The PEGASUS trial: Post-surgical liquid biopsy-guided treatment of stage III and high-risk stage II colon cancer patients.

  • Sara Lonardi
    Veneto Institute of Oncology (IOV)-IRCCS, Padua, Italy;
  • Clara Montagut
    University Hospital del Mar-IMIM, CIBERONC, Barcelona, Spain;
  • Filippo Pietrantonio
    IRCCS National Cancer Institute (INT), University of Milano, Milan, Italy;
  • Elena Elez
    Medical Oncology Department, Vall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology (VHIO), Barcelona, Spain;
  • Andrea Sartore-Bianchi
    Niguarda Cancer Center, ASST Grande Ospedale Metropolitano Niguarda, University of Milano, Milan, Italy;
  • Noelia Tarazona
    Biomedical Research Institute INCLIVA, University of Valencia, Valencia, Spain;
  • Stefania Sciallero
    IRCCS Ospedale Policlinico San Martino, Genova, Italy;
  • M. Giulia Zampino
    European Institute of Oncology IRCCS, Milan, Italy;
  • Stefania Mosconi
    Cancer Center, ASST Papa Giovanni XXIII, Bergamo, Italy;
  • Susana Muñoz
    Vall d'Hebron Institute of Oncology (VHIO), Barcelona, Spain;
  • Luca Lazzari
    IFOM - the FIRC Institute of Molecular Oncology, Milan, Italy;
  • Paolo Luraghi
    IFOM - the FIRC Institute of Molecular Oncology, Milan, Italy;
  • Salvatore Siena
    Niguarda Cancer Center, ASST Grande Ospedale Metropolitano Niguarda, University of Milano, Milan, Italy;
  • Alberto F. Sobrero
    IRCCS Ospedale Policlinico San Martino, Genoa, Italy;
  • Roberto Labianca
    Cancer Center, ASST Papa Giovanni XXIII, Bergamo, Italy;
  • Valter Torri
    Mario Negri Institute for Pharmacological Research-IRCCS, Milan, Italy;
  • Alberto Bardelli
    Candiolo Cancer Institute-IRCCS, University of Torino, Torino, Italy;
  • Josep Tabernero
    Vall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology (VHIO), Barcelona, Spain;
  • Silvia Marsoni
    IFOM - the FIRC Institute of Molecular Oncology, Milan, Italy;

抄録

<jats:p> TPS4124 </jats:p><jats:p> Background: Moving stage III Colon Cancer (CC) into the precision medicine space is a priority in view of the lack of molecular markers driving adjuvant treatment. Retrospective studies have demonstrated the tremendous prognostic impact of circulating tumor DNA (ctDNA) analysis after curative intent surgery, and suggested that lack of conversion of ctDNA from detectable to undetectable after adjuvant chemotherapy reflects treatment failure. With these premises, we have designed the PEGASUS trial (NCT04259944). Methods: PEGASUS is a prospective multicentric study designed to prove the feasibility of using liquid biopsy (LB) to guide the post-surgical and post-adjuvant clinical management in 140 microsatellite stable Stage-III and T4N0 Stage-II CC patients. The LUNAR1 test (Guardant Health, Redwood City, CA, USA) will be used for ctDNA determination. For the efficacy analysis, the PEGASUS cohort will be compared with a 3:1 matched cohort of 420 patients from the TOSCA trial (NCT00646607). A LB executed 2-4 weeks post-surgery will guide a “Molecular Adjuvant” treatment: i) ctDNA+ patients will receive CAPOX for 3 months and ii) ctDNA- patients will receive capecitabine (CAPE) for 6 months but will be retested after 1 cycle, and if found ctDNA+ will be switched to CAPOX treatment. At the end of the “Molecular Adjuvant” treatment a further LB will be performed and instruct subsequent treatment. Positive patients (ctDNA+/+ and ctDNA-/+) will receive an up-scaled “Molecular Metastatic” systemic treatment for 6 months or until radiological progression or toxicity: i) ctDNA+/+ patients will be treated with FOLFIRI; ii) ctDNA-/+ patients with CAPOX. These patients will be subjected to a LB after 3 months and at the end of treatment: in case of positivity will be switched to FOLFIRI. ctDNA+/- patientswill receive a de-escalated treatment with CAPE for 3 months. 3 LB will be performed within 3 months and in case of positivity the patient will be switched to FOLFIRI. Patients with ctDNA-/- will be subjected to an interventional follow-up comprising 2 further LB and in case of positivity they will be switched to CAPOX treatment. PEGASUS is piggybacked to AlfaOmega (NCT04120935), a Master Observational Protocol that will follow patients from diagnosis to 5 years or recurrence/death (whichever comes first), collecting clinical data, radio-images and biological samples. AlfaOmega provides a clinical and logistic ecosystem for the seamless integration of PEGASUS clinical results with the biological underpinning of colon cancer. Clinical trial information: NCT04259944 . </jats:p>

収録刊行物

  • Journal of Clinical Oncology

    Journal of Clinical Oncology 38 (15_suppl), TPS4124-TPS4124, 2020-05-20

    American Society of Clinical Oncology (ASCO)

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