Whole-course management of traditional Chinese medicine in the treatment of EGFRIs related skin toxicity in lung cancer: A series of clinical studies.
Authors: Lu Xing Yu , Peng Mei Yan , Zhang Jingyi , Xue Chongxiang , Zhang Xu , Li Jia , Tan Kexin , Yu Yixuan , Dong Huijing , Hu Zinxin , Zheng Yumin , Cui Huijuan 
Published: June 2023

e21047 Background: Epidermal growth factor receptor inhibitors (EGFRIs) significantly prolong the survival of advanced lung cancer patients. Skin toxicities are the most common side effects caused by EGFRIs, which have the limited standard treatment, and seriously affect the long-term use of EGFRIs and the quality of life. Rash is the main type in the early stage of skin toxicity, and xerosis commonly complicated by pruritus usually occurs in the later stage regularly. Our team carried out a series of clinical studies, taking advantage of traditional Chinese medicine (TCM) in syndrome differentiation and treatment, to observe the efficacy and safety of TCM in the treatment of EGFRIs-related skin toxicity following in order. Methods: From September 2016 to September 2018, patients who occurred xerosis after using EGFRIs were enrolled and randomly divided into the treatment group and control group, respectively receiving Zizao Yangrong granules (ZYG) and placebo granules combined with vitamin E ointment. And then from August 2018 to September 2020, patients suffering from EGFRIs-related moderate to severe rash were enrolled and randomly divided into the treatment group and the control group, receiving Zhiyang Pingfu liquid and placebo liquid respectively, combined with minocycline and methylprednisolone for 14 days. Finally, based on the participants of the preliminary clinical trials, progression free survival (PFS) was determined by telephone follow-up every 3 months in patients with EGFRIs-related xerosis. Results: 66 patients finished the study of EGFRIs-related xerosis. The effective rates of xerosis among the treatment group and the control group were 84.8% and 69.7% (P < 0.05). The patients in the experimental group had better quality of life than that in the control group (P = 0.045). 54 patients finished the topical TCM for moderate to severe rash study, which the effective rates among the treatment group and the control group were 81.48% and 55.56% (P = 0.040). The median total dose of oral minocycline administration in the treatment group was lower than that in the control group (1000mg vs. 1400mg). In the end, 54 patients who received ZYG were successfully followed up. The median PFS in the treatment group was 41.6 months, and 40.9 months in the control group (HR = 0.85, 95%CI 0.48~1.51, P = 0.586). The median DLQI score of the 19 patients who received ZYG more than 8 weeks was 6, significantly higher than 4 before treatment (P＜0. 001). Conclusions: TCM had the great efficacy and safety in the treatment of EGFRIs related dermal toxicity, significantly improving the quality of life for patients. Long-term application of TCM will not affect the PFS of EGFRIs. The series of clinical studies suggested that the whole-course management of TCM in the treatment of EGFRIs related skin toxicity can increase the overall benefit of advanced lung cancer patients. Clinical trial information: ChiCTR1800017053 .