Intraperitoneal Chemotherapy Using Fluorouracil Implants Combined With Radical Resection and Postoperative Adjuvant Chemotherapy for Stage III Gastric Cancer: A Multi-Center, Randomized, Open-Label, Controlled Clinical Study

Xu, Yan; Zhang, Rupeng; Li, Chunfeng; Sun, Zhe; Deng, Jingyu; Wang, Xiaona; Ding, Xiaobo; Wang, Baogui; Qin, Xue; Ke, Bin; Zhan, Hongjie; Liu, Ning; Liu, Yong; Wang, Xuejun; Liang, Han; Xue, Yingwei; Xu, Hui

doi:10.3389/fonc.2021.670651

Cited by 7 publications

(5 citation statements)

References 26 publications

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“…The use of sustained-release 5-FU implants has shown survival benefits in different types of digestive system tumors such as colon cancer and primary hepatic cellular cancer[ 29 , 30 ]. Furthermore, a few studies on the treatment of gastric cancer, which showed similar results, were also reported by Chinese researchers[ 21 , 22 ]. However, P values of survival benefits obtained in previous studies on gastric cancer were lower, but close to 0.05.…”

Section: Discussionsupporting

confidence: 65%

“…Moreover, optimistic results concerning the use of sustained-release 5-FU implants in the treatment of gastric cancer have been shown. Recently, a multi-center, randomized, open-label, controlled clinical study showed that for cTNM stage III gastric cancer patients, the use of intraoperative 5-FU implants, combined with postoperative adjuvant chemotherapy, may reduce the risk of peritoneal recurrence and prolong progression-free survival significantly[ 22 ]. Another retrospective study with 5-FU implants in advanced gastric cancer patients showed that the use of 5-FU implants may improve 5-years overall survival (OS) and progression-free survival rates after surgery in gastric cancer patients[ 21 ].…”

Section: Introductionmentioning

confidence: 99%

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No long-term survival benefit with sustained-release 5-fluorouracil implants in patients with stages II and III gastric cancer

Wu¹,

Wu²,

Zheng³

et al. 2022

World J Gastroenterol

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BACKGROUND The prognosis of gastric cancer in an advanced stage remains poor. The exact efficacy of the use of intraoperative sustained-release chemotherapy with 5-fluorouracil (5-FU) in advanced-stage gastric cancer is still unelucidated. AIM To explore the long-term survival benefit of using sustained-release 5-FU implants in stage II and stage III gastric cancer patients. METHODS Patients with gastric cancer in a locally advanced stage and who underwent an R0 radical resection between Jan 2014, to Dec 2016, in this single institution were included. Patients with pathological diagnoses other than adenocarcinoma were excluded. All included patients were grouped according to whether intraoperative sustained-release (SR) chemotherapy with 5-FU was used or not (NSR). The primary end-point was 5-year overall survival. Kaplan–Meier method with log-rank test was used to analyze the overall survival of patients and Cox analysis was used to analyze prognosis factors of these patients. RESULTS In total, there were 563 patients with gastric cancer with locally advanced stage, who underwent an R0 radical resection. 309 patients were included in the final analysis. 219 (70.9%) were men, with an average age of 58.25 years. Furthermore, 56 (18.1%) received neoadjuvant chemotherapy, and 191 (61.8%) were in TNM stage III. In addition, 158 patients received intraoperative sustained-release chemotherapy with 5-FU and were included in the SR group, while the other 161 patients were included in the NSR group. The overall complication rate was 12.94% in the whole group and 10.81%, 16.46% in SR and NSR groups, respectively. There were no significant differences between the two groups in overall survival and complication rate ( P > 0.05). The multivariate cox analysis indicated that only N Stage and neoadjuvant therapy were independent influencing factors of survival. CONCLUSION Intraoperative sustained-release chemotherapy usage with 5-FU, did not improve the survival of patients who underwent an R0 radical resection in locally advanced stage of gastric cancer.

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Section: Discussionsupporting

confidence: 65%

Section: Introductionmentioning

confidence: 99%

No long-term survival benefit with sustained-release 5-fluorouracil implants in patients with stages II and III gastric cancer

Wu¹,

Wu²,

Zheng³

et al. 2022

World J Gastroenterol

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“…Extended release fluorouracil after radical surgery and postoperative adjuvant chemotherapy can considerably lower the probability of peritoneal recurrence and lengthen PFS in stage III gastric cancer. There was no obvious increase in the incidence of side effects compared with the control group (Xu et al 2021 ).…”

Section: Discussionmentioning

confidence: 96%

Effectiveness and safety of intraoperative intraperitoneal 5-Fu drug implantation in patients with colorectal cancer: a retrospective cohort study

Liu,

Hu,

Lai

2024

J Cancer Res Clin Oncol

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Purpose The purpose of this clinical study was to evaluate the efficacy and safety of intraoperative chemotherapy (IOC) with intraoperative intraperitoneal implantation of 5-fluorouracil (5-FU) in colorectal cancer (CRC) patients. Methods In this study, 165 patients who underwent colorectal radical surgery were selected, of whom 111 in the experimental group received surgical treatment with an intraperitoneal 5-fluorouracil (5-FU) implantation. Fifty-four patients who did not undergo intraperitoneal implantation of 5-FU were matched to compare the progression-free survival (PFS) and overall survival (OS) with the former. Results We also studied the differences in the changes of different biochemical indicators between the two groups before and after surgery, and there were significant differences in leukocytes, neutrophils, and lymphocytes before and after (P < 0.05), while for sodium ions, potassium ions, platelets, alanine transaminase, aspartate transaminase, creatinine, urea, and albumin, there were no significant differences. This may be related to the intraperitoneal chemotherapy implant entering the blood circulation. For 5-year OS, there were 85/111 (76.58%) in the 5-FU group (P = 0.013) and 35/54 (64.81%) in the control group; for 5-year PFS, there were 84/111 (75.68%) in the 5-FU group and 29/54 (53.70%) in the control group (P = 0.02). All the experimental groups were better than the control group with a significant difference in the experimental results. Conclusion For CRC surgery patients, intraperitoneal implantation of slow-release 5-FU drugs, which is a safe and simple procedure, can improve the prognosis of the patients. Clinical trial registration No clinical trials were performed in the study.

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“…Actually, this method can achieve high concentration in target tissue with limited systemic penetration. [47][48][49] The utilization of intraperitoneal injection of chemotherapy agents is expected to increase in the future.…”

Section: Cell Viability ð%þ ¼ Mean Absorbance Of Test Group Mean Abso...mentioning

confidence: 99%

Effect of thymoquinone on pharmacokinetics of 5-fluorouracil in rats and its effect on human cell line in vitro

2022

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Thymoquinone (TQ) is one of the components extracted from Nigella sativa seeds and has antioxidant, anti-inflammatory, and anticancer effects. We evaluated the effect of TQ on 5-fluorouracil (5-FU) pharmacokinetics (PK) in vivo and in vitro on human colorectal cancer cell line. Ten Adult male Wistar rats were assigned to two groups. TQ treated group received intraperitoneal TQ once daily for 14 consecutive days (5 mg/kg). Both groups received intraperitoneal 5-FU (50 mg/kg) on day 15 and blood samples were collected from retro-orbital plexus. The pharmacokinetics parameters were analyzed using high-performance liquid chromatography (HPLC). Moreover, various concentrations of 5-FU, TQ, and combination of 5-FU and TQ were added to the HT-29 cell line and cell viability was measured using 3- (4,5-dimethylthiazol-2-yl)-2,5-diphenyl tetrazolium bromide colorimetric assay. The maximum serum concentration ( Cmax), area under the curve (AUC), and time of maximum concentration ( Tmax) of 5-FU in TQ treated group were significantly increased approximately by 61, 60, and 24% compared to the control group, respectively. The combination of 5-FU with TQ (0.284 mM) showed a greater inhibitory effect on HT-29 cell growth compared to the alone 5-FU (0.027 and 0.055 mM) administration. TQ increases the AUC, Cmax, and Tmax of 5-FU and has a synergistic effect on the PK of 5-FU. Moreover, low concentration of TQ enhances the inhibitory effects of 5-FU on cell growth in colorectal cancer cell line. This synergistic effect might enhance the anticancer effects of low concentration of 5-FU, leading to drug dose reduction and reduced systemic toxicity of this chemotherapeutic agent.

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Intraperitoneal Chemotherapy Using Fluorouracil Implants Combined With Radical Resection and Postoperative Adjuvant Chemotherapy for Stage III Gastric Cancer: A Multi-Center, Randomized, Open-Label, Controlled Clinical Study

Cited by 7 publications

References 26 publications

No long-term survival benefit with sustained-release 5-fluorouracil implants in patients with stages II and III gastric cancer

No long-term survival benefit with sustained-release 5-fluorouracil implants in patients with stages II and III gastric cancer

Effectiveness and safety of intraoperative intraperitoneal 5-Fu drug implantation in patients with colorectal cancer: a retrospective cohort study

Effect of thymoquinone on pharmacokinetics of 5-fluorouracil in rats and its effect on human cell line in vitro

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