Evidence map›Paper›PMID 27016222›Full record

Trial reportGynecologic oncology2016

Use of comprehensive genomic profiling to direct point-of-care management of patients with gynecologic cancers.

Lorna Rodriguez-Rodriguez, Kim M Hirshfield, Veronica Rojas, Robert S DiPaola, Darlene Gibbon, Mira Hellmann, Sara Isani, Aliza Leiser, Gregory M Riedlinger, Allison Wagreich and 4 more

Abstract readClinical Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Gynecologic oncology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed, 2 pooled it
–field-weighted citation impact
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

18 citing papers in PubMed, 2 syntheses or guidelines pooled it.

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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

14 authors.

Lorna Rodriguez-RodriguezRutgers Cancer Institute of New Jersey, 195 Little Albany Street, New Brunswick, NJ 08903, USA. Electronic address: rodriglo@cinj.rutgers.edu.
Kim M HirshfieldRutgers Cancer Institute of New Jersey, 195 Little Albany Street, New Brunswick, NJ 08903, USA.
Veronica RojasRutgers Robert Wood Johnson Medical School, Rutgers University, 671 Hoes Lane, Piscataway, NJ 08854, USA.
Robert S DiPaolaRutgers Cancer Institute of New Jersey, 195 Little Albany Street, New Brunswick, NJ 08903, USA.
Darlene GibbonRutgers Cancer Institute of New Jersey, 195 Little Albany Street, New Brunswick, NJ 08903, USA.
Mira HellmannHackensack University Medical Center, John Theurer Cancer Center, 92 2nd Street, Hackensack, NJ, 07601, USA.
Sara IsaniRutgers Cancer Institute of New Jersey, 195 Little Albany Street, New Brunswick, NJ 08903, USA.
Aliza LeiserRutgers Cancer Institute of New Jersey, 195 Little Albany Street, New Brunswick, NJ 08903, USA.
Gregory M RiedlingerRutgers Cancer Institute of New Jersey, 195 Little Albany Street, New Brunswick, NJ 08903, USA.
Allison WagreichMorristown Medical Center, Atlantic Health System, 100 Madison Avenue, Morristown, NJ 07960, USA.
Siraj M AliFoundation Medicine, Inc., 150 Second Street, Cambridge, MA 02141, USA.
Julia A ElvinFoundation Medicine, Inc., 150 Second Street, Cambridge, MA 02141, USA.
Vincent A MillerFoundation Medicine, Inc., 150 Second Street, Cambridge, MA 02141, USA.
Shridar GanesanRutgers Cancer Institute of New Jersey, 195 Little Albany Street, New Brunswick, NJ 08903, USA. Electronic address: ganesash@cinj.rutgers.edu.

Funding

TRANSCRIPTIONAL PROFILINGP30CA072720 · NCI · UNIV OF MED/DENT NJ-R W JOHNSON MED SCH · PI Adam C Berger · 1997 to 2026
$94.5M
NCI NIH HHS P30 CA072720
6 · The paper itself

Abstract

objectiveTo determine the feasibility and clinical utility of using comprehensive genomic profiling (CGP) in the course of clinical care to identify clinically relevant tumor genomic alterations for patients with either rare or refractory gynecologic cancers to facilitate point-of-care management. Use of an expert, multidisciplinary, institutional molecular tumor board (MTB) assessment is discussed regarding input on putative targeted options for individualized therapy.

methodsA prospective clinical trial is ongoing. We report on the initial 69 patients with gynecologic cancers that were either rare or refractory to standard therapy. CGP was performed by Foundation Medicine, Inc. Genomic alterations were reviewed by members of an MTB. Consensus recommendations on genomically targeted, FDA-approved, on- and off-label therapies and clinical trials were sent to the treating physician, and decisions and outcomes were assessed.

resultsStudy outcomes were available for 64 patients. The mean number of genes altered per tumor was 4.97 (median=4; range, 1-26), and the average turnaround time from testing laboratory report to generation of formal recommendations was approximately three weeks. Evaluation of genomic and clinical data by the MTB led to generation of targeted treatment options in all 64 patients, and the percentage of patients for whom one or more of these recommendations were implemented by the treating physician was 39%. Sixty-four percent of the patients receiving targeted therapy based on a CGP result experienced radiologic response or showed evidence of clinical benefit or stable disease.

conclusionThese data suggest that an institutional MTB is a feasible venue for reviewing tumor genomic profiling results and generating clinical recommendations. These data also support the need for further studies and guidelines on clinical decision making with greater availability of broad genomically based diagnostics.

Indexed as

GenomicsPoint-of-Care SystemsAdultAgedAged, 80 and overFemaleGenital Neoplasms, FemaleHigh-Throughput Nucleotide SequencingHumansMiddle AgedMolecular Targeted TherapyProspective StudiesYoung AdultGenomic profilingGynecologic cancerMolecular tumor boardNext-generation sequencingPoint-of-carePrecision medicine

Identifiers

PMID27016222
PMCPMC5796528

What OpenQuestion holds

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Registered trials

None linked

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.