title: Phase II experience with ifosfamide/mesna in gynecologic malignancies: preliminary report of Gynecologic Oncology Group studies.
abstract: The Gynecologic Oncology Group initiated a series of phase II trials of ifosfamide/mesna in women with advanced or recurrent gynecologic malignancies in July 1985. Previously untreated patients received ifosfamide, 1.5 g/m2/d, intravenously (IV) for five days. Mesna was given IV in three doses every four hours after ifosfamide; each dose was 20% of the daily ifosfamide dose (ie, 300 mg/m2). All patients with ovarian and 87% of those with cervical cancer had undergone platinum-based therapy previously. Because of the toxicity encountered in previously treated ovarian cancer patients, the dose of ifosfamide was reduced to 1.2 g/m2/d in patients who had received prior chemotherapy or radiotherapy. In epithelial ovarian carcinoma, responses were observed in eight (21.6%) of 37 evaluable patients with three (8.1%) complete responses. Response duration was 2.1 to 20.3+ months with a median of 6.9+ months. In squamous carcinoma of the cervix, three (11.1%) of 27 evaluable patients had partial responses of 1.8, 2.2, and 3.1 months' duration. Of 29 untreated patients with mixed mesodermal tumors of the uterus, five (17.9%) had complete and four (14.3%) had partial responses for an overall response rate of 32.2%. Response duration was 1.4+ to 8.6 months with a median of 3.8 months. Toxicity included two deaths from renal insufficiency and a third related to neurologic impairment. Hematologic toxicity was manageable. Ifosfamide/mesna has activity in a wide range of gynecologic malignancies.
authors.affiliation: Department of Gynecologic Oncology, Indiana University School of Medicine, Indianapolis 46223.
authors.forename: G P
authors.initials: GP
authors.lastname: Sutton
authors.forename: J A
authors.initials: JA
authors.lastname: Blessing
authors.forename: G
authors.initials: G
authors.lastname: Photopulos
authors.forename: M L
authors.initials: ML
authors.lastname: Berman
authors.forename: H D
authors.initials: HD
authors.lastname: Homesley
mesh_terms: D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use; D016190:Carboplatin; D002277:Carcinoma / Q000188:drug therapy; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy; D002945:Cisplatin / Q000008:administration & dosage; D004341:Drug Evaluation; D005260:Female; D006801:Humans; D007069:Ifosfamide / Q000009:adverse effects / Q000627:therapeutic use*; D008623:Mercaptoethanol / Q000031:analogs & derivatives*; D015080:Mesna / Q000008:administration & dosage*; D008875:Middle Aged; D009373:Neoplasms, Germ Cell and Embryonal / Q000188:drug therapy; D009944:Organoplatinum Compounds / Q000008:administration & dosage; D010051:Ovarian Neoplasms / Q000188:drug therapy*; D002583:Uterine Cervical Neoplasms / Q000188:drug therapy*; D014594:Uterine Neoplasms / Q000188:drug therapy*
chemical_list: D009944:Organoplatinum Compounds; C023359:iproplatin; D008623:Mercaptoethanol; D016190:Carboplatin; D015080:Mesna; D002945:Cisplatin; D007069:Ifosfamide