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Phase Ib study of ixabepilone (I) in combination with epirubicin (E) in women with metastatic breast cancer


, : Phase Ib study of ixabepilone (I) in combination with epirubicin (E) in women with metastatic breast cancer. Journal of Clinical Oncology 26(15_suppl): 1058-1058

NlmCategory="UNASSIGNED">1058 Background: Ixabepilone and anthracyclines are effective in the treatment of breast cancer. The primary objective of this phase I trial was to determine the maximum tolerated doses of the combination of epirubicin and ixabepilone. The safety, tolerability, pharmacokinetic and antitumor activity of epirubicin and ixabepilone in combination administered every 3 weeks was assessed in women with advanced breast cancer. Eligible pts with a cumulative dose of ≤ 300 mg/m2 for doxorubicin, ≤ 450 mg/m2 for epirubicin and ≥ 3 months of progression free interval after adjuvant anthracycline were enrolled. Three dose levels were explored in a 3 + 3 dose escalation design: epirubicin/ixabepilone at 75/25, 75/30 and 75/35 mg/m2. PK blood samples were collected during cycle 1 and estimated by non-compartment analysis. Twenty-six pts have been enrolled to date, median age was 54 yrs (33-68). Eight pts received prior chemotherapy in adjuvant setting. Safety data are preliminary and available on 23 pts across the 3 dose levels for a total of 130 cycles (median 6 cycles, range 2-8). Neutropenia was the dose limiting toxicity, occurring in 1/6 pts at 75/25, 1/11 at 75/30 and 2/6 at 75/35 mg/m2. This included 1 pt with febrile neutropenia and 3 pts with grade 4 neutropenia of ≥ 5 days duration. Enrollment at 75/30 mg/m2 dose level is continuing. The most frequent grade 3 or 4 AE was neutropenia (4/23 and 15/23 respectively). Nonhematologic grade 3 and 4 toxicities were infrequent and included 2 pts with grade 3 neuropathy and 3 pts with grade 3 vomiting. No deaths were reported. No pharmacokinetic interaction was observed. Responses were seen at all dose levels tested. Of twelve women with measurable disease 10 achieved a partial response, one stable disease and one progressed. Six pts with non measurable disease had clinical benefit and/or no disease progression. Based on these preliminary data the recommended dose level of epirubicin 75 mg/m2 and ixabepilone 30 mg/m2 has a favourable toxicity and efficacy profile and warrants further investigation. [Table: see text].

US$29.90

PMID: 27951017


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