PBPC mobilization with paclitaxel, ifosfamide, and G-CSF with or without amifostine: results of a prospective randomized trial.
BACKGROUND
The impact of amifostine on PBPC mobilization with paclitaxel and ifosfamide plus G-CSF was assessed.


METHODS
Forty patients with a median age of 34 years (range, 19-53) who had germ cell tumor were evaluated for high-dose chemotherapy. Patients were randomly assigned to receive either a single 500-mg dose of amifostine (Group A, n = 20) or no amifostine (Group B, n = 20) before mobilization chemotherapy with paclitaxel (175 mg/m(2)) given over 3 hours and ifosfamide (5 g/m(2)) given over 24 hours (TI) on Day 1. G-CSF at 10 microg per kg per day was given subsequent to TI with or without amifostine from Day 3 until the end of leukapheresis procedures.


RESULTS
In 2 (10%) of 20 patients receiving amifostine and 3 (15%) of 20 patients not receiving it, no PBPC separation was performed because of mobilization failure. No significant differences were observed in the study arms with regard to the time from chemotherapy until first PBPC collection or the number of apheresis procedures needed to harvest more than 2.5 x 10(6) CD34+ cells per kg. Furthermore, leukapheresis procedures yielded comparable doses of CD34+ cells per kg (3.4 x 10(6) vs. 3.6 x 10(6); p = 0.82), MNCs per kg (2.7 x 10(8) vs. 2.6 x 10(8); p = 0.18), and CFU-GM per kg (15.9 x 10(4) vs. 19.3 x 10(4); p = 0.20). Patients in Group A had higher numbers of circulating CD34+ cells on Day 10 (103.0/microL vs. 46.8/microL; p = 0.10) and on Day 11 (63.0/microL vs.14.3/microL; p = 0.04) than did patients in Group B.


CONCLUSIONS
Administration of a single dose of amifostine before chemotherapy with TI mobilized higher numbers of CD34 cells in the circulation, but did not enhance the overall collection efficiency in the present trial.
Rick
O
O
Division of Internal Medicine and the Departments of Hematology and Medical Oncology, Charité, Campus Virchow Klinikum, Berlin, Germany. oliver.rick@charite.de
Schwella
N
N
Beyer
J
J
Dubiel
M
M
Krusch
A
A
Hildebrandt
M
M
Schleicher
J
J
Serke
S
S
Siegert
W
W
D000328:Adult; D004999:Amifostine / Q000008:administration & dosage / Q000494:pharmacology*; D018952:Antigens, CD34 / Q000097:blood; D001800:Blood Specimen Collection; D004305:Dose-Response Relationship, Drug; D016179:Granulocyte Colony-Stimulating Factor / Q000494:pharmacology*; D019650:Hematopoietic Stem Cell Mobilization; D006412:Hematopoietic Stem Cells / Q000276:immunology; D006801:Humans; D007069:Ifosfamide / Q000494:pharmacology*; D008875:Middle Aged; D009373:Neoplasms, Germ Cell and Embryonal / Q000188:drug therapy; D017239:Paclitaxel / Q000494:pharmacology*; D010865:Pilot Projects; D011446:Prospective Studies
D018952:Antigens, CD34; D016179:Granulocyte Colony-Stimulating Factor; D004999:Amifostine; D017239:Paclitaxel; D007069:Ifosfamide