Aim. The aim of the study is to examine the efficacy and safety of eribulin in HER2-negative metastatic breast cancer (BC) in Russian clinical practice. Materials and methods. The analysis included 459 patients with advanced BC from 44 federal and municipal medical clinics in Russia and received at least 2 courses of treatment with eribulin in accordance with the registered indications for drug. The average age of women was 56 years (between 29 and 81 years), 83% of patients had HER2-negative tumor subtype (49.9% - luminal BC and 33.1% - triple-negative BC) HER2-positive biological tumor subtype was registered in 17% of patients. Visceral metastases were diagnosed in 73% of patients and three-zone and multiple zone metastases were diagnosed in 41.6% of cases. The median number of prior lines of therapy in patients with disseminated disease was 2; anthracycline and taxane chemotherapy was applied in 94.3% of patients, and 38.1% of patients were recived CT plus capecitabine. Standard treatment regimen with eribulin was cotinuing (1.4 mg/m² as a 2-5-minute intravenous infusion administrated on days 1, 8 of a 21-day cycle) until disease progression, unacceptable toxic effects, or impossibility of the drug administration for any other reason. We estimated the efficacy and safety of treatment with eribulin in Russian patients with HER2-negative BC. Results. Objective response rate was achieved in 20.5% of cases, complete response rate was in 3.2%, partial - 17.3%, and the stable disease rate was marked in 52.7% of women, and in 19.7% of these cases was prolonged more than 6 months. The frequency of objective response was higher in luminal BC group compared with triple-negative BC: 23.5% vs 15.8%; tumor growth control 76.9% vs. 67.8%, respectively; p

Introduction.Eribulin, an non-taxane microtubule inhibitor, has been registered in Russia for patients with locally advanced or metastatic breast cancer (mBC) who received at least one chemotherapy regimen for a advanced disease, previous therapy should include anthracyclines and taxanes in adjuvant or metastatic setting, except the patients who could not be prescribed these drugs. We present our experience with eribulin in real clinical practice in Moscow and the Moscow Region.Patients and methods. We conducted a retrospective analysis of the experience with the use of eribulin in Moscow and the Moscow Region in 202 patients with mBC from January 2016 to February 2017 to assess the effectiveness and safety of the drug. All patients received previous therapy with anthracyclines and taxanes for locally advanced and / or metastatic cancer. The average age of patients at the time of inclusion in the analysis was 5 years (28–81). The status of the general condition on the ECOG 0-1 scale was registered in 81.3 % (100 / 123) of patients, the status of ECOG 2-3 in 18.7 % (23 / 123) of patients. The median of the number of courses of chemotherapy with eribulin is 4 (2–17). Patients received eribulin in 1-7 chemotherapy lines for metastatic disease. The average number of affected organs is 2 (1–5).Results.Complete response (CR) was in 3 (2 %) patients. Partial response (PR) was in 24 (15.7 %) patients, stabilization of the disease – in 89 (58. 2 %). Progression of the disease was recorded in 37 (24.1 %) patients. The median of progression-free survival (PFS) on the therapy was 4.64 (95 % CI 2.97-6.87) months. Stabilization of the disease for more than 6 months was registered in 28 (18.3 %) patients. The most significant toxicity was neutropenia and polyneuropathy (21 patients (10.4 %) and 7 patients (3.5 %), respectively).Dose reduction due to neutropenia was required by 26 patients (12.9 %). The objective response rate (ORR) depended on the chemotherapy line: in 1-3 lines the efficacy of the treatment was higher: the ORR was 21.6 %, compared to the 4th and subsequent lines – 12.3 %, respectively. With HER2-positive mBC, eribulin showed clinically significant results in combination with trastuzumab.Conclusions.Our analysis confirms that eribulin has a predictable and manageable safety profile, is an effective drug for the treatment of patients with different subtypes of mBC in a real clinical setting.

The article presents the experience of 19 Russian medical institutions on the use of eribulin in combination with trastuzumab in various treatment lines of metastatic HER2+ breast cancer in routine clinical practice. Aim. The main objective of this retrospective observational study was to evaluate the efficacy and tolerability of eribulin and trastuzumab combo in HER2+ breast cancer patients pretreated with anthracyclines and taxanes. The analysis included 60 patients who received at least 2 cycles of eribulin in combination with trastuzumab. 2 patients (3.3%) received treatment as the 1st line, as the 2nd 14 (23.3%), as the 3rd 16 (26.7%), and as the 4th and more 28 (46.7%). Materials and methods. Complete response was achieved in 2 (3.3%) patients, partial response in 9 (15%), stable disease in 33 (55%), stabilization for more than 6 months in 11 (18.3%), disease progression was detected in 16 (26.7%) patients. The objective response rate was 18.3% in the whole group, the clinical benefit rate 36.7%. Results. The objective response rate in the group of the luminal subtype (ER/PR+HER2+) was 26.9%, in HER2-overexpressed subtype (ER-PR-HER2+) 8.8% and 64.7%, respectively, disease progression was recorded 2.3 times more often 35.3% versus 15.5% in the luminal subtype group. The median progression-free survival in patients with HER2+ breast cancer was 4.95 months (95% confidence interval CI 3.048.29 months), in luminal subtype 6.38 months (95% CI 3.338.54 months), in non-luminal 4.44 months (95% CI 2.47.96 months); p=0.306. The treatment was well tolerated, the spectrum of adverse events corresponded to the eribulin toxicity profile. Conclusions. The uniqueness of this study lies in the fact that on a large clinical material from the standpoint of real clinical practice, a very promising treatment regimen that is not used routinely in a number of countries has been studied, its effectiveness and satisfactory tolerance have been confirmed.