ABSTRACT
With the rapid development of organ donation and transplantation, it becomes increasingly important to improve the management system and ensure the quality and safety of organs for transplantation. Guide to the Quality and Safety of Organs for Transplantation (6th Edition) by European Committee provides the definitions of severe adverse reactions and severe adverse events in the perspective of biosafety early warning, delivers management and reporting processes, and encourages medical staff involved in organ transplantation to identify the adverse reactions and adverse events as soon as possible, and to carry out investigation, assessment and feedback. At the same time, it also systematically illustrates the warning and monitoring of organ transplantation risk, which is worthy of application in clinical study and practice.
ABSTRACT
Objective To investigate the clinical efficacy of neoadjuvant chemotherapy combined with radical gastrectomy for advanced gastric cancer.Methods The retrospective cross-sectional study was conducted.The clinicopathological data of 73 patients who underwent neoadjuvant chemotherapy combined with radical gastrectomy for advanced gastric cancer at the First Affiliated Hospital of Zhejiang University between June 2004 and December 2009 were collected.Neoadjuvant chemotherapy regimens included XELOX and FOLFOX.Patients received radical gastrectomy within 2 weeks after the completion of the last cycle of neoadjuvant chemotherapy and then continued to undergo postoperative neoadjuvant chemotherapy.Observation indicators:(1) adverse event of neoadjuvant chemotherapy;(2) surgical and postoperative situations;(3) follow-up situations.Follow-up using outpatient examination and telephone interview was performed to detect survival of patients up to December 2014.Measurement data with skewed distribution were described as M (range).Overall survival time was from the beginning of treatment to death or end of follow-up (patients with loss to follow-up).Progression-free survival time was from the beginning of treatment to tumor progression,recurrence and metastasis or death.The survival curve was drawn by the Kaplan-Meier method.Results (1) Adverse event of neoadjuvant chemotherapy:of 73 patients,38 received XELOX regimens and 35 received FOLFOX regimens,with a median cycle of 3 (range,1-7 cycles).There were 55 adverse events during neoadjuvant chemotherapy,including 47 with grade 1-2 and 8 with grade 3-4.(2) Surgical and postoperative situations:all the 73 patients underwent successful D2 radical gastrectomy for gastric cancer,including 40 receiving total gastrectomy,31 receiving distal gastrectomy,1 receiving total gastrectomy with transverse colon resection and 1 receiving distal gastrectomy with cholecystectomy.Of 73 patients,10 with postoperative complications were improved by conservative treatment,including 3 with pleural effusion,2 with peritoneal effusion,2 with anastomotic bleeding,2 with cholecystitis and 1 with lympha fistula.No patient received reoperations or died within 30 days postoperatively.Pathological TNM staging:22 patients were detected in stage Ⅰ-Ⅱ,45 in stage Ⅲ,4 in stage Ⅳ and 2 in stage T0N1M0.Three patients (in stage T0N0M0) had complete remission.Forty-three patients underwent postoperative chemotherapy.(3) Followup:all the 73 patients were followed up for 8-125 months,with a median time of 51 months.The median survival time,5-year overall survival rate and 5-year disease-free survival rate of 73 patients were 52 months,41.1％ and 34.2％,respectively.Conclusion XELOX and FOLFOX regimens of neoadjuvant chemotherapy combined with radical gastrectomy for advanced gastric cancer are safe and effective.