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 a nd ifosfamide plus G-CSF was assessed. STUDY DESIGN AND METHODS: Forty patients with a median age of 34 years (ran ge, 19-53) who had germ cell tumor were evaluated for high-dose chemotherap y. Patients were randomly assigned to receive either a single 500-mg dose o f amifostine (Group A, n = 20) or no amifostine (Group B, n = 20) before mo bilization chemotherapy with paclitaxel (175 mg/m(2)) given over 3 hours an d ifosfamide (5 g/m(2)) given over 24 hours (TI) on Day 1.G-CSF at 10 mug p er kg per day was given subsequent to TI with or without amifostine from Da y 3 until the end of leukapheresis procedures. RESULTS: In 2 (10%) of 20 patients receiving amifostine and 3 (15%) of 20 p atients not receiving it, no PBPC separation was performed because of mobil ization failure. No significant differences were observed in the study arms with regard to the time from chemotherapy until first PBPC collection or t he number of apheresis procedures needed to harvest more than 2.5 x 10(6) C D34+ 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 1 0(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/muL vs. 46.8/muL; p = 0.10) and o n Day 11 (63.0/ muL vs.14.3/muL; p = 0.04) than did patients in Group B. CONCLUSION: Administration of a single dose of amifostine before chemothera py with TI mobilized higher numbers of CD34 cells in the circulation, but d id not enhance the overall collection efficiency in the present trial.