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. STUDY DESIGN AND 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/m2) given over 3 hours and ifosfamide (5 g/m2) given over 24 hours (TI) on Day 1. G‐CSF at 10 μg 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 × 106 CD34+ cells per kg. Furthermore, leukapheresis procedures yielded comparable doses of CD34+ cells per kg (3.4 × 106 vs. 3.6 × 106; p = 0.82), MNCs per kg (2.7 × 108 vs. 2.6 × 108; p = 0.18), and CFU‐GM per kg (15.9 × 104 vs. 19.3 × 104; p = 0.20). Patients in Group A had higher numbers of circulating CD34+ cells on Day 10 (103.0/μL vs. 46.8/μL; p = 0.10) and on Day 11 (63.0/μL vs.14.3/μL; p = 0.04) than did patients in Group B. CONCLUSION: 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.