Abstract
ObjectiveTo 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.MethodA 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.ResultsRecurrence 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.ConclusionsThe 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.
Highlights
In the past 30 years, the incidence and mortality of lung cancer significantly increased
The hazard ratios after adjusting of age and disease stage (S vs. surface injection of rAd-p53 (SP)) of progression free survival (PFS) and overall survival (OS) are 1.772 and 2.047, 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
Summary
In the past 30 years, the incidence and mortality of lung cancer significantly increased. Lung cancer is the leading cause of death for all kinds of cancer in men and women worldwide. The American Cancer Society’s estimates for lung cancer in the United States for 2016 are: about 224,390 new cases of lung cancer (117,920 in men and 106,470 in women) and about158 deaths from lung cancer (85,920 in men and 72,160 in women). In China, over 1.6 million of the new cases are diagnosed each year, accounting for 12.7% of new cases for all cancer types, and over 1.37 million of the lung cancer patients die each year. The non-small cell lung cancer (NSCLC) is the most common type of lung cancer and accounts for about 75% - 85% of all cases. Radical surgery still remains the main and potentially curative treatment for the early stage NSCLC
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