title: Low-dose interleukin-11 in patients with bone marrow failure: update of the M. D. Anderson Cancer Center experience.
abstract: BACKGROUND
  Recombinant interleukin (IL)-11 is a thrombopoietic growth factor. The purpose of this study was to assess the toxicity, safety and efficacy of low-dose recombinant IL-11 in patients with bone marrow failure (BMF).
  
  
  METHODS
  Patients with BMF due to myelodysplastic syndromes (MDS), graft failure, chemotherapy or aplastic anemia (AA) were treated. Patients were required to have a platelet count of <20 x 10(9)/l, or a platelet count of <50 x 10(9)/l with an absolute neutrophil count <1 x 10(9)/l, or a hemoglobin value <10 g/dl. Treatment consisted of daily IL-11 at a dose of 10 mug/kg subcutaneously followed by a 2-week rest period. Two induction courses were given. Responders could receive maintenance therapy.
  
  
  RESULTS
  Thirty-three patients (MDS, n=14; AA, n=16; prolonged thrombocytopenia following stem cell transplantation or chemotherapy, n=3) were evaluable. Their median age was 58 years (range 5-85). Three patients (9%) had poor risk cytogenetics. Nine patients (27%) responded to IL-11 (six MDS, three AA). Of these, three patients treated with IL-11 alone (n=1) or IL-11 together with other growth factors (n=2) showed multilineage recovery. The median time to response was 0.9 months (range 0.3-11). Factors associated with higher response rates in univariate analysis were age >50 years (P=0.008), diagnosis of MDS versus AA (P=0.025) and creatinine level >1 mg/dl (P=0.0004). The median response duration was 3 months (range 1.4-34.5+). Amongst responders, the median increment in platelet count was 111 x 10(9)/l (range 43-165). The most common side-effects were grade 1-2 lower extremity edema, conjunctival injections and fatigue. Grade 3 toxicities included arrhythmia (n=1) and transient ischemic attack (n=1). Ten patients (30%) had no side-effects.
  
  
  CONCLUSIONS
  Low-dose IL-11 has activity in patients with BMF and is generally well tolerated.
authors.affiliation: Department of Leukemia, University of Texas, M. D. Anderson Cancer Center, Houston, TX 77030, USA.
authors.forename: A-M
authors.initials: AM
authors.lastname: Tsimberidou
authors.forename: F J
authors.initials: FJ
authors.lastname: Giles
authors.forename: I
authors.initials: I
authors.lastname: Khouri
authors.forename: C
authors.initials: C
authors.lastname: Bueso-Ramos
authors.forename: S
authors.initials: S
authors.lastname: Pilat
authors.forename: D A
authors.initials: DA
authors.lastname: Thomas
authors.forename: J
authors.initials: J
authors.lastname: Cortes
authors.forename: R
authors.initials: R
authors.lastname: Kurzrock
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000741:Anemia, Aplastic / Q000150:complications; D001855:Bone Marrow Diseases / Q000188:drug therapy*; D016026:Bone Marrow Transplantation / Q000009:adverse effects; D002648:Child; D002675:Child, Preschool; D005260:Female; D006084:Graft Rejection / Q000150:complications; D006801:Humans; D017370:Interleukin-11 / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D009190:Myelodysplastic Syndromes / Q000150:complications; D013921:Thrombocytopenia / Q000150:complications / Q000188:drug therapy* / Q000209:etiology*; D016896:Treatment Outcome
chemical_list: D017370:Interleukin-11