tumorsMalignant tumoursMalignant tumours2224-50572587-6813Rosoncoweb10.18027/2224-5057-2017-7-4-21-28tumors-435Research ArticleОРИГИНАЛЬНЫЕ ИССЛЕДОВАНИЯORIGINAL REPORTSОПЫТ ПРИМЕНЕНИЯ ЭРИБУЛИНА В УСЛОВИЯХ РЕАЛЬНОЙ КЛИНИЧЕСКОЙ ПРАКТИКИERIBULIN MESYLATE: OUR EXPERIENCE IN A REAL-LIFE CLINICAL SETTINGФилоненкоД. В.FilonenkoD. V.filonenkodima@mail.ruБелоноговА. В.BelonogovA. V.

Александр В. Белоногов - дневной стационар №1

ГБУЗ Московская городская онкологическая больница № 62РоссияMoscow City Oncological Hospital No. 62Russian Federation201718012018742128Copyright © Филоненко Д.В., Белоногов А.В., 20182018Филоненко Д.В., Белоногов А.В.Filonenko D.V., Belonogov A.V.Данная работа распространяется под лицензией Creative Commons Attribution 4.0.This work is licensed under a Creative Commons Attribution 4.0 License.https://www.malignanttumors.org/jour/article/view/435Введение

Введение: Эрибулин впервые был зарегистрирован FDA в 2010 г. в качестве 3 линии терапии у пациентов с метастатическим раком молочной железы (мРМЖ), ранее получивших по крайней мере 2 линии химиотерапии по поводу распространенного процесса, включавшие антрациклины и таксаны. Далее в 2011 г. EMA одобрила эрибулин в качестве 2 линии химиотерапии. Пациенты должны были получать антрациклины и таксаны или в адъювантном, или лечебном режиме. К настоящему времени опубликован ряд исследований, подтверждающих эффективность и безопасность препарата. В настоящей работе представлен собственный опыт применения эрибулина в условиях реальной клинической практики.

Пациенты и методы

Пациенты и методы: С февраля 2016 по февраль 2017 г. лечение эрибулином получили 34 пациента с прогрессирующим мРМЖ с последующей оценкой эффективности и безопасности препарата. Все больные получили предшествующую терапию с использованием антрациклинов и таксанов по поводу местнораспространенного и/или метастатического рака. Средний возраст пациентов на момент включения в исследование составил 60 лет (от 39 до 79 лет). Статус общего состояния по шкале ECOG на момент включения был от 0 до 2. Медиана числа проведенных курсов химиотерапии эрибулином составила 5 (от 2 до 10 курсов). Пациенты получали эрибулин с первой по седьмую линии химиотерапии по поводу мРМЖ. Среднее количество пораженных органов – 2 (от 1 до 4 органов).

Результаты

Результаты: Полных регрессией отмечено не было. Частичная регрессия отмечена у 26,4% (9/34) пациентов, стабилизация болезни достигнута у 32,4% (11/34). Прогрессирование болезни зафиксировано у 41,2% (14/34) пациентов. Медиана выживаемости без прогрессирования на терапии эрибулином мРМЖ составила 4,09 (95% ДИ 2,6–6,53) месяца. Наиболее клинически значимой (3–4 степени) токсичностью стали нейтропения и полинейропатия. Нейтропения была отмечена у 14,7% (5/34), полинейропатия также у 14,7% (5/34) пациентов. 5 больным (14,7%) потребовалась редукция дозы эрибулина в связи с нейтропенией.

Background

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

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

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

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.

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The authors declare that there are no conflicts of interest present.