Clinical Evaluation of Javanica Oil Emulsion Injection Combined with the Radiotherapy in the Treatment of Esophageal Cancer: A Systematic Review and Meta-Analysis.

OBJECTIVES: This meta-analysis aimed to assess the clinical effectiveness and safety of Javanica oil emulsion injection (JOEI) combined with the radiotherapy (RT) for treating esophageal cancer (EC).

DESIGN: A literature search was conducted for collecting the randomized controlled trials (RCTs) on EC treated by JOEI in the Cochrane Library, PubMed, Embase, the Chinese Biomedical Literature Database (SinoMed), the China National Knowledge Infrastructure Database, the China Science and Technology Journal Database (VIP), and the Wanfang Database from inception to February 4, 2017. The quality of the RCTs was evaluated by the Cochrane risk of bias assessment tool, and objective remission rate, performance status, adverse drug reactions (ADRs), 1-year survival rate, and 2-year survival rate were analyzed by Review Manager 5.3 and Stata 13.0 software.

RESULTS: A total of 11 RCTs with 909 participants were involved in this meta-analysis. The results showed that in comparison with RT alone, the JOEI combined with RT was associated with the better effects on improving objective remission rate (relative risk [RR] = 1.33, 95% confidence interval [CI 1.17-1.52], Z = 4.44, p < 0.00001), performance status (RR = 1.52, 95% CI [1.25-1.85], Z = 4.24, p < 0.00001), 1-year survival rate (RR = 1.37, 95% CI [1.17-1.60], Z = 3.86, p < 0.0001), and 2-year survival rate (RR = 1.36, 95% CI [1.09-1.70], Z = 2.68, p = 0.007). The differences between the two groups in objective remission rate, performance status, 1-year survival rate, and 2-year survival rate were statistically significant. Besides, the JOEI combined with RT could reduce the incidence of ADRs. Specifically, the statistically significant difference was detected between these two groups about leukopenia (RR = 0.39, 95% CI [0.25-0.61], Z = 4.19, p < 0.0001), radiation esophagitis (RR = 0.68, 95% CI [0.50-0.93], Z = 2.42, p = 0.02), thrombocytopenia (RR = 0.92, 95% CI [0.12-0.66], Z = 2.95, p = 0.003), and hemoglobin reduction (RR = 0.53, 95% CI [0.35-0.79], Z = 3.14, p = 0.002); however, there was no statistically significant difference for the outcome of nausea and vomiting (RR = 0.61, 95% CI [0.36-1.03], Z = 1.85, p = 0.06) between two groups.

CONCLUSION: This meta-analysis indicated that the combination of JOEI and RT was associated with the more beneficial treatment for patients with EC compared with only receiving RT. However, more well-designed and multicenter RCTs should be carried out to confirm this finding because of the limitations of enrolled 11 RCTs.