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
Aromatase inhibitor (AI) combined with Gonadotropin-releasing hormone agonist (GnRH-a) have been recognized as an effective approach to adjuvant endocrinotherapy for breast cancer (BC) in premenopausal patients with adverse predictive factors. However, the risk of non-optimal suppression of the ovaries due to the mechanism of action of aromatase inhibitors has been proven. Recently published SOFT-EST studies showed that the blood estradiol (E2) level in 37% of patients was above the level that was permissible for the purpose of this group of drugs. And although today there is no enough scientific justification to interpret this result, the introduction of aromatase inhibitors in adjuvant therapy in young women requires the search for tactics to reduce the risk of mediated increase in estradiol against the background of such therapy. Alertness occurs when the E2 serum level exceeds the menopause limit by the time the aromatase inhibitors are prescribed. Objective of the study. Determine the tactics for minimizing the risk of increasing estradiol against the background of aromatase inhibitors in combination with GnRH-a in adjuvant therapy for breast cancer in premenopausal patients. Material and methods. 47 patients of ≤ 50 years old with GR + HER2- Stages I-III Breast Cancer and a regular menstrual cycle before the start of neo-/adjuvant chemotherapy were studied. E2 and FSH levels were assessed at the stage prior to chemotherapy and immediately prior to administering adjuvant endocrinotherapy. After the completion of chemotherapy, only 7 out of 47 women had the menstrual cycle - patients without clinical and biochemical suppression of ovarian function (SOF). 86% of cases had cytostatic amenorrhea (n = 40), of which 23 cases (58%) showed that this condition was not combined with the biochemical response of sex hormones, i.e. there was no biochemical SOF. Thus, the study group included 30 patients, who were supposed to be treated with aromatase inhibitors + GnRH analogues, and had no clinical or biochemical menopause by the time adjuvant endocrinotherapy was prescribed. In order to reduce the risk of mediated increase in estradiol, even with pharmaceutical “switching off” ovarian function, the patients were prescribed the GnRH analogue (Buserelin Depot) before starting aromatase inhibitors therapy. Results and conclusion. A progressive decrease in E2 level was determined after each subsequent administration of Buserelin Depot. The median values remained low only after the third injection. Following the chemotherapy, a decrease in estradiol was accompanied by a physiological increase in the FSH levels in 73% of women. The administration of Buserelin Depot led to a significant decrease in FSH median (p <0.01) in 90% of patients. Aromatase inhibitors and continuing GnRH-a were prescribed to 97% of patients. The results indicate that the achievement of ovarian function suppression prior to the administration of IA, can be considered as a reliable tactics for adjuvant endocrinotherapy in patients of reproductive age. The dynamic assessment of reproductive hormones (E2, FSH) is recognized useful when choosing or correcting therapy in such patients.
Background. Working out of the second line chemotherapy of advanced gastric adenocarcinoma is a promising approach to cancer therapy. Ramucirumab, an anti-angiogenic agent specifically targeting vascular endothelial growth factor receptor-2 (VEGFR-2). In April 2014, the FDA approved ramucirumab as a single agent or in combination with paclitaxel for treatment of advanced gastric or gastroesophageal junction adenocarcinoma that has progressed on or after prior fluoropyrimidineor platinum containing chemotherapy based on data of REGARD and RAINBOW trials. Materials and Methods : From June 2016 to 15Jan 201837 pts with advanced GC were treated with ramucirumabin the second line treatment as single agent (11 pts) or in combination with paclitaxel (26 pts) in N.N.Blokhin National medical research center of oncology. Results : edian PFS (MPFS) and median OS (MOS) was 1,8 and 7,6 mons for monotherapy group. For combination group MPFS was 4,0mons, MOS -10,6 mons. Ramucirumab had an acceptable safety profile Conclusions :ur data are similar to the data of international randomized trials.
In metastatic breast cancer (MBC) the combination of Bevacizumab (Avastin) and chemotherapy (CT) failed to demonstrate an increase in overall survival with a significant improvement of the objective response rate and progression-free survival (PFS) in randomized trials of the 3d phase. Nevertheless, observational studies in the daily clinical practice for the use of Bevacizumab in MBC continue in the world. We present the results of our own observational study, which goal is to assess the efficacy and tolerability of Bevacizumab in combination with CT in patients with HER/2-negative metastatic and locally advanced breast cancer. The study included 34 patients with breast cancer (6-locally advanced, 28-metastatic) at the age of 29 to 66 years (mean – 49.5). Bevacizumab was administered at a dose of 7.5 to 15 mg/kg every 3 weeks in combination with CT. In total, the patients received 294 doses of Bevacizumab (median – 10). All patients with locally advanced breast cancer were operated on after the treatment completion, a pathologic complete response was registered in 33.3%. In MBC, the objective response was registered in 46,4%, tumor growth control in 89.3%, median PFS – 10 months. Typical for Bevacizumab adverse events, such as hypertension, proteinuria, were moderate and were met respectively in 14.7% and in 5.9% cases. In 1 (2.9%) patient the treatment was complicated by deep vein thrombosis and PE due to disease progression. Conclusion. Bevacizumab in combination with CT in breast cancer treatment can achieve high rates of objective response and PFS independent of the treatment line
The article presents a pooled experience of the use of eribulin in the real clinical practice of treatment of metastatic breast cancer in Russian oncological institutions. The effectiveness of the drug in monotherapy with HER2‑negative breast cancer was analyzed, groups of patients with most effective use of eribulin were identified depending on the localization of metastases, the most effective lines of therapy. The effectiveness of the drug in combination with trastuzumab in HER2‑positive breast cancer is described, as well as toxic reactions.
The article shows the experience of eribulin application in actual clinical practice in Oncology institutions of the Russian Federation concerning metastatic breast cancer. We have analyzed the efficacy of the drug in case of different subtypes of the tumor and have chosen patients, depending on the location of metastases and with proven maximum efficacy of eribulin. We have shown the side reactions and the possibility of application of eribulin in combination with other antineoplastic agents.
В статье представлен обобщенный опыт применения эрибулина в реальной клинической практике онкологических учреждений Российской Федерации при метастатическом раке молочной железы. Проанализирована эффективность препарата при различных подтипах опухоли, выделены группы больных в зависимости от локализации метастазов, у которых эрибулин оказался максимально эффективным. Описаны токсические реакции, а также оценена возможность комбинации препарата с другими противоопухолевыми средствами.
This article dials with the new opportunities for the treatment of HER2-positive breast cancer with the involvement of the central nervous system (CNS). In CEREBEL study was shown that trastuzumab was not inferior to lapatinib concerning the reduction the incidence of brain metastases and had statistically significant progression-free survival advantages. The new strategy of the 1st-line therapy in disseminated HER2-positive breast cancer is to apply dual receptor blockade using two monoclonal antibodies (trastuzumab + pertuzumab) in combination with taxanes. This approach has been highly effective, even in the patients with the involvement of the CNS: the addition of pertuzumab into the combination of trastuzumab + docetaxel has increased the median time to development of CNS metastases as first site of disease progression from 11,9 to 15 months, and median overall survival - from 26,3 to 34,4 months. On the progression of HER2-positive metastatic breast cancer after usage of trastuzumab and taxanes, the advantage of new drug - T-DM1 was proven over the combination of lapatinib and capecitabin, even in the patients with brain metastases: the advantage of median overall survival in these patients was reached 13,9 months.
Лимфома Ходжкина (ЛХ) стала одним из первых заболеваний, при котором была доказана возможность излечения: 10–20-летняя выживаемость без прогрессирования (ВБП) 70–90%. Однако поздние осложнения лечения (вторые опухоли, инфаркты миокарда, инфекции) существенно снижают общую выживаемость. Молодой возраст больных и прогноз на столь же долгую жизнь, как и у сверстников, делают актуальным сохранение высокого качества дальнейшей жизни. Повышенный риск тяжелых осложнений дал импульс к поиску новых вариантов лечения ЛХ высокоэффективных и малотоксичных. Инструментом для достижения такой цели стала позитронно-эмиссионная томография (ПЭТ) – больные с негативными результатами ПЭТ имеют лучший прогноз. В настоящее время изучается возможность адаптации терапии по результатам ПЭТ после проведения 2–3 циклов полихимиотерапии. Для оценки эффективности терапии ПЭТ выполнена 61 больному с распространенными стадиями ЛХ, которым проводилось лечение 6 циклами ЕАСОРР-14+лучевая терапия в ФГБУ «РОНЦ им.Н.Н.Блохина» МЗ РФ. 4-летняя ВБП была лучше при негативной ПЭТ (52 больных), чем при позитивной (9 больных) и составила 93,8% против 44,4%, р=0,002. ПЭТ-2 выполнена у 36 больных, 4-летняя ВБП составила 100% при ПЭТ- и 81,8% при ПЭТ+, р=0,032. Консолидирующая лучевая терапия выполнена у 65 больных и у 18 больных не проводилась, рецидив констатирован у 1 больного в каждой группе и различия в ВБП выявлено не было: 4-летняя ВБП 93,3% против 88,9%, соответственно, р=0.177. Небольшая численность групп, позволяет сделать лишь предварительные выводы о прогностической значимости ПЭТ-2 и ПЭТ после этапа химиотерапии для коррекции программы лечения.