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Results of a phase 3 study suggest that administering antihuman T-lymphocyte immune globulin (ATG) prior to hematopoietic stem cell transplant (HSCT) can decrease the risk and severity of chronic graft-versus-host disease (GVHD).
Study investigators included ATG in the conditioning regimens of leukemia patients receiving peripheral blood stem cells from an HLA-identical sibling donor.
Two years after HSCT, these patients had less than half the rate of chronic GVHD of patients who did not receive ATG.
In addition, patients who received ATG were less likely to have severe chronic GVHD.
Nicolaus Kroger, MD, of the University Medical Center Hamburg-Eppendorf in Hamburg, Germany, and his colleagues reported these results in NEJM.
The investigators enrolled 168 patients undergoing HSCT at 27 centers. They were randomized in a 1:1 ratio to receive ATG or not.
One hundred and fifty-five patients were randomized and evaluable—83 in the ATG group and 72 in the non-ATG group.
The only significant difference in baseline characteristics was age. The median age was 39 (range, 18-64) in the ATG group and 43.5 (range, 21-61) in the non-ATG group (P=0.04).
Most patients in both groups were male (63.9% and 55.6%, respectively), and most had acute myeloid leukemia (66.3% and 76.4%, respectively) rather than acute lymphoblastic leukemia (33.8% and 23.6%, respectively).
Most patients had intermediate-risk disease (75.9% and 82.1%, respectively), and a minority had high-risk cytogenetics (37.3% and 30.6%, respectively).
The median time between diagnosis and HSCT was about 5 months in both groups. Both groups had a median of 2 courses of chemotherapy before transplant (overall range, 1-8).
Most patients in both groups received busulfan plus cyclophosphamide as conditioning—67.5% of the ATG group and 70.8% of the non-ATG group. Some received total-body irradiation plus cyclophosphamide (27.7% and 25.0%, respectively), and a few received total-body irradiation plus etoposide (4.8% and 4.2%, respectively).
Results
After a median follow-up of 24 months, the cumulative incidence of chronic GVHD was significantly lower in the ATG group than the non-ATG group—32.2% and 68.7%, respectively (P<0.001).
In addition, patients in the ATG group were significantly less likely to have severe or extensive chronic GVHD.
According to revised Seattle criteria, the rate of limited chronic GVHD was 20.5% in the ATG group and 30.6% in the non-ATG group. And the rates of extensive chronic GVHD were 6% and 33.3%, respectively (P<0.001).
According to revised NIH criteria, the rate of mild chronic GVHD was 15.7% in the ATG group and 16.7% in the non-ATG group. The rates of moderate chronic GVHD were 8.4% and 25%, respectively. And the rates of severe chronic GVHD were 2.4% and 22.2%, respectively (P<0.001).
However, all other outcomes, when assessed alone, were similar between the treatment groups.
The rate of 2-year relapse-free survival was 59.4% in the ATG group and 64.6% in the non-ATG group (P=0.21). The overall survival rates were 74.1% and 77.9%, respectively (P=0.46).
The incidence of relapse was 32.2% and 35.5%, respectively (P=0.17). Infectious complications occurred in 57.8% and 54.2%, respectively (P=0.65). And the rates of acute GVHD were 10.8% and 18.1%, respectively (P=0.13).
However, the rate of a composite endpoint of chronic GVHD-free and relapse-free survival at 2 years was significantly higher in the ATG group than the non-ATG group—36.6% and 16.8%, respectively (P=0.005). 
Image courtesy of PLOS ONE
Results of a phase 3 study suggest that administering antihuman T-lymphocyte immune globulin (ATG) prior to hematopoietic stem cell transplant (HSCT) can decrease the risk and severity of chronic graft-versus-host disease (GVHD).
Study investigators included ATG in the conditioning regimens of leukemia patients receiving peripheral blood stem cells from an HLA-identical sibling donor.
Two years after HSCT, these patients had less than half the rate of chronic GVHD of patients who did not receive ATG.
In addition, patients who received ATG were less likely to have severe chronic GVHD.
Nicolaus Kroger, MD, of the University Medical Center Hamburg-Eppendorf in Hamburg, Germany, and his colleagues reported these results in NEJM.
The investigators enrolled 168 patients undergoing HSCT at 27 centers. They were randomized in a 1:1 ratio to receive ATG or not.
One hundred and fifty-five patients were randomized and evaluable—83 in the ATG group and 72 in the non-ATG group.
The only significant difference in baseline characteristics was age. The median age was 39 (range, 18-64) in the ATG group and 43.5 (range, 21-61) in the non-ATG group (P=0.04).
Most patients in both groups were male (63.9% and 55.6%, respectively), and most had acute myeloid leukemia (66.3% and 76.4%, respectively) rather than acute lymphoblastic leukemia (33.8% and 23.6%, respectively).
Most patients had intermediate-risk disease (75.9% and 82.1%, respectively), and a minority had high-risk cytogenetics (37.3% and 30.6%, respectively).
The median time between diagnosis and HSCT was about 5 months in both groups. Both groups had a median of 2 courses of chemotherapy before transplant (overall range, 1-8).
Most patients in both groups received busulfan plus cyclophosphamide as conditioning—67.5% of the ATG group and 70.8% of the non-ATG group. Some received total-body irradiation plus cyclophosphamide (27.7% and 25.0%, respectively), and a few received total-body irradiation plus etoposide (4.8% and 4.2%, respectively).
Results
After a median follow-up of 24 months, the cumulative incidence of chronic GVHD was significantly lower in the ATG group than the non-ATG group—32.2% and 68.7%, respectively (P<0.001).
In addition, patients in the ATG group were significantly less likely to have severe or extensive chronic GVHD.
According to revised Seattle criteria, the rate of limited chronic GVHD was 20.5% in the ATG group and 30.6% in the non-ATG group. And the rates of extensive chronic GVHD were 6% and 33.3%, respectively (P<0.001).
According to revised NIH criteria, the rate of mild chronic GVHD was 15.7% in the ATG group and 16.7% in the non-ATG group. The rates of moderate chronic GVHD were 8.4% and 25%, respectively. And the rates of severe chronic GVHD were 2.4% and 22.2%, respectively (P<0.001).
However, all other outcomes, when assessed alone, were similar between the treatment groups.
The rate of 2-year relapse-free survival was 59.4% in the ATG group and 64.6% in the non-ATG group (P=0.21). The overall survival rates were 74.1% and 77.9%, respectively (P=0.46).
The incidence of relapse was 32.2% and 35.5%, respectively (P=0.17). Infectious complications occurred in 57.8% and 54.2%, respectively (P=0.65). And the rates of acute GVHD were 10.8% and 18.1%, respectively (P=0.13).
However, the rate of a composite endpoint of chronic GVHD-free and relapse-free survival at 2 years was significantly higher in the ATG group than the non-ATG group—36.6% and 16.8%, respectively (P=0.005).
Image courtesy of PLOS ONE
Results of a phase 3 study suggest that administering antihuman T-lymphocyte immune globulin (ATG) prior to hematopoietic stem cell transplant (HSCT) can decrease the risk and severity of chronic graft-versus-host disease (GVHD).
Study investigators included ATG in the conditioning regimens of leukemia patients receiving peripheral blood stem cells from an HLA-identical sibling donor.
Two years after HSCT, these patients had less than half the rate of chronic GVHD of patients who did not receive ATG.
In addition, patients who received ATG were less likely to have severe chronic GVHD.
Nicolaus Kroger, MD, of the University Medical Center Hamburg-Eppendorf in Hamburg, Germany, and his colleagues reported these results in NEJM.
The investigators enrolled 168 patients undergoing HSCT at 27 centers. They were randomized in a 1:1 ratio to receive ATG or not.
One hundred and fifty-five patients were randomized and evaluable—83 in the ATG group and 72 in the non-ATG group.
The only significant difference in baseline characteristics was age. The median age was 39 (range, 18-64) in the ATG group and 43.5 (range, 21-61) in the non-ATG group (P=0.04).
Most patients in both groups were male (63.9% and 55.6%, respectively), and most had acute myeloid leukemia (66.3% and 76.4%, respectively) rather than acute lymphoblastic leukemia (33.8% and 23.6%, respectively).
Most patients had intermediate-risk disease (75.9% and 82.1%, respectively), and a minority had high-risk cytogenetics (37.3% and 30.6%, respectively).
The median time between diagnosis and HSCT was about 5 months in both groups. Both groups had a median of 2 courses of chemotherapy before transplant (overall range, 1-8).
Most patients in both groups received busulfan plus cyclophosphamide as conditioning—67.5% of the ATG group and 70.8% of the non-ATG group. Some received total-body irradiation plus cyclophosphamide (27.7% and 25.0%, respectively), and a few received total-body irradiation plus etoposide (4.8% and 4.2%, respectively).
Results
After a median follow-up of 24 months, the cumulative incidence of chronic GVHD was significantly lower in the ATG group than the non-ATG group—32.2% and 68.7%, respectively (P<0.001).
In addition, patients in the ATG group were significantly less likely to have severe or extensive chronic GVHD.
According to revised Seattle criteria, the rate of limited chronic GVHD was 20.5% in the ATG group and 30.6% in the non-ATG group. And the rates of extensive chronic GVHD were 6% and 33.3%, respectively (P<0.001).
According to revised NIH criteria, the rate of mild chronic GVHD was 15.7% in the ATG group and 16.7% in the non-ATG group. The rates of moderate chronic GVHD were 8.4% and 25%, respectively. And the rates of severe chronic GVHD were 2.4% and 22.2%, respectively (P<0.001).
However, all other outcomes, when assessed alone, were similar between the treatment groups.
The rate of 2-year relapse-free survival was 59.4% in the ATG group and 64.6% in the non-ATG group (P=0.21). The overall survival rates were 74.1% and 77.9%, respectively (P=0.46).
The incidence of relapse was 32.2% and 35.5%, respectively (P=0.17). Infectious complications occurred in 57.8% and 54.2%, respectively (P=0.65). And the rates of acute GVHD were 10.8% and 18.1%, respectively (P=0.13).
However, the rate of a composite endpoint of chronic GVHD-free and relapse-free survival at 2 years was significantly higher in the ATG group than the non-ATG group—36.6% and 16.8%, respectively (P=0.005).