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Interim results of a prospective randomised single-centre phase III study comparing mFOLFIRINOX and mFOLFOX6 regimens in the first-line treatment of HER2-negative gastric adenocarcinoma

https://doi.org/10.33667/2078-5631-2024-17-42-48

Abstract

Given the poor treatment outcomes of disseminated gastric cancer (dGC), the search for new drug treatment options remains a pressing issue. According to some literature, the use of a chemotherapeutic triplet in the first line improves patient survival rates. An interim analysis of a prospective randomised phase III trial examines the comparison of the chemotherapeutic regimens mFOLFIRINOX and mFOLFOX6 in the first-line treatment of HER2-negative gastric adenocarcinoma. In this interim analysis, significant differences between patients receiving mFOLFIRINOX or mFOLFOX6 regarding the primary endpoint of mVBP were detected only in the group of patients with dissemination to the retroperitoneal lymph nodes. Overall, based on the results of this work, it can be concluded that the majority of patients do not require intensification of first-line treatment for gastric adenocarcinoma in the form of mFOLFIRINOX chemotherapy. However, final conclusions on the efficacy of the triple combination can only be drawn upon completion of the entire study.

About the Authors

D. A. Gavrilova
N.N. Blokhin National Medical Investigation Centre of Oncology
Russian Federation

Gavrilova Daria. A. - oncologist of the Chemotherapy Dept № 2 of N.N. Trapeznikov

Moscow



N. S. Besova
N.N. Blokhin National Medical Investigation Centre of Oncology
Russian Federation

Besova Natalia. S. - PhD Med, Leading Researcher of the Chemotherapy Dept № 2 of N.N. Trapeznikov

Moscow



E. S. Obarevich
N.N. Blokhin National Medical Investigation Centre of Oncology
Russian Federation

Obarevich Ekaterina. S. -oncologist of the Chemotherapy Dept № 2 of N.N. Trapeznikov

Moscow



G. G. Makiev
N.N. Blokhin National Medical Investigation Centre of Oncology
Russian Federation

Makiev Georgii. G. - oncologist of the Chemotherapy Dept № 2 of N.N. Trapeznikov

Moscow



A. B. Rays
N.N. Blokhin National Medical Investigation Centre of Oncology
Russian Federation

Rays Anastasia. B. - oncologist of the Chemotherapy Dept № 2 of N.N. Trapeznikov

Moscow



E. V. Artamonova
N.N. Blokhin National Medical Investigation Centre of Oncology
Russian Federation

Artamonova Elena V. - MD, professor, head of the chemotherapy Dept № 1 of N.N. Trapeznikov

Moscow



I. S. Stylidi
N.N. Blokhin National Medical Investigation Centre of Oncology
Russian Federation

Stylidi Ivan S. - DM Sci (habil.), Academic of the Russian Academy of Sciences. Professor, Director

Moscow



A. A. Tryakin
N.N. Blokhin National Medical Investigation Centre of Oncology
Russian Federation

Tryakin Alexey A. - MD, professor, deputy director (Research Institute CO) on scientific work, head of the chemotherapy Dept № 2 of N.N. Trapeznikov

Moscow



References

1. Smyth E. C., Nilsson M., Grabsch H. I. et al. Gastric cancer. Lancet. 2020; 396 (10251): 635–48. Doi:10.1016/s0140–6736(20)31288–5

2. Ferlay J, Colombet M, Soerjomataram I, Parkin DM, Piñeros M, Znaor A, Bray F. Cancer statistics for the year 2020: An overview. Int J. Cancer. 2021. DOI: 10.1002/ijc.33588

3. Janjigian Y.Y., Shitara K., Moehler M. et al. First-line nivolumab plus chemotherapy versus chemotherapy alone for advanced gastric, gastro-oesophageal junction, and oesophageal adenocarcinoma (CheckMate 649): A randomised, open-label, phase 3 trial. Lancet. 2021; 398: 27–40. DOI: 10.1016/S0140–6736(21)00797–2

4. Al-Batran SE, Hartmann JT, Probst S, Schmalenberg H, Hollerbach S, Hofheinz R, Rethwisch V, Seipelt G, Homann N, Wilhelm G, Schuch G, Stoehlmacher J, Derigs HG, Hegewisch-Becker S, Grossmann J, Pauligk C, Atmaca A, Bokemeyer C, Knuth A, Jäger E; Arbeitsgemeinschaft Internistische Onkologie. Phase III trial in metastatic gastroesophageal adenocarcinoma with fluorouracil, leucovorin plus either oxaliplatin or cisplatin: a study of the Arbeitsgemeinschaft Internistische Onkologie. J. Clin. Oncol. 2008 Mar 20; 26 (9): 1435–42. DOI: 10.1200/JCO.2007.13.9378

5. Koizumi W, Narahara H, Hara T, Takagane A, Akiya T, Takagi M, Miyashita K, Nishizaki T, Kobayashi O, Takiyama W, Toh Y, Nagaie T, Takagi S, Yamamura Y, Yanaoka K, Orita H, Takeuchi M. S‑1 plus cisplatin versus S‑1 alone for first-line treatment of advanced gastric cancer (SPIRITS trial): a phase III trial. Lancet Oncol. 2008 Mar; 9 (3): 215–21. DOI: 10.1016/S1470–2045(08)70035–4

6. Kang YK, Kang WK, Shin DB, Chen J, Xiong J, Wang J, Lichinitser M, Guan Z, Khasanov R, Zheng L, Philco-Salas M, Suarez T, Santamaria J, Forster G, McCloud PI. Capecitabine/cisplatin versus 5-fluorouracil/cisplatin as first-line therapy in patients with advanced gastric cancer: a randomised phase III noninferiority trial. Ann Oncol. 2009 Apr; 20 (4): 666–73. DOI: 10.1093/annonc/mdn717

7. Van Cutsem E, Moiseyenko VM, Tjulandin S, Majlis A, Constenla M, et al. Phase III study of docetaxel and cisplatin plus fluorouracil compared with cisplatin and fluorouracil as first-line therapy for advanced gastric cancer: a report of the V325 Study Group. Journal Of Clinical. Oncology. 2006; 24 (31): 4991–4997. DOI: 10.1200/JCO.2006.06.8429

8. Shah MA, Janjigian YY, Stoller R, Shibata S, Kemeny M, Krishnamurthi S, Su YB, Ocean A, Capanu M, Mehrotra B, Ritch P, Henderson C, Kelsen DP. Randomized Multicenter Phase II Study of Modified Docetaxel, Cisplatin, and Fluorouracil (DCF) Versus DCF Plus Growth Factor Support in Patients With Metastatic Gastric Adenocarcinoma: A Study of the US Gastric Cancer Consortium. J. Clin. Oncol. 2015; 33 (33): 3874–9. DOI: 10.1200/JCO.2015.60.7465

9. Park H., Jin R.U., Wang-Gillam A., Suresh R., Rigden C., Amin M., Tan B. R., et al. FOLFIRINOX for the Treatment of Advanced Gastroesophageal Cancers: A Phase 2 Nonrandomized Clinical Trial. JAMA Oncol. 2020; 6 (8): 1231–1240. DOI: 10.1001/jamaoncol.2020.2020

10. Zaanan A., Bouche O., de la Fouchardiere C., Samalin-Scalzi E., Le Malicot K., Pernot S., et al. 5-fluorouracil and oxaliplatin with or without docetaxel in the first- line treatment of HER2 negative locally advanced (LA) unresectable or metastatic gastric or gastro-esophageal junction (GEJ) adenocarcinoma (GASTFOX-PRODIGE51): A randomized phase III trial sponsored by the FFCD. Ann Oncol. 2023; 34 (4): s1318 (A LBA77). DOI: https://doi.org/10.1016/j.annonc.2023.10.078

11. Ramaswamy A., Bhargava P.G., Biswajit D., Kapoor A., Srinivas S., Shetty O. et al. A two-arm randomized open-label prospective design superiority phase III clinical trial to compare the efficacy of docetaxel-oxaliplatin-capecitabine/5 fluorouracil (DOC/F) followed by docetaxel versus CAPOX/mFOLFOX‑7 in advanced gastric cancers (DOC-GC study). Journal of Clinical Oncology. 2024; 42 (3) suppl (LBA248) https://doi.org/10.1200/JCO.2024.42.3

12. Obarevich E.S., Besova N.S., Davydov M.M. et al. Study the effectiveness of a combined approach for treatment of patients with disseminated stomach cancer. Journal of N.N. Blokhin Russian Cancer Research Center RAMS. 2016; 27(2): 83–88.


Review

For citations:


Gavrilova D.A., Besova N.S., Obarevich E.S., Makiev G.G., Rays A.B., Artamonova E.V., Stylidi I.S., Tryakin A.A. Interim results of a prospective randomised single-centre phase III study comparing mFOLFIRINOX and mFOLFOX6 regimens in the first-line treatment of HER2-negative gastric adenocarcinoma. Medical alphabet. 2024;(17):42-48. (In Russ.) https://doi.org/10.33667/2078-5631-2024-17-42-48

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ISSN 2078-5631 (Print)
ISSN 2949-2807 (Online)