Total neoadjuvant chemotherapy according to the FOLFIRINOX regimen for locally advanced adenocarcinoma of the stomach and cardioesophageal junction: interim results

Purpose. To study the efficacy and safety of total neoadjuvant chemotherapy (NACT) with the FOLFIRINOX regimen for locally advanced gastric (GC) and cardioesophageal junction (CEJ) cancer.Patients and methods. Patients with histologically confirmed locally advanced gastric adenocarcinoma and CEJ, clini...

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Main Authors: M. V. Sedova, M. A. Batov, A. A. Kolomeytseva, V. M. Khomyakov, N. N. Volchenko, A. A. Fedenko
Format: Article
Language:Russian
Published: QUASAR, LLC 2023-09-01
Series:Исследования и практика в медицине
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Online Access:https://www.rpmj.ru/rpmj/article/view/932
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author M. V. Sedova
M. A. Batov
A. A. Kolomeytseva
V. M. Khomyakov
N. N. Volchenko
A. A. Fedenko
author_facet M. V. Sedova
M. A. Batov
A. A. Kolomeytseva
V. M. Khomyakov
N. N. Volchenko
A. A. Fedenko
author_sort M. V. Sedova
collection DOAJ
description Purpose. To study the efficacy and safety of total neoadjuvant chemotherapy (NACT) with the FOLFIRINOX regimen for locally advanced gastric (GC) and cardioesophageal junction (CEJ) cancer.Patients and methods. Patients with histologically confirmed locally advanced gastric adenocarcinoma and CEJ, clinical stage cT3 or higher and/or regional lymph node involvement (cN+), without evidence of distant metastasis were included in our open-label, single-centre, non-randomised study. In the FLOT control group, patients received 4 courses preoperatively and 4 postoperatively with follow-up. I In the FOLFIRINOX group 8 courses of chemotherapy were administered in neoadjuvant mode, followed by surgery and observation. The tumor regression grade was assessed in accordance with Becker, Mandard and G. A. Lavnikova scales.Results. The study included 136 patients, 119 of whom started treatment according to the protocol (ITT population). Fiſty-nine patients were enrolled into the FLOT group and 60 into the FOLFIRINOX group. One-year progression-free survival (PFS) was 67,5 % in the FLOT group and 90,4 % in the FOLFIRINOX group (p = 0,29). The estimated 2-year PFS in the FLOT group was 61,4 % [95 % CI, 48,4–77,9 %]. Median PFS and overall survival (OS) were not reached. The incidence of events (progression or death) was lower in the FOLFIRINOX group (odds ratio [OR] 0,40 [95 % CI 0,16–0,97, p = 0,047]). Adverse prognostic factors regardless of treatment were lymphatic (L1), vascular (V1) and perineural invasion (Pn1), and regional lymph node involvement aſter chemotherapy (ypN+) [p = 0,046; p = 0,014; p = 0,0021; p = 0,04, respectively]. There was no correlation between pathological complete response and survival rates.Conclusion. Total neoadjuvant chemotherapy with the FOLFIRINOX regimen for locally advanced GC/ CEJ demonstrated comparable to the perioperative FLOT one-year PFS rate. No association was found between tumor regression grade and survival outcomes.
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spelling doaj-art-932b2c3822704e52941228d798752a982025-02-03T07:12:17ZrusQUASAR, LLCИсследования и практика в медицине2410-18932023-09-0110382010.17709//2410-1893-2023-10-3-1513Total neoadjuvant chemotherapy according to the FOLFIRINOX regimen for locally advanced adenocarcinoma of the stomach and cardioesophageal junction: interim resultsM. V. Sedova0M. A. Batov1A. A. Kolomeytseva2V. M. Khomyakov3N. N. Volchenko4A. A. Fedenko5P. Hertsen Moscow Oncology Research Institute – Branch of the National Medical Research Radiological Centre, Ministry of Health of the Russian FederationP. Hertsen Moscow Oncology Research Institute – Branch of the National Medical Research Radiological Centre, Ministry of Health of the Russian FederationP. Hertsen Moscow Oncology Research Institute – Branch of the National Medical Research Radiological Centre, Ministry of Health of the Russian FederationP. Hertsen Moscow Oncology Research Institute – Branch of the National Medical Research Radiological Centre, Ministry of Health of the Russian FederationP. Hertsen Moscow Oncology Research Institute – Branch of the National Medical Research Radiological Centre, Ministry of Health of the Russian FederationP. Hertsen Moscow Oncology Research Institute – Branch of the National Medical Research Radiological Centre, Ministry of Health of the Russian FederationPurpose. To study the efficacy and safety of total neoadjuvant chemotherapy (NACT) with the FOLFIRINOX regimen for locally advanced gastric (GC) and cardioesophageal junction (CEJ) cancer.Patients and methods. Patients with histologically confirmed locally advanced gastric adenocarcinoma and CEJ, clinical stage cT3 or higher and/or regional lymph node involvement (cN+), without evidence of distant metastasis were included in our open-label, single-centre, non-randomised study. In the FLOT control group, patients received 4 courses preoperatively and 4 postoperatively with follow-up. I In the FOLFIRINOX group 8 courses of chemotherapy were administered in neoadjuvant mode, followed by surgery and observation. The tumor regression grade was assessed in accordance with Becker, Mandard and G. A. Lavnikova scales.Results. The study included 136 patients, 119 of whom started treatment according to the protocol (ITT population). Fiſty-nine patients were enrolled into the FLOT group and 60 into the FOLFIRINOX group. One-year progression-free survival (PFS) was 67,5 % in the FLOT group and 90,4 % in the FOLFIRINOX group (p = 0,29). The estimated 2-year PFS in the FLOT group was 61,4 % [95 % CI, 48,4–77,9 %]. Median PFS and overall survival (OS) were not reached. The incidence of events (progression or death) was lower in the FOLFIRINOX group (odds ratio [OR] 0,40 [95 % CI 0,16–0,97, p = 0,047]). Adverse prognostic factors regardless of treatment were lymphatic (L1), vascular (V1) and perineural invasion (Pn1), and regional lymph node involvement aſter chemotherapy (ypN+) [p = 0,046; p = 0,014; p = 0,0021; p = 0,04, respectively]. There was no correlation between pathological complete response and survival rates.Conclusion. Total neoadjuvant chemotherapy with the FOLFIRINOX regimen for locally advanced GC/ CEJ demonstrated comparable to the perioperative FLOT one-year PFS rate. No association was found between tumor regression grade and survival outcomes.https://www.rpmj.ru/rpmj/article/view/932total neoadjuvant chemotherapyneoadjuvant chemotherapyfolfirinoxflotgastric cancer, gastroesophageal junction cancertumor regression grade
spellingShingle M. V. Sedova
M. A. Batov
A. A. Kolomeytseva
V. M. Khomyakov
N. N. Volchenko
A. A. Fedenko
Total neoadjuvant chemotherapy according to the FOLFIRINOX regimen for locally advanced adenocarcinoma of the stomach and cardioesophageal junction: interim results
Исследования и практика в медицине
total neoadjuvant chemotherapy
neoadjuvant chemotherapy
folfirinox
flot
gastric cancer, gastroesophageal junction cancer
tumor regression grade
title Total neoadjuvant chemotherapy according to the FOLFIRINOX regimen for locally advanced adenocarcinoma of the stomach and cardioesophageal junction: interim results
title_full Total neoadjuvant chemotherapy according to the FOLFIRINOX regimen for locally advanced adenocarcinoma of the stomach and cardioesophageal junction: interim results
title_fullStr Total neoadjuvant chemotherapy according to the FOLFIRINOX regimen for locally advanced adenocarcinoma of the stomach and cardioesophageal junction: interim results
title_full_unstemmed Total neoadjuvant chemotherapy according to the FOLFIRINOX regimen for locally advanced adenocarcinoma of the stomach and cardioesophageal junction: interim results
title_short Total neoadjuvant chemotherapy according to the FOLFIRINOX regimen for locally advanced adenocarcinoma of the stomach and cardioesophageal junction: interim results
title_sort total neoadjuvant chemotherapy according to the folfirinox regimen for locally advanced adenocarcinoma of the stomach and cardioesophageal junction interim results
topic total neoadjuvant chemotherapy
neoadjuvant chemotherapy
folfirinox
flot
gastric cancer, gastroesophageal junction cancer
tumor regression grade
url https://www.rpmj.ru/rpmj/article/view/932
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AT aakolomeytseva totalneoadjuvantchemotherapyaccordingtothefolfirinoxregimenforlocallyadvancedadenocarcinomaofthestomachandcardioesophagealjunctioninterimresults
AT vmkhomyakov totalneoadjuvantchemotherapyaccordingtothefolfirinoxregimenforlocallyadvancedadenocarcinomaofthestomachandcardioesophagealjunctioninterimresults
AT nnvolchenko totalneoadjuvantchemotherapyaccordingtothefolfirinoxregimenforlocallyadvancedadenocarcinomaofthestomachandcardioesophagealjunctioninterimresults
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