TremelImumab and Durvalumab Combination for the Non-OperatIve Management (NOM) of Microsatellite InstabiliTY (MSI)-High Resectable Gastric or Gastroesophageal Junction Cancer: The Multicentre, Single-Arm, Multi-Cohort, Phase II INFINITY Study

  • Alessandra Raimondi
    Department of Medical Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori, 20133 Milano, Italy
  • Federica Palermo
    Department of Medical Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori, 20133 Milano, Italy
  • Michele Prisciandaro
    Department of Medical Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori, 20133 Milano, Italy
  • Massimo Aglietta
    Medical Oncology Unit, Candiolo Cancer Institute—FPO, IRCCS, 10060 Candiolo, Italy
  • Lorenzo Antonuzzo
    Clinical Oncology Unit, Careggi University Hospital, 50139 Florence, Italy
  • Giuseppe Aprile
    Department of Clinical Oncology, Azienda ULSS 8 Berica-Ospedale di Vicenza, 36100 Vinceza, Italy
  • Rossana Berardi
    Department of Clinical Oncology, Università Politecnica delle Marche—AOU Ospedali Riuniti di Ancona, 60126 Ancona, Italy
  • Giovanni G. Cardellino
    Department of Oncology, Presidio Ospedaliero “Santa Maria della Misericordia”—ASUFC, 33100 Udine, Italy
  • Giovanni De Manzoni
    Department of Surgery, Azienda Ospedaliero Universitaria Integrata di Verona—Borgo Trento, 37126 Verona, Italy
  • Ferdinando De Vita
    Medical Oncology Unit, Azienda Ospedaliero Universitaria dell’Università degli Studi della Campania “Luigi Vanvitelli”, 80131 Naples, Italy
  • Massimo Di Maio
    Department of Oncology, Ospedale Mauriziano Umberto I, 10128 Turin, Italy
  • Lorenzo Fornaro
    Medical Oncology 2, Azienda Ospedaliero Universitaria Pisana, 56126 Pisa, Italy
  • Giovanni L. Frassineti
    Department of Medical Oncology, Istituto Romagnolo per lo Studio dei Tumori “Dino Amadori”(IRST)-IRCCS, 47014 Meldola, Italy
  • Cristina Granetto
    Medical Oncology, Azienda Ospedaliera S. Croce e Carle, 12100 Cuneo, Italy
  • Francesco Iachetta
    Department of Medical Oncology, Azienda Unità Sanitaria Locale—IRCCS di Reggio Emilia, 42122 Reggio Emilia, Italy
  • Sara Lonardi
    Department of Clinical and Experimental Oncology, IRCCS Istituto Oncologico Veneto, 35128 Padua, Italy
  • Roberto Murialdo
    Medical Oncology, Ospedale Policlinico San Martino, 16132 Genoa, Italy
  • Elena Ongaro
    Department of Medical Oncology, Centro di Riferimento Oncologico di Aviano (CRO), IRCCS, 33081 Aviano, Italy
  • Francesca Pucci
    Medical Oncology Unit, Azienda Ospedaliero Universitaria di Parma, 43126 Parma, Italy
  • Margherita Ratti
    Oncology Department, Azienda Socio-Sanitaria Territoriale di Cremona, 26100 Cremona, Italy
  • Nicola Silvestris
    Department of Molecular Medicine, Faculty of Advanced Medical Sciences, Tabriz University of Medical Sciences, 15731 Tabriz, Iran
  • Valeria Smiroldo
    Humanitas Cancer Center, Humanitas Clinical and Research Center, Rozzano, 20089 Milan, Italy
  • Andrea Spallanzani
    Medical Oncology Unit, Azienda Ospedaliero Universitaria di Modena, 41125 Modena, Italy
  • Antonia Strippoli
    Medical Oncology Unit, Policlinico Universitario A. Gemelli, 00168 Rome, Italy
  • Stefano Tamberi
    Medical Oncology, Azienda USL Della Romagna, 48018 Faenza, Italy
  • Emiliano Tamburini
    Medical Oncology Unit, Azienda Ospedaliera Cardinale G. Panico, 73039 Tricase, Italy
  • Alberto Zaniboni
    Department of Medical Oncology, Fondazione Poliambulanza, 25124 Brescia, Italy
  • Maria Di Bartolomeo
    Department of Medical Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori, 20133 Milano, Italy
  • Chiara Cremolini
    Department of Translational Research and New Technologies in Medicine and Surgery, University of Pisa, 56126 Pisa, Italy
  • Carlo Sposito
    Gastrointestinal Surgery and Liver Transplantation Unit, Fondazione IRCCS Istituto Nazionale dei Tumori, 20133 Milan, Italy
  • Vincenzo Mazzaferro
    Gastrointestinal Surgery and Liver Transplantation Unit, Fondazione IRCCS Istituto Nazionale dei Tumori, 20133 Milan, Italy
  • Filippo Pietrantonio
    Department of Medical Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori, 20133 Milano, Italy

説明

<jats:p>In resectable gastric or gastroesophageal junction cancer (GC/GEJC), the powerful positive prognostic effect and the potential predictive value for a lack of benefit from the combination of adjuvant/peri-operative chemotherapy for the MSI-high status was demonstrated. Given the high sensitivity of MSI-high tumors for immunotherapy, exploratory trials showed that combination immunotherapy induces a high rate of complete pathological response (pCR), potentially achieving cancer cure without surgery. INFINITY is an ongoing phase II, multicentre, single-arm, multi-cohort trial investigating the activity and safety of tremelimumab and durvalumab as neoadjuvant (Cohort 1) or potentially definitive (Cohort 2) treatment for MSI-high/dMMR/EBV-negative, resectable GC/GEJC. About 310 patients will be pre-screened, to enroll a total of 31 patients, 18 and 13 in Cohort 1 and 2, at 25 Italian Centres. The primary endpoint of Cohort 1 is rate of pCR (ypT0N0) and negative ctDNA after neoadjuvant immunotherapy, of Cohort 2 is 2-year complete response rate, defined as absence of macroscopic or microscopic residual disease (locally/regionally/distantly) at radiological examinations, tissue and liquid biopsy, during non-operative management without salvage gastrectomy. The ongoing INFINITY proof-of-concept study may provide evidence on immunotherapy and the potential omission of surgery in localized/locally advanced GC/GEJC patients selected for dMMR/MSI-high status eligible for radical resection.</jats:p>

収録刊行物

  • Cancers

    Cancers 13 (11), 2839-, 2021-06-07

    MDPI AG

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