Capecitabine plus gemcitabine in thymic epithelial tumors: Final analysis of a phase II trial.

7528 Background: Thymic epithelial tumors (TETs) are rare malignancies, with an estimated incidence of about 3 cases per 100,000 inhabitants. No standard treatment is available for recurrent disease. In 2005, a multi-institutional phase II trial was started on the combination of gemcitabine and capecitabine in pretreated patients with TETs. Final results of this phase II study are presented. Methods: Eligibility criteria for the study were mainly the following: histologic diagnosis of TET by central review; at least one prior systemic chemotherapy treatment; progressive disease. Treatment consisted of oral capecitabine (650 mg/mq twice daily on days 1–14) and i.v. gemcitabine (1000 mg/mq on days 1 and 8) every 3 weeks. The radiographic response rate was chosen as primary end point and employed to calculate the study sample. Secondary end points were progression-free survival, toxicity, and overall survival. Results: Thirty patients (18 men, 12 women; median age 57 years, range 48–61 years)were enrolled in this phase II trial from November, 2005 to June 2013. The majority of patients (73%) had thymoma, while the remaining had thymic carcinoma.Of note, 63% of patients showed disease progression within 2 months from the last dose of the last systemic therapy received. The most important grade 3 toxicity was neutropenia in eight patients. Twelve patients had a response (three complete responses and eight partial responses). Among thymic carcinoma patients, we observed three partial responses. Median PFS was 11 months (95% CI 3–17 months). The PFS for patients with thymoma and thymic carcinoma was 11 months (95% CI 6–17 months) and 6 months (95% CI 3–11 months), respectively. Thirteen patients are dead at the time of the analysis (median OS, 16 months). Conclusions: Capecitabine and gemcitabine is a highly active combination therapy in thymic epithelial tumors and should be routinely included in the managment of recurrent/metastatic disease.