Clinical Study Of "FuZhengKangAi" Decoction With Gefitinib In Treatment Of Advanced NSCLC

ObjectiveTo observe and discuss the efficacy of "FuZhengKangAi" decoction with gefitinib on advanced non-small-cell lung cancer (NSCLC), and the effect in improvement of symptoms, reduction of toxic side effects, raise in quality of life and prolongation of survival. To provide an integration of TCM and Western medicine in treatment of advanced NSCLC, especially those with EGFR mutation.MethodSeventy stageâ…¢/â…£NSCLC patients were continuously recruited. Medications were given as follows:"FuZhengKangAi" decoction 250ml, po, qd, and Gefitinib 250mg, po, qd. Gefitinib was given until disease progression, occurrence of intolerable adverse side effect or death. "FuZhengKangAi" decoction was given until death or unable to receive medication. CT scan and laboratory examination were performed before medication, after the first month and every 3 months for tumor assessment. The objective response rate (ORR), disease control rate (DCR), progression-free survival (PFS), median survival time (MST),1-year survival rate, adverse effect and quality of life (QoL) were observed in the 70 patients.ResultSeventy patients completed the study, in which there were 42 cases of first line treatment,25 cases of second line treatment and 3 cases of third line treatment. For short-term efficacy, the ORR was 30.0%, DCR was 85.7%. Inter-group analysis suggested sex and smoking condition had statistical difference in DCR. For patients receiving first-line treatment, ORR was 21.4% and DCR was 83.3%, inter-group analysis indicated smoking condition had statistical difference in DCR. For patients receiving second-line treatment, ORR was 44.0% and DCR was 88.0%, inter-group analysis indicated age had statistical difference in ORR. For long-term efficacy, the overall median PFS (mPFS) was 8.5 months; 1-year survival rate was 69.9%. There was statistical difference in sex, smoking condition and PS scoring for PFS. In first-line treatment, median PFS (mPFS) was 7.7 months; 1-year survival rate was 64.9%. There was statistical difference in sex, smoking condition and PS scoring for PFS. In second-line treatment, median PFS (mPFS) was 11.4 months; 1-year survival rate was 79.4%. There was statistical difference in PS scoring for PFS. The median survival time was not reached for overall, first-line and second-line treatment. As for the quality of life, there were statistical differences for the pre-and post-treatment in EORTC QLQ-LC43 score, FACT-L score and TCM syndrome score, with improvement after treatment. The most common adverse events were grade rashes (35.7%) and diarrhea (24.3%). Interstitial lung disease was not observed and there was none treatment-related death.ConclusionThe treatment of advanced NSCLC using "FuZhengKangAi" decoction with gefitinib has a higher disease control rate, an improvement in quality of life and slight and tolerable adverse effect. Therefore, this is a complete, effective and acceptable treatment regime.