P2.03a-026 Pemetrexed (Alimta) in Maintenance Therapy of 194 Patients with Advanced Non-Small-Cell Lung Cancer (NSCLC): Topic: Clinical Trials

Abstract

The effectiveness and safety of continuation maintenance therapy with pemetrexed versus the watch-and-wait approach was proved by a large randomized phase III trial (Paz-Ares et al., 2013). We focused on continuance maintenance therapy with pemetrexed (Alimta) in routine clinical practice in the Czech Republic. The primary objective of our analysis was to evaluate the overall survival, defined as the length of time from the start of maintenance therapy to the date of death. Data was summarized using the standard descriptive statistics, absolute and relative rates for categorical variables, averages for continuous variables, 95% confidence intervals, as well as median, minimum and maximum values. Kaplan-Meier survival curves were used to display the patient survival. All analyzes and graphical outputs were performed in the SAS 9.4 Software. The analyzed cohort of NSCLC patients treated with pemetrexed maintenance therapy in the Czech Republic as on March 2016 involved 194 patients. The median age was 64,0 years; stage IV was the predominant clinical stage (84,5%), 52.6% of patients were men, and 47,4% women. Adenocarcinoma was in 190 patients. From a total of 194 patients, treatment response was assessed in 173 patients. Among the assessed patients one showed complete regression (CR), 34 of them (19.7%) showed partial regression (PR), stable disease (SD) was the most frequent response, reported in 95 patients (54,9%); progression occurred in 36 patients (20.8%). Adverse events led to the termination of treatment in only 6 (3.5%) patients. The median number of cycles of maintenance therapy in our study was 5.0 (1.0; 24.0), and the median duration of maintenance therapy was 13.0 weeks. In the registration trial, the median number of cycles was 4.0 (1.0; 44.0). Median overall survival (median OS), was 15.4 months (95% CI: (12,7-18.18). The continuation maintenance therapy with pemetrexed (Alimta) has been shown to be effective and well tolerated in the Czech population. Treatment had to be terminated only in 6 (3.5%) patients due to adverse events. In the registration trial involving 359 patients (Paz-Ares et al., 2013), the continuation maintenance therapy with pemetrexed led to the median OS of 13.9 months, whereas in the Czech Republic, the median OS has been 15,4 months so far. However, a lower number of patients treated in the Czech Republic must be taken into account, and therefore this result is considered as preliminary.