Abstract
Introduction The effectiveness of continuation maintenance therapy with pemetrexed versus the watch-and-wait approach was proved by a large randomised phase III trial. We focused on continuance maintenance therapy with pemetrexed in routine clinical practice in the Czech Republic.
Methods The primary objective 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 summarised using the standard descriptive statistics, absolute and relative rates for categorial 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. The analysed cohort of NSCLC patients involved 164 patients.
Results The median age was 63,0 years; stage IV was the predominant clinical stage (85,4%), 53.7% of patients were men, 46.3% women. Adenocarcinoma was in 163 patients, and large-cell carcinoma in one. Treatment response was assessed in 138 patients. Among the assessed patients, 19.5% showed PR. SD was the most frequent response (48.8%); PD occurred in 15.2% patients. Adverse events led to the termination of treatment in 3.6% 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 15.7 (3,0 – 58.2) weeks. The primary objective, median overall survival (median OS), was 18.7 months (95% CI: (14,6; 22,8).
Conclusion The continuation maintenance therapy with pemetrexed has been shown to be effective and well tolerated in the Czech population. Median overall survival (median OS), was 18.7 months (95% CI: (14,6; 22,8).
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