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Dragon III: Neoadjuvant Chemotherapy FLOT versus SOX for Gastric Cancer

By Birendra Kumar Sah, Benyan Zhang, Huan Zhang, Jian Li, Fei Yuan, Tao Ma, Min Shi, Wei Xu, Zhenglun Zhu, Wentao Liu, Chao Yan, Chen Li, Bingya Liu, Min Yan, Zhenggang Zhu

Posted 23 Jun 2020
medRxiv DOI: 10.1101/2020.06.21.20136887

Background: Neoadjuvant chemotherapy with docetaxel, oxaliplatin, fluorouracil, and leucovorin (the FLOT regimen) has shown promising results in terms of pathological response and survival rate. However, tegafur gimeracil oteracil potassium capsule (S-1) plus oxaliplatin (the SOX regimen) is a more favorable chemotherapy regimen in Eastern countries. We conducted this study to evaluate the safety and efficacy of both regimens and to explore a suitable regimen for gastric cancer patients. Methods: Patients with locally advanced gastric cancer (LAGC) were 1:1 randomly assigned to receive either 4 cycles of the FLOT regimen or 3 cycles of the SOX regimen before curative gastrectomy. The primary endpoint was the comparison of complete or subtotal tumor regression grading (TRG1a+ TRG1b) in the primary tumor. Results: Altogether, 74 patients were enrolled between August 2018 and March 2020. There was no significant difference in pretreatment clinicopathological parameters between the FLOT group and the SOX group (p>0.05). There was no significant difference in adverse effects or postoperative morbidity and mortality between the two groups (p>0.05). Similarly, there was no significant difference in the proportion of tumor regression grading between the FLOT group and the SOX group (p>0.05). In the ITT population, complete or subtotal TRG was 20.0% in the FLOT group versus 32.4% in the SOX group (p>0.05). Conclusion: Our study demonstrates that the FLOT and SOX regimens are similarly effective for locally advanced gastric cancer patients in terms of clinical downstaging and pathological response. A large-scale phase III randomized controlled trial is necessary to validate this result.

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