Deng Bo, Sun Tianyu, Tang Bo, Tao Shaolin, Kang Poming, Qian Kai, Jiang Bin, Li Kun, Li Kunkun, Zhou Jinghai, Wang Ruwen, Tan Qunyou
Department of Thoracic Surgery, Institute of Surgery Research, Daping Hospital, Third Military Medical University, Chongqing 400042, China.
Oncotarget. 2017 Nov 6;8(63):107089-107095. doi: 10.18632/oncotarget.22333. eCollection 2017 Dec 5.
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.
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 10 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.
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.
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.
评估根治性手术联合重组人p53腺病毒（rAd-p53）基因治疗可切除非小细胞肺癌的疗效。
163例符合纳入标准的可切除非小细胞肺癌患者随机分为两组：单纯根治性手术组（S组）和根治性手术加手术创面注射2×10个rAd-p53单位组（SP组）。所有患者均随访至少3年，评估疗效和安全性。研究终点以局部区域复发或远处转移（Rec-Met）率为主要终点，无进展生存期（PFS）、总生存期（OS）和安全性评估为次要终点。
SP组术后复发或转移（Rec/Met）为24/82（29.27%），S组为37/81（45.68%）。经卡方检验，Rec/Met率差异有统计学意义（p = 0.0304）。调整年龄和疾病分期后（S组 vs. SP组），PFS和OS的风险比分别为1.772（95%CI，1.102至2.848）和2.047（95%CI，1.109至3.377）。SP组与S组的3年PFS分别为71.9%和46.9%，3年OS分别为88.4%和67.0%。采用Log-Rank检验，两个治疗组之间的PFS和OS差异均有统计学意义，p值分别为0.0165和0.0191。
rAd-p53创面注射对NSCLC患者根治性手术后预防复发或转移、改善PFS和OS有显著效果。
