title: Early phase II Gynecologic Oncology Group experience with ifosfamide/mesna in gynecologic malignancies.
abstract: Starting in July 1985, the Gynecologic Oncology Group conducted a series of phase II trials with ifosfamide/mesna in advanced or recurrent gynecologic malignancies. Previously untreated patients received 1.5 g/m2 i.v. ifosfamide daily for 5 days. Mesna was given i.v. q4h x 3 following ifosfamide; each dose was 20% of the daily ifosfamide dose. All patients with ovarian and 87% of those with cervical cancer had previously undergone platinum-based therapy. Because of the toxicity encountered in previously treated patients with ovarian carcinoma, the dose of ifosfamide was reduced to 1.2 g/m2 daily in all patients who had received prior chemo- or radiotherapy. In epithelial ovarian carcinoma, responses were observed in 8 (20.0%) of 41 evaluable patients, with 3 (7.0%) complete responses. Response duration was 2.1-20.3+ months, with a median of 6.9+ months. In squamous-cell carcinoma of the cervix, 3 (11.1%) of 27 evaluable patients showed partial responses of 1.8, 2.2, and 3.1 months' duration. Of 26 untreated patients with mixed mesodermal tumors of the uterus, 5 (19.2%) achieved complete and 3 (11.5%) showed partial responses, for an overall response rate of 30.7%. Response duration was 1.4(+)-8.6 months, with a median of 3.8 months. Toxicity included two deaths due to 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: Gynecologic Oncology Group, Philadelphia, PA 19107.
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: D000970:Antineoplastic Agents / Q000627:therapeutic use*; D002277:Carcinoma / Q000188:drug therapy; D004341:Drug Evaluation; D005260:Female; D006801:Humans; D007069:Ifosfamide / Q000008:administration & dosage* / Q000009:adverse effects; D008623:Mercaptoethanol / Q000031:analogs & derivatives*; D015080:Mesna / Q000008:administration & dosage*; D008875:Middle Aged; D010051:Ovarian Neoplasms / Q000188:drug therapy*; D012509:Sarcoma / Q000188:drug therapy; D002583:Uterine Cervical Neoplasms / Q000188:drug therapy*
chemical_list: D000970:Antineoplastic Agents; D008623:Mercaptoethanol; D015080:Mesna; D007069:Ifosfamide