Key results of a multicenter, non-interventional, retrospective study of Ixabepilone therapy in routine clinical practice in patients with locally advanced or metastatic breast cancer after failure of previous therapy NIRMA

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Chemotherapy is an integral part of drug treatment of patients with metastatic breast cancer (mBC), regardless of the biological subtype of the tumor, and the availability of a large number of effective drug treatment options can significantly increase life expectancy. Intensive neoadjuvant and adjuvant chemo ± targeted therapy, as well as pretreatment for the metastatic form of the disease, can significantly reduce the effectiveness of subsequent lines of chemotherapy, which complicates the choice of treatment options. That is why the results of modern observational studies of real clinical practice are of exceptional value. Ixabepilone is a semi-synthetic analogue of epothilone B, used for locally advanced or metastatic breast cancer when previous therapy is ineffective. The purpose of this study is to evaluate the efficacy and tolerability of ixabepilone alone and in combination with chemoor target drugs in real clinical practice in the Russian Federation. Methods. A multicenter, non-interventional, retrospective study of ixabepilone therapy in routine clinical practice in patients with locally advanced or metastatic breast cancer with ineffectiveness of previous therapy NIRMA (CLO1418141) included 101 patients who received ixabepilone as monotherapy and in various combinations in the 1st and subsequent lines of therapy from 01.01.2021 to 31.12.2023 in 15 oncological institutions of the Russian Federation. Results. The median of previous therapy lines for metastatic disease was 3. Ixabepilone therapy was administered alone (n=58), in combination with capecitabine (n=30), or in combination with trastuzumab (n=13). The median PFS was 5.77 months. [95 % CI 5.31–6.07] The objective response rate was 35.64 % (36/101), including 1 complete and 35 partial responses. Disease control rate in intensively pre-treated patients with mBC reached 84.16 % (84/101). Adverse events (AE) of any severity were recorded in 25.74 % of cases. The main adverse events with ixabepilone were neutropenia and peripheral polyneuropathy. In no case did toxicity lead to early discontinuation of treatment or death. In patients with mBC progression after anthracyclines and taxanes, the combination of ixabepilone with capecitabine or ixabepilone with trastuzumab demonstrates extremely high disease control rates in modern Real Clinical Practice (RCP). Ixabepilone monotherapy is an option of choice in patients with breast cancer progression after anthracyclines, taxanes and capecitabine.