medsovetМедицинский СоветMeditsinskiy sovet = Medical Council2079-701X2658-5790REMEDIUM GROUP Ltd.10.21518/2079-701X-2021-4S-64-78medsovet-6212Research ArticleОРИГИНАЛЬНЫЕ ИССЛЕДОВАНИЯORIGINAL RESEARCHРамуцирумаб в комбинации с паклитакселом или FOLFIRI во второй линии лечения больных диссеминированным раком желудка после доцетаксела в первой линии в рутинной клинической практикеRamucirumab with paclitaxel or FOLFIRI as second-line treatment in docetaxel-pre-treated patients with metastatic gastric cancer in real-world settinghttps://orcid.org/0000-0002-1693-0523БесоваН. С.BesovaN. S.

Бесова Наталия Сергеевна, к.м.н., ведущий научный сотрудник онкологического отделения лекарственных методов лечения (химиотерапевтического) № 2 НИИ клинической онкологии имени академика РАН и РАМН Н.Н. Трапезникова

115478, Москва, Каширское шоссе, д. 24 

Natalia S. Besova, Cand. Sci. (Med.), Leading Researcher of the Oncology Department (Chemotherapy) No. 2 of the Research Institute of Clinical Oncology named after Academician of the Russian Academy of Sciences and the Russian Academy of Medical Sciences N.N. Trapeznikov

24, Kashirskoye Shosse, Moscow, 115478

besovans@mail.ruhttps://orcid.org/0000-0002-5039-6360ТитоваТ. А.TitovaТ. А.

Титова Татьяна Александровна, к.м.н., врач-онколог онкологического отделения лекарственных методов лечения (химиотерапевтического) № 1 НИИ клинической онкологии имени академика РАН и РАМН Н.Н. Трапезникова

115478, Москва, Каширское шоссе, д. 24 

Tatiana A. Titova, Cand. Sci. (Med.), Oncologist of the Oncology Department (Chemotherapy) No. 1 of the Research Institute of Clinical Oncology named after Academician of the Russian Academy of Sciences and the Russian Academy of Medical Sciences N.N. Trapeznikov

24, Kashirskoye Shosse, Moscow, 115478

https://orcid.org/0000-0003-0428-260XТрякинА. А.TryakinА. А.

Трякин Алексей Александрович, д.м.н., заведующий онкологическим отделением лекарственных методов лечения (химиотерапевтического) № 2 НИИ клинической онкологии имени академика РАН и РАМН Н.Н. Трапезникова

115478, Москва, Каширское шоссе, д. 24 

Aleksey A. Tryakin, Dr. Sci. (Med.), Head of the Oncology Department (Chemotherapy) No. 2 of the Research Institute of Clinical Oncology named after Academician of the Russian Academy of Sciences and the Russian Academy of Medical Sciences N.N. Trapeznikov

24, Kashirskoye Shosse, Moscow, 115478

https://orcid.org/0000-0001-7728-9533АртамоноваЕ. В.ArtamonovaЕ. V.

Артамонова Елена Владимировна, д.м.н., заведующая онкологическим отделением лекарственных методов лечения (химиотерапевтического) № 1 НИИ клинической онкологии имени академика РАН и РАМН Н.Н. Трапезникова

115478, Москва, Каширское шоссе, д. 24 

117997, Москва, ул. Островитянова, д. 1 

Elena V. Artamonova, Dr. Sci. (Med.), Head of the Oncology Department (Chemotherapy) No. 1 of the Research Institute of Clinical Oncology named after Academician of the Russian Academy of Sciences and the Russian Academy of Medical Sciences N.N. Trapeznikov; Professor of the Department of Oncology and Radiation Therapy of the Medical Faculty

 24, Kashirskoye Shosse, Moscow, 115478

https://orcid.org/0000-0001-9885-3922ОбаревичЕ. С.ObarevichЕ. S.

Обаревич Екатерина Сергеевна, врач-онколог онкологического отделения лекарственных методов лечения (химиотерапевтического) № 2 НИИ клинической онкологии имени академика РАН и РАМН Н.Н. Трапезникова

115478, Москва, Каширское шоссе, д. 24 

Ekaterina S. Obarevich, Oncologist of the Oncology Department (Chemotherapy) No. 2 of the Research Institute of Clinical Oncology named after Academician of the Russian Academy of Sciences and the Russian Academy of Medical Sciences N.N. Trapeznikov

24, Kashirskoye Shosse, Moscow, 115478

 

СтрояковскийД. Л.StroyakovskiyD. L.

Строяковский Даниил Львович, к.м.н., заведующий отделением химиотерапии, Московская городская онкологическая больница № 62 Департамента здравоохранения города Москвы

143423, Россия, Московская область, Красногорский район, п/о Степановское, поселок Истра, д. 27, стр. 1–26 

Daniil L. Stroyakovskiy, Cand. Sci. (Med.), Head of the Department of Chemotherapy

Bldg. 1–26, Settlement Istra, Stepanovskoe, Krasnogorsk District,  Moscow Region, 143423

https://orcid.org/0000-0001-7457-3889КалининА. Е.KalininО. Е.

Калинин Алексей Евгеньевич, к.м.н., врач-онколог, старший научный сотрудник онкологического отделения хирургических методов лечения № 6 НИИ клинической онкологии имени академика РАН и РАМН Н.Н. Трапезникова

115478, Москва, Каширское шоссе, д. 24 

Oleksiy E. Kalinin, Cand. Sci. (Med.), Oncologist, Senior Researcher of the Oncology Department No. 6 of Surgical Methods of Treatment of the Research Institute of Clinical Oncology named after Academician of the Russian Academy of Sciences and the Russian Academy of Medical Sciences N.N. Trapeznikov

24, Kashirskoye Shosse, Moscow, 115478

https://orcid.org/0000-0002-0493-1166СтилидиИ. С.StilidiI. S.

Стилиди Иван Сократович, чл.-корр. РАН, д.м.н., профессор, директор;  заведующий кафедрой онкологии и лучевой терапии лечебного факультета; профессор кафедры онкологии и паллиативной медицины хирургического факультета

115478, Москва, Каширское шоссе, д. 24 

117997,  Москва, ул. Островитянова, д. 1 

125993,  Москва, ул. Баррикадная, д. 2/1, стр. 1 

Ivan S. Stilidi, Corresponding Member of the Russian Academy of Sciences, Dr. Sci. (Med.), Professor, director;  Head of the Department of Oncology and Radiation Therapy of the Medical Faculty;  Professor of the Department of Oncology and Palliative Care of the Department of Surgery

24, Kashirskoye Shosse, Moscow, 115478

1, Ostrovityanov St., Moscow, 117997

2/1, Bldg. 1, Barrikadnaya St., Moscow, 125993

Национальный медицинский исследовательский центр онкологии имени Н.Н. БлохинаРоссияBlokhin National Medical Research Center of OncologyRussian FederationНациональный медицинский исследовательский центр онкологии имени Н.Н. Блохина; Российский национальный исследовательский медицинский университет имени Н.И. ПироговаРоссияBlokhin National Medical Research Center of Oncology; Pirogov Russian National Research Medical UniversityRussian FederationМосковская городская онкологическая больница № 62РоссияMoscow City Oncological Hospital No. 62Russian FederationНациональный медицинский исследовательский центр онкологии имени Н.Н. Блохина; Российский национальный исследовательский медицинский университет имени Н.И. Пирогова; Российская медицинская академия непрерывного профессионального образованияРоссияBlokhin National Medical Research Center of Oncology; Pirogov Russian National Research Medical University; Russian Medical Academy of Continuous Professional EducationRussian Federation20211206202104S6478Copyright © Бесова Н.С., Титова Т.А., Трякин А.А., Артамонова Е.В., Обаревич Е.С., Строяковский Д.Л., Калинин А.Е., Стилиди И.С., 20212021Бесова Н.С., Титова Т.А., Трякин А.А., Артамонова Е.В., Обаревич Е.С., Строяковский Д.Л., Калинин А.Е., Стилиди И.С.Besova N.S., Titova Т.А., Tryakin А.А., Artamonova Е.V., Obarevich Е.S., Stroyakovskiy D.L., Kalinin О.Е., Stilidi I.S.Данная работа распространяется под лицензией Creative Commons Attribution 4.0.This work is licensed under a Creative Commons Attribution 4.0 License.https://www.med-sovet.pro/jour/article/view/6212Введение

Введение. Комбинация рамуцирумаба (Р) с паклитакселом (Пакли) – стандарт второй линии терапии при диссеминированной аденокарциноме желудка или кардиоэзофагеального перехода (дРЖ). В последние годы растет число пациентов, получающих доцетаксел в периоперационной терапии или терапии первой линии. Эффективность Пакли + Р у таких пациентов изучена недостаточно. Нами предпринят ретроспективный анализ результатов применения комбинаций Пакли + Р или FOLFIRI с рамуцирумабом (FOLFIRI + Р) в терапии второй линии после доцетаксела в первой линии в условиях реальной клинической практики.

Материалы и методы

Материалы и методы. Задачей исследования было сравнение показателей выживаемости без прогрессирования (ВБП) и общей выживаемости (ОВ) у пациентов, получивших доцетаксел в терапии первой линии в наблюдательном мультицентровом исследовании RAMSELGA.

Результаты и обсуждение

Результаты и обсуждение. Из 163 пациентов 46 (28,2%) ранее получали доцетаксел. Вторая линия терапии включала в себя Пакли + Р (n = 19) и FOLFIRI + Р (n = 27). Медианы ВБП и ОВ в группе Пакли + Р составили 7,9 (95% ДИ: 6,2–9,7) и 18,1 (95% ДИ: 15,1–21,2) мес., в группе FOLFIRI + Р – 7,1 (95% ДИ: 4,3–9,9) и 15,8 (95% ДИ: 12,1–19,5) мес. Статистически значимых различий не было выявлено. Среди специфических побочных явлений наиболее частыми были гипертензия 1–2-й степени (ст.), носовые кровотечения 1–2-й ст.: 78,9 и 21,1% в группе Пакли + Р и 29,6 и 22,2% в группе FOLFIRI + Р. В группе FOLFIRI + Р отмечены: гипертензия 4-й ст. (1 больной), смерть от геморрагического инсульта (1 больной), желудочное кровотечение (2 больных, 1 с летальным исходом), перфорация желудка 3-й ст. (1 больной).

Заключение

Заключение. Комбинация FOLFIRI + Р может стать альтернативой существующему стандарту после изучения в рамках сравнительного рандомизированного исследования. 

Introduction

Introduction. Ramucirumab (R) with paclitaxel (PTX) is a global standard for second-line (2L) therapy in advanced gastroesophageal adenocarcinoma (GEA). More and more patients (pts) get treated with taxanes in the perioperative or 1st line metastatic setting. For those pts the benefit of a combination of R+P is unclear, and many physicians would choose an irinotecan based regimen as 2L. We present data of retrospective analysis from pts with GEA with docetaxel-containing 1st line treated with ramucirumab and paclitaxel (R+PTX) or FOLFIRI (R+FOLFIRI) as 2L in a «real-life» setting.

Materials and methods

Materials and methods. We identified 46 docetaxel pre-treated pts from RAMSELGA data-base who received R+PTX (n = 19) or R+FOLFIRI (n = 27) as 2L.

Results and discussion

Results and discussion. The median progression-free survival (MPFS) and median overall survival (MOS) for pts treated with R+PTX were 7.9 (95% ДИ: 6.2–9.7) and 18.1 (15.1–21.2) months, and those for pts treated with R+FOLFIRI – 7.1 (95% ДИ: 4.3–9.9) and 15,8 (12.1–19.5) months, respectively. There are no significant differences. Main adverse events of special interest were hypertension grade (gr) 1-2, epistaxis gr 1-2: 78.9% и 21.1% in R+PTX group and 29.6% и 22.2% in R+FOLFIRI group, there were serious adverse events in R+FOLFIRI: hypertension gr4 (1 pt), gastrointestinal haemorrhage (1pt), gastrointestinal perforation gr 3 (1pt), death of stroke (1 pt) and gastrointestinal haemorrhage (1pt).

Conclusion

Conclusion: docetaxel pre-treated pts seemed to derive pronounced benefit from FOLFIRI-Ram, providing a rationale for a phase III trial.

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