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Systematic review and meta-analysis of docetaxel perioperative chemotherapy regimens in gastric and esophagogastric tumors.
Uson Junior, PLS, Santos, VM, Bugano, DDG, Victor, EDS, Rother, ET, Maluf, FC
Scientific reports. 2019;(1):15806
Abstract
FLOT regimen became the standard perioperative treatment in several centers around the world for esophagogastric tumors despite concerns about toxicity. In addition, FLOT has never been compared with other docetaxel-based regimens. To address this question, we conducted a systematic review of PubMed, Embase and Web of Science including prospective or retrospective studies of docetaxel based perioperative regimen in gastric and esophagogastric tumors. Data regarding chemotherapy regimens, efficacy and toxicity were extracted. Outcomes were compared using a random effects model. Of 548 abstracts, 16 were considered eligible. Comparing the studies with meta-analysis we can see that the regimens are similar in terms of pathological complete response, resection rate, progression free survival and overall survival in one year, without significant heterogeneity. The meta-regression of docetaxel dose failed to show any association with dose ranging between 120-450 mg/m². Regarding the toxicity of the regimens it is noted that the regimens are quite toxic (up to 50-70% of grade 3-4 neutropenia). The results of this meta-analysis with a combined sample size of more than 1,000 patients suggest that docetaxel perioperative regimens are equivalent in outcomes. Prospective trials addressing modified regimens should be performed to provide less toxic strategies and be applicable to all patients.
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Impact of enhanced recovery after surgery on postoperative rehabilitation, inflammation, and immunity in gastric carcinoma patients: a randomized clinical trial.
Wang, WK, Tu, CY, Shao, CX, Chen, W, Zhou, QY, Zhu, JD, Xu, HT
Brazilian journal of medical and biological research = Revista brasileira de pesquisas medicas e biologicas. 2019;(5):e8265
Abstract
We determined the effects of enhanced recovery after surgery (ERAS) in patients undergoing radical surgery for gastric carcinoma. Sixty patients undergoing radical gastrectomy for gastric carcinoma in Lishui Hospital between March and October 2016 were randomized to receive either ERAS (30 patients) or conventional care (30 patients, controls). Clinical, economic, and laboratory indices were analyzed. ERAS patients showed faster recovery and shorter postoperative hospital stays than the controls (P<0.05). Some clinical indices (i.e., time to first flatus and defecation, time to removal of drainage tubes, time to resumption of oral feeding, time to postoperative mobilization, and postoperative complications) were significantly better in ERAS patients than in controls. Duration of postoperative infusion was lower in ERAS patients than in controls (P<0.05). In ERAS patients, serum albumin and prealbumin were higher on postoperative day 7, C-reactive protein was lower on postoperative days 3 and 7, and neutrophil count was lower on postoperative day 3 compared to the values in controls (P<0.05 for all). IgM levels were higher in ERAS patients on postoperative days 3 and 7 (P<0.05), while IgG levels were higher on postoperative day 3 (P<0.05). Total T lymphocytes were higher in ERAS patients on postoperative day 3, while helper T cells and CD4+/CD8+ ratio were higher on postoperative days 3 and 7 (P<0.05 for all). In gastric carcinoma patients, ERAS may reduce perioperative inflammation, improve immunity and postoperative nutrition, shorten hospitalization, and enhance rehabilitation.
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Efficacy of vonoprazan in prevention of bleeding from endoscopic submucosal dissection-induced gastric ulcers: a prospective randomized phase II study.
Hamada, K, Uedo, N, Tonai, Y, Arao, M, Suzuki, S, Iwatsubo, T, Kato, M, Shichijo, S, Yamasaki, Y, Matsuura, N, et al
Journal of gastroenterology. 2019;(2):122-130
Abstract
BACKGROUND Vonoprazan, potassium-competitive acid blocker, is expected to reduce incidence of delayed bleeding after gastric endoscopic submucosal dissection (ESD); however, preliminary data to design a large-scale comparative study are lacking. This study aimed to assess the efficacy of vonoprazan in preventing delayed bleeding after gastric ESD. METHODS In this single-center randomized phase II trial, a modified screened selection design was used with a threshold non-bleeding rate of 89% and an expected rate of 97%. In this design, Simon's optimal two-stage design was first applied for each parallel group, and efficacy was evaluated in comparison with the threshold rate using binomial testing. Patients were randomly assigned in a 1:1 ratio to receive either vonoprazan 20 mg (VPZ group) or lansoprazole 30 mg (PPI group) for 8 weeks from the day before gastric ESD. The primary endpoint was the incidence of delayed bleeding, defined as endoscopically confirmed bleeding accompanied by hematemesis, melena, or a decrease in hemoglobin of ≥ 2 g/dl. RESULTS Delayed bleeding occurred in three of 69 patients (4.3%, 95% CI 0.9-12.2%, p = 0.047) in the VPZ group, and four of 70 (5.7%, 95% CI 1.6-14.0%, p = 0.104) in the PPI group. As only vonoprazan showed significant reduction in delayed bleeding compared with the threshold rate, it was determined to be efficacious treatment. CONCLUSIONS Vonoprazan efficaciously reduced the delayed bleeding rate in patients with an ESD-induced gastric ulcer. A large-scale, randomized, phase III study is warranted to definitively test the effectiveness of vonoprazan compared with proton pump inhibitors.
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Chinese Herbal Medicine (Xiaoaiping) Injections for Chemotherapy-Induced Thrombocytopenia: A Randomized, Controlled, Multicenter Clinical Trial.
Qi, S, Li, X, Dong, Q, Lai, H, Porter, D, Tian, S, Hou, L, Chen, X, Li, X, Wang, K
Journal of alternative and complementary medicine (New York, N.Y.). 2019;(6):648-655
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Abstract
Objectives: The study aims to evaluate the therapeutic efficacy and safety of Chinese herbal medicine (Xiaoaiping) injections for chemotherapy-induced thrombocytopenia (CIT) in nonsmall cell lung cancer (NSCLC) and gastric cancer. Design: A randomized, controlled, multicenter study from December 2013 to August 2015. Settings/Location: All patients are from China. Subjects: One hundred forty patients with either NSCLC or gastric cancer were enrolled in this trial. Interventions: The intervention group (n = 70) was given Xiaoaiping injections (1 dose/day for 10 days) with chemotherapy, whereas the control group (n = 70) was given chemotherapy only. The follow up period was 11 days after the final injection. Outcome measures: Platelet (PLT) count was tested at day 0, 7, 14, and 21 as the primary outcome for evaluation. Safety measurements, including red blood cells (RBC), hemoglobin (HBG), white blood cells (WBC), neutrophil (NE)#, aspartate aminotransferase (AST), alanine aminotransferase (ALT), lactate dehydrogenase (LDH), creatine kinase (CK), creatinine (Cr), and blood urea nitrogen (BUN) were tested at day 0 and 21 as the secondary outcomes. Results: (1) Two patients in the intervention group and four patients in the control group were lost upon follow-up. (2) PLT count: there was no significant difference in PLT count between the two groups from baseline (day 0), day 7, and day 14. At day 21, the intervention group indicated an upward trend of PLT count with a statistically significant difference than that of the control group (p < 0.05). (3) NSCLC there was significant difference in PLT count between the two groups on day 21 (p < 0.01). (4) Gastric cancer: there was no significant difference in PLT count between the two groups during this trial (p > 0.05). (5) There was no statistically significant difference between the intervention group and the control group with the safety figures (secondary outcomes) RBC, HGB, WBC, NE#, AST, ALT, LDH, CK, Cr, and BUN measured (p > 0.05). (6) Adverse events: one gastric cancer patient in the control group was diagnosed with gastrointestinal bleeding on day 3. Conclusions: In conclusion, Xiaoaiping injections may provide a safe and effective option for CIT in patients with NSCLC.
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Proximal versus total gastrectomy for proximal early gastric cancer: A systematic review and meta-analysis.
Xu, Y, Tan, Y, Wang, Y, Xi, C, Ye, N, Xu, X
Medicine. 2019;(19):e15663
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Abstract
BACKGROUND Recently, the incidence of proximal early gastric cancer (EGC) has been rising rapidly. Prevalent surgical methods are proximal gastrectomy (PG) and total gastrectomy (TG); however, which method is superior remains controversial. We conducted a systematic review and meta-analysis of original articles to compare the short- and long-term clinical outcomes of PG with TG for proximal EGC. METHODS Databases, including PubMed, Embase, Web of Science, and Cochrane Library were searched up to October 2018. The Newcastle-Ottawa scale was utilized to conduct quality assessments, and publication bias was evaluated using Egger test. STATA version 14.0 was used to perform the meta-analysis. RESULTS A total of 2036 patients with proximal EGC in 18 studies were included in the meta-analysis. The results showed that PG was potentially superior to TG regarding operation time, intraoperative blood loss volume, and long-term nutritional status. Overall survival between the PG and TG groups was not significantly different. PG was associated with a high incidence of 2 kinds of postoperative complications: anastomotic stenosis and reflux esophagitis. However, the incidence of these complications associated with esophagojejunostomy with double-tract reconstruction (DTR) was comparable with that of TG. CONCLUSIONS PG has several advantages over TG for the treatment of proximal EGC, including surgical outcomes and long-term nutritional status. However, anastomotic stenosis and reflux esophagitis frequently occurred in patients undergoing PG. Esophagojejunostomy with DTR could offer a solution to reducing the incidence of these complications.
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Comparative efficacy of various anti-ulcer medications after gastric endoscopic submucosal dissection: a systematic review and network meta-analysis.
Kim, EH, Park, SW, Nam, E, Lee, JG, Park, CH
Surgical endoscopy. 2019;(4):1271-1283
Abstract
BACKGROUND The comparative efficacy of various anti-ulcer medications after gastric endoscopic submucosal dissection (ESD) has not been fully evaluated. Recently, vonoprazan, a novel potassium-competitive acid blocker, has also been used in ulcer treatment after ESD. METHODS We searched for all relevant randomized controlled trials examining the efficacy of anti-ulcer medications after gastric ESD, published through October 2017. Healing of iatrogenic ulcers was investigated at 4-8 weeks after ESD. A network meta-analysis was performed to calculate the network estimates. RESULTS Twenty-one studies with 2005 patients were included. Concerning the comparative efficacy for ulcer healing at 4 weeks after ESD, no network inconsistency was identified (Cochran's Q-test, df = 10, P = 0.13; I2 = 34%). A combination therapy of proton-pump inhibitor (PPI) and muco-protective agent was superior to PPI alone [risk ratio (RR) (95% confidence interval, CI) 1.69 (1.20-2.39)]. The combination therapy of PPI and muco-protective agents tended to be superior to vonoprazan [RR (95% CI) 1.98 (0.99-3.94)]. There was no difference of ulcer healing effect between PPI and vonoprazan [RR (95% CI) PPI vs. vonoprazan, 1.17 (0.64-2.12)]. Concerning the ulcer healing rate at 8 weeks after ESD, however, vonoprazan was superior to PPI [RR (95% CI) 1.27 (1.03-1.56)]. Additionally, vonoprazan tended to be superior to the combination therapy of PPI and muco-protective agent [RR (95% CI) 1.20 (0.96-1.51)]. CONCLUSIONS A combination therapy of PPI and muco-protective agent was superior to PPI alone for ulcer healing at 4 weeks after ESD. In the ulcer healing effect at 8 weeks after ESD, vonoprazan was superior to PPI.
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Thirty-Day Readmission After Radical Gastrectomy for Gastric Cancer: A Meta-analysis.
Dan, Z, YiNan, D, ZengXi, Y, XiChen, W, JieBin, P, LanNing, Y
The Journal of surgical research. 2019;:180-188
Abstract
BACKGROUND Readmission is a commonly accepted parameter to evaluate surgical quality, but previous studies reported inconsistent results in radical gastrectomy. The purpose of our study is to clarify the prevalence, potential causes, and risk factors of 30-d readmission after radical gastrectomy for gastric cancer. METHODS PubMed and Embase were systematically searched from inception to September 2018 for any possible inclusion. Prevalence, potential causes, and risk factors of 30-d readmission in included studies were extracted using a standardized EXCEL table. The overall 30-d readmission rate was pooled using a random-effects model. Odds ratios with 95% confidence intervals were used to estimate potential risk factors for 30-d readmission. Publication bias was assessed using a funnel plot and statistical tests. RESULTS A total of nine studies with 16,581 patients were included in the current meta-analysis. The pooled 30-d readmission rate after radical gastrectomy was 8% (95% confidence interval, 0.04-0.12). Nutritional difficulty and surgical site infections were the main causes for 30-d readmission. Cardiovascular comorbidity, total gastrectomy, nutritional risk screening 2002 score ≥3, any complications, laparoscopic gastrectomy, and C-reactive protein on postoperative day 3 ≥12 were strong predictors for 30-d readmission, whereas combined multiorgan resection was a weaker predictor. No significant publication bias was identified through the funnel plot and statistical tests. CONCLUSIONS The 30-d readmission rate after radical gastrectomy ranges from 4% to 12% and can mainly result from nutritional difficulty and surgical site infections. Nutritional risk screening 2002 score ≥3, cardiovascular comorbidity, total gastrectomy, any complications, and laparoscopic gastrectomy were potential risk factors for 30-d readmission.
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Long noncoding RNA FEZF1-AS1 in human cancers.
Zhou, Y, Xu, S, Xia, H, Gao, Z, Huang, R, Tang, E, Jiang, X
Clinica chimica acta; international journal of clinical chemistry. 2019;:20-26
Abstract
Long noncoding RNAs (lncRNAs) have been shown to play key roles in various human tumors. Ectopic expression of the lncRNA FEZ finger zinc 1 antisense 1 (FEZF1-AS1) have been reported in different cancers, including colorectal cancer, gastric neoplasia, hepatocellular carcinoma and so on. Summarizing all literature correlated with FEZF1-AS1, it is obvious that FEZF1-AS1 is mainly involved in tumorigenesis and progression through competing endogenous RNA (ceRNA) which sponges tumor-suppressive microRNA (miRNA) and recruiting mechanism. Moreover, the aberrant expression of FEZF1-AS1 is related to clinical features of patients with cancers, and regulates cellular proliferation, anti-apoptosis, invasion and metastasis through diverse underlying mechanisms. The role of FEZF1-AS1 in carcinogenesis and progression suggests that it may be a potential diagnostic biomarker or a novel therapeutic target for cancers.
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Changes in bone metabolism after gastric cancer surgery in male patients: a prospective observational study.
Atsumi, Y, Rino, Y, Wada, H, Kitani, Y, Ozawa, Y, Aoyama, T, Oshima, T, Yukawa, N, Yoshikawa, T, Masuda, M
Gastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association. 2019;(1):237-243
Abstract
BACKGROUND Several retrospective studies have shown that bone disorders occur after gastric cancer surgery. This study was designed to prospectively evaluate the changes in bone metabolism after gastrectomy for gastric cancer. METHODS We prospectively enrolled 39 men with early gastric cancer who underwent gastrectomy. We excluded women to avoid the effects of menopause. We employed dual energy X-ray absorptiometry (DEXA) to measure bone mineral density (BMD) of the lumbar spine. DEXA was performed before and 1 and 2 years after surgery. The serum levels of alkaline phosphatase (ALP), 1,25-dihydroxy vitamin D [1,25(OH)2VD], 25-hydroxy vitamin D [25(OH)VD], and estradiol were measured before surgery and every 3 months until 2 years after surgery. RESULTS DEXA revealed that BMD significantly decreased by 0.036 ± 0.033 g/cm2 12 months after gastrectomy (P < 0.001) and by 0.046 ± 0.040 g/cm2 24 months after gastrectomy (P < 0.001). The serum ALP level significantly increased by 38.31 ± 103.8 IU/L 24 months after surgery (P = 0.013). The serum 25(OH)VD level significantly decreased by 4.88 ± 6.42 ng/ml 24 months after surgery (P < 0.001), whereas the serum 1,25(OH)2VD levels were consistently in the normal range. The serum estradiol level significantly increased by 2.94 ± 7.49 pg/ml 12 months after gastrectomy (P = 0.035). A lower preoperative body mass index (BMI) significantly correlated with the reduction in BMD 12 months after surgery; the correlation coefficient was 0.37 (P = 0.025). CONCLUSIONS This study showed that a significant decrease in BMD was observed for up to 24 months after gastrectomy, not only 12 months.
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Safety of early oral feeding after total laparoscopic radical gastrectomy for gastric cancer (SOFTLY): Study protocol for a randomized controlled trial.
Wang, Q, Guo, BY, Zhao, QC, Yan, ZD, Shang, LF, Yu, J, Ji, G
Trials. 2019;(1):384
Abstract
BACKGROUND Gastric cancer is the third most common cause of cancer-related deaths and has the fifth highest incidence worldwide, especially in eastern Asia, central and Eastern Europe, and South America. Currently, surgery is the only curative treatment for gastric cancer; however, there is an increasing trend toward laparoscopic radical gastrectomy. Early oral feeding (EOF) has been shown to benefit clinical outcomes compared with open gastrectomy under conditions of enhanced recovery after surgery. There are a lack of guidelines and evidence for the safety and feasibility of EOF in patients undergoing laparoscopic radical gastrectomy. Thus, a prospective randomized trial is warranted. METHODS/DESIGN The EOF after total laparoscopic radical gastrectomy (SOFTLY) study is a single-center, parallel-arm, non-inferiority randomized controlled trial which will enroll 200 patients who are pathologically diagnosed with gastric cancer and undergo laparoscopic radical gastrectomy. The primary endpoint, incidence of anastomotic leakage, is based on 1.9% in the control group in the CLASS-01 study. The patients will be randomized (1:1) into two groups: the EOF group will receive a clear liquid diet on post-operative day 1 (POD1) and the delayed oral feeding (DOF) group will receive a clear liquid diet on post-operative day 4 (POD4). The demographic and pathologic characteristics will be recorded. Total and oral nutritional intake, general data, total serum protein, serum albumin, blood glucose, and temperature will be recorded before surgery and at the time of hospitalization. Adverse events will also be recorded. The occurrence of post-operative fistulas, including anastomotic leakage, will be recorded as the main severe post-operative adverse event and represent the primary endpoint. DISCUSSION The safety and feasibility of EOF after gastrectomy has not been established. The SOFTLY trial will be the first randomized controlled trial involving total laparoscopic radical gastrectomy, in which the EOF group (POD1) will be compared with the DOF group (POD4). The results of the SOFTLY trial will provide data on the safety and feasibility of EOF after total laparoscopic radical gastrectomy. TRIAL REGISTRATION Chinese Clinical Trial Registry, ChiCTR-IOR-15007660 . Registered on 28 December 2015. The study has full ethical and institutional approval.