Clinic Study Of Different Dose-schedule Regimens Of Cisplatin Plus Vinorelbine In The Treatment Of The Patients With Non-small Cell Lung Cancer

Background: Non small- cell lung cancer is one of the most commonly malignant diseases that severely threaten human health. Chemotherapy plays an important role in combination therapy of advanced or metastatic NSCLS. Platinum-based combination chemotherapy is currently recommended as the classical first-line treatment for patients with NSCLC. High dose of platinum in single dose is commonly given and the side effects of gastrointestinal tract, nephrotoxicity, myelosuppression and so on have deeply influenced patients'quality of life. It is necessary to explore the efficacy and safety of treatments with different dose of cisplatin in clinical trials.Objective: To investigate the therapeutic effects and side effects of different dose-schedule of cisplatin plus vinorelbine in the standard first-line treatment of advanced non-small cell lung cancer. The changes of patients'quality of life and kidney function caused by different treatments were studied.Methods: A total of 143 NSCLC patients were divided into the three groups. In the low dose consecutive administration group, cisplatin was administered on day 1~5 at 15mg/m2; in the middle dose consecutive administration group, cisplatin was administered on day 1~3 at 25mg/m2; and in the high dose group, cisplatin was administered on day 1 at 80mg/m2. All the patients in the three groups received vinorelbine on days 1 and 8 at 25mg/m2 intravenously. Four weeks was defined as one cycle. The therapeutic effects , side effects, the status of fatigue and the changes of trace urinary proteins were evaluated after two cycles of chemotherapy. The Response Evaluation Criteria In Solid Tumors (RECIST) was used to assess therapeutic effects. The treatment of the recent safety was guided according to Common Teminology Criteria for Adverse Events,Version3.0(CTCAE3.0) of NCI. Cancer-related fatigue (CRF) was the most commonly factor that could affect patients'quality of life.We used the fatigue symptom inventory (FSI), which had been proved to have good validity and reliability, to evaluate patients'fatigue intensity, duration and the extension to which fatigue had interfered with quality of life before and after chemotherapy. Radioimmunoassay was applied to detect the levels of urinary albumin, immunoglobulin G andβ2 microglobulin.Results: In the evaluable 129 cases, the response rates of the three groups were 31.1%,31.8% and 37.5% respectively, which had no significant differences (P>0.05). The incidences of gradeⅢ～Ⅳgastrointestinal tract reaction and gradeⅢ～Ⅳmyelosuppression in the high dose group were significantly higher than those of middle and low dose groups. In the high dose group,the post-chemotherapy fatigue scores were significantly higher than those of pre-chemotherapy and the concentrations of albumin, IgG andβ2-MG in urine all increased. While in the middle and low dose groups, the albumin, IgG in urine remained unchanged, onlyβ2-MG increased.Conclusion: The low dose cisplatin combined with NVB was confirmed to have low toxic side effects and light influences on patients'quality of life and kidney function, side effects were mild, the influence of patients'were slight which made patients well tolerated.