title: Pilot study of low-dose interleukin-11 in patients with bone marrow failure.
abstract: OBJECTIVE
  Interleukin-11 (IL-11) is a thrombopoietic cytokine that attenuates postchemotherapy thrombocytopenia at doses of 50 microg/kg/d subcutaneously. Very little is known about the activity of IL-11 in patients with bone marrow failure states.
  
  
  METHODS
  Our preliminary experience with IL-11 at doses of 50 microg/kg/d suggested that patients with bone marrow failure developed significant peripheral and pulmonary edema after the prolonged dosing necessary for treating these conditions. We, therefore, initiated a study of low-dose IL-11 (starting dose, 10 microg/kg/d).
  
  
  RESULTS
  Sixteen patients were assessable for response. Six patients had diploid cytogenetics; the others had a variety of chromosomal abnormalities. Six (38%) of 16 patients showed a platelet response to IL-11, and two had a multilineage response (to IL-11 alone, n = 1; to IL-11 plus G-CSF and erythropoietin, n = 1). The median increase in peak platelet counts was 95 x 10(9)/L above baseline in the responders (range, increase of 55 x 10(9)/L to 130 x 10(9)/L above baseline). Responders included five of 11 patients with myelodysplasia and one of four patients with aplastic anemia. Response durations were 12, 13, 14+, 25, 30, and 30+ weeks. Side effects of IL-11 were mild (peripheral edema, n = 7; conjunctival injection, n = 7; myalgia, n = 1; all grade 1). Seven patients had no side effects.
  
  
  CONCLUSIONS
  Our pilot study suggests that administration of low-dose IL-11 (10 microg/kg/d) can raise platelet counts without significant toxicity in selected thrombocytopenic patients with bone marrow failure.
authors.affiliation: Department of Bioimmunotherapy, University of Texas M.D. Anderson Cancer Center, Houston, TX 77030, USA. rkurzoc@mdanderson.org
authors.forename: R
authors.initials: R
authors.lastname: Kurzrock
authors.forename: J
authors.initials: J
authors.lastname: Cortes
authors.forename: D A
authors.initials: DA
authors.lastname: Thomas
authors.forename: S
authors.initials: S
authors.lastname: Jeha
authors.forename: S
authors.initials: S
authors.lastname: Pilat
authors.forename: M
authors.initials: M
authors.lastname: Talpaz
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000741:Anemia, Aplastic / Q000188:drug therapy*; D001854:Bone Marrow Cells / Q000166:cytology; D002648:Child; D002675:Child, Preschool; D004334:Drug Administration Schedule; D004921:Erythropoietin / Q000627:therapeutic use; D005260:Female; D016179:Granulocyte Colony-Stimulating Factor / Q000627:therapeutic use; D006801:Humans; D017370:Interleukin-11 / Q000008:administration & dosage / Q000627:therapeutic use*; D007621:Karyotyping; D008297:Male; D008875:Middle Aged; D009190:Myelodysplastic Syndromes / Q000188:drug therapy*; D010865:Pilot Projects; D010976:Platelet Count; D013921:Thrombocytopenia / Q000188:drug therapy*
chemical_list: D017370:Interleukin-11; D004921:Erythropoietin; D016179:Granulocyte Colony-Stimulating Factor