Tegafur 100mg / Uracil 224mg capsules

BACKGROUND: Tegafur-uracil (UFT), an oral fluoropyrimidine developed in Asia, has been investigated as a maintenance or adjuvant therapy in various malignancies. Its use in head and neck cancers, however, remains limited to small retrospective studies, primarily from East Asia. Given the need for cost-effective maintenance strategies in resource-limited settings, we conducted an exploratory systematic review to evaluate the clinical utility of UFT in non-metastatic head and neck squamous cell carcinoma (HNSCC) and nasopharyngeal carcinoma (NPC). METHODS: We systematically searched PubMed, EMBASE, and Cochrane Library from inception through 1 May 2025 for retrospective cohort studies evaluating UFT after definitive therapy in non-metastatic HNSCC or NPC. Study selection followed PRISMA guidelines. Given the heterogeneity of included studies, we performed a structured narrative synthesis using the SWiM (Synthesis Without Meta-analysis) framework to summarize survival outcomes, treatment settings, and clinical contexts. RESULTS: Seven retrospective studies (four HNSCC, three NPC) involving 508 patients were included. UFT was generally administered at 300-400 mg/day for 6-12 months. Across studies, UFT use was associated with favorable disease-free and overall survival trends in high-risk subgroups, including patients with extranodal extension and persistent EBV DNA. Treatment adherence and toxicity profiles were acceptable. CONCLUSIONS: While the evidence remains limited and heterogeneous, this review highlights recurring signals of benefit associated with UFT maintenance therapy in selected high-risk patients. Prospective trials are warranted to confirm these findings and better define a possible role of UFT in maintenance therapy in some advanced non-metastatic HNSCC and NPC.

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Background: Patients with non-metastatic head and neck squamous cell carcinoma (HNSCC) face high risks of recurrence after curative-intent treatment. Maintenance therapy aims to prolong disease control during this vulnerable period. Tegafur-uracil (UFT), an oral fluoropyrimidine with a favorable toxicity profile, has demonstrated efficacy in other solid tumors. This study systematically evaluated the survival benefits of UFT as a maintenance therapy in HNSCC. Methods: A systematic review and meta-analysis were conducted according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines, with the protocol registered on the Open Science Framework. PubMed, Embase, and CENTRAL were searched through May 2025. Eligible studies included adult patients with non-metastatic HNSCC who received UFT after curative treatment, with comparison to observation or standard care. Hazard ratios (HRs) for progression-free survival (PFS) and overall survival (OS) were pooled using random-effects models. Trial sequential analysis (TSA) was performed to assess the conclusiveness of the findings. Results: Six observational studies including 1,373 patients were analyzed. UFT maintenance therapy was associated with improved PFS (HR: 0.68; 95% confidence interval (CI): 0.56 - 0.81; P < 0.001) and OS (HR: 0.54; 95% CI: 0.42 - 0.71; P < 0.001) compared with observation. TSA suggested that the available evidence may be sufficient to support a potential benefit for PFS, while for OS, further studies are still needed to strengthen the conclusions. Sensitivity analyses showed broadly consistent results; however, most included studies carried a moderate to serious risk of bias due to their non-randomized designs, which warrants cautious interpretation. Conclusions: UFT maintenance therapy may be associated with improved survival outcomes in patients with non-metastatic HNSCC. Its oral formulation, relatively low toxicity, and potential cost-effectiveness suggest that it could represent a feasible treatment option. However, these observations currently indicate only a possible trend and should not be regarded as definitive conclusions. Further prospective randomized controlled trials are required to validate the efficacy of UFT maintenance therapy and to establish standardized protocols for patient selection and dosing.

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Nasopharyngeal carcinoma (NPC) remains a challenging malignancy with high rates of recurrence following definitive therapy. This meta-analysis aimed to evaluate the efficacy of tegafur-uracil (UFT) maintenance therapy in patients with non-metastatic NPC after curative treatment. A systematic literature search of PubMed, Embase, and the Cochrane Library was performed to identify eligible studies. Three retrospective cohort studies including a total of 558 patients were analyzed. Random-effects meta-analysis demonstrated that UFT maintenance therapy significantly improved both progression-free survival [hazard ratio (HR)=0.53, 95% confidence interval (CI)=0.35-0.81] and overall survival (HR=0.37, 95%CI=0.21-0.65) compared to observation alone. Sensitivity analyses confirmed the robustness of these findings. However, trial sequential analysis indicated that the cumulative evidence did not meet the a priori information size required for a conclusive result, highlighting the need for further high-quality studies. In summary, UFT maintenance therapy may represent a promising option to reduce recurrence and improve survival in non-metastatic NPC, particularly in settings where access to novel agents is limited, but additional prospective studies are needed to confirm its clinical benefit.

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BACKGROUND: Efficacy of adjuvant chemotherapy in patients with stage II colon cancer is still controversial. The SACURA trial is a randomised-controlled study evaluating the superiority of 1-year adjuvant treatment with oral tegafur-uracil (UFT) to surgery alone for stage II colon cancer. METHODS: Patients were randomly assigned to the surgery-alone group or UFT group (UFT at 500-600 mg/day for 5 days, followed by 2-day rest, for 1 year). The primary end-point was disease-free survival (DFS). Target sample size was 2000, determined with one-sided alpha of 0.05, power of 0.9 and assumed hazard ratio (HR) 0.729. RESULTS: A total of 1982 patients (997 in the surgery-alone group and 985 in the UFT group) were analysed. Median follow-up was 69.5 months, median age was 66 years and for stage IIA/IIB/IIC, the distribution was 84%/13%/3%. The 5-year DFS rate was 78.4% in the surgery-alone group and 80.2% in the UFT group. The HR for DFS was 0.91 (95% confidence interval [CI], 0.75-1.10; p = 0.31); superiority of UFT was not demonstrated. Approximately 9% of patients experienced second cancers, which consist 40.7% of the DFS events. The 5-year relapse-free and overall survival rates of the surgery-alone and UFT group were 84.6% and 87.2% (HR, 0.82; 95% CI, 0.65-1.04) and 94.3% and 94.5% (HR, 0.93; 95% CI, 0.66-1.31), respectively. Subgroup analysis failed to disclose superiority in prognosis of adding UFT to the patients with risk factors for recurrence. CONCLUSIONS: Superiority of 1-year adjuvant UFT over surgery alone was not demonstrated in stage II colon cancer. Patients with risk factors for recurrence did not benefit from UFT. TRIAL REGISTRATION: ClinicalTrials. Gov. #NCT00392899.

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PURPOSE: Tegafur-uracil (UFT) is the standard postoperative adjuvant therapy for stage IB lung adenocarcinoma (LUAD) in Japan. This study aimed to determine whether UFT is effective in stage IB LUAD with and without epidermal growth factor receptor (EGFR) mutations. METHODS: This retrospective study included 169 patients with stage IB LUAD who underwent complete resection at our department between 2010 and 2021. We investigated the clinicopathological and prognostic impact of EGFR mutations as well as the postoperative use of UFT. RESULTS: EGFR mutation-positive cases tended to show a higher cumulative recurrence rate than EGFR mutation-negative cases (p = 0.081), while overall survival was comparable between the groups (p = 0.238). In the entire cohort, UFT administration was not an independent prognostic factor in the multivariate regression analysis (p = 0.112). According to a stratification analysis, UFT administration was independently associated with favorable overall survival (p = 0.031) in EGFR mutation-negative cases, while it was not associated with recurrence-free survival (p = 0.991) or overall survival (p = 0.398) in EGFR mutation-positive cases. CONCLUSION: UFT administration can improve the prognosis of EGFR mutation-negative LUAD but not EGFR mutation-positive LUAD. Thus, clinical trials of adjuvant-targeted therapy for EGFR mutation-positive stage IB LUAD should also be conducted in Japan.

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BACKGROUND: Total neoadjuvant therapy (TNT) is a novel treatment strategy that is an alternative to preoperative chemoradiotherapy (CRT) for locally advanced rectal cancer (LARC). However, an optimal protocol for TNT has not yet been established. The present study will be an open-label, single-arm, single-center trial to develop a new protocol. METHODS: Thirty LARC patients at high risk of distant metastasis will receive CRT consisting of long-course radiation, concurrent with tegafur/uracil, oral leucovorin, irinotecan (TEGAFIRI), followed by mFOLFOX-6 or CAPOX before undergoing surgery. DISCUSSION: Since previous findings showed a high percentage of grade 3-4 adverse events with the TEGAFIRI regimen for CRT and TNT, the primary outcome of this study will be safety and feasibility. Our regimen for CRT consists of the biweekly administration of irinotecan for good patient compliance. The novel combination approach of this treatment may improve the long-term outcomes of LARC. TRIAL REGISTRATION: Japan Registry of Clinical Trials jRCTs031210660.

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Background: This retrospective single-center cohort study evaluated the efficacy and safety of a combination of neoadjuvant luteinizing hormone-releasing hormone (LHRH) antagonist and tegafur-uracil (UFT) therapy (NCHT) and investigated the medical records of patients with high-risk PCa who underwent robot-assisted radical prostatectomy (RARP). The therapy was followed by RARP for high-risk PCa. Materials and Methods: The enrolled patients were divided into two groups: low-intermediate-risk PCa patients who underwent RARP without neoadjuvant therapy (non-high-risk) and those who underwent NCHT followed by RARP (high-risk group). This study enrolled 227 patients (126: non-high-risk and 101: high-risk group). Patients in the high-risk-group had high-grade cancer compared to those in the non-high-risk-group. Results: At the median follow-up period of 12.0 months, there were no PCa deaths; two patients (0.9%) died of other causes. Twenty patients developed biochemical recurrence (BCR); the median time until BCR was 9.9 months after surgery. The 2-year biochemical recurrence-free survival rates were 94.2% and 91.1% in the non-high-risk and high-risk-group, respectively (p = 0.465). Grade ≥3 NCHT-related adverse events developed in nine patients (8.9%). Conclusions: This study indicates that combining neoadjuvant LHRH antagonists and UFT followed by RARP may improve oncological outcomes in patients with high-risk PCa.

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