Phase II trial of ifosfamide and mesna in leiomyosarcoma of the uterus: a Gynecologic Oncology Group study.
OBJECTIVE
The purpose of this study was to evaluate the activity of ifosfamide (isophosphamide) in patients with advanced or recurrent leiomyosarcoma not previously exposed to chemotherapy.


METHODS
This is a phase II groupwide study of the Gynecologic Oncology Group. Thirty-five patients were treated with ifosfamide 1.5 gm/m2 daily intravenously for 5 days with mesna (mercaptoethane sodium sulfonate). Fifty-six patients had received prior abdominal hysterectomy and 15 prior radiotherapy. The dose was reduced to 1.2 gm/m2 daily in patients who had received prior radiotherapy.


RESULTS
Gynecologic Oncology Group grade III or IV granulocytopenia occurred in 4 (11%) patients, and none had grade IV thrombocytopenia. One (2.8%) patient had grade IV neurotoxicity. Partial responses were observed in 6 of 35 (17.2%) patients. The 95% confidence interval for response was 6.6% to 33.7%.


CONCLUSIONS
These results indicate that ifosfamide has modest activity in patients with advanced or recurrent leiomyosarcomas of the uterus.
Sutton
G P
GP
Section of Gynecologic Oncology, Indiana University Medical School.
Blessing
J A
JA
Barrett
R J
RJ
McGehee
R
R
D000328:Adult; D000368:Aged; D000380:Agranulocytosis / Q000139:chemically induced; D004341:Drug Evaluation; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D007069:Ifosfamide / Q000009:adverse effects / Q000627:therapeutic use*; D007890:Leiomyosarcoma / Q000188:drug therapy*; D015080:Mesna / Q000627:therapeutic use*; D008875:Middle Aged; D012074:Remission Induction; D014594:Uterine Neoplasms / Q000188:drug therapy*
D015080:Mesna; D007069:Ifosfamide