Maintenance treatment of Uracil and Tegafur (UFT) in responders following first-line fluorouracil-based chemotherapy in metastatic gastric cancer: a randomized phase II study

摘要: // Wenhua Li 1,2 , Xiaoying Zhao Huijie Wang Xin Liu Xinmin Mingzhu Huang Lixin Qiu Wen Zhang Zhiyu Chen Weijian Guo Jin 1,2,* and Xiaodong Zhu 1 Department of Medical Oncology, Fudan University Shanghai Cancer Center, Shanghai, China 2 College, University, * contributed equally to this work Correspondence to: Zhu, email: Li, Keywords : gastric carcinoma; UFT; chemotherapy; maintenance treatment Received October 24, 2016 Accepted December 01, Published 12, Abstract Background: Maintenance therapy proves be effective in advanced lung breast cancer after initial chemotherapy. The purpose phase II study was evaluate the efficacy safety Uracil Tegafur (UFT) metastatic patients following first-line fluorouracil-based Methods: Metastatic with stable disease or a better response completion chemotherapy were randomized oral UFT (360mg/m2 × weeks) every 3 weeks until progression/intolerable toxicity observation (OBS). primary endpoint progression-free survival (PFS); secondary endpoints overall (OS) safety.  Results: trial closed interim analysis 58 enrolled (120 planned) patients. Median PFS not improved group compared OBS (3.2 months versus 3.6 months, P = 0.752), as well median OS (14.2 for both, 0.983). However, subgroup showed that low baseline hemoglobin (< 120 g/L) associated poorer ( 0.032), while normal benefit from 0.008). Grade 4 toxicities anemia (3.4%), thrombocytopenia (3.4%) diarrhea (6.9%). Conclusions: This did show superiority non-selected responding level at is predictive biomarker favorable patient subsets treatment.