Efficacy of oral UFT as adjuvant chemotherapy to curative resection of colorectal cancer: multicenter prospective randomized trial

Kato, Tomoyuki; Ohashi, Yasuo; Nakazato, Hiroaki; Koike, Akihiko; Saji, Shigetoyo; Suzuki, Hayato; Takagi, Hiroshi; Nimura, Yuji; Hasumi, Akitake; Baba, Shigeaki; Manabe, Tadao; Maruta, M.; Miura, Kaoru; Yamaguchi, Akihiro

doi:10.1007/s00423-002-0278-x

Cited by 60 publications

(53 citation statements)

References 17 publications

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“…These results may be attributed to a higher dosage of UFT, rigorous surgical procedures and high quality of the clinical trial. The dosage of UFT per day of 600 mg in this study was greater than the 300-400 mg used in previous UFT studies (Kodaira et al, 1998;Sakamoto et al, 1999;Kato et al, 2002;Meta-Analysis Group, 2004). In this study, TME with lateral pelvic lymphadenectomy was chosen as the control treatment.…”

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confidence: 67%

“…The local recurrence rate in this extended TME was estimated to be lower than simple TME (Akasu and Moriya, 1997;Mori et al, 1998). Although individual RCTs comparing oral fluoropyrimidines with surgery alone showed improvement in both DFS and local recurrence in rectal cancer, but not in OS (Kodaira et al, 1998;Kato et al, 2002), meta-analyses of RCTs related to fluoropyrimidines in the 1980s showed significant benefits in both DFS and OS (Sakamoto et al, 1999;Meta-Analysis Group, 2004). In contrast, there has been no evaluation on DFS and OS in other therapies including 5-FU/leucovorin (LV) and radiation, in Japan.…”

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confidence: 92%

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Cost-effectiveness of adjuvant chemotherapy with uracil–tegafur for curatively resected stage III rectal cancer

Hisashige¹,

Yoshida

Kodaira

2008

Br J Cancer

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Recently, the National Surgical Adjuvant Study of Colorectal Cancer in Japan, a randomised controlled trial of oral uracil -tegafur (UFT) adjuvant therapy for stage III rectal cancer, showed remarkable survival gains, compared with surgery alone. To evaluate value for money of adjuvant UFT therapy, cost-effective analysis was carried out. Cost-effectiveness analysis of adjuvant UFT therapy was carried out from a payer's perspective, compared with surgery alone. Overall survival and relapse-free survival were estimated by Kaplan -Meier method, up to 5.6 years from randomisation. Costs were estimated from trial data during observation. Qualityadjusted life-years (QALYs) were calculated using utility score from literature. Beyond observation period, they were simulated by the Boag model combined with the competing risk model. For 5.6-year observation, 10-year follow-up and over lifetime, adjuvant UFT therapy gained 0.50, 0.96 and 2.28 QALYs, and reduced costs by $2457, $1771 and $1843 per person compared with surgery alone, respectively (3% discount rate for both effect and costs). Cost-effectiveness acceptability and net monetary benefit analyses showed the robustness of these results. Economic evaluation of adjuvant UFT therapy showed that this therapy is cost saving and can be considered as a cost-effective treatment universally accepted for wide use in Japan.

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confidence: 67%

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confidence: 92%

Cost-effectiveness of adjuvant chemotherapy with uracil–tegafur for curatively resected stage III rectal cancer

Hisashige¹,

Yoshida

Kodaira

2008

Br J Cancer

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“…Five relevant trials identified as Japanese Foundation for Multidisciplinary Treatment of Cancer (JFMC) 7-1 (Kodaira et al, 1998), JFMC15-1, JFMC15-2 , Tokai Adjuvant Chemotherapy Study Group for Colorectal Cancer (TAC-CR) (Kato et al, 2002), and National Surgical Adjuvant Study of Colorectal Cancer (NSAS-CC) (Akasu et al, 2006) were included in the metaanalysis involving a total of 2091 patients. In trials JFMC7-1, JFMC15-1, and JFMC 15-2, patients who were randomly assigned to the experimental group received intravenous mitomycin C (6 mg m À2 ) at 1 week and once monthly for 6 months.…”

Section: Selection Of Trialsmentioning

confidence: 99%

“…Patients enrolled in these trials had been followed up for 5 -7 years. Toxicity data were not collected, because detailed analysis of side effects can be found in the published reports of the individual trials (Kodaira et al, 1998;Kato et al, 2002;Watanabe et al, 2004;Akasu et al, 2006). All investigators and the Clinical Trial Committee of all the trials agreed to join in the meta-analysis.…”

Section: Protocol and Data Collection For The Meta-analysismentioning

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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“…Although intravenous administration of anticancer drugs is generally avoided in patients with stage II-Dukes' B colorectal cancer in Japan as in Western countries (Laurie, Moertel, et al, 1989;Moertel, Fleming, et al, 1990), administration of oral Study Group of Japan, 1995;Sakamoto, Hamada, et al, 2001;Muto, Koyama et al, 2002;Kato, Ohashi et al, 2002). Among the various oral fluoropyrimidine preparations, Orzel (UFT+LV Taiho Pharmaceutical Co., Ltd., Tokyo, Japan) has already been approved and is widely marketed in Europe (Mukai, Moriya, et al, 2001;Douillard, Hoff, et al, 2002;Carmichael, Popiela, et al, 2002).…”

Section: Introductionmentioning

confidence: 99%

Efficacy of Postoperative Adjuvant Oral Immunochemotherapy in Patients With Dukes' B Colorectal Cancer

Mukai

Tajima

Nakasaki

et al. 2003

ACRT

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Among 370 patients who underwent radical resection of primary colorectal cancer over a 17-year period, 167 had stage II-Dukes' B cancer. After excluding 10 patients treated with intravenous drugs other than 5-FU or hepatic arterial injection and 11 patients with rare histological types other than typical differentiated adenocarcinoma, the remaining 146 patients were used to assess the utility of Japanese-style oral postoperative adjuvant immunochemotherapy. Ninety-one patients who received oral chemotherapy with/without immunotherapy as postoperative adjuvant therapy had a 5-year survival rate of 89.1%, while the rate was 66.5% for patients without such therapy (non-chemotherapy; n=55, p=0.0015). When the 91 patients were divided into those treated with chemotherapy plus immunotherapy (immunochemotherapy; n=61) and those treated with chemotherapy alone (chemotherapy-only; n=30), the 5-year survival rates of the immunochemotherapy, chemotherapy-only, and non-chemotherapy groups were 92.2%, 83.5%, and 66.5%, respectively (immunochemotherapy vs. non-chemotherapy, p=0.0022). When 30 patients were selected from each of the 3 groups and compared by the propensity score matching method, a significant difference was found between the immunochemotherapy and chemotherapy-only groups (p=0.0364), as well as between the immunochemotherapy and non-chemotherapy groups (p=0.0055). These results suggest that Japanese-style oral immunochemotherapy is useful as postoperative adjuvant therapy in patients with stage II-Dukes' B colorectal cancer.

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Efficacy of oral UFT as adjuvant chemotherapy to curative resection of colorectal cancer: multicenter prospective randomized trial

Abstract: It is suggested that the consecutive administration of UFT at 400 mg/day was an effective and highly safe therapeutic method as postoperative adjuvant chemotherapy for rectal cancer.

Cited by 60 publications

References 17 publications

Cost-effectiveness of adjuvant chemotherapy with uracil–tegafur for curatively resected stage III rectal cancer

Cost-effectiveness of adjuvant chemotherapy with uracil–tegafur for curatively resected stage III rectal cancer

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

Efficacy of Postoperative Adjuvant Oral Immunochemotherapy in Patients With Dukes' B Colorectal Cancer

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