Surgery combined with adenoviral p53 gene therapy for treatment of non-small cell lung cancer: a phase II study
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Bo Deng1,*, Tianyu Sun1,*, Bo Tang1,*, Shaolin Tao1, Poming Kang1, Kai Qian1, Bin Jiang1, Kun Li1, Kunkun Li1, Jinghai Zhou1, Ruwen Wang1 and Qunyou Tan1
1Department of Thoracic Surgery, Institute of Surgery Research, Daping Hospital, Third Military Medical University, Chongqing 400042, China
*These authors have contributed equally to this work
Qunyou Tan, email: [email protected]
Keywords: adenoviral p53 gene; non-small cell lung cancer; radical surgery; recurrence; metastasis
Received: June 27, 2017 Accepted: September 20, 2017 Published: November 06, 2017
Objective: To assess the efficacy of radical surgery combined with recombinant adenoviral human p53 (rAd-p53) gene therapy in treatment of resectable non-small cell lung cancer.
Method: A total of 163 patients with resectable NSCLC meeting the inclusion criteria were randomly assigned to two groups: radical surgery alone (S) and radical surgery plus surgical wound surface injection of 2 x 1012 rAd-p53 units (SP). All patients were followed up for at least 3 years for efficacy and safety. Study endpoints were loco-regional recurrence or distant metastasis (Rec-Met) rate as primary endpoints, and progression free survival (PFS), overall survival (OS) and safety assessments as secondary endpoints.
Results: Recurrence or metastasis (Rec/Met) after surgery were 24/82 (29.27%) in SP group and 37/81 (45.68%) in S group. The difference in the Rec/Met rate was statistically significant (p = 0.0304) by chi-square test. The hazard ratios after adjusting of age and disease stage (S vs. SP) of PFS and OS are 1.772 (95% CI, 1.102 to 2.848) and 2.047 (95% CI, 1.109 to 3.377), respectively. The 3 years PFS and OS for SP vs. S were 71.9% vs. 46.9%, and 88.4% vs. 67.0%, respectively. Differences in PFS and OS between two treatment groups were significant with the p values of 0.0165 and 0.0191, respectively, using Log-Rank test.
Conclusions: The wound surface injection of rAd-p53 showed efficacious effects in preventing recurrence or metastasis and improving PFS and OS after a radical surgery in patients with NSCLC.
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