Controlled trial of fluorouracil and low-dose leucovorin given for 6 months as postoperative adjuvant therapy for colon cancer.

O’Connell, Michael J.; Mailliard, James A.; Kahn, Michael; Macdonald, John S.; Haller, Daniel G.; Mayer, Robert J.; Wieand, Harry S.

doi:10.1200/jco.1997.15.1.246

Cited by 535 publications

(230 citation statements)

References 11 publications

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“…Unfortunately, steady-state plasma 5FU levels do not correlate with toxicity (Jodrell et al, 2001) and hence pharmacokinetic monitoring is not used to identify patients who are at increased risk of toxicity (Tebbutt et al, 2000). In randomised controlled trials, dose reductions are common after the first two cycles and 15 -30% of patients fail to complete chemotherapy (Wolmark et al, 1993;O'Connell et al, 1997;Poplin et al, 2005). The relationship between systemic exposure and treatment efficacy has not been demonstrated, however, and can only be ascertained by conducting prospective randomised studies that compare a targeted dose adjustment to a fixed dose (Milano et al, 1994).…”

Section: Discussionmentioning

confidence: 99%

Failure to complete adjuvant chemotherapy is associated with adverse survival in stage III colon cancer patients

et al. 2007

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Two recent North American studies have shown that completion of 5-fluorouracil (5FU)-based adjuvant chemotherapy is a major prognostic factor for the survival of elderly stage III colon cancer patients. The aim of the present study was to confirm this finding in a population-based series from Australia. The study cohort comprised 851 stage III colon cancer patients treated by surgery alone and 461 who initiated the Mayo chemotherapy regime. One-third of patients who initiated chemotherapy failed to complete more than three cycles of treatment. Independent predictors for failure to complete were treatment in district or rural hospitals, low socioeconomic index and treatment by a low-volume surgeon. Patients who failed to complete chemotherapy showed worse cancer-specific survival compared not only to those who completed treatment (HR ¼ 2.24; 95% confidence interval (CI) (1.66 -3.03), Po0.001) but also to those treated by surgery alone (HR ¼ 1.37; 95% CI (1.09 -1.72), P ¼ 0.008). The current and previous studies demonstrate the importance of completing adjuvant 5-FU-based chemotherapy for colon cancer. Further prospective studies are required to identify better the physiological and socioeconomic factors responsible for failure to complete chemotherapy so that appropriate improvements in health service delivery can be made.

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Section: Discussionmentioning

confidence: 99%

Failure to complete adjuvant chemotherapy is associated with adverse survival in stage III colon cancer patients

et al. 2007

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“…In einer Studie, in denen Patienten mit Stadium-II-Tumoren und Hochrisikocharakteristika eine kleine Untergruppe darstellten, konnte kein Benefit einer adjuvanten Chemotherapie gegenüber der alleinigen operativen Therapie gezeigt werden [879]. Im Gegensatz dazu stellten in der MOSAIC-Studie Patienten mit Stadium-II-Tumoren mit einem T4-Tumor, einer Tumorperforation, einem Ileus, einem schlecht differenzierten Tumor, einer Blutgefäßinvasion und/oder weniger als 10 untersuchten Lymphknoten eine Hochrisikopopulation dar, bei der die postoperative adjuvante FOLFOX4-Chemotherapie im Vergleich zu einer 5FU/FS-Chemotherapie zu einer nicht signifikanten Verbesserung des 10-Jahre-krankheitsfreien-Überlebens um 3,7 % Prozentpunkte führte.…”

Section: Level Of Evidence 1aunclassified

S3-Leitlinie – Kolorektales Karzinom

Schmiegel

Buchberger

Follmann³

et al. 2017

Z Gastroenterol

151

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“…from the results of numerous large-scale randomised trials and from the pooled analysis of clinical trials (Wolmark et al, 1993; International Multicentre Pooled Analysis of Colon Cancer Trials (IMPACT) investigators, 1995;O'Connell et al, 1997). In 2004, results from the Multicenter International Study of Oxaliplatin/5-FU/Leucovorin in the Adjuvant Treatment of Colon Cancer (MOSAIC) trial demonstrated that combination chemotherapy with 5-FU/LV (de Gramont regimen) plus oxaliplatin was significantly superior to 5-FU/LV alone (André et al, 2004).…”

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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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Controlled trial of fluorouracil and low-dose leucovorin given for 6 months as postoperative adjuvant therapy for colon cancer.

Cited by 535 publications

References 11 publications

Failure to complete adjuvant chemotherapy is associated with adverse survival in stage III colon cancer patients

Failure to complete adjuvant chemotherapy is associated with adverse survival in stage III colon cancer patients

S3-Leitlinie – Kolorektales Karzinom

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

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