医学
卡培他滨
胸腺癌
吉西他滨
中性粒细胞减少症
胸腺瘤
内科学
胃肠病学
临床终点
化疗
临床研究阶段
外科
进行性疾病
毒性
肿瘤科
癌症
临床试验
结直肠癌
作者
Carlo Buonerba,Margaret Ottaviano,Piera Federico,F Calabrese,Claudia von Arx,Simona Iaccarino,Lucia Nappi,Irene Tucci,Giuseppe Di Lorenzo,Elide Matano,Vincenzo Damiano,Giovannella Palmieri
标识
DOI:10.1200/jco.2014.32.15_suppl.7528
摘要
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.
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