Randomized study of gefitinib versus pemetrexed as maintenance treatment in patients with advanced glandular non-small cell lung cancer.

Gefitinib was compared with pemetrexed as maintenance therapy in Patients with Advanced Glandular Non-small Cell Lung Cancer, mainly regarding clinical effect and side effect. A randomized trial of pemetrexed as study group (500 mg/m(2), dl) versus gefitinib as the control group [250 mg on night 1, 250 mg on morning 2 (every day)] was conducted in 188 patients, 94 cases in each group with a therapy cycle of 21 days. In addition, the study group was also treated with folic acid, vitB12 and dexamethasone. Therapeutic effects and adverse reactions of the two groups were compared. Patients of two groups completed four cycles of chemotherapy mostly, and there was no complete remission (CR) case. The median-cycle of chemotherapy was 2 for the study group, and partial response (PR), stable disease (SD), progressive disease (PD) were observed in 28 (29.8%), 34 (36.2%), 32 (34.0%) cases respectively. The median-cycle was 3 for the control group, PR, SD and PD were observed in 17 (18.1%), 23 (24.5%), 54 (57.4%) cases respectively. The effective rates were 29.8% and 18.1% for pemetrexed (28 cases) and gefitinib (17 cases) respectively (P > 0.05). However, there was a statistically significant difference in disease control rates between the 2 groups (65.0% vs 42.6%; P < 0.05). Adverse reactions occurred in two groups were mainly mild adverse reactions of 1-2 degree, without renal failure. The study group and control group had three and five cases of mild infection respectively, without statistically significant difference. There was no significant difference in the incidence rate of rash and alopecia between the two groups (P > 0.05). However, the number of cases with neutropenia, anemia, thrombocytopenia, gastrointestinal reactions and fatigue in the study group was lower than that of the control group, with a statistically significant difference (P < 0.05). Considering the disease control rate and the tolerance of patients with advanced NSCLC, pemetrexed is strongly recommended to be used in clinical.

RCT Entities:   Population Interventions Outcomes