title: [Efficiency, safety and tolerability of recombinant human interleukin-3 (rhIL-3) as supportive therapy accompanying dose-intensive carboplatin containing chemotherapy in ovarian cancer with special regard to thrombocytopenia].
abstract: OBJECTIVE
  In a prospective, randomized, placebo-controlled double-blind trial we evaluated to what extent a dose-intensification of adjuvant chemotherapy is possible with the help of Interleukin-3 (rhIL-3).
  
  
  METHODS
  Following initial surgery, 12 patients with primary ovarian cancer have been treated with Carboplatin and Cyclophosphamide (dosage: AUC 4 according to Calvert). After randomisation, a group of 6 patients prophylacticly received rhIL-3 against myelosuppression on days 3-12 of the cycle, in contrast to a group of 6 patients who received placebo-injections.
  
  
  RESULTS
  The patients treated with rhIL-3 showed less hematologic side-effects. Adherence to 4-weekly chemotherapy courses was more frequent in the rhIL-3-group (73% vs. 44%, p = 0.005). An intensification of the chemotherapy with 3-weekly courses did not succeed significantly. Observed side-effects of rhIL-3-therapy were headaches, fever, flu-like symptoms, rashes and blisters at the site of injection which excluded 2 of 6 patients from the study.
  
  
  CONCLUSIONS
  Supportive rhIL-3 to adjuvant Carboplatin-based chemotherapy enables a better keeping of 4-weekly courses in contrast to the placebo-group due to faster recovery of hematologic parameters. Due to the side-effects, of IL-3, this cytokine cannot be recommended for routine clinical use.
authors.affiliation: Universitäts-Frauenklinik Göttingen. hmeden@med.uni-goettingen.de
authors.forename: H
authors.initials: H
authors.lastname: Meden
authors.forename: M
authors.initials: M
authors.lastname: Fock
authors.forename: T
authors.initials: T
authors.lastname: Krauss
authors.forename: W
authors.initials: W
authors.lastname: Kuhn
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D016190:Carboplatin / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use*; D003520:Cyclophosphamide / Q000008:administration & dosage; D005260:Female; D006801:Humans; D007377:Interleukin-3 / Q000009:adverse effects / Q000627:therapeutic use*; D008875:Middle Aged; D009367:Neoplasm Staging; D010051:Ovarian Neoplasms / Q000188:drug therapy* / Q000473:pathology; D011446:Prospective Studies; D011994:Recombinant Proteins / Q000009:adverse effects / Q000627:therapeutic use; D012449:Safety; D013921:Thrombocytopenia / Q000139:chemically induced* / Q000628:therapy*
chemical_list: D007377:Interleukin-3; D011994:Recombinant Proteins; D003520:Cyclophosphamide; D016190:Carboplatin