Ancestim (r-metHuSCF) in combination with filgrastim to rescue mobilization and collection of peripheral blood progenitor cells for autologous transplantation. Compassionate use in 288 patients at 62 sites in France (1998–2003)

Abstract

6642 Background: Approximately 15% of patients (pts) eligible for HDC and peripheral blood progenitor cell (PBPC) transplantation, failed to generate an adequate PBPC graft. Methods: Ancestim (r-metHuSCF, Amgen, Thousand Oaks, CA) was delivered on a named-pt basis under the French Temporary Authorization for Use program to 288 pts with prior failure to achieve 20 CD34+ cells/μL peripheral blood (no leukapheresis attempt, n = 209 pts) or failure to collect an adequate PBPC yield (2x106 CD34+ cells/kg; n = 64 pts) (no. of prior failed attempts: 1 to 5)(median age 53 yrs [1 –70 yrs], n ≤ 18 yrs of age = 31) (lymphomas, 140 pts; myeloma, 84 pts; CLL, 21 pts; Ewing's sarcoma, 12 pts; neuroblastomas, 11 pts; other tumor types: 20 pts). Ancestim (20μg/kg/d) was combined with filgrastim alone (10μg/kg/d; median 7 d, 151 pts) or with chemotherapy and filgrastim (5μg/kg/d, median 12 d, 136 pts). Results: An autograft appropriate to support HDC (2x106 CD34+ cells/kg) was obtained from 106 (37%) of 288 pts after rescue with ancestim (72 of 209 pts with prior failure(s) to mobilize CD34+ cells to the peripheral blood; 29 of 64 pts with prior failure(s) of collection of an adequate CD34+ cell yield). In the 134 pts to undergo leukaphereses after the ancestim attempt, the median (range) CD34+ cell yield was 2.77 (0.03 to 39.05) x 106 cells/kg. To date, 85 pts have undergone transplantation. Hematological recovery was comparable to those obtained with filgrastim-mobilized PBPCs (platelets > 20 x 109/L : median 13 d; neutrophils > 0.5 109/L : median : 12 d). Only 2 pts have experienced anaphylactoid symptoms associated with systemic histamine release after inadvertent IV injection. Conclusions: The combination of ancestim and filgrastim allows to rescue an important number of pts who experienced prior failure of PBPC mobilization and/or collection, without any significant toxicity in this large multicenter series. Author Disclosure Employment or Leadership Consultant or Advisory Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Amgen France; Amgen UK Amgen, Inc.