Amifostine does not reduce the toxicity of the fludarabine and cyclophosphamide regimen in patients with chronic lymphocytic leukemia.
OBJECTIVE
Amifostine is an organic thiophosphate that may selectively protect normal tissues from the toxicities of chemotherapy. The combination of fludarabine and cyclophosphamide (FC) is highly active in patients with chronic lymphocytic leukemia (CLL). Infection is a serious toxicity of the FC regimen.


METHODS
Amifostine was added to the FC regimen in a phase II study of 46 patients with CLL. Patients received FCA (fludarabine 30 mg/m(2) i.v. daily for 3 days, cyclophosphamide 300 mg/m(2) i.v. daily for 3 days, and amifostine 500 mg i.v. over 15 min daily for 3 days starting 30 min before cyclophosphamide) at intervals of 4-6 weeks for a maximum of six courses.


RESULTS
Patients receiving FCA had equivalent rates of sepsis, early death, objective response and survival to those observed in a prior series of 78 patients treated with FC. Amifostine-associated toxicities included nausea, vomiting, and hypotension.


CONCLUSIONS
The study amifostine regimen did not reduce the toxicity or activity of the FC regimen in patients with CLL.
Giles
Francis J
FJ
Department of Leukemia, The University of Texas, M.D. Anderson Cancer Center, 1400 Holcombe Boulevard, Houston, TX 77030, USA. frankgiles@aol.com
Shi
Gary Guangping
GG
Cortes
Jorge E
JE
Thomas
Deborah
D
Keating
Anna R
AR
Kantarjian
Hagop M
HM
Keating
Michael J
MJ
O'Brien
Susan M
SM
D004999:Amifostine / Q000627:therapeutic use*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects*; D003520:Cyclophosphamide / Q000008:administration & dosage; D005260:Female; D006801:Humans; D015451:Leukemia, Lymphocytic, Chronic, B-Cell / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D008297:Male; D008875:Middle Aged; D011837:Radiation-Protective Agents / Q000627:therapeutic use*; D018805:Sepsis / Q000139:chemically induced / Q000517:prevention & control; D015996:Survival Rate; D014740:Vidarabine / Q000008:administration & dosage / Q000031:analogs & derivatives*
D011837:Radiation-Protective Agents; D003520:Cyclophosphamide; D014740:Vidarabine; D004999:Amifostine; C024352:fludarabine