Neoadjuvant FLOT versus SOX phase II randomized clinical trial for patients with locally advanced gastric cancer

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

doi:10.1038/s41467-020-19965-6

Cited by 81 publications

(71 citation statements)

References 20 publications

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“…[6,7,11] Furthermore, cancer therapy assisted by nanomaterial deliveries has shown promising potential for its secure and effective tumor targeting. [10,12,13] Although there are many advantages, traditional administration of these drugs causes off-target accumulation and serious systemic adverse effects; [14][15][16] however, the delivery of nanomaterials remains limited by uncertain clearance mechanisms, poor maneuverability, and complex synthetic processes. [17][18][19] Thus, new drug carriers with improved administration techniques and biosecurity, as well as effective tumor-targeting, are required.…”

Section: Introductionmentioning

confidence: 99%

Ultrasound‐Responsive Microfluidic Microbubbles for Combination Tumor Treatment

Huang

Zhang

Zhao

et al. 2021

Advanced Therapeutics

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Anticancer treatment is a worldwide challenge, and there are constant endeavors in this field to develop intelligent drug delivery systems to improve the therapeutic effect. This paper presents novel ultrasound-responsive delivery microbubbles (UDMs), with chemotherapeutic-encapsulated hydrogel shells and therapeutic gas cores. These are developed using microfluidic electrospray to treat pancreatic tumors. As the hydrogel shells are composed of thermo-sensitive poly(N-isopropylacrylamide) (PNIPAM), they can contract under mild hyperthermia generated by the acoustic-wave-induced oscillation of the encapsulated gas. Thus, by triggering with ultrasound, the chemotherapeutic Gemcitabine (Gem) encapsulated in the hydrogel shells and the hydrogen sulfide (H 2 S) encased in the cores can be controllably released. Based on the UDMs, it is demonstrated that the multiple drug-loaded microcarriers exhibit an excellent tumor-killing effect through combination therapy. The Gem and H 2 S coloaded UDMs have good therapeutic efficacy and adaptability in an orthotopic pancreatic implantation tumor model established in mice. These results indicate that the proposed UDMs have a large potential for codelivery of multiple drugs for treating deep-seated tumors and for realizing combination drug treatment to avoid untoward reactions.

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Section: Introductionmentioning

confidence: 99%

Ultrasound‐Responsive Microfluidic Microbubbles for Combination Tumor Treatment

Huang

Zhang

Zhao

et al. 2021

Advanced Therapeutics

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“…The efficacy in the FLOT group in this study was similar to that observed in several other studies. [11][12][13][14]26 The FLOT plus apatinib combination therapy did not result in significantly higher DCR, nor did it significantly improve the TRG and ypTNM stages. We considered that this may be related to the small sample size.…”

Section: Discussionmentioning

confidence: 99%

“… 13 In 2020, a clinical trial showed that a neoadjuvant FLOT regimen has similar safety and effectiveness for LAGC to that of a tegafur, gimeracil, and oteracil potassium capsule plus oxaliplatin regimen. 14 With this evidence, the application of FLOT for neoadjuvant therapy in patients with gastric cancer will like become more popular.…”

Section: Introductionmentioning

confidence: 99%

“…11 The efficacy of FLOT was further demonstrated in subsequent clinical trials. [12][13][14] In 2017, the AIO-FLOT3 trial showed that patients with LAGC who received FLOT neoadjuvant chemotherapy and proceeded to surgery had favorable survival. 12 Results from another clinical trial in 2019 showed that perioperative FLOT improved overall survival compared with perioperative fluorouracil or capecitabine plus cisplatin and epirubicin in locally advanced, resectable gastric or gastroesophageal junction adenocarcinoma.…”

Section: Introductionmentioning

confidence: 99%

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Perioperative Safety and Effectiveness of Neoadjuvant Therapy with Fluorouracil, Leucovorin, Oxaliplatin, and Docetaxel Plus Apatinib in Locally Advanced Gastric Cancer

Zhang¹,

Zhang²,

Yang³

et al. 2021

CMAR

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Purpose The trend in neoadjuvant therapy for locally advanced gastric cancer (LAGC) is to use more drugs or therapies in combination. This study aimed to assess the safety and effectiveness of neoadjuvant chemotherapy with fluorouracil, leucovorin, oxaliplatin, and docetaxel (FLOT) plus apatinib in the treatment of LAGC. Patients and Methods We collected clinical data from patients with LAGC who received neoadjuvant FLOT and apatinib therapy and underwent surgery from January 2017 to December 2020. Patients were divided into either the FLOT group (in which patients received FLOT neoadjuvant therapy and surgery) or the FLOTA group (in which patients received FLOT plus apatinib neoadjuvant therapy and surgery). Results The FLOT and FLOTA groups contained 44 and 31 patients, respectively. There were significant differences between the FLOT and FLOTA groups in the objective response rate (50.00% vs. 80.65%, respectively, p = 0.008) and average change from baseline in the target lesion size (−26.16 ± 34.61 vs. −54.32 ± 36.11, respectively, p < 0.001). There were also significant differences in the pretreatment clinical tumor-node-metastasis (cTNM) and post treatment cTNM stages for the FLOT group (p = 0.001) and for the FLOTA group (p < 0.001). There were no significant differences between the FLOT and FLOTA groups in post neoadjuvant therapy cTNM stages (p = 0.525), R0 rate (p = 0.397), tumor regression grade (p = 0.397), or post treatment pathological TNM stage (p = 0.180). Some neoadjuvant therapy-related adverse events occurred significantly more frequently in the FLOTA group, including diarrhea (all grades), pain (all grades), oral mucositis (all grades), and hand-foot syndrome (all grades). Conclusion The FLOTA regimen can achieve better perioperative efficacy and acceptable toxicity compared with that of the FLOT regimen in neoadjuvant treatment of LAGC. The FLOTA regimen for neoadjuvant therapy for LAGC merits further study.

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“…In contrast, SOX regimen is the preferred neoadjuvant chemotherapy regimen in the East. The phase II randomized clinical trial NCT03636893 reported 74 patients with locally advanced resectable GC, and the primary outcomes did not show statistically significant differences between neoadjuvant FLOT and SOX regimens[ 54 ]. The FLOT and SOX groups showed desired therapeutic effect, yet several hematological grade 3–4 adverse events were observed (29.0% and 16.1%, respectively).…”

Section: Prospects Of Icis For Neoadjuvant Treatment Of Gcmentioning

confidence: 99%

Research status on immunotherapy trials of gastric cancer

Liang¹,

Wu²,

Yu³

et al. 2021

WJCC

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The breakthrough of immune checkpoint inhibitor (ICI) therapy has created extensive opportunities for cancer immunotherapy. Especially, the block of programmed death-1/programmed death ligand 1 (PD-L1) axis using ICIs has become a new therapeutic strategy to treat advanced gastric cancer (GC). However, in the past decade, single-arm and randomized trials for single-drug ICI therapy showed that the therapeutic effect was not satisfactory, including clinical trials for advanced GC. However, after selecting suitable predictive biomarkers and developing a combination of anti-angiogenic targeted drugs and other chemotherapeutic drugs, the objective response rate and progression-free survival of patients with gastric cancer were improved significantly. The United States Food and Drug Administration has approved treatment with pembrolizumab for patients with advanced GC with PD-L1 expression or microsatellite instability-high/mismatch repair deficiency. In this review, the updated data from the latest trial results of combination immunotherapy for GC are presented. Based on the outcome of combination therapy, we discuss its possible molecular mechanism and summarize effective predictive biomarkers. We also discuss possible problems stemming from results of other clinical trials of ICI treatment and propose other directions for ICI therapy.

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Neoadjuvant FLOT versus SOX phase II randomized clinical trial for patients with locally advanced gastric cancer

Cited by 81 publications

References 20 publications

Ultrasound‐Responsive Microfluidic Microbubbles for Combination Tumor Treatment

Ultrasound‐Responsive Microfluidic Microbubbles for Combination Tumor Treatment

Perioperative Safety and Effectiveness of Neoadjuvant Therapy with Fluorouracil, Leucovorin, Oxaliplatin, and Docetaxel Plus Apatinib in Locally Advanced Gastric Cancer

Research status on immunotherapy trials of gastric cancer

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