| BackgroundLung cancer has the highest incidence and death rate of tumors in the world,accounting for 20% of all tumor related deaths,most of them are non-small cell lung cancer.Most of the NSCLC patients are diagnosed with advanced stage.The platinum-based doublet chemotherapy is the standard first-line treatment for advanced(?B-?)non-small cell lung cancer.A number of studies have shown that the continued prolongation of chemotherapy cycles after chemotherapy of platinum regimens in 4~6 cycles has no additional survival benefit.In order to maximize the patient's survival,continued treatment after 4~6 cycles of first-line chemotherapy which reached the remission of the tumor was defined as maintenance therapy.At present,the maintenance of chemotherapy mainly refers to the maintenance of chemotherapy,but there are still some problems such as bone marrow suppression and drug resistance in the maintenance of chemotherapy.Yifei Sanjie Fang(pill)is a Chinese patent medicine created by Professor Lin Lizhu on the basis of years of clinical experience.The basic research found that Yifei Sanjie Decoction(pills)can induce tumor cell apoptosis and inhibit cell proliferation and metastasis,lung cancer cells grown in nude mice resistant to inhibition of tumor growth.Clinical research has found that the pill can extend the advanced non-small cell lung cancer survival period and life quality,reduce the toxicity of chemotherapy.Yifei Sanjie Fang(pill)may replace chemotherapy as a maintenance therapy for advanced non-small cell lung cancer ObjectiveYifei Sanjie Fang(pill)maintenance therapy is compared with chemotherapy alone maintenance treatment,to evaluate the effect of Yifei Sanjie Fang(pill)on progression free survival(PFS)and incidence of myelosuppression in patients with advanced non-small cell lung cancer.MethodAfter more than 4 cycles of first-line chemotherapy after tumor imaging evaluation for stability(SD)included in the study above stage ?B-? patients,90 patients were divided into Yifei Sanjie Decoction(pill)group of 46 cases and maintenance chemotherapy group 44 cases,progression free survival(PFS)were observed in the two groups.The survival analysis was carried out on the basis of gender stratification.The possible prognostic factors in the two groups were collected,and a proportional hazard model(COX regression)was introduced to select the prognostic factors that might affect the survival period.Result(1)PFS time: the average PFS time of chemotherapy group was 175.954±26.370 days,the median PFS time was 122 days,the average PFS time of Yifei Sanjie pill group was 264.237±44.024 days,and the median PFS time was 174 days.The average PFS and median PFS in Yifei Sanjie pill group were longer than those in the chemotherapy group,but the difference between the two groups was not statistically significant.(2)According to gender stratified survival analysis,in male patients,the PFS time of Yifei Sanjie Fang(pill)group was lower than that of chemotherapy group,but the difference between the two groups was not statistically significant.In the female patients,the PFS of Yifu Sanjie pill group was significantly longer than that of the chemotherapy group,and the difference between the two groups was statistically significant.(3)According to PS scores survival analysis,in patients with PS score ?1,the median PFS in Yifei Sanjie pill group was 45 days longer than that in chemotherapy group,but the difference between the two groups was not statistically significant.In patients with PS score=2,the median PFS in Yifei Sanjie pill group was 94 days longer than that in chemotherapy group,and the difference between the two groups was not statistically significant.(4)The possible factors were introduced into the COX model for multi factor analysis,Only the number of metastatic organs was statistic ally significant(P<0.05).(5)In the Yifei Sanjie Fang(pill)group,only 4 patients(8.7%)had 1 degrees of bone marrow suppression and no myelosuppression of 2 degrees or more.Maintenance chemotherapy group of 9 patients(25.0%)had 1 degrees of bone marrow suppression,6 cases(16.7%)occurred in 2 patients with myelosuppression,4 patients(11.1%)had 3 degrees of bone marrow suppression,1 cases(2.8%)had 4 degrees of myelosuppression.The difference between the two groups was statistically significant(P<0.001).(6)In the group of Yifu Sanjie Fang(pill),the score of KPS was increased after treatment in 19.6% of the patients,69.6% of the patients remained stable,and 10.8% of the patients had a lower KPS score after treatment.In the chemotherapy maintenance group,only 2.8% of the patients had a higher KPS score after treatment,58.3% of the patients remained stable,and 38.9% of the patients had a lower KPS score than the former,and the two groups were statistically significant(P<0.001).(7)4.3% of the patients in Yifei Sanjie prescription(pill)group had higher PS scores after treatment,91.4% of patients maintained stable scores,and 4.3% patients had a lower PS score than before.In the chemotherapy group,72.2% of the patients had stable PS scores,while 27.8% of the patients had lower scores after treatment.But the difference between the two groups was not statistically significant(P=0.007).Conclusion(1)In the maintenance treatment of ?B-? non-small cell lung cancer,Yifei Sanjie Fang(pill)prolongs the progression free survival time of the patients not inferior to the chemotherapy maintenance group.(2)Female patients and patients with higher PS score may be more able to benefit from the treatment of Yifei Sanjie Fang(pill),but further research is needed to confirm the conclusion.(3)The number of metastatic organs is adverse prognostic factors for advanced non small cell lung cancer patients,the risk of death in patients with metastatic organ of more than 2 is 1.69 times of the only single transfer.(4)The incidence of blood toxicity in the Yifei Sanjie Fang(pill)group was significantly lower than that in the chemotherapy maintenance treatment group,indicating that the Yifei Sanjie Fang(pill)has low toxicity and good safety.(5)Yifei Sanjie prescription(pill)is superior to chemotherapy in maintaining patients' physical condition and improving their quality of life. |
PDF Full Text Request