Feasibility trial of high-dose 7-day continuous-infusion ifosfamide given on an outpatient basis.
High-dose ifosfamide (HD-IFX) has shown significant antitumor activity in advanced sarcoma and breast carcinoma. The use of uroprotective agents and the availability of ambulatory continuous-infusion pumps has allowed dose escalation in the administration of ifosfamide (IFX) on an outpatient schedule. We report the results of a phase II trial of IFX given at high doses to heavily pretreated patients. IFX was infused at 2 g/m2 per day for a total of 7 days through a central venous access, with cycles being repeated every 21 days. Mesna was given concomitantly at equimolar doses. No hematopoietic support was used. A total of 27 heavily pretreated patients whose disease had progressed during conventional-dose chemotherapy were included (14 sarcomas, 10 breast carcinomas, and 3 bladder carcinomas). Reversible neutropenia and gastrointestinal toxicity were the most frequently encountered toxicities. Only two patients developed transient renal failure, and two others developed central nervous system toxicity. No treatment-related death was observed. Of 22 patients who were evaluable for response, 6 (27%) showed an objective response (OR), all ORs being partial responses (PRs) with a median duration of 6 months, and 12 patients had stable disease (SD; 55%) with a median duration of 3.5 months. The median overall survival (OS) was 6 months. Three patients underwent high-dose chemotherapy after showing a response to our IFX schedule. We conclude that continuous-infusion IFX given in an outpatient setting is a feasible and active regimen that produces, a manageable toxicity profile in heavily pretreated breast cancer and sarcoma patients. Early institution of this schedule in less advanced stages could improve the results obtained.
Bellmunt
J
J
Medical Oncology Department, Hospital General Universitari Vall d'Hebron, Barcelona, Spain.
Eres
N
N
Ribas
A
A
Casado
S
S
Albanell
J
J
Baselga
J
J
D018906:Antineoplastic Agents, Alkylating / Q000008:administration & dosage*; D001859:Bone Neoplasms / Q000188:drug therapy; D001943:Breast Neoplasms / Q000188:drug therapy; D002295:Carcinoma, Transitional Cell / Q000188:drug therapy; D004334:Drug Administration Schedule; D005240:Feasibility Studies; D005260:Female; D006410:Hematopoiesis / Q000187:drug effects; D006801:Humans; D007069:Ifosfamide / Q000008:administration & dosage*; D007262:Infusions, Intravenous; D012509:Sarcoma / Q000188:drug therapy / Q000556:secondary; D012983:Soft Tissue Neoplasms / Q000188:drug therapy; D015996:Survival Rate; D016896:Treatment Outcome; D001749:Urinary Bladder Neoplasms / Q000188:drug therapy
D018906:Antineoplastic Agents, Alkylating; D007069:Ifosfamide