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Randomized, Controlled, Dose-Range Study of Ro 25-8315 Given Before and After a High-Dose Combination Chemotherapy Regimen in Patients With Metastatic or Recurrent Breast Cancer Patients

From the Department of Oncology, Institut Paoli-Calmettes, Marseille; Institut Curie and Quintiles, Paris; Centre René Huguenin, St Cloud; Centre Léon Bérard, Lyon; Hôpital Hautepierre and Quintiles SA, Strasbourg, France; Eberhard-Karls-Universität, Tübingen, and Amtsgartenweg 13, Badenweiler, Germany; and Hoffmann-La Roche Inc, Basel, Switzerland.

Address reprint requests to Patrice Viens, MD, Department of Medical Oncology, Institut Paoli-Calmettes, 232 Blvd Sainte Marguerite, 13273 Marseille Cedex 9, France; email: viensp{at}marseille .fnclcc.fr.

PURPOSE: To evaluate the safety, pharmacokinetics, and efficacy of three different dose levels of pegylated granulocyte colony-stimulating factor (Ro 25-8315) on progenitor cell mobilization and hematologic recovery in cancer patients.

PATIENTS AND METHODS: Breast cancer patients (n = 36) were randomly assigned to receive before (part I) and after (part II) chemotherapy either a single-dose injection of Ro 25-8315 (20 µg/kg, n = 9; 60 µg/kg, n = 9; 100 µg/kg, n = 10) or a standard daily dose of filgrastim (part I, 10 µg/kg/d; part II, 5 µg/kg/d) (control group, n = 8).

RESULTS: Overall, Ro 25-8315 was well tolerated. In part I, more progenitor cell mobilization was observed with Ro 25-8315 100 µg/kg. The peak of circulating CD34⁺ cells was obtained at day +5 in the four groups, and the absolute neutrophil count (ANC) returned to less than 20 x 10⁹/L by day +15. In part II, high levels of circulating CD34⁺ cells (> 20 cells/µL) were obtained in all four groups. The chemotherapy-induced neutropenia (< 1 x 10⁹/L) was similar in the four groups. Ro 25-8315 100 µg/kg was more effective than filgrastim in reducing the number of patients with an ANC less than 0.5 x 10⁹/L on day +12 after chemotherapy.

CONCLUSION: A single injection of Ro 25-8315 100 µg/kg might be the optimal dose for steady-state peripheral-blood progenitor cell mobilization. A single injection of 20, 60, or 100 µg/kg could be as efficient as daily administration of filgrastim to correct chemotherapy-induced cytopenia. The optimal dose of Ro 25-8315 should be determined according to the planned chemotherapy regimen.

P.VdA. and R.C. declare a financial interest in the company whose product was studied in the present report. P.VdA. declares a financial interest in a competing company whose product was studied in the present report.

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