Objective: To observe the effect, toxicity, survival, influence on quality of life and lung cancer related symptoms of traditional Chinese medicine FeiJi capsules and FeiJi capsules plus single agent chemotherapy in the treatment of elderly patients with advanced NSCLC.Methods: 90 elderly patients (≥70y) with advanced (IIIb/IV)NSCLC were randomized divided into 3 groups: A group: NVB chemotherapy and Traditional Chinese Medicine FeiJi Capsules, B group: FeiJi Capsules without chemotherapy, and C group NVB monotherapy group (control group).Short term effect, survival, toxicity, improvement of symptoms and quality of life were evaluated after at least 2 cycles of treatment .The short term effect and toxicity were evaluated according to WHO standards and quality of life was evaluated by KPS points, body weight and QOL points.Results: The response rates (CR+PR) of A, B and C group were 33.3%, 0% and 24.14%.B group was lower than A and C group(P<0.05).There was no significant differences between A and C groups. Stabilizing rates were 85.19%, 66.35% and 68.22%(P>0.05). Median survival times were 10 ,9 and 8 months; 6 months survival rates were 85.19%,66.35%å'Œ68.22%(P>0.05); One-year survival rates were 34.16%, 17.61% and 18.88%(P>0.05). There were no significant differences among the three groups (log Rank test, P=0.15). Hematological toxicity: 2 cases had mild anemia and no leukothrombopenia in the group B, much lower than group A and C (P<0.01) which thrombopenia rates were 7.41% and 17.24%; anemia rates were 14.81% and 34.48%(P>0.05). Digestive system reaction: 2 cases (6.67%) in B group had mild gastrointestinal reaction, much lower than A and C group. Incidence of gastrointestinal reaction in A group was 44.44%, C group was72.41%(P<0.05). There were no significant differences among the three groups on liver and kidney function injury (P>0.05). 88.89% of A group, 86.67% of B group had symptomatic improvement, significantly better than C group which was 44.83%(P<0.01). There were no significant differences on KPS points and bodyweight change in the three groups. Quality of life points were improved in 33.33%of A group patients and 40% of B group patients, much better than C group which is 6.9% (P<0.01).Conclusion: FeiJi Capsule group had significant lower response rate than control group (single agent NVB chemotherapy group),but there were nosignificant differences on stabilizing rate and survival. Furthermore adverse effects were much lower than chemotherapy group and had apparent advantages on improvement of lung cancer related symptoms and quality of life. FeiJi capsule combined with NVB chemotherapy group had higher effective rate, disease control rate and longer median survival times and lower incidence of adverse effect, greater improvement of lung cancer related symptoms as well as quality of life. Above results show FeiJi capsules can improve effect of chemotherapy and decrease its adverse effect. Feiji capsules combined with sigle agent chemotherapy shows systematic benefits on response rate, survival, improvement of lung cancer related symptoms and quality of life compared with Feiji group. Though adverse effects were more frequent, severe adverse effects were rare and easy to be controlled. Based on above results, for well- appearing elderly advanced non-small cell lung cancer patients(KPS≥60), it is reasonable to treat them with single agent chemotherapy and traditional Chinese medicine which have the effects of supplementing Qi and nourishing yin, promoting blood circulation and removing blood stasis, invigorating the spleen and tonoifying the lung. As for poor- appearing patients (KPS<60), traditional Chinese Medicine and symptoms release and supportive therapy should be the main choice. |