BackgroundThe maintenance treatment for non-small-cell lung cancer (NSCLC) is a hotspot in tumor circle in recent years。The toxicity accumulation and over-treatment were the "bottleneck" of maintenance treatment。More and more studies show that Traditional Chinese Medicine (TCM) has certain advantage in improving the quality of life and extension of survival in advanced tumor patients Therefore developing the usage of TCM as maintenance treatment in advanced tumor maybe a beneficial complementary to the current integration therapy。ObjectiveTo observe the efficacy and safety of "KangAiFuZheng" decoction as a maintenance treatment for advanced NSCLC patients achieved CR, PR or NC after first-line platinum-based chemotherapy, through the progression-free survival (PFS), median survival time (MST) and the improvement of symptoms and raise in quality of life。To assess the feasibility of TCM as maintenance therapy in advanced NSCLC。MethodAccording to the inclusion and exclusion criteria,64 advanced (stageⅢB/Ⅳ) NSCLC patients who reached relief or stable disease (CR,PR,SD) after first-line platinum-based chemotherapy were randomly assigned to the treatment group and control group, with 32 cases in each group。"FuZhengKangAi" decoction with best support care (BSC) was given to the treatment group, while only BSC was given to the control group。Observation and follow-up were performed regularly。The major observation indexes include median progression free survival (PFS), median survival time (MST),1-year survival rate, and the patients were assessed every 2 months for their physical status (PS score), quality of life and change in TCM syndrome。 ResultIn the 64 included cases,3 cases dropout and 61 patients completed the study。There were 31 patients in treatment group and 30 patients in control group。There was no statistical difference (P>0.05) in the age,sex,histology, staging and TCM syndrome differentiation between 2 groups。The long term efficacy in the treatment group were MST 15.1 months, PFS 6.2 months, 1-year survival rate 68.5%, while that in the control group were 8.1 months, 4.1 months and 31.8% respectively。There were statistical difference (P<0.05) between the 2 groups in terms of MST and TTP。For the quality of life, there were increase in EORTC QLQ-LC43 score, FACT-L score and ECOG PS score in both groups, but the improvement in the treatment group was more obvious and had statistical difference (P<0.05)。For adverse events,3 patients in the treatment group showed grade 1 nausea (NCI-CTCAE) on the second day of treatment, and the symptom disappeared after 10 minutes without further treatment。No other adverse event arose。Conclusion1.For advanced NSCLC (stage IIIB/IV) patients achieved CR,PR or NC after first-line platinum-based chemotherapy, using "FuZhengKangAi" decoction can achieve benefit in PFS and MST。2. "FuZhengKangAi" decoction can better relieve and improve symptoms, and raise the quality of life when compared with BSC。3. This maintenance therapy is safe, effective and acceptable for advanced NSCLC patients, and therefore worth further study and promotion。... |