Ifosfamide/liposomal daunorubicin is a well tolerated and active first-line chemotherapy regimen in advanced soft tissue sarcoma: results of a phase II study.
BACKGROUND
The anthracycline/ifosfamide combination is the most effective chemotherapy in soft tissue sarcoma. To improve the tolerability and potential efficacy of this combination, the authors combined a moderate dose of continuous infusion ifosfamide with liposomal daunorubicin (L-Dauno).


METHODS
In a single-arm, Phase II study, 40 patients with a median age of 57 years (range, 19-78 years) were enrolled. Of these, 35 patients were treated with first-line chemotherapy. The treatment regimen was comprised of ifosfamide at a dose of 5 g/m(2) over 24 hours and L-Dauno at a dose of 100 mg/m(2) every 4 weeks with granulocyte-colony-stimulating factor support.


RESULTS
Eleven (31%) of 35 anthracycline/ifosfamide-naive patients achieved a partial/complete response, 6 patients (17%) had stable disease, and 13 patients (37%) had disease progression. Three patients were not evaluable, and there were two intermittent deaths. The median time to disease progression was 6 months, the median overall survival was 14 months, and the median time to treatment failure was 15 months. Toxicity was tolerable.


CONCLUSIONS
The combination of Ifosfamide and L-Dauno was found to be a highly active chemotherapy regimen for first-line treatment of soft tissue sarcoma. Therefore, we believe randomized studies with this regimen are warranted.
Siehl
Jan M
JM
Medizinische Klinik III, Campus Benjamin Franklin, Hindenburgdamm 30, 12200 Berlin, Germany. janmichael.siehl@charite.de
Thiel
Eckhard
E
Schmittel
Alexander
A
Hütter
Gero
G
Deckert
Peter M
PM
Szelényi
Hubert
H
Keilholz
Ulrich
U
D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D003630:Daunorubicin / Q000008:administration & dosage; D018450:Disease Progression; D004334:Drug Administration Schedule; D005260:Female; D016179:Granulocyte Colony-Stimulating Factor / Q000008:administration & dosage; D006801:Humans; D007069:Ifosfamide / Q000008:administration & dosage; D007262:Infusions, Intravenous; D008081:Liposomes; D008297:Male; D020714:Maximum Tolerated Dose; D008875:Middle Aged; D012509:Sarcoma / Q000188:drug therapy* / Q000473:pathology; D015996:Survival Rate; D016896:Treatment Outcome
D008081:Liposomes; D016179:Granulocyte Colony-Stimulating Factor; D007069:Ifosfamide; D003630:Daunorubicin