Crump, M

de Vries, EGE

Hofstra, LS

Kiese, B

Kristensen, GB

Lahousen, M

Meden, H

Oberling, F

Sklenar, [No Value]

Sluiter, WJ

Sorbe, B

Trope, CG

Vindevoghel, A

Willemse, PHB

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/m(2)) day 1, every 3 weeks for six cycles. Patients were randomized to receive rhIL-3 (5 mu g/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 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 &lt;.005). Eosinophil counts were higher day 1 of cycles 2 to 6 in the rhIL-3 group (P &lt;.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 mu g/kg/d is, therefore, not of clinical benefit in this chemotherapeutic regimen. (C) 1998 by American Society of Clinical Oncology.</p

ARTS repository - University of Groningen

Randomized trial of recombinant human interleukin-3 versus placebo in prevention of bone marrow depression during first-line chemotherapy for ovarian carcinoma

Randomized trial of recombinant human interleukin-3 versus placebo in prevention of bone marrow depression during first-line chemotherapy for ovarian carcinoma

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ARTS repository - University of Groningen