Clinical Research Papers:
Maintenance treatment of Uracil and Tegafur (UFT) in responders following first-line fluorouracil-based chemotherapy in metastatic gastric cancer: a randomized phase II study
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Wenhua Li1,2, Xiaoying Zhao1,2, Huijie Wang1,2, Xin Liu1,2, Xinmin Zhao1,2, Mingzhu Huang1,2, Lixin Qiu1,2, Wen Zhang1,2, Zhiyu Chen1,2, Weijian Guo1,2, Jin Li1,2,* and Xiaodong Zhu1,2,*
1 Department of Medical Oncology, Fudan University Shanghai Cancer Center, Shanghai, China
2 Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, China
* Xiaodong Zhu and Jin Li contributed equally to this work
Xiaodong Zhu, email:
Jin Li, email:
Keywords: gastric carcinoma; UFT; chemotherapy; maintenance treatment
Received: October 24, 2016 Accepted: December 01, 2016 Published: December 12, 2016
Background: Maintenance therapy proves to be effective in advanced lung and breast cancer after initial chemotherapy. The purpose of this phase II study was to evaluate the efficacy and safety of Uracil and Tegafur (UFT) maintenance in metastatic gastric cancer patients following the first-line fluorouracil-based chemotherapy.
Methods: Metastatic gastric cancer patients with stable disease or a better response after the completion of first-line chemotherapy were randomized to oral UFT (360mg/m2 × 2 weeks) every 3 weeks until disease progression/intolerable toxicity or to observation (OBS). The primary endpoint was progression-free survival (PFS); the secondary endpoints were overall survival (OS) and safety.
Results: The trial was closed after the interim analysis of the 58 enrolled (120 planned) patients. Median PFS was not improved in the UFT group compared with the OBS group (3.2 months versus 3.6 months, P = 0.752), as well as the median OS (14.2 months for both, P = 0.983). However, subgroup analysis showed that low baseline hemoglobin (< 120 g/L) was associated with poorer PFS with maintenance therapy (P = 0.032), while the normal hemoglobin patients benefit from the UFT treatment (P = 0.008). Grade 3 to 4 toxicities in the UFT group were anemia (3.4%), thrombocytopenia (3.4%) and diarrhea (6.9%).
Conclusions: This trial did not show superiority of UFT maintenance in non-selected patients responding to fluorouracil-based first-line chemotherapy. The normal hemoglobin level at baseline is a predictive biomarker for favorable patient subsets from the maintenance treatment.
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