Oral Uracil and Tegafur Plus Leucovorin Compared With Intravenous Fluorouracil and Leucovorin in Stage II and III Carcinoma of the Colon: Results From National Surgical Adjuvant Breast and Bowel Project Protocol C-06

Lembersky, Barry C.; Wieand, H. Samuel; Petrelli, Nicholas J.; O’Connell, Michael J.; Colangelo, Linda H.; Smith, Roy E.; Seay, Thomas E.; Giguere, Jeffrey K.; Marshall, M. Ernest; Jacobs, Andrew; Colman, Lauren K.; Soran, Atilla; Yothers, Greg; Wolmark, Norman

doi:10.1200/jco.2005.04.7498

Cited by 285 publications

(197 citation statements)

References 12 publications

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“…Auch wenn in einer randomisierten Studie UFT + Folinsäure vs. 5-FU/FS [940] kein Unterschied im Gesamtüberleben und im krankheitsfreien Überleben bestand und in einer japanischen Metaanalyse von drei Studien sogar ein signifikanter Vorteil für Gesamtüberleben und DFS erreicht werden konnte [941], wird UFT aktuell nicht empfohlen, da es keine Zulassung zur adjuvanten Chemotherapie des Kolonkarzinoms in Deutschland besitzt. …”

Section: Level Of Evidence 2bunclassified

S3-Leitlinie – Kolorektales Karzinom

Schmiegel

Buchberger

Follmann³

et al. 2017

Z Gastroenterol

147

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Section: Level Of Evidence 2bunclassified

S3-Leitlinie – Kolorektales Karzinom

Schmiegel

Buchberger

Follmann³

et al. 2017

Z Gastroenterol

147

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“…UFT has now been clinically tested for lung cancer , breast cancer (Noguchi et al, 2005), and for gastric cancer (Kinoshita et al, 2005) in an adjuvant setting in Japan. Recently, UFT has also been tested in Western countries, regarding its efficacy for both advanced and curatively resected colon cancer (Carmichael et al, 2002;Douillard et al, 2002;Lembersky et al, 2006).…”

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confidence: 99%

An individual patient data meta-analysis of adjuvant therapy with uracil–tegafur (UFT) in patients with curatively resected rectal cancer

et al. 2007

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Uracil -Tegafur (UFT), an oral fluorinated pyrimidine chemotherapeutic agent, has been used for adjuvant chemotherapy in curatively resected colorectal cancer patients. Past trials and meta-analyses indicate that it is somewhat effective in extending survival of patients with rectal cancer. The objective of this study was to perform a reappraisal of randomised clinical trials conducted in this field. We designed an individual patient-based meta-analysis of relevant clinical trials to examine the benefit of UFT for curatively resected rectal cancer in terms of overall survival (OS), disease-free survival (DFS), and local relapse-free survival (LRFS). We analysed individual patient data of five adjuvant therapy randomised clinical trials for rectal cancer, which met the predetermined inclusion criteria. These five trials had a combined total of 2091 patients, UFT as adjuvant chemotherapy compared to surgery-alone, 5-year follow-up, intention-to-treat-based analytic strategy, and similar endpoints (OS and DFS). In a pooled analysis, UFT had significant advantage over surgery-alone in terms of both OS (hazard ratio, 0.82; 95% confidence interval (CI), 0.70 -0.97; P ¼ 0.02) and DFS (hazard ratio, 0.73; 95%CI, 0.63 -0.84; Po0.0001). This individual patient-based meta-analysis demonstrated that oral UFT significantly improves both OS and DFS in patients with curatively resected rectal cancer.

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“…However 5-FU concentrations in the normal mucosa were approximately onethird of those measured in tumour tissue. Three phase III studies have been conducted to compare the efficacy and toxicity of UFT and bolus 5-FU, both modulated by leucovorin (LV) (Carmichael et al, 2002;Douillard et al, 2002;Lembersky et al, 2006). The results documented that they are equivalent in efficacy and that UFT/LV has a more favourable toxicity profile, with less neutropenia, diarrhoea, nausea, vomiting and mucositis.…”

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confidence: 99%

Uracil/ftorafur/leucovorin combined with irinotecan (TEGAFIRI) or oxaliplatin (TEGAFOX) as first-line treatment for metastatic colorectal cancer patients: results of randomised phase II study

et al. 2007

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This randomised phase II study evaluates the safety and efficacy profile of uracil/tegafur/leucovorin combined with irinotecan (TEGAFIRI) or with oxaliplatin (TEGAFOX). One hundred and forty-three patients with measurable, non-resectable metastatic colorectal cancer were randomised in a multicentre study to receive TEGAFIRI (UFT 250 mg m À2 day days 1 -14, LV 90 mg day days 1 -14, irinotecan 240 mg m À2 day 1; q21) or TEGAFOX (UFT 250 mg m À2 day days 1 -14, LV 90 mg day days 1 -14, oxaliplatin 120 mg m À2 day 1; q21). Among 143 randomised patients, 141 were analysed (68 received TEGAFIRI and 73 TEGAFOX). The main characteristics of the two arms were well balanced. The most common grade 3 -4 treatment-related adverse events were neutropenia (13% of cases with TEGAFIRI; 1% in the TEGAFOX group). Diarrhoea was prevalent in the TEGAFIRI arm (16%) vs TEGAFOX (4%). Six complete remission (CR) and 19 partial remission (PR) were recorded in the TEGAFIRI arm (odds ratio (OR): 41.7; 95% confidence limit (CL), 29.1 -55.1%), and six CR and 22 PR were recorded in the TEGAFOX group, (OR: 38.9; 95% CL, 27.6 -51.1). At a median time follow-up of 17 months (intequartile (IQ) range 12 -23), a median survival probability of 20 and 19 months was obtained in the TEGAFIRI and TEGAFOX groups, respectively. Median time to progression was 8 months for both groups. TEGAFIRI and TEGAFOX are both effective and tolerable first-line therapies in MCRC patients. The employment of UFT/LV given in doublet combination is interesting and the presented data appear comparable to equivalent infusion regimens described in the literature. The safety profile of the two combinations also allows an evaluation with other biological agents such as monoclonal antibodies.

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Oral Uracil and Tegafur Plus Leucovorin Compared With Intravenous Fluorouracil and Leucovorin in Stage II and III Carcinoma of the Colon: Results From National Surgical Adjuvant Breast and Bowel Project Protocol C-06

Abstract: UFT+LV achieved similar DFS and OS when compared with an intravenous, weekly, bolus FU+LV regimen. The two regimens were equitoxic and generally well tolerated.

Cited by 285 publications

References 12 publications

S3-Leitlinie – Kolorektales Karzinom

S3-Leitlinie – Kolorektales Karzinom

An individual patient data meta-analysis of adjuvant therapy with uracil–tegafur (UFT) in patients with curatively resected rectal cancer

Uracil/ftorafur/leucovorin combined with irinotecan (TEGAFIRI) or oxaliplatin (TEGAFOX) as first-line treatment for metastatic colorectal cancer patients: results of randomised phase II study

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