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Ensayo controlado aleatorizado2014

Anticolorectal cancer activity of the omega-3 polyunsaturated fatty acid eicosapentaenoic acid

Cockbain AJ, Volpato M, Race AD, Munarini A, Fazio C, Belluzzi A, Loadman PM, Toogood GJ, Hull MA

Gut · 94 citas

Cómo se estudió

Diseño
Ensayo controlado aleatorizado (indexado por PubMed)
Estudiado en
Personas
Resultado principal
Eventos clínicos como enfermedad o muerte

Quién lo pagó

Financiación
Financiación independiente
Organización sin fines de lucro
Cancer Research UK
Gobierno
National Institute for Health and Care Research
Gobierno
Medical Research Council
Gobierno
National Institute for Health Research (NIHR)

Según 4 financiadores declarados.

Publicación

Publicado
2014-01-27 · Gut · vol. 63 · número 11 · págs. 1760–1768
Editorial
BMJ
Citado
113 citas · más que el 98% de estudios similares · 8.4× el promedio de su campo
Impacto
Entre el 10 % más citado de su campo
Referencias
33 trabajos
Acceso
De pago
Áreas de investigación
Fatty Acid Research and Health · Cancer, Lipids, and Metabolism · Colorectal Cancer Treatments and Studies
Palabras clave
eicosapentaenoic acid, omega-3 fatty acids, colorectal liver metastases, hepatectomy, antiangiogenic activity, tumor vascularity, Ki-67 proliferation index, overall survival, disease-free survival, tolerability
MeSH
humans, colorectal neoplasms, liver neoplasms, eicosapentaenoic acid, anticarcinogenic agents, chromatography, liquid, immunohistochemistry, double-blind method, adult, aged, aged, 80 and over, middle aged, female, male, tandem mass spectrometry, platelet endothelial cell adhesion molecule-1

9 autores

  • Andrew J. Cockbain🇬🇧Leeds Teaching Hospitals NHS Trust; St James's University Hospital
  • Milène Volpato🇬🇧St James's University Hospital
  • Amanda D. Race🇬🇧University of Bradford
  • Alessandra Munarini🇮🇹IRCCS Azienda Ospedliero-Universitaria di Bologna Policlinico di Sant'Orsola; University of Bologna
  • Chiara Fazio🇮🇹IRCCS Azienda Ospedliero-Universitaria di Bologna Policlinico di Sant'Orsola; University of Bologna
  • Andrea Belluzzi🇮🇹IRCCS Azienda Ospedliero-Universitaria di Bologna Policlinico di Sant'Orsola; University of Bologna
  • Paul M. Loadman🇬🇧University of Bradford
  • Giles J. Toogood🇬🇧Leeds Teaching Hospitals NHS Trust; St James's University Hospital
  • Mark A. Hull🇬🇧 · autor de correspondenciaSt James's University Hospital

Resumen

El texto original del estudio, en el idioma en que se publicó.

Background

Oral administration of the omega-3 fatty acid eicosapentaenoic acid (EPA), as the free fatty acid (FFA), leads to EPA incorporation into, and reduced growth of, experimental colorectal cancer liver metastases (CRCLM).

Design

We performed a Phase II double-blind, randomised, placebo-controlled trial of EPA-FFA 2 g daily in patients undergoing liver resection surgery for CRCLM. The patients took EPA-FFA (n=43) or placebo (n=45) prior to surgery. The primary end-point was the CRCLM Ki67 proliferation index (PI). Secondary end-points included safety and tolerability of EPA-FFA, tumour fatty acid content and CD31-positive vascularity. We also analysed overall survival (OS) and disease-free survival (DFS).

Results

The median (range) duration of EPA-FFA treatment was 30 (12-65) days. Treatment groups were well matched with no significant difference in disease burden at surgery or preoperative chemotherapy. EPA-FFA treatment was well tolerated with no excess of postoperative complications. Tumour tissue from EPA-FFA-treated patients demonstrated a 40% increase in EPA content (p=0.0008), no difference in Ki67 PI, but reduced vascularity in 'EPA-naïve' individuals (p=0.075). EPA-FFA also demonstrated antiangiogenic activity in vitro. In the first 18 months after CRCLM resection, EPA-FFA-treated individuals obtained OS benefit compared with placebo, although early CRC recurrence rates were similar.

Conclusions

EPA-FFA therapy is safe and well tolerated in patients with advanced CRC undergoing liver surgery. EPA-FFA may have antiangiogenic properties. Remarkably, limited preoperative treatment may provide postoperative OS benefit. Phase III clinical evaluation of prolonged EPA-FFA treatment in CRCLM patients is warranted.

Trial identifier

ClinicalTrials.gov NCT01070355.

Resumen vía Europe PMC. Los derechos de autor siguen siendo de los autores o la editorial.

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