Evidence map›Paper›PMID 34200267›Full record

ArticleCancers2021

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, Federica Palermo, Michele Prisciandaro, Massimo Aglietta, Lorenzo Antonuzzo, Giuseppe Aprile, Rossana Berardi, Giovanni G Cardellino, Giovanni De Manzoni, Ferdinando De Vita and 22 more

Open access · goldAbstract read
In one paragraph

Article in Cancers, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 31 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
31citing papers in PubMed, 1 pooled it
6.5field-weighted citation impact, top 3% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

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.

2 · The registry

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.

3 · Its place in the literature

Who cites it

31 citing papers in PubMed, 1 synthesis or guideline pooled it, 51 citations in OpenAlex.

  1. Pooled it
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  19. Observational
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

32 authors at 20 institutions in 2 countries.

Alessandra RaimondiDepartment of Medical Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori, 20133 Milano, Italy.
Federica PalermoDepartment of Medical Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori, 20133 Milano, Italy.
Michele PrisciandaroDepartment of Medical Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori, 20133 Milano, Italy.ORCID 0000-0001-5596-469X
Massimo AgliettaMedical Oncology Unit, Candiolo Cancer Institute-FPO, IRCCS, 10060 Candiolo, Italy.
Lorenzo AntonuzzoClinical Oncology Unit, Careggi University Hospital, 50139 Florence, Italy.
Giuseppe AprileDepartment of Clinical Oncology, Azienda ULSS 8 Berica-Ospedale di Vicenza, 36100 Vinceza, Italy.
Rossana BerardiDepartment of Clinical Oncology, Università Politecnica delle Marche-AOU Ospedali Riuniti di Ancona, 60126 Ancona, Italy.ORCID 0000-0002-9529-2960
Giovanni G CardellinoDepartment of Oncology, Presidio Ospedaliero "Santa Maria della Misericordia"-ASUFC, 33100 Udine, Italy.
Giovanni De ManzoniDepartment of Surgery, Azienda Ospedaliero Universitaria Integrata di Verona-Borgo Trento, 37126 Verona, Italy.
Ferdinando De VitaMedical Oncology Unit, Azienda Ospedaliero Universitaria dell'Università degli Studi della Campania "Luigi Vanvitelli", 80131 Naples, Italy.
Massimo Di MaioDepartment of Oncology, Ospedale Mauriziano Umberto I, 10128 Turin, Italy.ORCID 0000-0001-8906-3785
Lorenzo FornaroMedical Oncology 2, Azienda Ospedaliero Universitaria Pisana, 56126 Pisa, Italy.
Giovanni L FrassinetiDepartment of Medical Oncology, Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori"(IRST)-IRCCS, 47014 Meldola, Italy.
Cristina GranettoMedical Oncology, Azienda Ospedaliera S. Croce e Carle, 12100 Cuneo, Italy.
Francesco IachettaDepartment of Medical Oncology, Azienda Unità Sanitaria Locale-IRCCS di Reggio Emilia, 42122 Reggio Emilia, Italy.
Sara LonardiDepartment of Clinical and Experimental Oncology, IRCCS Istituto Oncologico Veneto, 35128 Padua, Italy.
Roberto MurialdoMedical Oncology, Ospedale Policlinico San Martino, 16132 Genoa, Italy.
Elena OngaroDepartment of Medical Oncology, Centro di Riferimento Oncologico di Aviano (CRO), IRCCS, 33081 Aviano, Italy.
Francesca PucciMedical Oncology Unit, Azienda Ospedaliero Universitaria di Parma, 43126 Parma, Italy.
Margherita RattiOncology Department, Azienda Socio-Sanitaria Territoriale di Cremona, 26100 Cremona, Italy.
Nicola SilvestrisDepartment of Molecular Medicine, Faculty of Advanced Medical Sciences, Tabriz University of Medical Sciences, 15731 Tabriz, Iran.ORCID 0000-0001-7814-7318
Valeria SmiroldoHumanitas Cancer Center, Humanitas Clinical and Research Center, Rozzano, 20089 Milan, Italy.
Andrea SpallanzaniMedical Oncology Unit, Azienda Ospedaliero Universitaria di Modena, 41125 Modena, Italy.ORCID 0000-0001-6955-7139
Antonia StrippoliMedical Oncology Unit, Policlinico Universitario A. Gemelli, 00168 Rome, Italy.
Stefano TamberiMedical Oncology, Azienda USL Della Romagna, 48018 Faenza, Italy.
Emiliano TamburiniMedical Oncology Unit, Azienda Ospedaliera Cardinale G. Panico, 73039 Tricase, Italy.
Alberto ZaniboniDepartment of Medical Oncology, Fondazione Poliambulanza, 25124 Brescia, Italy.
Maria Di BartolomeoDepartment of Medical Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori, 20133 Milano, Italy.
Chiara CremoliniDepartment of Translational Research and New Technologies in Medicine and Surgery, University of Pisa, 56126 Pisa, Italy.
Carlo SpositoGastrointestinal Surgery and Liver Transplantation Unit, Fondazione IRCCS Istituto Nazionale dei Tumori, 20133 Milan, Italy.
Vincenzo MazzaferroGastrointestinal Surgery and Liver Transplantation Unit, Fondazione IRCCS Istituto Nazionale dei Tumori, 20133 Milan, Italy.
Filippo PietrantonioDepartment of Medical Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori, 20133 Milano, Italy.ORCID 0000-0002-8530-8420
Fondazione IRCCS Istituto Nazionale dei Tumori · ITAgostino Gemelli University Polyclinic · ITA. O. Ordine Mauriziano di Torino · ITAzienda Ospedaliera Universitaria Integrata Verona · ITAzienda Ospedaliera Universitaria Pisana · ITAzienda Ospedaliera Universitaria Università degli Studi della Campania Luigi Vanvitelli · ITAzienda Ospedaliero-Universitaria Careggi · ITAzienda Ospedaliero-Universitaria di Modena · ITAzienda Sanitaria Ospedaliera S.Croce e Carle Cuneo · ITAzienda Sanitaria Unità Locale di Reggio Emilia · ITAzienda Unità Sanitaria Locale Della Romagna · ITCandiolo Cancer Institute · ITCentro di Riferimento Oncologico · ITFondazione Poliambulanza Istituto Ospedaliero · ITHumanitas University · ITIstituti Ospitalieri di Cremona · ITIstituto Oncologico Veneto · ITIstituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori · ITMarche Polytechnic University · ITOspedale di Parma · IT

Funding

AstraZeneca Academic study with support of AstraZeneca
6 · The paper itself

Abstract

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.

Indexed as

CTLA4gastric cancermicrosatellite instabilitynon-operative managementPD-L1pre-operative treatment

Identifiers

PMID34200267
PMCPMC8201030
OpenAlexW3171305553

What OpenQuestion holds

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Registered trials

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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.