Randomized, Controlled, Multicenter Clinical Study Of The Treatment Of Epidermal Growth Factor Receptor Inhibitors Associated With Skin Adverse Events

This thesis consists of two parts:the literature review and the clinical observation.The literature review is made up of two parts:One is about the present situation of the molecular targeted drugs treatment in tumor,the relationship between the molecular targeted drugs treatment and epidermal growth factor,epidermal growth factor receptor,epidermal growth factor receptor inhibitors.As well,it introduces the basic knowledge of epidermal growth factor receptor inhibitors(EGFRIs),including its relationship with malignant tumors,the typical drugs,the dermatologic toxicities of the drugs and their mechanisms,progress,diagnosis and treatment.Then, the article summarizes related significant study.And in this part the author emphasizes on pathology,mechanism,pattern of manifestation,incidence,Western medicine treatment,prevention and nursing of the EGFRIs related dermatologic toxicities.The other is about the relationship between EGFRIs related dermatologic toxicities and acne vulgaris,the viewpoints in traditional Chinese medicine(TCM) of epidermal growth factor receptor inhibitors related acneiform eruptions,including its synrome differentiation and classification,internal therapy,external therapy or the two combined therapy,obtaining ideal clinical curative effect.Objective The clinical observation is to observe the curative effect of external Chinese medicine with actions of self-made Zhiyang Pingfu decoction on EGFRIs-related dermatologic toxicities,including papulopustular rash,pruritus,Xerosis,paronychia and review the safety and satisfaction.Background The advent of targeted therapies has been an enormous breakthrough for cancer patients.Dermatologic toxicities are the most common side effects associated with EGFRIs.Treatment recommendations from studies and expert panels include antibiotics,corticosteroid,etc.The efficacy of traditional Chinese medicine,however,has rarely been investigated.Method The patients (n=201) with malignant cancer suffering from papulopustular rash after using EGFRIs diagnosed pathologically were enrolled and then randomly divided into treatment group (n=131) and control group (n=70).The treatment group was treated externally with Zhiyang Pingfu decoction, and control group,with tropical and/or systemic management according to MASCC skin toxicity study group recommendations all for 14 days.The development and severity(according to MASCC Study Group EGFRI-dermatologic adverse Events grading scale and the Common Terminology Criteria of Adverse Events V4.0)of papulopustular rash,accompanying pruritus,Xerosis,paronychia were assessed,and safety indexes of routine blood test and liver and kidney functions were observed in two groups before and after treatment,as well as the follow-up of PFS(progression-free survival).Results 185 of 201 patients ultimately finished clinical study,among which the effective rate of treatment group were respectively 90.1%,57.9%,57.9%,16.5% in papulopustular rash, pruritus,Xerosis,paronychia,by contrast,12.9%、28.6%、1.6%、0% for control group.The analysis of SPSS 13.0 software showed that all P<0.05 with statistical significance. The curative effect of Chinese medicinal was better than that of recommendeded treatment.There were no significant hematological toxicity and adverse reactions observed in the tests of routine blood test and liver and kidney functions.No difference between the two groups of PFS.Conclusion Self-made Zhiyang Pingfu decoction has significant curative effect on EGFRIs-related dermatologic toxicities in abating papulopustular rash and relieving pruritus,Xerosis,paronychia,and has no adverse reactions.Chinese medicinal used externally could be considered as a possible treatment option for EGFRIs-related dermatologic toxicities.Prospective, more randomized trials are necessary to confirm these findings.