Neoadjuvant chemotherapy with docetaxel, oxaliplatin, fluorouracil, and leucovorin (FLOT regimen) has shown promising results in terms of pathological response and survival rate in patients with locally advanced resectable gastric cancer (LAGC). However, tegafur gimeracil oteracil potassium capsule (S-1) plus oxaliplatin (SOX regimen) is the preferred chemotherapy regimen in Eastern countries. Here, we conduct an open label, two-arm, phase II randomized interventional clinical trial (Dragon III; ClinicalTrials.gov: NCT03636893) to evaluate the safety and efficacy of both regimens. Patients with LAGC are randomly assigned to receive either 4 cycles of the neoadjuvant FLOT regimen (40 patients) or 3 cycles of the SOX regimen (34 patients) before gastrectomy. The primary endpoint is the comparison of complete (TRG1a) or subtotal (TRG1b) tumor regression grading in the primary tumor. There are no significant differences in adverse effects or postoperative morbidity and mortality between the two groups. No significant differences in the proportion of tumor regression grading between the FLOT group and the SOX group are found. Complete or subtotal TRG is 20.0% in the FLOT group versus 32.4% in the SOX group. Therefore, our study does not find statistically significant differences between neoadjuvant FLOT and SOX regimens for the primary outcomes reported here in locally advanced gastric cancer.
Background: The evidence of combining neoadjuvant chemotherapy with targeted therapy for patients with locally advanced gastric cancer is inadequate. We conducted a singlearm phase II trial to evaluate the efficacy and safety of S-1, oxaliplatin and apatinib (SOXA) in patients with locally advanced gastric adenocarcinoma. Methods: Treatment-naïve patients received three preoperative cycles of S-1 (80e120 mg/day on days 1e14) and oxaliplatin (130 mg/m 2 on day 1) and two cycles of apatinib (500 mg/day for 21 days) at 3-week intervals, followed by surgery. The primary end-point was pathologic response rate (pRR). This trial is registered at ChiCTR.gov.cn: ChiCTR-OPC-16010061. Results: Of 29 patients included, median age was 60 (range, 43e73) years; 20 (69.0%) were male. The pRR was 89.7% (95% confidence interval [CI], 72.7%e97.8%; 26 of 29 patients; P < 0.001) with 28 patients treated with surgery. All 29 patients were available for preoperative response evaluation, achieving an objective response rate of 79.3% (95% CI, 60.3% e92.0%) and a disease control rate of 96.6% (95% CI, 82.2%e99.9%). The margin-free resection rate was 96.6% (95% CI, 82.2%e99.9%). The pathologic complete response rate was 13.8% (95%CI, 1.2%e26.3%). Downstaging of overall TNM stage was observed in 16
Contrasting results have been reported regarding the associations between plasma total homocysteine (tHcy) and B vitamin levels and age-related macular degeneration (AMD) risk. Thus, we aimed to systematically evaluate these associations. Relevant case control studies in English were identified via a thorough search of the PubMed, Medline, and Embase databases from inception to June 2014. The results were pooled using Review Manager 5.2.1. Eleven studies (including 1072 cases and 1202 controls) were eligible for analysis of tHcy levels; additionally, 3 studies (including 152 cases and 98 controls) were eligible for analysis of folic acid and vitamin B12 levels. The cumulative results demonstrated that the plasma tHcy level among the AMD cases was 2.67 μmol/L (95% confidence interval [CI], 1.60-3.74) higher than that among the controls. In contrast, the vitamin B12 level among the AMD cases was 64.16 pg/mL (95% CI, 19.32-109.00) lower than that among the controls. Subgroup analyses showed that the folic acid level was 1.66 ng/mL (95% CI, 0.10-3.21) lower for the wet type. Together, the results demonstrated that AMD is associated with elevated tHcy levels and decreased vitamin B12 levels. Plasma tHcy may act as a modulator of the risk for AMD based on the current evidence.
Purpose We investigated the risk factors for early postoperative complications after gastric cancer surgery. Materials and methods The data from a total of 273 patients with gastric cancer were analyzed by univariate and multivariate analysis. We applied physiological and operative severity score for the enumeration of morbidity and mortality (POSSUM) to compare risk-adjusted surgical outcomes among different surgical units. Results Among the preoperative variables, patient gender, chronic obstructive pulmonary disease, surgical unit, and intraoperative blood loss were independent risk factors for a higher rate of postoperative complications. There were significant differences in complication rates among different surgical units (P=0.001). The observed-to-expected morbidity ratio (O-to-E ratio) ranged from 0.81 to 1.63. Units with low surgical work volume had higher complication rates. Postoperative length of stay was significantly shorter (P=0.000) and the rate of moderate and severe complications was significantly lower (P=0.001) in specialized unit.Conclusions POSSUM is a valid system for risk-adjusted evaluation of surgical outcomes. We conclude that surgical experience and work volume greatly influence the outcome, with overall surgical outcome in specialized centers superior to that in other units. Hence, gastric cancer surgery should be performed in specialized centers. Risk factors identified in this study need further confirmation by a prospective study involving a larger cohort.
We applied physiological and operative severity score for the enumeration of morbidity and mortality (POSSUM) to evaluate overall surgical outcome and investigated the role of gender for early post-operative complications in gastric cancer surgery. The data from a total of 357 patients of gastric cancer were analysed by univariate and multivariate analysis. Post-operative complications were recorded according to definition of POSSUM. Post-operative complications of male and female patients were compared separately. The observed to estimated morbidity ratio (O:E) was 1.01. Among the pre-operative variables, patient gender was one of the independent risk factors for a higher rate of post-operative complications (risk ratio 1.777, P = 0.024). Post-operative complication was significantly higher in female patients. Similarly, post-operative length of stay was significantly longer and more severe complications were observed in female patients (P = 0.03). In conclusion, POSSUM system is a valid algorithm for risk-adjusted surgical audit. We conclude that a patient's gender influences the early post-operative complications after gastric cancer surgery. A detailed understanding on disparity of early post-operative complications between men and women may provide valuable information to improve surgical outcome of gastric cancer. However, results of this study need further confirmation by a prospective study involving a larger cohort.
BackgroundThe selection of an anastomosis method after a distal gastrectomy is a highly debatable topic; however, the available documentation lacks the necessary research based on a comparison of early postoperative complications. This study was conducted to investigate the difference of early postoperative complications between Billroth I and Billroth II types of anastomosis for distal gastrectomies.MethodsA total of 809 patients who underwent distal gastrectomies for gastric cancer during four years were included in the study. The only study endpoint was analysis of in-patients' postoperative complications. The risk adjusted complication rate was compared by POSSUM (Physiological and operative severity score for enumeration of morbidity and mortality) and the severity of complications was compared by Rui Jin Hospital classification of complication.ResultsComplication rate of Billroth II type of anastomosis was almost double of that in Billroth I (P = 0.000). Similarly, the risk adjusted complication rate was also higher in Billroth II group. More severe complications were observed and the postoperative duration was significantly longer in Billroth II type (P = 0.000). Overall expenditure was significantly higher in Billroth II type (P = 0.000).ConclusionBillroth II method of anastomosis was associated with higher rate of early postoperative complications. Therefore, we conclude that the Billroth I method should be the first choice after a distal gastrectomy as long as the anatomic and oncological environment of an individual patient allows us to perform it. However more prospective studies should be designed to compare the overall surgical outcomes of both anastomosis methods.
BackgroundFor gastric cancer (GC) with extensive lymph node metastasis (bulky N2 and/or para-aortic lymph node metastases), there is no standard therapy worldwide. In Japan, preoperative chemotherapy (PCT) followed by D2 gastrectomy plus para-aortic lymph node dissection (PAND) is considered the standard treatment for these patients. However, in China, the standard operation for GC patients with only bulky N2 metastases was D2 gastrectomy. Besides, after PCT, whether doing PAND improves survival or not is debatable for GC patients with para-aortic lymph node (PAN) metastases. Therefore, we conducted this study to investigate whether D2 lymphadenectomy alone is suitable for these patients after PCT.MethodsWe retrospectively collected data on patients from our electronic medical record system. GC patients with bulky N2 and/or PAN metastases who underwent D2 lymphadenectomy alone after PCT were enrolled. The survival outcomes and chemotherapy responses were analyzed and compared with the results of the JCOG0405 study.ResultsFrom May 2009 to December 2017, a total of 83 patients met all eligibility criteria and were enrolled. The median survival duration for all patients was 40.0 months. The 3-year and 5-year OS rates for all patients were 50.3% and 45.6%, respectively. For patients with only bulky N2 metastasis, the 3-year and 5-year OS rates were 77.1% and 71.6%, respectively, which were similar to the results of the JCOG0405 study (82.7% and 73.4%). For patients with only PAN metastases, the 3-year and 5-year OS rates were 50.0% and 50.0%, respectively, which seemed to be lower than those of the JCOG0405 study (64.3% and 57.1%). For patients with bulky N2 and PAN metastases, the 3-year and 5-year OS rates were 7.4% and 0.0%, respectively, which were lower than those of the JCOG0405 study (20.0% and 20.0%).ConclusionThe results of our study suggest that D2 lymphadenectomy alone is suitable for GC patients with only bulky N2 metastasis after PCT. However, D2 lymphadenectomy alone perhaps is not suitable for patients with bulky N2 and PAN metastases after PCT.
These results indicate for the first time that the combination of serum miR-126 and MDCT is useful for the prediction of LNM in GC.
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