Adenovirus-mediated delivery of herpes simplex virus @entity1014 kinase administration improves outcome of recurrent high-grade XXXX .

@entity1 @entity5 @entity11 @entity1014 @entity4540 @entity463 @entity1349
BACKGROUND: This randomized, open-label, multicenter, phase II clinical trial was conducted to assess the anti- @entity5 efficacy and safety of replication-deficient adenovirus mutant @entity1014 kinase (ADV-TK) in combination with @entity4540 administration in @entity1 with recurrent high-grade @entity11 (HGG). @entity1 AND METHODS: 53 @entity1 with recurrent HGG were randomly allocated to receive intra-arterial cerebral infusion of ADV-TK or conventional treatments. The primary end point was 6-month progression-free survival (PFS-6). Secondary end points included progression-free survival (PFS), @entity1349 ( @entity1349 ), safety, and clinical benefit. This trial is registered with Clinicaltrials.gov, NCT00870181. RESULTS: In ADV-TK group, PFS-6 was 54.5%, the median PFS was 29.6 weeks, the median @entity1349 was 45.4 weeks, and better survivals were achieved when compared with control group. The one-year PFS and @entity1349 were 22.7% and 44.6% in ADV-TK group respectively, and clinical benefit was 68.2%. There are 2 @entity1 alive for more than 4 years without progression in ADV-TK group. In the subgroup of @entity463 received ADV-TK, PFS-6 was 71.4%, median PFS was 34.9 weeks, median @entity1349 was 45.7 weeks respectively, much better than those in control group. The one-year PFS and @entity1349 were 35.7% and 50.0% in ADV-TK group respectively. ADV-TK/ @entity4540 gene therapy was well tolerated, and no treatment-related severe adverse events were noted. CONCLUSION: Our study demonstrated a notable improvement of PFS-6, PFS and @entity1349 in ADV-TK treated group, and the efficacy and safety appear to be comparable to other reported treatments used for recurrent HGG. ADV-TK gene therapy is therefore a valuable therapeutic option for recurrent HGG.
