Evidence map›Paper›PMID 37845764›Full record

ArticleJournal of translational medicine2023

The Molecular Tumor Board of the Regina Elena National Cancer Institute: from accrual to treatment in real-world.

Patrizio Giacomini, Fabio Valenti, Matteo Allegretti, Matteo Pallocca, Francesca De Nicola, Ludovica Ciuffreda, Maurizio Fanciulli, Stefano Scalera, Simonetta Buglioni, Elisa Melucci and 23 more

Open access · goldAbstract read
In one paragraph

Article in Journal of translational medicine, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 1 pooled it
10.0field-weighted citation impact, top 2% 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

7 citing papers in PubMed, 1 synthesis or guideline pooled it, 14 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Observational
  4. Article
  5. Article
  6. Article
  7. Article
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

33 authors at 4 institutions in 2 countries.

Patrizio GiacominiClinical Trial Center, Biostatistics and Bioinformatics, IRCCS-Regina Elena National Cancer Institute, 00144, Rome, Italy. patrizio.giacomini@ifo.it.ORCID http://orcid.org/0000-0001-6109-1709
Fabio ValentiUOC Translational Oncology Research, IRCCS-Regina Elena National Cancer Institute, 00144, Rome, Italy.
Matteo AllegrettiUOC Translational Oncology Research, IRCCS-Regina Elena National Cancer Institute, 00144, Rome, Italy.
Matteo PalloccaClinical Trial Center, Biostatistics and Bioinformatics, IRCCS-Regina Elena National Cancer Institute, 00144, Rome, Italy.
Francesca De NicolaSAFU, Department of Research, Advanced Diagnostics, and Technological Innovation, IRCCS-Regina Elena National Cancer Institute, 00144, Rome, Italy.
Ludovica CiuffredaSAFU, Department of Research, Advanced Diagnostics, and Technological Innovation, IRCCS-Regina Elena National Cancer Institute, 00144, Rome, Italy.
Maurizio FanciulliSAFU, Department of Research, Advanced Diagnostics, and Technological Innovation, IRCCS-Regina Elena National Cancer Institute, 00144, Rome, Italy.
Stefano ScaleraClinical Trial Center, Biostatistics and Bioinformatics, IRCCS-Regina Elena National Cancer Institute, 00144, Rome, Italy.
Simonetta BuglioniDepartment of Pathology, IRCCS-Regina Elena National Cancer Institute, 00144, Rome, Italy.
Elisa MelucciDepartment of Pathology, IRCCS-Regina Elena National Cancer Institute, 00144, Rome, Italy.
Beatrice CasiniDepartment of Pathology, IRCCS-Regina Elena National Cancer Institute, 00144, Rome, Italy.
Mariantonia CarosiDepartment of Pathology, IRCCS-Regina Elena National Cancer Institute, 00144, Rome, Italy.
Edoardo PescarmonaDepartment of Pathology, IRCCS-Regina Elena National Cancer Institute, 00144, Rome, Italy.
Elena GiordaniUOC Translational Oncology Research, IRCCS-Regina Elena National Cancer Institute, 00144, Rome, Italy.
Francesca SperatiClinical Trial Center, Biostatistics and Bioinformatics, San Gallicano Dermatological Institute IRCCS, 00144, Rome, Italy.
Nicoletta JannittiPharmacy Unit, Medical Direction, IRCCS-Regina Elena National Cancer Institute and San Gallicano Institute, 00144, Rome, Italy.
Martina BettiClinical Trial Center, Biostatistics and Bioinformatics, IRCCS-Regina Elena National Cancer Institute, 00144, Rome, Italy.
Marcello Maugeri-SaccàClinical Trial Center, Biostatistics and Bioinformatics, IRCCS-Regina Elena National Cancer Institute, 00144, Rome, Italy.
Fabiana Letizia CecereMedical Oncology 2, IRCCS-Regina Elena National Cancer Institute, 00144, Rome, Italy.
Veronica VillaniNeuro-Oncology Unit, IRCCS-Regina Elena National Cancer Institute, 00144, Rome, Italy.
Andrea PaceNeuro-Oncology Unit, IRCCS-Regina Elena National Cancer Institute, 00144, Rome, Italy.
Marialuisa AppetecchiaOncological Endocrinology Unit, IRCCS-Regina Elena National Cancer Institute, 00144, Rome, Italy.
Patrizia ViciPhase IV Studies, IRCCS-Regina Elena National Cancer Institute, 00144, Rome, Italy.
Antonella SavareseMedical Oncology 1, IRCCS-Regina Elena National Cancer Institute, 00144, Rome, Italy.
Eriseld KrasniqiPhase IV Studies, IRCCS-Regina Elena National Cancer Institute, 00144, Rome, Italy.
Virginia FerraresiSarcomas and Rare Tumors Departmental Unit, IRCCS-Regina Elena National Cancer Institute, 00144, Rome, Italy.
Michelangelo RussilloSarcomas and Rare Tumors Departmental Unit, IRCCS-Regina Elena National Cancer Institute, 00144, Rome, Italy.
Alessandra FabiPrecision Medicine Unit in Senology, Fondazione Policlinico Universitario A. Gemelli IRCCS, 00168, Rome, Italy.
Lorenza LandiClinical Trial Center: Phase 1 and Precision Medicine, IRCCS-Regina Elena National Cancer Institute, 00144, Rome, Italy.
Gabriele MinutiClinical Trial Center: Phase 1 and Precision Medicine, IRCCS-Regina Elena National Cancer Institute, 00144, Rome, Italy.
Federico CappuzzoMedical Oncology 2, IRCCS-Regina Elena National Cancer Institute, 00144, Rome, Italy.
Massimo ZeuliClinical Trial Center, Biostatistics and Bioinformatics, IRCCS-Regina Elena National Cancer Institute, 00144, Rome, Italy.
Gennaro CilibertoScientific Direction, IRCCS-Regina Elena National Cancer Institute, 00144, Rome, Italy.
Istituti di Ricovero e Cura a Carattere Scientifico · ITSan Gallicano Hospital · ITAgostino Gemelli University Polyclinic · ITNational Cancer Institute · MY

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundMolecular Tumor Boards (MTB) operating in real-world have generated limited consensus on good practices for accrual, actionable alteration mapping, and outcome metrics. These topics are addressed herein in 124 MTB patients, all real-world accrued at progression, and lacking approved therapy options.

methodsActionable genomic alterations identified by tumor DNA (tDNA) and circulating tumor DNA (ctDNA) profiling were mapped by customized OncoKB criteria to reflect diagnostic/therapeutic indications as approved in Europe. Alterations were considered non-SoC when mapped at either OncoKB level 3, regardless of tDNA/ctDNA origin, or at OncoKB levels 1/2, provided they were undetectable in matched tDNA, and had not been exploited in previous therapy lines.

resultsAltogether, actionable alterations were detected in 54/124 (43.5%) MTB patients, but only in 39 cases (31%) were these alterations (25 from tDNA, 14 from ctDNA) actionable/unexploited, e.g. they had not resulted in the assignment of pre-MTB treatments. Interestingly, actionable and actionable/unexploited alterations both decreased (37.5% and 22.7% respectively) in a subset of 88 MTB patients profiled by tDNA-only, but increased considerably (77.7% and 66.7%) in 18 distinct patients undergoing combined tDNA/ctDNA testing, approaching the potential treatment opportunities (76.9%) in 147 treatment-naïve patients undergoing routine tDNA profiling for the first time. Non-SoC therapy was MTB-recommended to all 39 patients with actionable/unexploited alterations, but only 22 (56%) accessed the applicable drug, mainly due to clinical deterioration, lengthy drug-gathering procedures, and geographical distance from recruiting clinical trials. Partial response and stable disease were recorded in 8 and 7 of 19 evaluable patients, respectively. The time to progression (TTP) ratio (MTB-recommended treatment vs last pre-MTB treatment) exceeded the conventional Von Hoff 1.3 cut-off in 9/19 cases, high absolute TTP and Von Hoff values coinciding in 3 cases. Retrospectively, 8 patients receiving post-MTB treatment(s) as per physician's choice were noted to have a much longer overall survival from MTB accrual than 11 patients who had received no further treatment (35.09 vs 6.67 months, p = 0.006).

conclusionsMTB-recommended/non-SoC treatments are effective, including those assigned by ctDNA-only alterations. However, real-world MTBs may inadvertently recruit patients electively susceptible to diverse and/or multiple treatments.

Indexed as

NeoplasmsBiomarkers, TumorDNA, NeoplasmHigh-Throughput Nucleotide SequencingHumansMutationNational Cancer Institute (U.S.)Retrospective StudiesUnited StatesBiomarkers, TumorDNA, NeoplasmAccess to treatmentCirculating tumor DNA (ctDNA)Digital PCR (dPCR)Molecular tumor boardNext generation sequencing (NGS)Off-labelTarget therapyTumor DNA (tDNA)

Identifiers

PMID37845764
PMCPMC10577953
OpenAlexW4387672046

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