Gp. Sutton et al., A PHASE-II GYNECOLOGIC-ONCOLOGY-GROUP TRIAL OF IFOSFAMIDE AND MESNA IN ADVANCED OR RECURRENT ADENOCARCINOMA OF THE ENDOMETRIUM, Gynecologic oncology, 63(1), 1996, pp. 25-27
In other Gynecologic Oncology Group (GOG) studies, ifosfamide demonstr
ated antineoplastic activity against ovarian epithelial tumors, squamo
us carcinomas of the cervix, uterine sarcomas, and trophoblastic disea
se, Responses were also observed in 15% of patients with endometrial a
denocarcinoma previously exposed to chemotherapy, This is a phase II t
rial of ifosfamide in patients with chemotherapy-naive advanced or rec
urrent endometrial adenocarcinoma, Thirty-seven patients with advanced
adenocarcinoma of the endometrium recurrent after surgery and/or radi
otherapy were treated with ifosfamide 1.2 g/m(2) intravenously daily f
or 5 days every 4 weeks and mesna 300 mg/m(2) intravenously every 4 hr
for 3 doses daily for 5 days with each course, Three patients were in
eligible-one due to a second primary, one did not have an endometrial
primary, and the other because of wrong cell type, One patient was ine
valuable for response; thus, 33 were evaluable for response, All patie
nts had undergone hysterectomy and 24 had received radiotherapy before
entering the trial, Eleven had GOG performance status of 0, 18 had a
status of 1, and 4 had performance status of 2, Median age was 68 year
s (range, 41-86 years), Grade 3 or 4 neutropenia occurred in eight pat
ients each and grade 3 thrombocytopenia was observed in one patient. O
ne patient had a grade 4 neurotoxicity, Complete responses were observ
ed in two patients (6.1%) and partial responses in six (18.2%) for an
overall response rate of 24.3%, Ifosfamide in this dose and schedule i
s an active drug in the treatment of patients with advanced or recurre
nt adenocarcinoma of the endometrium. (C) 1996 Academic Press, Inc.