EU Real-World Evidence Supports the Expansion Indications for Drugs and Its Enlightenment to China

Objective To analyze the value of EU real-world evidence(RWE)in supporting the expanded indications for drugs and to provide reference for the decision-making of expanding drug indications supported by RWE in China.Methods By searching relevant domestic and foreign literature and case analysis,the practice of the RWE of EU to support the expansion indications for drugs was investigated.Results and Conclusion The EU uses RWE to carry out adaptive path research,which provides a new idea for drug R&D and approval.Besides,it also provides evidence in supporting the research of expanded indications for drugs.With the increasing cognition of RWE,it will play a key role in medical and regulatory decisions in China.

Long-term outcomes of endoscopic submucosal dissection and surgery for undifferentiated intramucosal gastric cancer regardless of size

BACKGROUND The clinical outcomes of endoscopic submucosal dissection(ESD)for undifferentiated(UD)intramucosal early gastric cancer(EGC)compared with those of surgery,regardless of lesion size,are not well known.Furthermore,there is a concern regarding the treatment plan before and after ESD in cases of UD intramucosal EGC within expanded indications.AIM To evaluate clinical outcomes of ESD compared with those of surgery in UD intramucosal EGC patients regardless of tumor size.METHODS We enrolled patients with UD intramucosal EGC after ESD with complete resection or surgery from January 2005 to August 2020 who met the within or beyond expanded indications with lesion size>2 cm(the only non-curative factor).Overall,123 and 562 patients underwent ESD and surgery,respectively.After propensity-score matching,clinical and long-term outcomes,i.e.,recurrencefree survival(RFS)and overall survival(OS),were analyzed.The multivariable Cox proportional hazard model with treatment modality and ESD indication was used to evaluate the recurrence risk.RESULTS After matching,119 patients each were finally enrolled in the ESD and surgery groups.The median length of hospital stay was shorter in the ESD group than surgery group(4.0 vs 9.0 days,P<0.001).Four cases of recurrence after ESD were local recurrences,all of which occurred within 1 year.Total recurrence was seven(5.9%)and two(1.7%)in the ESD and surgery groups,respectively.No difference was observed between the two groups with respect to OS(P=0.948).However,the ESD group had inferior RFS compared with the surgery group(P=0.031).ESD was associated with the risk of recurrence after initial treatment in all enrolled patients(hazard ratio,5.2;95%confidence interval:1.0-25.8,P=0.045).CONCLUSION Although OS was similar between the two groups,surveillance endoscopy was important for the ESD than for the surgery group because RFS was inferior and local recurrence was an issue.