A Study Of Different Gemcitabine Dosage Regimens As Maintanence Chemotherapy In Advanced Non-small Cell Lung Cancer

Objective:1.To evaluate and compare the efficacy and toxicity in advanced non-small-cell lung cancer(NSCLC) patients treated by different G(Gemcitabine) maintenance chemotherapy regimens:gemcitabine at a low dose of 250mg/m~2 in 6h prolonged infusion(L-G) and normal dosage Gemcitabine infusion(N-G).2.To evaluate the effect on quality of life(QoL) of two regimens.3.To analyze and compare the pharmacoeconomics in two groups.Method:1.60 patients with stageⅢb orⅣNSCLC who demonstrated disease controlling(CR+PR+SD) within one month after four cycles of platinum-based first-line chemotherapy,were randomly divided into two groups.Of 56 patients with evaluable response,which receive either L-G regimen(28 cases) or N-G regimen(28 cases) respectively,the response rate and toxicity were compared in two groups of patients.2.EORTC QLQ-C30 and QLQ-LC13 questionnaires(Chinese edition) were filled in and KPS were detected before and after 2 cycles of maintenance chemotherapy to evaluate the effect on QoL of two regimens.3.Analyzed the pharmacoeconomics in two groups by Cost Effectiveness Analysis and Cost Minimization Analysis.Results:1.Efficacy and toxicity of two groups:①The response rate of L-G group was 17.9%,and N-G group was 14.3%(P＞0.05).②Median time to progression were 4.2 months and 4.0 months(P＞0.05) in L-G group and N-G group,median survival time were 10.8 months and 10.6 months(P＞0.05),and l-year survival rate were 35.7%and 32.1%(P＞0.05),respectively.③Toxicity:L-G group was associated with less grade 3-4 neutropenia and thrombocytopenia than N-G group(P＜0.05).Haematoglobin decrease didn't show statistical difference in two groups.There was no statistically difference in nonhematologic toxicity between two groups.2.Evaluation and comparison of quality of life:①The increase rate of KPS were high up to 32.1%and 35.7%in L-G group and N-G group respectively(P＞0.05).②Mean scores of five functional status(physical functioning,role functioning, cognitive functioning,emotional functioning and social functioning) and global QoL increased in two groups after maintenance chemotherapy,but scores improved showed no statistical difference(P＞0.05).while mean scores of two general symptoms (fatigue and appetite loss) and disease associated symptoms(dyspnoea,coughing, haemoptysis,pain in chest,pain in arm or shoulder and pain in other location) dccreased,but scores decreased showed no statistical difference either(P＞0.05).The response rate of QoL in two groups showed no significantly statistical difference.③Scores increased in financial difficulties of N-G group after maintenance chemotherapy showed statistical difference(P＜0.05),while L-G group showed none. 3.Pharmacoeconomics:L-G regimen was cheaper than N-G regimen both in Cost Effectiveness Analysis and Cost Minimization Analysis,and showed statistical differece(P＜0.05).Conclusions:1.Compared with normal dosage infusion G regimen,prolonged infusion of low-dose G regimen had less grade 3 and 4 thrombocytopenia and neutropenia toxicity,but objective response rate and prostecdtive efficacy showed no statistical difference.2.Both regimens did not decrease the QoL of most patients with advanced NSCLC.Scores of single item in financial difficulties showed that the patients accepted N-G regimen went into financial dilemma.3.L-G regimen showed prominent dominance in pharmacoeconomics compared with N-G regimen.