The Study On Sensitizing Effect Of FuZheng KangAi Decoction With TKIs In Treating EGFR Mutation-negative Advanced NSCLC

ObjectiveConsidering the poor efficacy of molecular targeted therapy (epidermal growth factor receptor-tyrosine kinase inhibitors, EGFR-TKIs), chemotherapy is more preferred when treating EGFR mutation-negative advanced non-small-cell lung cancer (NSCLC). However, many patients refused chemotherapy in clinical practice, this study was to investigate the sensitizing effect of FuZheng KangAi decoction with TKIs in treating advanced NSCLC without EGFR mutation, and compared with standard chemotherapy regimens so as to provide these patients with an integrative treatment combining TCM and western medicine.Methods70 cases of stage IIIB/IV NSCLC with negative status of EGFR mutation (negative for Exon 19 deletions and Exon21 L858R) were continuously recruited. Before treatment all samples of lung cancer underwent EGFR-PCR to detect the status of EFGR mutation (ARMS).According to the patient’s will we divided them into experimental group and control group,35 cases in each group. FuZheng KangAi decoction (200ml, bid, po) and TKIs (Gefitinib or Erlotinib) were given to the experimental group until the occurrence of disease progression, intolerable adverse effects or death. While FuZheng KangAi decoction (200ml, bid,po) and platinum-based standard chemotherapy (GP/NP/TP/DP/ AP regimen) was given to the control group, repeated every 21 days for 6 cycles, or until the occurrence of disease progression, intolerable adverse effects or death.6 weeks before and after the treatment, assessments for tumour condition were carried out. The primary endpoints of this study were progression-free survival (PFS) and disease control rate (DCR), while the secondary endpoints were objective response rate (ORR), overall survival (OS), adverse reactions and 1-year survival rate.ResultsUp to the last follow-up time,34 cases in the experimental group and 33 in the control group were evaluable. ORR was 8.82% in the experimental group, not as well as 24.24% in the control group, but the difference was not statistically significant (P=0.109). DCR was 64.70% in the experimental group and 72.73% in the control group, the difference also was not statistically significant (P=0.600). In terms of mPFS, the experimental group was quite closed to the control group (4.8 vs.6.6 m, P=0.400). In terms of MST, the difference of the two groups was not statistically significant either (12.0 vs.13.1 m, P=0.747).1-year survival rate was 46.67% in the experimental group and 51.19% in the control group.5 cases in the experimental group survived over 2 year and among which 2 were still alive, while none of the cases in the control group was observed survived that long.The incidence of adverse reactions in the experimental group was 41.18%, mainly grade Ⅰ-Ⅱ rashes and diarrhea. The incidence of adverse reactions in the control group was 72.73%, such as nausea and vomiting, neutropenia, hair loss, etc. No cases of severe adverse effects such as interstitial lung disease, severe damage of heart, liver and kidney function, and treatment related death were observed in both groups.Conclusion1. Regarding the lower ORR and DCR, we might say that when treating EGFR mutation-negative advanced NSCLC, the combination regimen of FuZheng KangAi decoction and TKIs was not as efficient as the control group, but still quite impressive. Besides, cases of long-term survival in the experimental group were far more than that in the control group, the reason of this needs further study.2. The combination regimen of FuZheng KangAi decoction and TKIs was superior to the former similar researches in Asia, which indicated that FuZheng KangAi decoction might enhance the efficacy of TKIs.3. For NSCLC patients with negative status of EGFR mutation who rejected chemotherapy, the regimen of FuZheng KangAi decoction combining TKIs might be acceptable with mild toxic effects.