Cyclophosphamide or ifosfamide in patients with advanced and/or recurrent endometrial carcinoma: a randomized phase II study of the EORTC Gynecological Cancer Cooperative Group

Currently, available chemotherapy regimens for patients with advanced or re current endometrial cancer are generally not curative. Thus, there is a nee d to identify more active single agents in this disease. In this study pati ents pre-treated and not pre-treated with first line combination chemothera py were entered into a randomized phase II study of either cyclophosphamide (CYCLO) or Ifosfamide (LFOS). Patients and method: Sixty one eligible pati ents with recurrent or metastatic histologically proven, adenocarcinoma of the uterine corpus entered the study. The median age at entry was 62 (range 40-74) years. Twenty patients (33%) had prior hormonal treatment and 31 (5 1%) prior chemotherapy. CYCLO was given at a dose of 1200 mg/m(2) and IFOS at a dose of 5 g/m(2). Both drugs were administered i.v. over 24 hours on d ay one every three weeks. Adequate pre- and post hydration as well as use o f Mesna in the Ifosfamide arm were mandatory. Results: A median of two trea tment cycles (range 1-12) per patient were given. In the chemotherapy-naive patients, in the CYCLO arm two PRs (RR 14%, C.I. 2-43%) were seen and in t he IFOS arm two CRs, two PRs, (RR 25%, C.I. 7-52%) were observed. No respon ses were seen in pre-treated patients. The duration of responses were: 15(), 7(+) months for the CRs, 15(+) and 5 months for PRs in LFOS arm and 67(), 4 months in CYCLO arm. The hematological toxicity was dose-limiting and similar in both treatment arms. No serious non hematological toxicities wer e reported, but a transient increase of the creatinine blood level was seen in two IFOS patients (6%). Conclusion: Ifosfamide is an active drug in the treatment of chemotherapy-naive patients with advanced endometrial cancer and its application in currently used (combination) regimens should be cons idered. (C) 1999 Elsevier Science Ireland Ltd. All rights reserved.