HIGH-DOSE THERAPY FOLLOWED BY AUTOLOGOUS PERIPHERAL-BLOOD STEM-CELL TRANSPLANTATION FOR PATIENTS WITH HODGKINS-DISEASE AND NON-HODGKINS-LYMPHOMA USING UNPRIMED AND GRANULOCYTE-COLONY-STIMULATING FACTOR-MOBILIZED PERIPHERAL-BLOOD STEM-CELLS

Purpose: To evaluate (1) the effect of granulocyte colony-stimulating factor (G-CSF) on peripheral-blood stem-cell (PBSC) mobilization; (2) the rate of hematopoietic recovery after G-CSF-mobilized PBSC transpla ntation; and (3) the outcome of high-dose myeloablative therapy and PB SC transplantation in patients with relapsed or refractory lymphoma. P atients and Methods: Ninety-five patients with lymphoma underwent high -dose therapy followed by PBSC transplant in three sequentially treate d cohorts of patients in a nonrandomized study. The first 30 patients received nonmobilized PBSCs (unprimed) without G-CSF after transplant, the next 26 patients received PBSC that were mobilized with G-CSF 5 m u g/kg/d (primed-5) plus G-CSF after transplant, and the last 39 patie nts received PBSC mobilized by G-CSF 10 mu g/kg/d (primed-10) plus G-C SF after transplant. The conditioning regimen consisted of fractionate d total-body irradiation (FTBI) 12 Gy in combination with etoposide 60 mg/kg and cyclophosphamide 100 mg/kg. patients with prior radiotherap y received carmustine (BCNU) 450 mg/m(2) instead of FTBI. Results: The use of G-CSF-mobilized PBSCs in combination with C-CSF posttransplant resulted in a significantly accelerated time to recovery of both gran ulocyte and platelet when compared with the unprimed group. The median number of days to an absolute granulocyte count (ANC) of greater than 0.5 x 10(9)/L was 10 days for G-CSF primed versus 20 days for the unp rimed (P = .0001). The median days to platelet transfusion independenc e was 16 and 31 days (P = .0001) for the G-CSF primed and unprimed, re spectively. There were also significant reductions in the number of pl atelet (P = .02) and RBC transfusions (P = .006) far the G-CSF primed. Multivariate analysis of prognostic factors identified CD34(+) cell d ose as the only additional factor predicting engraftment. Sixty-nine p atients are alive at a median follow-up of 15.9 months (range, 7.4 to 63.7). The cumulative probability of 2-year disease-free survival is 5 9% (95% confidence interval [CI], 36% to 79%) and 39% (95% CI 25% to 5 5%) for patients with Hodgkin's disease and non-Hodgkin's lymphoma, re spectively. Conclusion: The use of G-CSF-mobilized PBSC after high-dos e myeloablative therapy resulted in a rapid, complete, and sustained h ematopoietic recovery. Disease-free survival over 2 years can be achie ved in some patients with relapsed lymphoma after high-dose therapy an d PBSC transplantation. However, longer followup is required to confir m the curability of this approach. (C) 1994 by American Society of Cli nical Oncology.