Oral Epigallocatechin-3-gallate Solution During Radiotherapy For Non-small Cell Lung Cancer Patients:a Long-term Observation

Background and purpose: Radiotherapy is one of the important therapies of cancer,which can lead to tissue damage,such as radiation lung injury,radiation esophageal injury,radiation skin damage and abnormal changes in hemopoietic system and immune syetem,et al.Epigallocatechin-3-gallate(EGCG)is the most abundant catechin in green tea.It has been demonstrated that EGCG has anti-inflammatory,antioxidant,anti-apoptosis,and adjusting immunity effects.Some studies have found that EGCG exerts a radioprotective effect.EGCG can mitigate acute radiation-induced esophagitis,inhibit pulmonary inflammation and fibrosis,and reduce the severity of cardiovascular disease.The purpose of this study was to observe the effects of EGCG on radiation toxicity of esophagus,lung and heart in patients with locally advanced lung cancer,and to observe the effects of EGCG on tumor response rate and progression-free survival(PFS)after radiotherapy.Methods: All patients underwent radiotherapy(RT).The EGCG group received 10-15 m L of EGCG solution at a concentration of 440 ?mol/L three times a day during RT and during the following 2 weeks.The control group consisted of contemporaneous patients who did not receive EGCG treatment.Follow-up was conducted to assess the patients' general condition and related symptoms and to perform blood work,electrocardiography,and chest CT every 3months following the treatment;The primary analysis was the late toxicity grading of the heart,esophagus,and lung after the application of EGCG.At the end of treatment,the tumor responses were evaluated by chest CT based on the Response Evaluation Criteria in Solid Tumors(RECIST)version 1.1.Progression free survival is defined as the time from the end of radiotherapy until the patient is diagnosed with progression or death.T test was used to compare the demographic characteristics and clinical data between the two groups.The OR chi-square test was used to analyze the late toxicity grading of the two groups.The tumor response between the two groups was compared by chi-square test.Kaplan-meier method was used to obtain the survival curve and the PFS between the two groups were compared.A value of p<0.05 was considered statistically significant for all statistical analyses.Result: We retrospectively analyzed 74 patients from the our hospital from September 2012 to September 2016(37 received EGCG and 37 received supportive treatment).Six months after the end of radiotherapy,the EGCG group(45.9%)had a lower grade of grade 1-3 late heart toxicity than the control group(64.2%)(p<0.05).At 12 months after the end of radiotherapy,Grade 1-3 heart toxicity in the EGCG group(51.4%)was lower than that the control group(67.6%)(p < 0.05).At 6 months after the end of radiotherapy,the proportion of grade 1-3 late esophageal toxicity in the EGCG group(10.8%)was lower than that in the control group(21.6%)(p>0.05).At 12 months after the end of radiotherapy,the EGCG group(16.2%)had a lower grade of late esophageal toxicity in grades 1-3 than in the control group(24.3%),but there was no significant difference between the two groups(p>0.05).At 6months after the end of radiotherapy,the proportion of 1-2 grade late lung toxicity in the EGCG group and the control group was 94.5% and 91.9%,and there was no statistical difference between the two groups(p>0.05).At 12 months after the end of radiotherapy,there was no significant difference in the proportion of 1-2 grade late lung toxicity between the EGCG group(94.5%)and the control group(97.3%),and there was no statistical significance(p>0.05).No grade 3 advanced lung toxicity occurred in either the EGCG group or the control group.The tumor response rates were similar in both groups.The median PFS of the EGCG group was 8 months(95% CI=6.0-9.9).The median PFS of the control group was 9 months(95% CI=7.0-10.9).There was no significant difference in median PFS between the two groups(p>0.05).Conclusion: Oral EGCG solution can alleviate radiation-induced late heart toxicity,but has no significant effect on the late esophageal and pulmonary toxicity,as well as the tumor response rate and patient PFS after radiotherapy.