Surgery combined with adenoviral p53 gene therapy for treatment of non-small cell lung cancer: a phase II study

• DOI: 10.18632/oncotarget.22333
• Publication Date: 2017-11-08T12:25:35Z
• Authors: Bo Deng; Tianyu Sun; Bo Tang; Shaolin Tao; Poming Kang; Kai Qian; Bin Jiang; Kun Li; Kunkun Li; Jinghai Zhou; Ruwen Wang; Qunyou Tan
• Keywords: Clinical endpoint

To assess the efficacy of radical surgery combined with recombinant adenoviral human p53 (rAd-p53) gene therapy in treatment resectable non-small cell lung cancer.A total 163 patients NSCLC meeting inclusion criteria were randomly assigned to two groups: alone (S) and plus surgical wound surface injection 2 x 1012 rAd-p53 units (SP). All followed up for at least 3 years safety. Study endpoints loco-regional recurrence or distant metastasis (Rec-Met) rate as primary endpoints, progression free survival (PFS), overall (OS) safety assessments secondary endpoints.Recurrence (Rec/Met) after 24/82 (29.27%) SP group 37/81 (45.68%) S group. The difference Rec/Met was statistically significant (p = 0.0304) by chi-square test. hazard ratios adjusting age disease stage (S vs. SP) PFS OS are 1.772 (95% CI, 1.102 2.848) 2.047 1.109 3.377), respectively. 71.9% 46.9%, 88.4% 67.0%, Differences between groups p values 0.0165 0.0191, respectively, using Log-Rank test.The showed efficacious effects preventing improving a NSCLC.