Japanese Journal of Clinical Oncology 33:78-85 (2003)
© 2003 Foundation for Promotion of Cancer Research
A Dose-finding Study of Glycosylated G-CSF (Lenograstim) Combined with CHOP Therapy for Stem Cell Mobilization in Patients with Non-Hodgkin’s Lymphoma
1 Hematology Division, National Cancer Center Hospital, Tokyo, 2 Department of Internal Medicine, Nagoya University School of Medicine, Nagoya, 3 Department of Hematology–Oncology, Aichi Cancer Center, Nagoya, 4 Department of Internal Medicine, Sapporo Hokuyu Hospital, Sapporo, 5 Department of Internal Medicine, Hamamatsu University School of Medicine, Hamamatsu, Shizuoka, 6 Department of Internal Medicine, Kumamoto University School of Medicine, Kumamoto, 7 Department of Internal Medicine, Kumamoto National Hospital, Kumamoto, 8 Department of Hematology and Immunology, Kanazawa Medical University, Kanazawa, 9 Department of Chemotherapy, Tokyo Metropolitan Komagome Hospital, Tokyo and 10 Department of Medical Oncology, Niigata Cancer Center, Niigata, Japan
Background: Peripheral blood stem cell (PBSC) reinfusion has been widely used for hematopoietic reconstitution after high-dose chemotherapy. However, the optimal dose of granulocyte colony-stimulating factor (G-CSF) for PBSC mobilization in combination with chemotherapy for autograft remains unknown.
Methods: To find the optimal dose of glycosylated G-CSF (lenograstim) for PBSC mobilization in combination with chemotherapy for aggressive non-Hodgkin’s lymphoma (NHL), we conducted a dose-finding study on 43 newly diagnosed patients who had unfavorable prognostic factors. They received four to six courses of cyclophosphamide, doxorubicin, vincristine and prednisolone combined with lenograstim every 2 weeks (biweekly CHOP therapy). PBSC apheresis was started after the third course of biweekly CHOP therapy. Lenograstim was given daily from day 3 until the day of the last apheresis. The optimum dose of lenograstim was assessed based on mobilization efficacy and safety profiles at a daily single dose of 2, 5 and 10 µg/kg for eight patients in each level.
Results: The collected number of CD34+ cells in the first apheresis products was higher in the 5 µg/kg group than in the 2 µg/kg group (median, 4.22 x 106 vs 2.49 x 106 CD34+ cells/kg, P = 0.051). The highest dose of 10 µg/kg (median, 2.99 x 106 CD34+ cells/kg) failed to show a dose dependence in PBSC mobilization. The efficacy and safety of the 5 µg/kg dose were further confirmed in an additional 19 patients.
Conclusions: The present study suggests that the recommended dose of lenograstim for PBSC mobilization with CHOP therapy in untreated NHL is 5 µg/kg.
+ For reprints and all correspondence: Kensei Tobinai, Hematology Division, National Cancer Center Hospital, 5–1–1 Tsukiji, Chuo-ku, Tokyo 104-0045, Japan. E-mail: ktobinai@ncc.go.jp