tumorsMalignant tumoursMalignant tumours2224-50572587-6813Rosoncoweb10.18027/2224-5057-2018-8-1-38-47tumors-494Research ArticleОРИГИНАЛЬНЫЕ ИССЛЕДОВАНИЯORIGINAL REPORTSЭффективность и безопасность индукционной химиотерапии по схеме FOLFIRINOX при погранично резектабельном и нерезектабельном раке поджелудочной железыEfficacy and safety of FOLFIRINOX induction chemotherapy in borderline resectable and unresectable pancreatic cancerПокатаевИ. А.PokataevI. A.

к. м. н., научный сотрудник, отделение клинической фармакологии и химиотерапии

MD, PhD Med, oncologist, Department of Clinical Pharmacology and Chemotherapy

pokia@mail.ruБазинИ. С.BazinI. S.

д. м. н., с. н. с. отделение клинической фармакологии и химиотерапии

MD, DSc Med, Senior Researcher, Department of Clinical Pharmacology and Chemotherapy

igorbazin@gmail.comПоповаА. С.PopovaA. S.

аспирант, отделение клинической фармакологии и химиотерапии

PhD-student, Department of Clinical Pharmacology and Chemotherapy

annpopova93@gmail.comПодлужныйД. В.PodluzhnyD. V.

к. м. н., зав. отделением, хирургическое отделение №7 опухолей печени и поджелудочной железы

MD, PhD Med, Head of The Surgical Department No. 7 of Tumors of Liver and Pancreas

dr.podluzhny@gmail.comКотельниковА. Г.KotelnikovA. G.

д. м. н., профессор, в. н. с., хирургическое отделение №7 опухолей печени и поджелудочной железы

MD, DSc Med, Professor, Senior Researcher, Surgical Department No. 7 of Tumors of Liver and Pancreas

kotelnikovag@mail.ruСагайдакИ. В.SagaydakI. V.

д. м. н., профессор, в. н. с., хирургическое отделение №7 опухолей печени и поджелудочной железы

MD, DSc Med, Professor, Senior Researcher, Surgical Department No. 7 of Tumors of Liver and Pancreas

КудашкинН. Е.KudashkinN. E.

к. м. н., с. н. с., хирургическое отделение №7 опухолей печени и поджелудочной железы

MD, PhD Med, Senior Researcher, Surgical Department No. 7 of Tumors of Liver and Pancreas

dr.kudashkin@mail.ruФайнштейнИ. А.FainsteinI. A.

д. м. н., в. н. с., отделение радиохирургии

MD, DSc Med, Leading Researcher, Department of Radiosurgery

anapar1@yandex.ruВалиевР. К.ValievR. K.

к. м. н., зав. отделением, отделение радиохирургии

MD, PhD Med, Head of the Department of Radiosurgery

sakartvelo77@inbox.ruНазаренкоА. В.NazarenkoA. V.

к. м. н., зав. отделением, отделение радиотерапии

MD, PhD Med, Head of the Department of Radiotherapy

АлиеваС. Б.AlievaS. B.

к. м. н., с. н. с., отделение радиологии

PhD, Senior Researcher, Department of Radiology

drsevil@mail.ruАбгарянМ. Г.AbgaryanM. G.

к. м. н., с. н. с., отделение абдоминальной онкологии

MD, PhD Med, Senior Researcher, Department of Abdominal Oncology

abgaryan.mikael@gmail.comГладилинаИ. А.GladilinaI. A.

д. м. н., врач, отделение радиохирургии

MD, DSc Med, Department of Radiosurgery

ФедянинМ. Ю.FedyaninM. Yu.

к. м. н., с. н. с., отделение клинической фармакологии и химиотерапии

MD, PhD Med, Senior Researcher, Department of Clinical Pharmacology and Chemotherapy

fedianinmu@mail.ruСехинаО. В.SehinaO. V.

к. м. н., врач-онколог, отделение клинической фармакологии и химиотерапии

PhD, MD, Department of Clinical Pharmacology and Chemotherapy

doc-sehina@mail.ruЧекиниД. А.ChekiniD. A.

к. м. н., врач-онколог, отделение клинической фармакологии и химиотерапии

PhD, MD, Department of Clinical Pharmacology and Chemotherapy

jenneta@inbox.ruЭльснукаеваХ. Х.ElsnukaevaKh. Kh. M.

аспирант, отделение клинической фармакологии и химиотерапии

PhD, MD, Department of Clinical Pharmacology and Chemotherapy

Elsnukaeva1992@mail.ruТюляндинС. А.TjulandinS. A.

д. м. н., профессор, зав. отделением, отделение клинической фармакологии и химиотерапии

MD, DSc Med, Professor, Head of the Department of Clinical Pharmacology and Chemotherapy

stjulandin@gmail.comФГБУ «НМИЦ онкологии им. Н. Н. Блохина» Министерства здравоохранения РФРоссияN.N. Blokhin Russian Cancer Research CenterRussian FederationФГБУ «НМИЦ онкологии им. Н. Н. Блохина» Министерства здравоохранения РФРоссияN. N. Blokhin Russian Cancer Research CenterRussian Federation201810052018813847Copyright © Покатаев И.А., Базин И.С., Попова А.С., Подлужный Д.В., Котельников А.Г., Сагайдак И.В., Кудашкин Н.Е., Файнштейн И.А., Валиев Р.К., Назаренко А.В., Алиева С.Б., Абгарян М.Г., Гладилина И.А., Федянин М.Ю., Сехина О.В., Чекини Д.А., Эльснукаева Х.Х., Тюляндин С.А., 20182018Покатаев И.А., Базин И.С., Попова А.С., Подлужный Д.В., Котельников А.Г., Сагайдак И.В., Кудашкин Н.Е., Файнштейн И.А., Валиев Р.К., Назаренко А.В., Алиева С.Б., Абгарян М.Г., Гладилина И.А., Федянин М.Ю., Сехина О.В., Чекини Д.А., Эльснукаева Х.Х., Тюляндин С.А.Pokataev I.A., Bazin I.S., Popova A.S., Podluzhny D.V., Kotelnikov A.G., Sagaydak I.V., Kudashkin N.E., Fainstein I.A., Valiev R.K., Nazarenko A.V., Alieva S.B., Abgaryan M.G., Gladilina I.A., Fedyanin M.Y., Sehina O.V., Chekini D.A., Elsnukaeva K.K., Tjulandin S.A.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/494Цель исследования

Цель исследования. Оценить эффективность и безопасность применения режима FOLFIRINOX в качестве индукционной терапии при погранично резектабельном и нерезектабельном раке поджелудочной железы.

Материалы и методы

Материалы и методы. В проспективное исследование включались пациенты с погранично резектабельным и нерезектабельным раком поджелудочной железы без отдаленных метастазов. Пациенты получали до 6 курсов индукционной химиотерапии по схеме FOLFIRINOX (оксалиплатин 85 мг/м2 в/в, иринотекан 180 мг/м2 в/в, фолинат кальция 400 мг/м2 в/в, 5‑фторурацил 400 мг/м2 в/в стр. и 2400 мг/м2 в/в 46‑час. инфузия) каждые 14 дней. При достижении рентгенологических признаков резектабельности пациентов оперировали. В случае сохранения нерезектабельности пациентам назначалась поддерживающая химиотерапия. Основной конечной точкой была одногодичная выживаемость без прогрессирования.

Результаты исследования

Результаты исследования. В исследование включено 32 пациента. Медиана длительности наблюдения составила 7,0 месяцев. Одногодичная выживаемость без прогрессирования составила 55,3%. Одногодичная общая выживаемость пациентов в данном исследовании составила 83,2%. Восемь пациентов (25%) прооперировали после индукционной терапии, у 7 из них удалось выполнить R0‑резекцию. Основными проявлениями токсичности 3–4 степени были нейтропения (46,9%), диарея (12,5%), а также рост печеночных трансаминаз (12,5%).

Выводы

Выводы. Режим FOLFIRINOX показал высокую активность в качестве индукционной химиотерапии рака поджелудочной железы. Применение данного режима возможно только для пациентов с хорошим соматическим статусом в связи с его высокой токсичностью.

Objective

Objective. To evaluate efficacy and safety of FOLFIRINOX regimen as induction therapy in borderline resectable and unresectable pancreatic cancer.

Materials and methods

Materials and methods. A prospective study included patients with borderline resectable and unresectable pancreatic cancer without distant metastases. Patients received up to 6 courses of induction chemotherapy with FOLFIRINOX regimen (oxaliplatin 85 mg/m2 i. v., irinotecan 180 mg/m2 i. v., calcium folinate 400 mg/m2 i. v., 5‑fluorouracil 400 mg/m2 i. v. bolus and 2 400 mg/m2 i. v. 46‑hours infusion) repeated every 14 days. Patients underwent surgery when radiologic signs of resectability were achieved. Maintenance chemotherapy was prescribed to the patients in cases of unresectability preservation. The primary endpoint was 1‑year progression-free survival.

Results of the study

Results of the study. The study included 32 patients. The median follow-up was 7.0 months. The one-year progression-free survival was 55.3%. The one-year overall survival of patients in this study was 83.2%. Eight patients (25%) underwent surgery after induction therapy, and in 7 of them it was possible to perform R0 resection. The main manifestations of 3–4 grade toxicity were neutropenia (46.9%), diarrhea (12.5%), and elevation of hepatic transaminases (12.5%).

Conclusions

Conclusions. The FOLFIRINOX regimen showed high potential as induction chemotherapy in pancreatic cancer. The use of this regimen is possible only in patients with good performance status due to its high toxicity.

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