[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].
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.
Meden
H
H
Universitäts-Frauenklinik Göttingen. hmeden@med.uni-goettingen.de
Fock
M
M
Krauss
T
T
Kuhn
W
W
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*
D007377:Interleukin-3; D011994:Recombinant Proteins; D003520:Cyclophosphamide; D016190:Carboplatin