Long-term Pemetrexed Administration in 22 Patients with Non-small Cell Lung Cancer in a Japanese Phase II Randomized Study

Objective. Previously treated patients with non-small cell lung cancer (225 patients) were given pemetrexed in a Japanese phase II randomized study (Study NS01). We analyzed data from those patients within the group who received long-term administration (22 patients). Methods. We evaluated safety in the 22 patients receiving 10 or more courses of pemetrexed (defined as long-term administration), in terms of survival without grade 3/4 toxicity, incidence of common grade 3/4 toxicities, progression-free survival, and duration of response. Results. Median survival without grade 3/4 toxicity was 5.6 months. Hematologic toxicities exacerbated to grade 3/4 after the 10th course were leukopenia in 1 patient and neutropenia in 2 patients; nonhematologic toxicities exacerbated to grade 3/4 after the 10th course were alanine aminotransferase elevation and malaise, in 1 patient each. Grade 3/4 toxicities that newly occurred after the 10th course were vertigo and dizziness in 1 patient each, both of which were grade 3. Median progression-free survival was 10.0 months, and median duration of response was 9.0 months. Conclusion. In 22 patients who received long-term administration of pemetrexed, there was no unexpected or irreversible toxicity.