title: High-dose epirubicin for untreated patients with advanced tumours: a phase I study.
abstract: In a phase I study, epirubicin was administered as an intravenous bolus at an initial dose of 105 mg/m2 in untreated patients with advanced tumours considered resistant to antineoplastic treatment. A 15 mg/m2 dose escalation was done every 3 patients if toxicity was below grade 3 or every 6 patients if at least 1 patient had grade 3 toxicity. 18 patients entered the study. The dose was (mg/m2): 105 (3 patients), 120 (3), 135 (3), 150 (6) and 165 (3). The maximally tolerated dose was 165 mg/m2. The dose-limiting toxicity was neutropenia. Other side-effects were nausea/vomiting (78%) and alopecia (100%). 4 patients stopped treatment because of a decrease in left ventricular ejection function, without clinical signs of cardiotoxicity. A complete response was observed in a patient with abdominal metastases from unknown origin at 105 mg/m2 and a partial response in 2 out of 7 patients with non-operable non-small cell lung cancer, at 135 and 150 mg/m2, respectively. The recommended dose for phase II trial is 135-150 mg/m2.
authors.affiliation: Division of Oncology, S. Orsola-Malpighi Hospital, Bologna, Italy.
authors.forename: A
authors.initials: A
authors.lastname: Martoni
authors.forename: B
authors.initials: B
authors.lastname: Melotti
authors.forename: M
authors.initials: M
authors.lastname: Guaraldi
authors.forename: M A
authors.initials: MA
authors.lastname: Pacciarini
authors.forename: A
authors.initials: A
authors.lastname: Riva
authors.forename: F
authors.initials: F
authors.lastname: Pannuti
mesh_terms: D000328:Adult; D000368:Aged; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy; D004334:Drug Administration Schedule; D004341:Drug Evaluation; D015251:Epirubicin / Q000008:administration & dosage* / Q000627:therapeutic use / Q000633:toxicity; D005260:Female; D006402:Hematologic Diseases / Q000139:chemically induced; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000188:drug therapy*
chemical_list: D015251:Epirubicin