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Hofstra, LS; Kristensen, GB; Willemse, PH; Vindevoghel, A; Meden, H; Lahousen, M; Oberling, F; Sorbe, B; Crump, M; Sklenar, I; Sluiter, WJ; Kiese, B; Trope, CG; de Vries, EG.
Randomized trial of recombinant human interleukin-3 versus placebo in prevention of bone marrow depression during first-line chemotherapy for ovarian carcinoma.
J Clin Oncol. 1998; 16(10):3335-3344 Doi: 10.1200/JCO.1998.16.10.3335 [OPEN ACCESS]
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Co-authors Med Uni Graz: Lahousen Manfred
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Abstract:: PURPOSE: To determine whether recombinant human interleukin-3 (rhIL-3) reduces bone marrow depression and improves chemotherapeutic schedule adherence in ovarian cancer patients receiving first-line combination chemotherapy. PATIENTS AND METHODS: In a randomized multicenter study, 185 patients received carboplatin (dose based on projected area under the concentration-time curve [AUC]=4) and cyclophosphamide (750 mg/m2) day 1, every 3 weeks for six cycles. Patients were randomized to receive rhIL-3 (5 microg/kg) or placebo once daily subcutaneously on days 3 to 12. RESULTS: Adherence to chemotherapeutic regimen, mean chemotherapy cycle length, tumor response rate, and median survival at 24 months did not differ between groups. The number of side effects-primarily allergic reactions, flu-like symptoms and fever-were higher in the rhIL-3 group, which resulted in 21 discontinuations compared with one in the placebo group. Compared with placebo, the rhIL-3 group had higher platelet counts day 1 of cycles 2 to 6. The number of patients with World Health Organization (WHO) grade IV thrombocytopenia or number of platelet transfusions did not differ. Leukocyte counts differed only in cycles 1 and 2 between groups. The leukocyte nadir occurred earlier in the rhIL-3 (day 12) than in the placebo group (day 15, P=.006). Leukocytes and neutrophils were only higher in the rhIL-3 group day 1 of cycle 2. In cycles 4 and 5, more patients with WHO grade IV neutropenia received rhIL-3 (P < .005). Eosinophil counts were higher day 1 of cycles 2 to 6 in the rhIL-3 group (P < .0001). CONCLUSION: rhIL-3 had stimulatory hematopoietic effects. This did not result either in reduction of platelet transfusions or in improvement of chemotherapeutic schedule adherence. There were more side effects in the rhIL-3 group than in the placebo group. rhIL-3 at 5 microg/kg/d is, therefore, not of clinical benefit in this chemotherapeutic regimen.
Find related publications in this database (using NLM MeSH Indexing): Adult -; Aged -; Antibodies -; Antineoplastic Combined Chemotherapy Protocols - adverse effects; Bone Marrow - drug effects; Carboplatin - administration and dosage; Cyclophosphamide - administration and dosage; Disease Progression - administration and dosage; Double-Blind Method - administration and dosage; Female - administration and dosage; Humans - administration and dosage; Interleukin-3 - adverse effects; Leukocyte Count - drug effects; Middle Aged - drug effects; Neutropenia - chemically induced; Ovarian Neoplasms - drug therapy; Platelet Count - drug effects; Recombinant Proteins - adverse effects