Trial reportAnnals of surgery2005
Increase of survival benefit in advanced resectable colon cancer by extent of adjuvant treatment: results of a randomized trial comparing modulation of 5-FU + levamisole with folinic acid or with interferon-alpha.
Trial report in Annals of surgery, 2005. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers, 1 of them a synthesis that pooled it.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
17 citing papers in PubMed, 1 synthesis or guideline pooled it, 43 citations in OpenAlex.
- Colorectal cancer treatment.BMJ clinical evidence · 2010Pooled it
- Microsatellite instability and Beta2-Microglobulin mutations as prognostic markers in colon cancer: results of the FOGT-4 trial.British journal of cancer · 2012Trial
- Adjuvant chemoradiotherapy of advanced resectable rectal cancer: results of a randomised trial comparing modulation of 5-fluorouracil with folinic acid or with interferon-α.British journal of cancer · 2010Trial
- Continuous sensing of IFNα by hepatic endothelial cells shapes a vascular antimetastatic barrier.eLife · 2022Article
- Patient-centered developments in colon- and rectal cancer with a multidisciplinary international team: From translational research to national guidelines.World journal of gastrointestinal surgery · 2021Review
- Introduction of complete mesocolic excision with central vascular ligation as standardized surgical treatment for colon cancer in Greece. Results of a pilot study and bi-institutional cooperation.Archives of medical science : AMS · 2019Article
- Adjuvant Chemotherapy of Locally Advanced Colon Cancer: Final Results of a Randomized Trial Comparing 5-Fluorouracil and Folinic Acid with Folfiri.Visceral medicine · 2019Article
- Are Colon and Rectal Cancer Two Different Tumor Entities? A Proposal to Abandon the Term Colorectal Cancer.International journal of molecular sciences · 2018Review
- Complete Mesocolic Excision With Central Vascular Ligation in Comparison With Conventional Surgery for Patients With Colon Cancer - The Experiences at Two Centers.Annals of coloproctology · 2018Article
- IFNα gene/cell therapy curbs colorectal cancer colonization of the liver by acting on the hepatic microenvironment.EMBO molecular medicine · 2016Article
- Proteins of the VEGFR and EGFR pathway as predictive markers for adjuvant treatment in patients with stage II/III colorectal cancer: results of the FOGT-4 trial.Journal of experimental & clinical cancer research : CR · 2014Article
- Lymph node metastasis of carcinomas of transverse colon including flexures. Consideration of the extramesocolic lymph node stations.International journal of colorectal disease · 2014Article
- Interferon-α enhances 5'-deoxy-5-fluorouridine-induced apoptosis by ERK-dependant upregulation of thymidine phosphorylase.BioMed research international · 2013Article
- Levamisole usage as an adjuvant to hepatitis B vaccine in hemodialysis patients, yes or no?Nephro-urology monthly · 2013Article
- Dimerumic acid inhibits SW620 cell invasion by attenuating H₂O₂-mediated MMP-7 expression via JNK/C-Jun and ERK/C-Fos activation in an AP-1-dependent manner.International journal of biological sciences · 2011Article
- The role of superoxide anions in the development of distant tumour recurrence.British journal of cancer · 2006Article
- Colon cancer: survival after curative surgery.Langenbeck's archives of surgery · 2005Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThe benefit of adjuvant therapy in curatively resected lymph node-positive colon cancer was established using 5-fluorouracil (5-FU) and levamisole (LEV) for 12 months. 5-FU cytotoxicity can be modulated by folinic acid (FA) or interferon-alpha (INF-alpha). The aim of this study was to investigate the efficacy of modulating 5-FU+ LEV by either FA or IFN-alpha in the adjuvant treatment of high-risk colon cancer.
methodsPatients with curatively resected colon cancer (stages UICC IIb and III) were stratified according to T, N, and participating center and randomized to receive a 12-month treatment using 5-FU + LEV alone or in combination with FA or IFN-alpha.
resultsA total of 855 of 904 entered patients (94.6%) were eligible. The median follow-up of all eligible patients was 4.6 years. Addition of FA to 5-FU + LEV improved recurrence-free and overall survival in comparison with 5-FU + LEV alone (P = 0.007 and P = 0.004, respectively, 1-sided). The 5-year overall survival rates were 60.5% (95% confidence interval, 54.3-66.7) and 72.0% (95% confidence interval, 66.5-77.5) for 5-FU + LEV and 5-FU + LEV + FA, respectively. Addition of INF-alpha showed a tendency to improve recurrence-free survival, however, without altering overall survival. Toxicities (WHO III + IV) were generally tolerable except one toxic death in the control arm and were observed in 9.9% of the patients receiving 5-FU + LEV alone and in 13.3% and in 30.7% of patients receiving additional FA and IFN-alpha, respectively.
conclusionsAddition of IFN-alpha was associated with increased toxicity without markedly influencing the outcome and should therefore not be recommended for adjuvant treatment. Addition of FA increased the 5-year recurrence-free and overall survival rate by 9.3 and 11.5 percentage points, respectively. 5-FU + LEV + FA for 12 months may be an effective adjuvant treatment option for locally advanced high-risk colon cancer.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.