期刊
ONCOTARGET
卷 7, 期 4, 页码 4369-4378出版社
IMPACT JOURNALS LLC
DOI: 10.18632/oncotarget.6737
关键词
recurrent high-grade glioma; gene therapy; ADV-TK; glioblastoma
资金
- Foundation for the Excellent Medical Staff of Beijing [2011-3-034]
- National Major Scientific and Technological Special Project for Significant New Drugs Development [2011ZX09101-001-10, 2012ZX100002017-009]
- Beijing Municipal Administration of Hospitals Clinical Medicine Development of Special Funding Support [ZY201311]
- National Key Technology Research and Development Program of the Ministry of Science and Technology of China [2014BAI04B02]
- National Science Foundation of China [81230038, 81472783, 81090414, 81025011]
- 973 Program of China [2015CB553903]
Background: This randomized, open-label, multicenter, phase II clinical trial was conducted to assess the anti-tumor efficacy and safety of replication-deficient adenovirus mutant thymidine kinase (ADV-TK) in combination with ganciclovir administration in patients with recurrent high-grade glioma (HGG). Patients and Methods: 53 patients 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), overall survival (OS), 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 OS was 45.4 weeks, and better survivals were achieved when compared with control group. The one-year PFS and OS were 22.7% and 44.6% in ADV-TK group respectively, and clinical benefit was 68.2%. There are 2 patients alive for more than 4 years without progression in ADV-TK group. In the subgroup of glioblastoma received ADV-TK, PFS-6 was 71.4%, median PFS was 34.9 weeks, median OS was 45.7 weeks respectively, much better than those in control group. The one-year PFS and OS were 35.7% and 50.0% in ADV-TK group respectively. ADV-TK/ganciclovir 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 OS 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.
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