title: Unexpected toxicities in elderly patients treated with oral idarubicin in metastatic breast cancer: the GINECO experience.
abstract: OBJECTIVE
  Chemotherapy can be considered for many elderly patients with metastatic hormone-resistant breast cancer. Idarubicin, the only orally administrated cytotoxic agent belonging to the anthracycline family, may be a potential alternative to intravenous chemotherapy for this population for quality-of-life reasons.
  
  
  METHODS
  Between November 2000 and June 2001, 26 consecutive patients were included in an open, multicentre, phase II trial. All patients presented with metastatic hormone-resistant breast cancer and were over 70 years old. Eligibility requirements included the following: no prior chemotherapy for their metastatic disease, performance status (PS) 0-2, normal heart function, blood counts and liver function. Treatment consisted of oral idarubicin 20 mg/m2/week, and the dose was individually adjusted according to the observed haematological toxicity. A multi-dimensional geriatric assessment (MGA) was performed at baseline to assess the potential prognostic value of geriatric co-variates (autonomy, physical ability, co-morbidity, nutritional status, cognitive function) on chemotherapy feasibility and efficacy.
  
  
  RESULTS
  The trial was stopped after three toxic deaths were recorded. Two patients died of septicaemia with and without neutropenia, and the remaining patient developed congestive heart failure unresponsive to appropriate medication. Treatment was stopped for six other patients because of severe toxicity. Among the 19 patients who could be evaluated, disease had progressed in 14 (74%) at the first evaluation (2 months). Other than poor PS, no particular MGA factor proved helpful in predicting such a poor outcome.
  
  
  CONCLUSIONS
  Owing to the lack of efficacy and unacceptably high toxicity, weekly oral idarubicin should not be given to patients over 70 years old with poor PS and metastatic hormone-resistant breast cancer. The data obtained do not support the use of oral idarubicin in elderly patients, but oral administration of other drugs (vinorelbine, capecitabine) should be assessed, with careful monitoring of the patients, in light of our findings.
authors.affiliation: Medical Oncology Department, Centre Hospitalier Lyon-Sud, Hospices Civils de Lyon, France. gilles.freyer@chu-lyon.fr
authors.forename: Gilles
authors.initials: G
authors.lastname: Freyer
authors.forename: Alain
authors.initials: A
authors.lastname: Lortholary
authors.forename: Corinne
authors.initials: C
authors.lastname: Delcambre
authors.forename: Thierry
authors.initials: T
authors.lastname: Delozier
authors.forename: Gilles
authors.initials: G
authors.lastname: Piot
authors.forename: Françoise
authors.initials: F
authors.lastname: Genin
authors.forename: Eric
authors.initials: E
authors.lastname: Pujade-Lauraine
mesh_terms: D000284:Administration, Oral; D000367:Age Factors; D000368:Aged; D000369:Aged, 80 and over; D000903:Antibiotics, Antineoplastic / Q000008:administration & dosage* / Q000009:adverse effects*; D018931:Antineoplastic Agents, Hormonal / Q000494:pharmacology; D001943:Breast Neoplasms / Q000188:drug therapy*; D015897:Comorbidity; D019008:Drug Resistance, Neoplasm; D005260:Female; D006801:Humans; D015255:Idarubicin / Q000008:administration & dosage* / Q000009:adverse effects*; D009362:Neoplasm Metastasis; D009503:Neutropenia / Q000139:chemically induced; D018805:Sepsis / Q000139:chemically induced
chemical_list: D000903:Antibiotics, Antineoplastic; D018931:Antineoplastic Agents, Hormonal; D015255:Idarubicin