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.
Background: Eribulin mesylate was initially approved in 2010 by FDA as a third-line treatment for women with advanced breast cancer (ABC) pretreated with at least two lines of chemotherapy, and then in 2011 it was approved by EMA as a second-line therapy. Patients should have received an anthracycline and a taxane in either the adjuvant or metastatic setting. Since then, several studies have been conducted confirming its efficacy and safety. We report our experience of using eribulin in our centre in a real-life clinical setting. Materials and methods: 34 patients with ABC were enrolled to receive eribulin. From February 2016 to February 2017, patients were treated with standard doses of eribulin and evaluated for toxicity and responses. All of them had previously received anthracyclines and taxanes in either the adjuvant or metastatic setting. Median age was 60 years (range: 39–79). ECOG performance status was 1 or 2 at the time of enrollment. Median number of cycles of eribulin was 5 (range 2–10). Patients received eribulin from first-line chemotherapy to seventh-line chemotherapy for ABC. Median number of envolved visceral organs was 2 (range 1–4). Results: There were no complete responses. Partial responses were achieved in 26.4% (9/34), stabilization of the disease in 32.4% (11/34) and progression of the disease in 41.2% (14/34) of patients. The median progression-free survival was 4.09 months (range: 2.6–6.53). Main toxicities (grade 3–4) included peripheral neuropathy and neutropenia. Neuropathy was marked in 14.7% (5/34) and neutropenia in 14.7% (5/34) of patients. Dose reductions were required in 14.7% (5/34) of patients because of neutropenia. Conclusion: Our experience shows that eribulin has clinical activity as well as satisfactory tolerability in unselected patients in a reallife clinical setting. Thus, in our opinion, eribulin can represent a new option in treatment of ABC patients.
The experience of the joint research by the Department of Chemistry, Lomonosov Moscow State University, and the Federal State Budgetary Scientific Institution "N.N. Blokhin Russian Cancer Research Center" (FSBSI "N.N. Blokhin RCRC"), on the application of medium-intensity ultrasound in combination with chemotherapy and sonosensitizers in the treatment of cancer diseases was summarized. A cycle of preclinical trials showed that the method allows enhancing the damaging effect of ultrasound on the tumor, while no metastasis-promoting and toxic effects are exerted. The combined method is being currently tested in clinical trials.
The clinical efficacy and tolerability of intrapleural sclerotherapy using a binary catalyst system teraftal + ascorbic acid and intrapleural immunotherapy with allogeneic LAK cells and low-dose recombinant interleukin-2 (roncoleukin) in patients with tumor (metastatic) pleurisy at various chemoresistant malignancies was studied. The results showed that this treatment is highly effective (objective response when sclerotherapy was 82%), and immunotherapy (IL-2/ LAK 92.4% and IL-2 80%), relatively rarely give recurrences and satisfactorily tolerated patients.
The clinical efficacy and tolerability of intrapleural sclerotherapy using a binary catalyst system "teraftal + ascorbic acid" and intrapleural immunotherapy with allogeneic LAK cells and low-dose recombinant interleukin-2 (roncoleukin) in patients with tumor (metastatic) pleurisy at various chemoresistant malignancies was studied. The results showed that this treatment is highly effective (objective response when sclerotherapy was 82%), and immunotherapy (IL-2/ LAK - 92.4% and IL-2 - 80%), relatively rarely give recurrences and satisfactorily tolerated patients .
Abstract In work the efficacy and tolerance of the binary catalytic systems with teraftal, oxycobalamin or ephyther as the catalyzators with ascorbic acid as the reducer by the intrapleural administration to mice with i.p. transplanted tumors is described. It was shown through efficacy of malignant pleurisy treatment, pleurodesis inducing and «acute» toxicity that the most perspective for clinical investigation are Oc+AA and Tph+AA. Tph+AA with molar parity of components as 1:100 demonstrates the best therapeutically data with high pleu- rodesis inducing, terapeutical index TI>1,5. Eph+AA with the used dosage do not demonstrate enough efficacy. Key words: mice, experimental malignant pleurisy, binary catalytic system, efficacy, pleurodesis. Введение Ранее в эксперименте бинарная каталитиче- ская система ТФ+АК с молярным соотношением компонентов 1 : 10 М/мл и дозовым соотношением 1 : 2,2 мг/кг была охарактеризована как хорошо переносимая и высокоэффективная при внутри-
The drug Herceptin blocking receptor Her2/neu (ErbB2) was introduced in clinical practice and is successfully used in treatment of breast cancer patients. Development of novel effective and cheap drugs against HER2/neu is a perspective trend. Tests of such drugs require adequate tumor models in vivo. Sensitivity of tumor models to the drugs often depends on biology of tumor growth in deferent types of animals. We adapted SKBR3, tumor cell lines with hyperexpression of HER2/neu, to the subcutaneous growth in Balb/c nude mice of Blokhin Russian Cancer Reseach Center breeding. The purpose of the study was to evaluate Hercepin-sensitivity of subcutaneous breast cancer xenografts SKBR3 transplanted to the nude mice of Blokhin Russian Cancer Reseach Center breeding
692 A.L. Nikolaev, A.V. Gopin, V.E. Bozhevlnov, N.V. Andronova, D.V. Filonenko, E.M. Treschalina SOME ASPECTS OF ULTRASONIC NANOMEDICINE M.V.Lomonosov Moscow State University, Chemistry Department Russia, 119992, Moscow. 1, Leninskie gory, b.3, the Moscow State University, Chemistry Department Tel.: (495)939-3207 e-mail: nic@radio.chem.msu.ru 2 State University, N.N.Blokhin Russian Oncological Scientific Centre of Russian Academy of Medical Sciences Russia, 115478, Moscow. 24, Kashirskoe shosse