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    Poster Networking

    Venous Thromboembolism

    Poster Networking Session

    PB0980 - TINzaparin PROphylaxis in Patients with Metastatic COLorectal Cancer (PROTINCOL)

    Monday, June 26, 2023
    18:30 – 19:30 ET
    Room: Exhibition

      Presenting Author(s)

    • Andrés J. Muñoz Martín, MD PhD (he/him/his)

      Associate Professor
      Medical Oncology Service, Hospital General Universitario Gregorio Marañón, Universidad Complutense, Madrid, Spain.
      Madrid, Madrid, Spain

      • Co-Author(s)

    • Jd

      Juan de la Cámara Gómez

      Clinical Oncologist
      Medical Oncology Service. Complejo Hospitalario Universitario de A Coruña (CHUAC)
      A Coruña, Galicia, Spain

    • SC

      Sonia Candamio Folgar

      Clinical Oncologist
      Hospital Clínico Universitario de Santiago CHUS
      Santiago de Compostela, Galicia, Spain

    • MC

      Marta Covela

      Medical Oncologist
      Medical Oncology Service. Hospital Universitario Lucus Augusti
      Lugo, Galicia, Spain

    • MR

      Manuel Ramos Vazquez

      Medical Oncologist
      Centro Oncológico de Galicia
      A Coruña, Galicia, Spain

    • MC

      Marinha Costa Rivas

      Medical Oncologist
      Hospital Ribera Povisa
      Vigo (Pontevedra), Galicia, Spain

    • FP

      Francisco José Pelegrín Mateo

      Medical Oncologist
      Medical Oncology Service. Hospital de la Santa Creu i Sant Pau
      Barcelona, Catalonia, Spain

    • VP

      Vicente Palomar Abril

      Medical Oncologist
      Hospital Verge dels Lliris
      Alcoi (Alicante), Comunidad Valenciana, Spain

    • AC

      Antía Cousillas Castiñeiras

      Medical Oncologist
      Medical Oncology Service. Complejo Hospitalario Universitario de Pontevedra
      Pontevedra, Galicia, Spain

    • MG

      Mónica Guillot Morales

      Medical Oncologist
      Medical Oncology Service. Hospital Universitari Son Espases
      Palma de Mallorca, Islas Baleares, Spain

    • RQ

      Rosa Querol Niñerola

      Medical Oncologist
      Medical Oncology Service. Hospital Universitari Parc Taulí
      Sabadell (Barcelona), Catalonia, Spain

    • MP

      María Luz Pellón Augusto

      Medical Oncologist
      Medical Oncology Service. Complejo Hospitalario Universitario de Ferrol
      Ferrol (Coruña), Galicia, Spain

    • MP

      Montserrat Pàmpols Felip

      Medical Oncologist
      Hospital Universitario Arnau de Vilanova
      Lleida, Catalonia, Spain

    • EC

      Eva Coma Salvans

      Unidad de Atención Continuada Oncológica
      ICO L'Hospitalet
      L'Hospitalet de Llobregat, Catalonia, Spain

    • MG

      María García Ferron

      Medical Oncologist
      Hospital Infanta Cristina
      Parla (Madrid), Madrid, Spain

    • IG

      Ignacio García Escobar

      Medical Oncologist
      Hospital General Universitario de Toledo
      Toledo, Castilla-La Mancha, Spain

    • RM

      Raquel Molina

      Medical Oncologist
      Hospital Universitario Príncipe de Asturias de Alcalá de Henares
      Alcalá de Henares (Madrid), Madrid, Spain

    • EC

      Esteve Colomé

      Medical Manager
      LEO Pharma
      Barcelona, Catalonia, Spain

    • JS

      José Manuel Soria

      Head of Genomics of Complex Diseases Unit, PhD
      Genomics of Complex Diseases Unit, Biomedical Research Institute Sant Pau (IIB-Sant Pau), Barcelona, Spain
      Barcelona, Catalonia, Spain

    • MS

      Mercedes Salgado

      Medical Oncologist
      Medical Oncology Service, Complejo Hospitalario Universitario de Ourense, Ourense, Spain
      Ourense, Galicia, Spain

    Background: Colorectal cancer (CRC) is the third most commonly diagnosed cancer worldwide. CRC leads to increased activation of the clotting system and the propensity to develop venous thromboembolism (VTE) may be partially heritable. Over 50% of the variation in VTE susceptibility is thought to be explained by genetic determinants. The incidence of VTE in patients with CRC has been reported to be approximately 10%, especially in patients with advanced disease.

    Aims: Evaluate low molecular weight heparin (LMWH) versus observation for primary thromboprophylaxis in metastatic CRC outpatients who are receiving first line therapy.

    Methods: PROTINCOL (NCT05625932) is a randomized, open-label, multicenter study (figure 1). Patients will receive tinzaparin (75 IU/kg) or no treatment and they will be stratified based on: BRAF/RAS mutation, primary resection tumour and antiangiogenic therapy. The study outcomes will be assessed by a blind central independent adjudication committee.

    The primary efficacy endpoints will be the cumulative incidence of any VTE event (symptomatic or incidental) including symptomatic central venous catheter VTE.
    Secondary variables: clinically relevant bleedings as well as health-related quality of life and risk assessment of VTE based on a validated clinical-genetic model.
    Our hypothesis is that prophylactic LMWH will reduce 55% relative risk from an estimated VTE incidence of 13.5%. A total of 526 patients will be required. This study has received the independent ethics committee approval.

    Results: They are expected by the end of 2024.

    Conclusion(s): We selected a LMWH instead of a direct oral anticoagulant because CRC patients represent a high risk group for bleeding. For the first time in ambulatory prophylaxis of cancer-associated thrombosis, a precision medicine approach will be used in a randomized clinical trial. If the individualization of antithrombotic prophylaxis can reduce the complications of outpatient cancer treatment and be cost effective, it would be of great value in the future care of patients with metastatic CRC.