Annals of Oncology Advance Access originally published online on February 23, 2006
Annals of Oncology 2006 17(5):807-812; doi:10.1093/annonc/mdl013
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© 2006 European Society for Medical Oncology
Innovative schedule of oral idarubicin in elderly patients with metastatic breast cancer: comprehensive results of a phase II multi-institutional study with pharmacokinetic drug monitoring
1 Division of Medical Oncology C, Centro di Riferimento Oncologico, Aviano; 2 Experimental and Clinical Pharmacology Unit, Centro di Riferimento Oncologico, Aviano; 3 Epidemiology and Biostatistic Unit, Centro di Riferimento Oncologico, Aviano; 4 Cardiology Unit, Centro di Riferimento Oncologico, Aviano; 5 Division of Medical Oncology, Umberto Io Hospital, Ancona; 6 Division of Medical Oncology, General Hospital, Trento, Italy
* Correspondence to: Dr D. Crivellari, Division of Medical Oncology C, Centro di Riferimento Oncologico, Via Pedemontana Occidentale, 12, 33081 Aviano, Italy, Tel: +39 0434-659024; Fax: +39 0434 659453; E-mail: dcrivellari{at}cro.it
Background: To determine if protracted low-dose oral idarubicin (IDA), feasible in a previous dose-finding study, would result in similar activity and a better toxicity profile in patients with metastatic breast cancer.
Patients and methods: Elderly women (
65 years) with metastatic breast carcinoma were treated with 7.5 mg/day for 21 consecutive days, every 4 weeks. After the first fourteen patients, due to excessive toxicity, the protocol was amended to 5 mg/day. IDA and Idarubicinol (IDOL) plasma concentrations (Ctrough) were investigated in all patients.
Results: Between April 1999 and June 2004, 47 elderly patients were accrued in this two-part study (14 and 33 patients respectively). The median age was 74 and 75 years respectively. Visceral involvement was present in most patients. A partial response was noted in 7/31 patients (22%; 95% CI, 9.6–41.1%). Eleven patients had stable disease (33%). At the dose of 5 mg/day the treatment was well tolerated. Neutropenia grade 4 was present in only 6% of patients; alopecia > grade 1 and cardiotoxicity did not occur. The median time to progression was 3 months and the median overall survival was 17 months. IDA Ctrough and IDOL Ctrough levels were significantly associated with haematologic toxicity.
Conclusion: This study shows that idarubicin at the dose of 5 mg/day for 21 consecutive days is feasible and effective in elderly breast cancer patients but do not demonstrate an improvement in efficacy. A determination of the IDA and IDOL plasma levels (Ctrough) is predictive for toxicity.
Key words: oral Idarubicin, elderly breast cancer patients
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