Combination Regiment Of FuZhengKangAi Decotion And Erlotinib For Advanced NSCLC Patients

objectiveTo investigate the efficacy of FuZhengKangAi decotion with erlotinib on advanced non-small cell lung cancer (NSCLC) and evaluate the synergy between FuZhengKangAi decotion and erlotinib. To seek an efficient and low-toxic regiment in combination regiment of TCM and western medicine for advanced NSCLC patients, especially those with unknowned EGFR mutation.MethodsSixty advanced NSCLC patients were continuously recruited. Patients undertook combination regiment of FuZhengKangAi decotion(200ml po bid) and erlotinib(150mg po qd). Erlotinib was continued until disease progression, development of intolerable toxic effects, or death. FuZhengKangAi decotion was given until death or impossible oral administration. Within one month before treatment, chest radiography and hematologic testing were obtained.During the regiment, radiologic investigations and hematologic testing were performed every2months in the first half year and every3months afterwards. The progression-free survival (PFS), objective response rate(ORR), disease control rate(DCR),1-year survival rate, overall survival(OS), median survival time(MST), adverse effects were evaluated. ORR and DCR were evaluated when patients underwent the regiment for two months as the short-term evaluation index. PFS, OS, MST and1-year survival rate were long-term evaluation index.ResultsSixty patients underwent the study, in which there were15cases of first line treatment,38cases of second line treatment,7cases of third line treatment and9cases with EGFR positive mutation,9cases with EGFR negative mutation and42cases with unkowned EGFR mutation. For short-term efficacy, the ORR was25.0%, DCR was81.7%. Sub-group analysis suggested performance status and had statistical difference in DCR. In first-line treatment, ORR was20.0% and DCR was86.7%. In second-line treatment, ORR was28.9%and DCR was78.9%. In third-line treatment, ORR was14.3%and DCR was85.7%. For long-term efficacy, the overall median PFS (mPFS) was9.6months, MST was18.6months and1-year survival rate was77%.There was statistical difference in performance status for PFS. In first-line treatment, mPFS was10.6months, MST was20.7months and1-year survival rate was71%. In second-line treatment, mPFS was9.6months, MST was18.6months and1-year survival rate was77%. In third-line treatment, mPFS was7.3months, MST was14.1months and1-year survival rate was56%. The most common adverse events were rashes(48.3%) and diarrhea(26.6%), others are oral ulcer(13.3%) and liver dysfunction(1.7%). All of the side effects were Ⅰ-Ⅱ degree and symptoms improved after conventional treatment. There were no severe side effects and treatment-related death.ConclusionCombination regiment of FuZhengKangAi decotion and erlotinib for advanced NSCLC patients has a higher disease control rate, progression-free survival and tolerable adverse effcet. Therefore, this is an effective and torelant regiment.