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REPORTE CORTO / SHORT REPORT
EFFECT OF TRANSFER FACTOR ON MYELOSUPPRESSION AND RELATED MORBIDITY INDUCED BY CHEMOTHERAPY IN ACUTE LEUKAEMIAS O. Fernandez^1, N. Diaz^1, E. Morales^1, J. Toledo^1, E. Hernandez^1, S. Rojas^1, X. Madriz^2 and Pedro Lopez-Saura^2. ^1Hospital Universitario "Dr. Carlos J. Finlay", Ave. 31 y 114, Marianao, Ciudad de La Habana, Cuba. ^2Centro de Investigaciones Biologicas, P.O. Box 6996, Ciudad de La Habana, Cuba
Code Number: BA95079
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SUMMARYThe aim of this study is to determine the safety and efficacy of Transfer Factor in accelerating the haematopoietic recovery in patients with acute leukaemias, following intensive therapy to induce remission of the disease.
INTRODUCTION Important advances have been made in the treatment of acute leukaemias (AL), which have become curable diseases. However, an intensive therapy is required to achieve the cure, especially in acute myelocytic leukaemia (1, 2). Myelosuppression and the infections and hemorrhages that follow it, have emerged as the limiting toxicities of chemotherapy (3, 4). Transfer Factor (TF) preparations have been found to contain molecules with bone marrow-stimulating or protective action as clonal expansors (5). The aim of this study is to determine the safety and efficacy of TF in accelerating the haematopoietic recovery in patients with AL, following intensive therapy to induce remission of the disease.
METHODS Twenty-two patients with different types of AL (16 acute myelocytic leukaemia - AML-, 3 myelocytic blast crisis from chronic myelocytic leukaemia - BC - CML-, and 3 acute lymphocytic leukaemia-ALL) were studied. They were between 16 and 82 years (median 41) old. There were 13 male and 9 females. The criteria for patient eligibility were: to have a leukocyte count < 1.0 x 10^9/L, a platelet count < 30 x 10^9/L, and hypoplastic or aplastic bone marrow with < 5% blast cells after the end of induction treatment. Informed consent was obtained from the patients or relatives. The patients were randomly distributed in two groups. Group 1 (8 AML, 2 BC-CML and 1 ALL) received, after myelosuppression induced by chemotherapy, TF (1 unit daily, subcutaneous) until leukocyte count was > 2.5 x 10^9/L and platelet count > 80 x 10^9/L. Group 2 did not receive TF.
RESULTS Treatment with TF accelerated the recovery of neutrophils, leukocytes, platelets and hemoglobin. The incidence and severity of infections and hemorrhages were less in the TF group than in the control group. There was no evidence that TF accelerated the re-growth of leukaemic cells. It seems that TF is safe in AL, accelerating haematopoietic recovery. However, it should be used with caution until results of additional trials become available. Days to hematopoietic recovery (X+/-SD)
--------------------------------------------------------------- Parameters Group 1 (n=10)^* Group 2 (n=9)^** P --------------------------------------------------------------- Neutrophilis> 1.0 x 10^9/L 4.7+/-2.4 22.6+/-8.5 < 0.001 Leukocytes > 2.5 x 10^9/L 4.7+/-2.4 21.1+/-9.3 < 0.001 Platelets > 80 x 10^9/L 7.5+/-3.7 17.6+/-6.8 < 0.001 Haemoglobin 10 g/L 10.0+/-5.5 20.0+/-11.5 < 0.001 ---------------------------------------------------------------^*One patient with blast cells in pancytopenia period was not included ^**Two patients that died in aplasia were not included Transfusions and antibiotic treatments
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Group 1 (n=11) Group 2 (n=11) P
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Red-cells transfusions
(units) 1.0+/-1.1 3.5+/-2.6 < 0.01
Platelet transfusions
(units) 4.1+/-5.7 19.0+/-14.7 < 0.01
Leukocyte transfusions
(units) 1.4+/-3.3 5.6+/-9.0 n.s.
Antibiotics
(days of treatment) 10.0+/-7.1 24.9+/-16.5 < 0.05
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