tumorsMalignant tumoursMalignant tumours2224-50572587-6813Rosoncoweb10.18027/2224-5057-2025-049tumors-1491Research ArticleСОБСТВЕННЫЕ ИССЛЕДОВАНИЯ. ВОПРОСЫ ОНКОХИРУРГИИOWN RESEARCH. ONCOSURGERY ISSUESРезультаты проспективного одноцентрового рандомизированого исследования роли неоадъювантной химиотерапии в комбинированном лечении больных III стадией рака ободочной кишки (Node-Rads 3–5 баллов)Results of a prospective single-center randomized study on the role of neoadjuvant chemotherapy in the combined treatment of patients with stage III colon cancer (Node-Rads scores 3-5)https://orcid.org/0009-0002-1492-2164ДаниловаМ. А.DanilovaM. A.

Данилова Маргарита Алексеевна 

111123 Москва, Новогиреевская ул., 1, корп. 1 

Danilova Margarita Alekseevna

Build. Novogireevskaya St., Moscow 111123

danilova.ma856@yandex.ruhttps://orcid.org/0000-0003-4691-7490СемёновН. Н.SemenovN. N.

Семёнов Николай Николаевич

111123 Москва, Новогиреевская ул., 1, корп. 1 

Semenov Nikolai Nikolaevich

Build. Novogireevskaya St., Moscow 111123

https://orcid.org/0000-0001-9439-9873ДаниловМ. А.DanilovM. A.

Данилов Михаил Александрович

111123 Москва, Новогиреевская ул., 1, корп. 1 

Danilov Mikhail Aleksandrovich

Build. Novogireevskaya St., Moscow 111123

https://orcid.org/0000-0003-3363-6841ЛеонтьевА. В.LeontevA. V.

Леонтьев Александр Владимирович

111123 Москва, Новогиреевская ул., 1, корп. 1 

129090 Москва, Мещанская ул., 9 / 14, стр. 1 

Leontev Aleksandr Vladimirovich

Build. Novogireevskaya St., Moscow 111123

Build. 1 9/14 Meshchanskaya St., Moscow 129090

https://orcid.org/0000-0001-5436-3630СаакянГ. Г.SaakyanG. G.

Саакян Георгий Германович

111123 Москва, Новогиреевская ул., 1, корп. 1 

Saakyan Georgii Germanovich

Build. Novogireevskaya St., Moscow 111123

https://orcid.org/0000-0002-9611-6459АлиевВ. А.AlievV. A.

Алиев Вячеслав Афандиевич

111123 Москва, Новогиреевская ул., 1, корп. 1 

Aliev Vyacheslav Afandievich

Build. Novogireevskaya St., Moscow 111123

https://orcid.org/0000-0002-0340-7119ФеоктистоваП. С.FeoktistovaP. S.

Феоктистова Полина Сергеевна

111123 Москва, Новогиреевская ул., 1, корп. 1 

Feoktistova Polina Sergeevna

Build. Novogireevskaya St., Moscow 111123

https://orcid.org/0000-0001-5169-2199ЦвиркунВ. В.TsvirkunV. V.

Цвиркун Виктор Викторович

111123 Москва, Новогиреевская ул., 1, корп. 1 

Tsvirkun Viktor Viktorovich

Build. Novogireevskaya St., Moscow 111123

ГБУЗ г. Москвы «Московский клинический научно-практический центр им. А. С. Логинова Департамента здравоохранения г. Москвы»РоссияA. S. Loginov Moscow Clinical Scientific Center, Moscow Healthcare DepartmentRussian FederationГБУЗ г. Москвы «Московский клинический научно-практический центр им. А. С. Логинова Департамента здравоохранения г. Москвы» ; НОЧУ ВО «Московский финансово-промышленный университет „Синергия“»РоссияA. S. Loginov Moscow Clinical Scientific Center, Moscow Healthcare Department ; Moscow Financial and Industrial University “Synergy”Russian Federation2025301020251532939Copyright © Данилова М.А., Семёнов Н.Н., Данилов М.А., Леонтьев А.В., Саакян Г.Г., Алиев В.А., Феоктистова П.С., Цвиркун В.В., 20252025Данилова М.А., Семёнов Н.Н., Данилов М.А., Леонтьев А.В., Саакян Г.Г., Алиев В.А., Феоктистова П.С., Цвиркун В.В.Danilova M.A., Semenov N.N., Danilov M.A., Leontev A.V., Saakyan G.G., Aliev V.A., Feoktistova P.S., Tsvirkun V.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/1491

Цель исследования: Оценить влияние неоадьювантной химиотерапии (НеоАХТ) на результаты лечения III стадии рака ободочной кишки (Node-Rads 3–5).Материалы и методы: В проспективное одноцентровое рандомизированное исследование в МКНЦ им. А. С. Логинова ДЗМ включено 108 пациентов, разделенных на две группы: группа НеоАХТ (n = 54) и группа первичной хирургии (n = 54). В группе НеоАХТ проводили лечение по схемам CapOX (4 курса) или FOLFOX6 (6 курсов) с последующим оперативным вмешательством. Оценивались непосредственные результаты хирургического вмешательства (длительность операции, интраоперационная кровопотеря, частота конверсии, частота послеоперационных осложнений по Clavien-Dindo, количество койко-дней), результаты морфологического исследования, токсичность и завершенность проведенного химиотерапевтического этапа лечения.Результаты: НеоАХТ не оказала негативного влияния на хирургические исходы: медиана длительности операции составила 180 минут, медиана послеоперационного койко / дня — 8,7, интраоперационная кровопотеря — 50–100 мл в обеих группах. В группе НеоАХТ выявлено значимое увеличение частоты конверсии из лапароскопии в лапаротомию (p = 0,046). Частота послеоперационных осложнений 3a-b по Clavien-Dindo — 4,2 и 3,8 % соответственно (р = 1). При сравнении клинической и патоморфологической стадии опухоли после НеоАХТ отмечено значимое увеличение частоты выявления pN0 (p < 0,001), уменьшение частоты выявления лимфоваскулярной инвазии (p < 0,001), выраженное уменьшение частоты выявления pT4b (р = 0,053), pN2 (р = 0,06). Частота назначения адъювантной химиотерапии в группе НеоАХТ была значительно ниже: 44,7 % пациентов получали АХТ 6 месяца против 66,7 %, пациентов в группе первичной хирургии, p = 0,029).Заключение: НеоАХТ не увеличивает частоту хирургических осложнений, но способствует снижению стадии и, как следствие, сокращению объёма адъювантной химиотерапии. Включение в исследование пациентов 4–5 баллов по Node-RADS позволяет снизить риск завышения стадии при отборе на неоадъювантную терапию с 25–33 % до 8 %.

Background

Background: The optimal treatment strategy for patients with stage III colon cancer remains a subject of active research. While adjuvant chemotherapy (ACT) following surgery is the current standard, the potential role of neoadjuvant chemotherapy (NeoACT) in improving treatment outcomes is increasingly being investigated.

Objective

Objective: To evaluate the impact of neoadjuvant chemotherapy (NeoACT) on surgical outcomes in patients with stage III colon cancer (Node-RADS scores 3-5).

Materials and methods

Materials and methods: A prospective, single-center, randomized clinical trial included 108 patients divided into two groups: NeoACT (n = 54) and primary surgery (n = 54). Patients in the NeoACT group received chemotherapy using either the CapOX regimen (4 cycles) or FOLFOX6 (6 cycles), followed by surgery. Surgical outcomes (operation duration, intraoperative blood loss, conversion rate, postoperative complications according to Clavien-Dindo, and length ofhospital stay) and pathological findings were analyzed.

Results

Results: NeoACT did not adversely affect surgical outcomes. The median operation time was 180 minutes, and the median hospital stay was 8.7 days. Intraoperative blood loss was 50-100 ml in both groups. A statistically sig­nificant increase in conversion from laparoscopy to laparotomy was observed in the NeoACT group (p = 0.046). The rates of Clavien-Dindo grade 3a — b complications were 4.2 % and 3.8 %, respectively (p = 1). NeoACT resulted in a higher rate of pNO (p < 0.001), reduced incidence of pT4b (p = 0.053) and pN2 (p = 0.06), and lower presence of lymphovascular invasion (p < 0.001). Only 59.3 % of patients in the NeoACT group required 3 months of ACT, compared to 71.2 % of patients in the primary surgery group who received 6 months (p < 0.001).

Conclusion

Conclusion: NeoACT does not increase the rate of postoperative complications and contributes to tumor down­staging, leading to reduced need for adjuvant chemotherapy. The inclusion of patients with Node-RADS scores 4-5 minimized the risk of overtreatment from 25% to 8%.

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