Capecitabine-gemcitabine in thymic epithelial tumors.

e18536 Background: Thymic epithelial tumors (TET) are a rare disease. Once loco-regional treatments have failed, platinum-based chemotherapy is employed to prolong survival and palliate symptoms. In November 2005, we started prospective multi-center trial to test capecitabine-gemcitabine in pretreated TET. Mature results are awaited. We here retrospectively review all patients with TET treated at our Institution with this schedule. Methods: Patients with pathologically confirmed TET receiving at least one cycle of capecitabine-gemcitabine were included in this analysis. Descriptive statistics and frequency counts were used to summarize characteristics of the study population. Median numbers were presented with interquartile ranges. Results: Twenty-three patients were included in this single-center analysis. Six patients had a thymic carcinoma, while three, eight, two and four patients had a B1, B2, B2/B3 and B3 TET, respectively. Median age was 52 years (47-58).Eleven patients were female. Gemcitabine was delivered at the dose of 800-1,000 mg/m2 by 30-minute infusion on days 1 and 8 every 3 weeks along with oral capecitabine at the dose of 500-650 mg/m2 twice daily on days 1 to 14. Fourteen patients had an ECOG performance status of 0, one of 2, the remaining of 1. Seven patients had an IV a tumor, while the remaining had a IVb tumor. All patients, except for three for whom capecitabine-gemcitabine was the first line of therapy, had received a platinum-based regimen. Only one patient was primary refractory, while a complete response was obtained in 2 patients, a partial response in four patients, and the remaining had stable disease. Median PFS was 7 months (range, 4-9). Median survival was 12 months (6-20). Treatment was well tolerated. Twelve patients showed grade 3/4 toxicity, of whom two patients showed severe anemia, six severe neutropenia, four severe thrombocytopenia, two severe diarrhea and one severe fatigue. Conclusions: In this retrospective analysis, gemcitabine-capecitabine was confirmed to have a high activity in TET. Mature results from the ongoing multicenter trial are awaited.