male, they won’t be tested, and this is an opportunity that will be missed, she added. “Another option is to ask all donors if they have been pregnant or continue to ask donors their birth gender and then require that they answer both the male and female questions.”

Dr. Grima had no financial disclosures.

SAN DIEGO – Transgender male blood donors may have been pregnant at some point, an issue that can be missed at the time of blood donation. If HLA testing is not performed in these cases, male blood recipients can potentially be placed at risk.

In study results presented at the annual meeting of the American Association of Blood Banks, 3% of transgender males who were identified as such reported a prior history of pregnancy. Importantly, this pregnancy history may not be divulged unless transgender males are asked “female” questions, said Kathleen M. Grima, MD, executive medical officer at the American Red Cross and medical director of the blood bank at the Brooklyn Hospital Center, New York.

Several studies have suggested that blood from ever-pregnant female donors can present increased risks to male recipients. Research also has suggested that antibodies or other immune system factors that women develop when pregnant could trigger transfusion-related acute lung injury (TRALI), a serious inflammatory reaction that can result in death, in male blood-transfusion recipients.

For this reason, it is important to have pregnancy histories from blood donors, and obtaining those histories from transgender males “presents a challenge for blood centers,” she said. “At our center, when a donor requests a gender change from female to male, an HLA test is requested for the next donation.” But as first-time donors are qualified based on their stated gender, transgender donors who have been pregnant will not be identified unless they volunteer the information or are asked about their pregnancy history.

The AABB recommends that a facility can perform HLA testing on all apheresis plasma donors and all whole blood donors whose units are intended for production into plasma components or, as an alternative, obtain a pregnancy history from all female donors and perform HLA typing only on women with a history of one or more full-term pregnancies.

Dr. Grima explained that, prior to the implementation of the Food and Drug Administration’s “final rule” on requirements for blood and blood components, blood centers asked donors to identify their birth gender to determine eligibility. If gender had changed, the donor was then asked to answer both the male and female questions. The FDA’s final rule now allows blood centers to accept the donor’s stated gender and eligibility can be determined based on that gender.

Dr. Grima and her colleagues conducted a review to determine the number of transgender males who were actively donating with a large blood center and to assess the risk of failing to ask a transgender male donor about pregnancy.

From 2013 to 2015, there were 121 female donors who had changed their gender to male and 60 male donors who had changed their gender to female. Of this group, seven (6%) transgender male donors (female at birth) stated at one of their donations that they had a pregnancy history; three were apheresis donors who had been tested for HLA antibodies (one was positive and two negative). The other four were whole blood donors and had not been tested.

After 2016, donors self-identified their gender, and 326 had requested a gender change from female to male. Of this group, 5 (1.5%) answered yes to pregnancy questions, 56 said no, and 265 did not respond.

“In our system, if a donor identifies as a male, then they only see male questions,” she pointed out. The center subsequently added in a test for HLA antibodies, and 101 donors were tested. Of this group, 13 (13%) tested positive; 2 had answered yes to pregnancy, 4 answered no, and 7 did not respond to the pregnancy question.

Combining the two cohorts, there were 447 transgender males who were identified; 12 (3%) responded yes to pregnancy, and 5 (1%) tested positive for HLA antibodies.

“We are continuing to add the HLA test,” said Dr. Grima. “I’m not sure this is the best [approach], but we will see over time.”

But if a donor comes in for the first time or identifies as a male or transgender male, they won’t be tested, and this is an opportunity that will be missed, she added. “Another option is to ask all donors if they have been pregnant or continue to ask donors their birth gender and then require that they answer both the male and female questions.”

Dr. Grima had no financial disclosures.

SAN DIEGO – Transgender male blood donors may have been pregnant at some point, an issue that can be missed at the time of blood donation. If HLA testing is not performed in these cases, male blood recipients can potentially be placed at risk.

In study results presented at the annual meeting of the American Association of Blood Banks, 3% of transgender males who were identified as such reported a prior history of pregnancy. Importantly, this pregnancy history may not be divulged unless transgender males are asked “female” questions, said Kathleen M. Grima, MD, executive medical officer at the American Red Cross and medical director of the blood bank at the Brooklyn Hospital Center, New York.

Several studies have suggested that blood from ever-pregnant female donors can present increased risks to male recipients. Research also has suggested that antibodies or other immune system factors that women develop when pregnant could trigger transfusion-related acute lung injury (TRALI), a serious inflammatory reaction that can result in death, in male blood-transfusion recipients.

For this reason, it is important to have pregnancy histories from blood donors, and obtaining those histories from transgender males “presents a challenge for blood centers,” she said. “At our center, when a donor requests a gender change from female to male, an HLA test is requested for the next donation.” But as first-time donors are qualified based on their stated gender, transgender donors who have been pregnant will not be identified unless they volunteer the information or are asked about their pregnancy history.

The AABB recommends that a facility can perform HLA testing on all apheresis plasma donors and all whole blood donors whose units are intended for production into plasma components or, as an alternative, obtain a pregnancy history from all female donors and perform HLA typing only on women with a history of one or more full-term pregnancies.

Dr. Grima explained that, prior to the implementation of the Food and Drug Administration’s “final rule” on requirements for blood and blood components, blood centers asked donors to identify their birth gender to determine eligibility. If gender had changed, the donor was then asked to answer both the male and female questions. The FDA’s final rule now allows blood centers to accept the donor’s stated gender and eligibility can be determined based on that gender.

Dr. Grima and her colleagues conducted a review to determine the number of transgender males who were actively donating with a large blood center and to assess the risk of failing to ask a transgender male donor about pregnancy.

From 2013 to 2015, there were 121 female donors who had changed their gender to male and 60 male donors who had changed their gender to female. Of this group, seven (6%) transgender male donors (female at birth) stated at one of their donations that they had a pregnancy history; three were apheresis donors who had been tested for HLA antibodies (one was positive and two negative). The other four were whole blood donors and had not been tested.

After 2016, donors self-identified their gender, and 326 had requested a gender change from female to male. Of this group, 5 (1.5%) answered yes to pregnancy questions, 56 said no, and 265 did not respond.

“In our system, if a donor identifies as a male, then they only see male questions,” she pointed out. The center subsequently added in a test for HLA antibodies, and 101 donors were tested. Of this group, 13 (13%) tested positive; 2 had answered yes to pregnancy, 4 answered no, and 7 did not respond to the pregnancy question.

Combining the two cohorts, there were 447 transgender males who were identified; 12 (3%) responded yes to pregnancy, and 5 (1%) tested positive for HLA antibodies.

“We are continuing to add the HLA test,” said Dr. Grima. “I’m not sure this is the best [approach], but we will see over time.”

But if a donor comes in for the first time or identifies as a male or transgender male, they won’t be tested, and this is an opportunity that will be missed, she added. “Another option is to ask all donors if they have been pregnant or continue to ask donors their birth gender and then require that they answer both the male and female questions.”

Dr. Grima had no financial disclosures.

Adding bortezomib to the standard treatment regimen for diffuse large B-cell lymphoma (DLBCL) did not significantly impact outcomes, findings from the phase-2 PYRAMID trial showed.

When the proteasome inhibitor bortezomib was combined with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) in patients with previously untreated non–germinal center B-cell–like (non-GCB) DLBCL, a significant improvement in progression-free survival (PFS) was not observed.

There also was no increase in 2-year PFS among patients treated with the combination of bortezomib plus R-CHOP (VR-CHOP), according to findings from the open-label, randomized study published in the Journal of Clinical Oncology (2017 Sep 1. doi: 10.1200/JCO.2017.73.2784).

Adding bortezomib to the standard treatment regimen for diffuse large B-cell lymphoma (DLBCL) did not significantly impact outcomes, findings from the phase-2 PYRAMID trial showed.

When the proteasome inhibitor bortezomib was combined with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) in patients with previously untreated non–germinal center B-cell–like (non-GCB) DLBCL, a significant improvement in progression-free survival (PFS) was not observed.

There also was no increase in 2-year PFS among patients treated with the combination of bortezomib plus R-CHOP (VR-CHOP), according to findings from the open-label, randomized study published in the Journal of Clinical Oncology (2017 Sep 1. doi: 10.1200/JCO.2017.73.2784).

Adding bortezomib to the standard treatment regimen for diffuse large B-cell lymphoma (DLBCL) did not significantly impact outcomes, findings from the phase-2 PYRAMID trial showed.

When the proteasome inhibitor bortezomib was combined with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) in patients with previously untreated non–germinal center B-cell–like (non-GCB) DLBCL, a significant improvement in progression-free survival (PFS) was not observed.

There also was no increase in 2-year PFS among patients treated with the combination of bortezomib plus R-CHOP (VR-CHOP), according to findings from the open-label, randomized study published in the Journal of Clinical Oncology (2017 Sep 1. doi: 10.1200/JCO.2017.73.2784).