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

Abstract

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.

• Authors: Wenhua Li, Xiaoying Zhao, Huijie Wang, Xin Liu, Xinmin Zhao, Mingzhu Huang, Lixin Qiu, Wen Zhang, Zhiyu Chen, Weijian Guo, Jin Li, Xiaodong Zhu
• Journal: Oncotarget (Oncotarget) Vol. 8 Issue 23 Pg. 37826-37834 (Jun 06 2017) ISSN: 1949-2553 [Electronic] United States
• PMID: 27980221 (Publication Type: Clinical Trial, Phase II, Journal Article, Randomized Controlled Trial)

Chemical References

• Tegafur
• Uracil
• Fluorouracil

Topics

• Adult
• Aged
• Disease-Free Survival
• Female
• Fluorouracil (administration & dosage, therapeutic use)
• Humans
• Male
• Middle Aged
• Neoplasm Metastasis
• Stomach Neoplasms (drug therapy, pathology)
• Tegafur (administration & dosage, therapeutic use)
• Uracil (administration & dosage, therapeutic use)
• Young Adult