capecitabine plus gemcitabine in thymic epithelial tumors: final analysis of a Phase Ii trial

ABSTRACT  Background: A multi-institutional Phase II trial was initiated in 2005 to test the combination gemcitabine and capecitabine in patients with thymic epithelial malignancies (TETs). Patients & methods: Patients with histologic confirmation of TET diagnosis by central review who had received >1 systemic chemotherapy treatment were included. Patients received oral capecitabine (650 mg/mq twice daily on days 1–14) and intravenous gemcitabine (1000 mg/mq on days 1 and 8 every 3 weeks). Results: Of the 30 patients included (18 men, 12 women; median age: 57 years, range: 48–61 years), the majority (73%) had thymoma, and the remaining thymic carcinoma. Eight patients developed grade 3–4 neutropenia. A total of 12 patients had a response. Median progression-free survival was 11 months (range: 6.5–16.5). Conclusion: Capecitabine and gemcitabine is highly active in TETs.