title: Amonafide as first-line chemotherapy for metastatic breast cancer.
abstract: In a phase II study, 32 patients with advanced breast cancer previously unexposed to palliative cytotoxic chemotherapy were treated with amonafide, 800-900 mg intravenously over 3 h repeated every 4 weeks. Objective response was seen in 8 patients including 1 complete response, 10 patients had stable disease and 14 patients progressed so the overall response was 25% (95% confidence interval, 11-43%). The most frequently encountered side-effects were haematological (granulocytopenia > or = WHO grade 3 was encountered in 7/24 patients at 800 mg/m2 and in 3/8 patients at 900 mg/m2 amonafide) and nausea/vomiting (62%), despite prophylactic use of ondansetron. Non-haematological severe adverse reactions included neurotoxicity WHO grade 3 in 1 patient and orthostatic hypotension WHO grade 4 in another. In summary, the results of this trial suggest a limited therapeutic index of amonafide if used at this dose with this administration schedule.
authors.affiliation: Department of Internal Medicine I, Vienna University Medical School.
authors.forename: G
authors.initials: G
authors.lastname: Kornek
authors.forename: M
authors.initials: M
authors.lastname: Raderer
authors.forename: D
authors.initials: D
authors.lastname: Depisch
authors.forename: K
authors.initials: K
authors.lastname: Haider
authors.forename: B
authors.initials: B
authors.lastname: Fazeny
authors.forename: C
authors.initials: C
authors.lastname: Dittrich
authors.forename: W
authors.initials: W
authors.lastname: Scheithauer
mesh_terms: D000225:Adenine; D000328:Adult; D000368:Aged; D000380:Agranulocytosis / Q000139:chemically induced; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy*; D005260:Female; D006801:Humans; D007094:Imides / Q000009:adverse effects / Q000627:therapeutic use*; D007546:Isoquinolines / Q000009:adverse effects / Q000627:therapeutic use*; D008875:Middle Aged; D053644:Naphthalimides; D009325:Nausea / Q000139:chemically induced; D009362:Neoplasm Metastasis; D063065:Organophosphonates; D016896:Treatment Outcome; D014839:Vomiting / Q000139:chemically induced
chemical_list: D000970:Antineoplastic Agents; D007094:Imides; D007546:Isoquinolines; D053644:Naphthalimides; D063065:Organophosphonates; C037020:amonafide; D000225:Adenine