The dose of platelets given by transfusion to cancer patients who
become thrombocytopenic can be halved without increasing the risk of
bleeding, according to the results of a large study reported here at
the American Society of Hematology (ASH) 50th Annual Meeting and
Exposition. Several experts have predicted that this finding will
change clinical practice.

"We have shown that the lower dose is not adverse for the patient,"
said lead researcher Sherrill Slichter, MD, from the Puget Sound
Blood Center, in Seattle, Washington. Using fewer platelets per
transfusion would reduce the demand on the blood supply and should
also reduce costs, she said.

The PLADO study involved 1350 patients, and "the size of this trial
permits us to say that this is what we should be doing now," Dr.
Slichter commented at an official ASH press conference. "I will be
recommending that clinicians reduce the dose of platelets in
transfusions, as the risk is not there."

Current ASH president Kenneth Kaushansky, MD, professor of medicine
at the University of California, San Diego, told Medscape Oncology
that he agrees, and predicted that this trial will change clinical
practice. "Dr. Slichter is a pioneer in this area and is very well
respected. If she concludes that we can lower the dose of platelets,
then I am more than willing to go with that strategy," he said.

However, Dr. Kaushansky cautioned that "we must guard against
generalization," and emphasized that the recommendation pertains
only to patients comparable to those in the PLADO trial. Dr.
Slichter also made this point, and noted that nearly all the
participants had hematological malignancies (only 7 patients had
solid tumors), 70% had undergone bone-marrow transplants, and the
remaining 30% were treated with chemotherapy.

"This finding is important because it will decrease the utilization
of a scare resource and will also limit the exposure of patients to
blood products from donors," commented J. Evans Sadler, MD, PhD,
from the Division of Hematology at Washington University, in St.
Louis, Missouri. Dr. Sadler, who was not involved in the study, is a
cochair of the ASH Scientific Program Committee. He, too, predicted
that the results will change clinical practice.

Wait for Peer Review and Publication

"Not yet," urged Ron Strauss, MD, professor of pathology and
pediatrics at the University of Iowa Hospital, in Iowa City. "We
should continue to use the standard dose of platelets until these
results are peer reviewed and published," he commented to Medscape
Oncology, adding that conclusions are often tempered in the peer-
review process.

Dr. Strauss urged caution during an educational session. "I think it
is too risky to change practice," he said. However, Dr. Slichter
said that she disagreed, and that she felt the data were robust
enough to recommend a change in clinical practice. "It is safe based
on this study," she said.

"I am not sure," said Nancy Heddle, MSc, from McMaster University,
in Hamilton, Ontario. She also urged clinicians to wait until the
study undergoes peer review and publication before implementing
changes in clinical practice. At the same session, she presented
results from the STOP (Strategies for Transfusion of Platelets)
trial, which also investigated the use of a lower dose of platelets
for transfusion, although it involved a different patient
population ¡X patients with chemotherapy-induced thrombocytopenia,
the majority of whom had acute myeloid leukemia.

The STOP trial was stopped early because of safety concerns, in
particular 3 cases of grade 4 bleeding in the low-dose group,
which "may or may not be due to chance," said Ms. Heddle. However,
further analysis showed no benefit in the low-dose group, and a
trend toward a higher burden of bleeding, although this was not
statistically significant. She did acknowledge, however, that there
was a problem with the adjudication of grading of the bleeding
episodes, because there was some disagreement about the grades
assigned among those doing the assigning.

This issue did not arise in the PLADO trial, commented Dr. Slichter,
because the adjudication of bleeding grades was done by computer,
based on data gathered on a daily basis from physical examinations,
patient interviews, chart reviews, and laboratory results.

No Difference in Risk of Bleeding

The PLADO trial set out to determine the optimal prophylactic
platelet-dose strategy to prevent bleeding in thrombocytopenic
patients. It compared 3 different doses of platelets given by
transfusion: a low dose (1.1 ¡Ñ 1011 platelets/m2), a medium dose
(2.2 ¡Ñ 1011 platelets/m2), and a high dose (4.4 ¡Ñ 1011
platelets/m2). The medium dose corresponds most closely to the
standard dose currently used, Dr. Slichter noted.

Patients enrolled in the trial had hypoproliferative
thrombocytopenia and were expected to be hospitalized with platelet
counts of 10,000 mL or less for more than 5 days. This was the
trigger for a platelet transfusion, which was given prophylactically
on days when platelet counts reached or fell to below this level.

The results show that there was no significant difference in the
risk of bleeding across any of these doses, either in World Health
Organization grade 2 bleeding, which was the primary end point, or
in the more severe cases. "The incidence of grade 2 bleeding remains
high, at around 70%, regardless of dose," Dr. Slichter commented.

However, Dr. Kaushansky cautioned that "we must guard against
generalization," and emphasized that the recommendation pertains
only to patients comparable to those in the PLADO trial. Dr.
Slichter also made this point, and noted that nearly all the
participants had hematological malignancies (only 7 patients had
solid tumors), 70% had undergone bone-marrow transplants, and the
remaining 30% were treated with chemotherapy.

"This finding is important because it will decrease the utilization
of a scare resource and will also limit the exposure of patients to
blood products from donors," commented J. Evans Sadler, MD, PhD,
from the Division of Hematology at Washington University, in St.
Louis, Missouri. Dr. Sadler, who was not involved in the study, is a
cochair of the ASH Scientific Program Committee. He, too, predicted
that the results will change clinical practice.

Wait for Peer Review and Publication

"Not yet," urged Ron Strauss, MD, professor of pathology and
pediatrics at the University of Iowa Hospital, in Iowa City. "We
should continue to use the standard dose of platelets until these
results are peer reviewed and published," he commented to Medscape
Oncology, adding that conclusions are often tempered in the peer-
review process.

Dr. Strauss urged caution during an educational session. "I think it
is too risky to change practice," he said. However, Dr. Slichter
said that she disagreed, and that she felt the data were robust
enough to recommend a change in clinical practice. "It is safe based
on this study," she said.

"I am not sure," said Nancy Heddle, MSc, from McMaster University,
in Hamilton, Ontario. She also urged clinicians to wait until the
study undergoes peer review and publication before implementing
changes in clinical practice. At the same session, she presented
results from the STOP (Strategies for Transfusion of Platelets)
trial, which also investigated the use of a lower dose of platelets
for transfusion, although it involved a different patient
population ¡X patients with chemotherapy-induced thrombocytopenia,
the majority of whom had acute myeloid leukemia.

The STOP trial was stopped early because of safety concerns, in
particular 3 cases of grade 4 bleeding in the low-dose group,
which "may or may not be due to chance," said Ms. Heddle. However,
further analysis showed no benefit in the low-dose group, and a
trend toward a higher burden of bleeding, although this was not
statistically significant. She did acknowledge, however, that there
was a problem with the adjudication of grading of the bleeding
episodes, because there was some disagreement about the grades
assigned among those doing the assigning.

This issue did not arise in the PLADO trial, commented Dr. Slichter,
because the adjudication of bleeding grades was done by computer,
based on data gathered on a daily basis from physical examinations,
patient interviews, chart reviews, and laboratory results.

No Difference in Risk of Bleeding

The PLADO trial set out to determine the optimal prophylactic
platelet-dose strategy to prevent bleeding in thrombocytopenic
patients. It compared 3 different doses of platelets given by
transfusion: a low dose (1.1 ¡Ñ 1011 platelets/m2), a medium dose
(2.2 ¡Ñ 1011 platelets/m2), and a high dose (4.4 ¡Ñ 1011
platelets/m2). The medium dose corresponds most closely to the
standard dose currently used, Dr. Slichter noted.

Patients enrolled in the trial had hypoproliferative
thrombocytopenia and were expected to be hospitalized with platelet
counts of 10,000 mL or less for more than 5 days. This was the
trigger for a platelet transfusion, which was given prophylactically
on days when platelet counts reached or fell to below this level.

The results show that there was no significant difference in the
risk of bleeding across any of these doses, either in World Health
Organization grade 2 bleeding, which was the primary end point, or
in the more severe cases. "The incidence of grade 2 bleeding remains
high, at around 70%, regardless of dose," Dr. Slichter commented.

However, Dr. Kaushansky cautioned that "we must guard against
generalization," and emphasized that the recommendation pertains
only to patients comparable to those in the PLADO trial. Dr.
Slichter also made this point, and noted that nearly all the
participants had hematological malignancies (only 7 patients had
solid tumors), 70% had undergone bone-marrow transplants, and the
remaining 30% were treated with chemotherapy.

"This finding is important because it will decrease the utilization
of a scare resource and will also limit the exposure of patients to
blood products from donors," commented J. Evans Sadler, MD, PhD,
from the Division of Hematology at Washington University, in St.
Louis, Missouri. Dr. Sadler, who was not involved in the study, is a
cochair of the ASH Scientific Program Committee. He, too, predicted
that the results will change clinical practice.

Wait for Peer Review and Publication

"Not yet," urged Ron Strauss, MD, professor of pathology and
pediatrics at the University of Iowa Hospital, in Iowa City. "We
should continue to use the standard dose of platelets until these
results are peer reviewed and published," he commented to Medscape
Oncology, adding that conclusions are often tempered in the peer-
review process.

Dr. Strauss urged caution during an educational session. "I think it
is too risky to change practice," he said. However, Dr. Slichter
said that she disagreed, and that she felt the data were robust
enough to recommend a change in clinical practice. "It is safe based
on this study," she said.

"I am not sure," said Nancy Heddle, MSc, from McMaster University,
in Hamilton, Ontario. She also urged clinicians to wait until the
study undergoes peer review and publication before implementing
changes in clinical practice. At the same session, she presented
results from the STOP (Strategies for Transfusion of Platelets)
trial, which also investigated the use of a lower dose of platelets
for transfusion, although it involved a different patient
population ¡X patients with chemotherapy-induced thrombocytopenia,
the majority of whom had acute myeloid leukemia.

The STOP trial was stopped early because of safety concerns, in
particular 3 cases of grade 4 bleeding in the low-dose group,
which "may or may not be due to chance," said Ms. Heddle. However,
further analysis showed no benefit in the low-dose group, and a
trend toward a higher burden of bleeding, although this was not
statistically significant. She did acknowledge, however, that there
was a problem with the adjudication of grading of the bleeding
episodes, because there was some disagreement about the grades
assigned among those doing the assigning.

This issue did not arise in the PLADO trial, commented Dr. Slichter,
because the adjudication of bleeding grades was done by computer,
based on data gathered on a daily basis from physical examinations,
patient interviews, chart reviews, and laboratory results.

No Difference in Risk of Bleeding

The PLADO trial set out to determine the optimal prophylactic
platelet-dose strategy to prevent bleeding in thrombocytopenic
patients. It compared 3 different doses of platelets given by
transfusion: a low dose (1.1 ¡Ñ 1011 platelets/m2), a medium dose
(2.2 ¡Ñ 1011 platelets/m2), and a high dose (4.4 ¡Ñ 1011
platelets/m2). The medium dose corresponds most closely to the
standard dose currently used, Dr. Slichter noted.

Patients enrolled in the trial had hypoproliferative
thrombocytopenia and were expected to be hospitalized with platelet
counts of 10,000 mL or less for more than 5 days. This was the
trigger for a platelet transfusion, which was given prophylactically
on days when platelet counts reached or fell to below this level.

The results show that there was no significant difference in the
risk of bleeding across any of these doses, either in World Health
Organization grade 2 bleeding, which was the primary end point, or
in the more severe cases. "The incidence of grade 2 bleeding remains
high, at around 70%, regardless of dose," Dr. Slichter commented.

However, Dr. Kaushansky cautioned that "we must guard against
generalization," and emphasized that the recommendation pertains
only to patients comparable to those in the PLADO trial. Dr.
Slichter also made this point, and noted that nearly all the
participants had hematological malignancies (only 7 patients had
solid tumors), 70% had undergone bone-marrow transplants, and the
remaining 30% were treated with chemotherapy.

"This finding is important because it will decrease the utilization
of a scare resource and will also limit the exposure of patients to
blood products from donors," commented J. Evans Sadler, MD, PhD,
from the Division of Hematology at Washington University, in St.
Louis, Missouri. Dr. Sadler, who was not involved in the study, is a
cochair of the ASH Scientific Program Committee. He, too, predicted
that the results will change clinical practice.

Wait for Peer Review and Publication

"Not yet," urged Ron Strauss, MD, professor of pathology and
pediatrics at the University of Iowa Hospital, in Iowa City. "We
should continue to use the standard dose of platelets until these
results are peer reviewed and published," he commented to Medscape
Oncology, adding that conclusions are often tempered in the peer-
review process.

Dr. Strauss urged caution during an educational session. "I think it
is too risky to change practice," he said. However, Dr. Slichter
said that she disagreed, and that she felt the data were robust
enough to recommend a change in clinical practice. "It is safe based
on this study," she said.

"I am not sure," said Nancy Heddle, MSc, from McMaster University,
in Hamilton, Ontario. She also urged clinicians to wait until the
study undergoes peer review and publication before implementing
changes in clinical practice. At the same session, she presented
results from the STOP (Strategies for Transfusion of Platelets)
trial, which also investigated the use of a lower dose of platelets
for transfusion, although it involved a different patient
population ¡X patients with chemotherapy-induced thrombocytopenia,
the majority of whom had acute myeloid leukemia.

The STOP trial was stopped early because of safety concerns, in
particular 3 cases of grade 4 bleeding in the low-dose group,
which "may or may not be due to chance," said Ms. Heddle. However,
further analysis showed no benefit in the low-dose group, and a
trend toward a higher burden of bleeding, although this was not
statistically significant. She did acknowledge, however, that there
was a problem with the adjudication of grading of the bleeding
episodes, because there was some disagreement about the grades
assigned among those doing the assigning.

This issue did not arise in the PLADO trial, commented Dr. Slichter,
because the adjudication of bleeding grades was done by computer,
based on data gathered on a daily basis from physical examinations,
patient interviews, chart reviews, and laboratory results.

No Difference in Risk of Bleeding

The PLADO trial set out to determine the optimal prophylactic
platelet-dose strategy to prevent bleeding in thrombocytopenic
patients. It compared 3 different doses of platelets given by
transfusion: a low dose (1.1 ¡Ñ 1011 platelets/m2), a medium dose
(2.2 ¡Ñ 1011 platelets/m2), and a high dose (4.4 ¡Ñ 1011
platelets/m2). The medium dose corresponds most closely to the
standard dose currently used, Dr. Slichter noted.

Patients enrolled in the trial had hypoproliferative
thrombocytopenia and were expected to be hospitalized with platelet
counts of 10,000 mL or less for more than 5 days. This was the
trigger for a platelet transfusion, which was given prophylactically
on days when platelet counts reached or fell to below this level.

The results show that there was no significant difference in the
risk of bleeding across any of these doses, either in World Health
Organization grade 2 bleeding, which was the primary end point, or
in the more severe cases. "The incidence of grade 2 bleeding remains
high, at around 70%, regardless of dose," Dr. Slichter commented.

However, Dr. Kaushansky cautioned that "we must guard against
generalization," and emphasized that the recommendation pertains
only to patients comparable to those in the PLADO trial. Dr.
Slichter also made this point, and noted that nearly all the
participants had hematological malignancies (only 7 patients had
solid tumors), 70% had undergone bone-marrow transplants, and the
remaining 30% were treated with chemotherapy.

"This finding is important because it will decrease the utilization
of a scare resource and will also limit the exposure of patients to
blood products from donors," commented J. Evans Sadler, MD, PhD,
from the Division of Hematology at Washington University, in St.
Louis, Missouri. Dr. Sadler, who was not involved in the study, is a
cochair of the ASH Scientific Program Committee. He, too, predicted
that the results will change clinical practice.

Wait for Peer Review and Publication

"Not yet," urged Ron Strauss, MD, professor of pathology and
pediatrics at the University of Iowa Hospital, in Iowa City. "We
should continue to use the standard dose of platelets until these
results are peer reviewed and published," he commented to Medscape
Oncology, adding that conclusions are often tempered in the peer-
review process.

Dr. Strauss urged caution during an educational session. "I think it
is too risky to change practice," he said. However, Dr. Slichter
said that she disagreed, and that she felt the data were robust
enough to recommend a change in clinical practice. "It is safe based
on this study," she said.

"I am not sure," said Nancy Heddle, MSc, from McMaster University,
in Hamilton, Ontario. She also urged clinicians to wait until the
study undergoes peer review and publication before implementing
changes in clinical practice. At the same session, she presented
results from the STOP (Strategies for Transfusion of Platelets)
trial, which also investigated the use of a lower dose of platelets
for transfusion, although it involved a different patient
population ¡X patients with chemotherapy-induced thrombocytopenia,
the majority of whom had acute myeloid leukemia.

The STOP trial was stopped early because of safety concerns, in
particular 3 cases of grade 4 bleeding in the low-dose group,
which "may or may not be due to chance," said Ms. Heddle. However,
further analysis showed no benefit in the low-dose group, and a
trend toward a higher burden of bleeding, although this was not
statistically significant. She did acknowledge, however, that there
was a problem with the adjudication of grading of the bleeding
episodes, because there was some disagreement about the grades
assigned among those doing the assigning.

This issue did not arise in the PLADO trial, commented Dr. Slichter,
because the adjudication of bleeding grades was done by computer,
based on data gathered on a daily basis from physical examinations,
patient interviews, chart reviews, and laboratory results.

No Difference in Risk of Bleeding

The PLADO trial set out to determine the optimal prophylactic
platelet-dose strategy to prevent bleeding in thrombocytopenic
patients. It compared 3 different doses of platelets given by
transfusion: a low dose (1.1 ¡Ñ 1011 platelets/m2), a medium dose
(2.2 ¡Ñ 1011 platelets/m2), and a high dose (4.4 ¡Ñ 1011
platelets/m2). The medium dose corresponds most closely to the
standard dose currently used, Dr. Slichter noted.

Patients enrolled in the trial had hypoproliferative
thrombocytopenia and were expected to be hospitalized with platelet
counts of 10,000 mL or less for more than 5 days. This was the
trigger for a platelet transfusion, which was given prophylactically
on days when platelet counts reached or fell to below this level.

The results show that there was no significant difference in the
risk of bleeding across any of these doses, either in World Health
Organization grade 2 bleeding, which was the primary end point, or
in the more severe cases. "The incidence of grade 2 bleeding remains
high, at around 70%, regardless of dose," Dr. Slichter commented.