Evidence map›Paper›PMID 22966018›Full record

ArticleClinical cancer research : an official journal of the American Association for Cancer Research2012

Personalized medicine in a phase I clinical trials program: the MD Anderson Cancer Center initiative.

Apostolia-Maria Tsimberidou, Nancy G Iskander, David S Hong, Jennifer J Wheler, Gerald S Falchook, Siqing Fu, Sarina Piha-Paul, Aung Naing, Filip Janku, Rajyalakshmi Luthra and 4 more

5 registry-linked trialsOpen access · bronzeAbstract read
In one paragraph

Article in Clinical cancer research : an official journal of the American Association for Cancer Research, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 5 registered trials, which are not on this map. Cited by 312 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
312citing papers in PubMed, 3 pooled it
18.8field-weighted citation impact, top 1% 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.

NCT02363647 naterminatednot on this mapstarted 2015, after this paper: background citation

Personalized Cancer Therapy for Patients With Metastatic Medullary Thyroid or Metastatic Colon Cancer

TypeinterventionalSponsorIcahn School of Medicine at Mount SinaiRan2015 to 2022Enrolled10ConditionsMedullary Thyroid Cancer, Colon CancerArmsTumor Genomic Analysis
NCT02628379 completednot on this mapstarted 2015, after this paper: background citation

A Prospective Observational Trial Evaluating Outcomes of FoundationOne - Directed Matched Targeted Therapy in Patients With Cancer of Unknown Primary (CUP)

TypeobservationalSponsorFoundation MedicineRan2015 to 2017Enrolled125ConditionsNeoplasms, Unknown Primary, CUP, Metastatic Disease, Poorly Differentiated Adenocarcinoma
NCT02758080 naunknown statusnot on this mapstarted 2016, after this paper: background citation

Pragmatic Clinical Trial of Matching Malignant Hematologic Cancer Patients With Adequate Early Phase Clinical Trials by Next-generation Sequencing

TypeinterventionalSponsorSeoul National University HospitalRan2016 to 2019Enrolled90ConditionsHematologic MalignanciesArmsMatching on the basis of molecular analysis, Matching on the basis of physician's choice
NCT05177666 unknown statusnot on this mapstarted 2021, after this paper: background citation

Patients With Advanced Refractory Solid Tumors Who Failed Standard Treatments and Matched Individualized Treatment Based on Tumor Molecular Characteristics: a Prospective Registration Study

TypeobservationalSponsorThe University of Hong Kong-Shenzhen HospitalRan2021 to 2024Enrolled120ConditionsFeasibility, Effectiveness, Safety, Targeted Molecular TherapyArmsTargeted therapy
NCT05767528 unknown statusnot on this mapstarted 2022, after this paper: background citation

Clinical Study of Neoadjuvant Therapy Outcome Prediction of Muscle-invasive Bladder Cancer Based on PTC Drug Sensitivity Detection

TypeobservationalSponsorChinese PLA General HospitalRan2022 to 2024Enrolled40ConditionsMuscle-Invasive Bladder CarcinomaArmsPatient-derived tumor-like cell clusters (PTC) drug sensitivity testing
3 · Its place in the literature

Who cites it

312 citing papers in PubMed, 3 syntheses or guidelines pooled it, 537 citations in OpenAlex.

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252 more citing papers are in PubMed but not listed here.

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 at 1 institution in 1 country.

Apostolia-Maria TsimberidouDepartment of Investigational Cancer Therapeutics, Phase I Clinical Trials Program, The University of Texas MD Anderson Cancer Center, Houston, Texas 77030, USA. atsimber@mdanderson.org
Nancy G Iskander
David S Hong
Jennifer J Wheler
Gerald S Falchook
Siqing Fu
Sarina Piha-Paul
Aung Naing
Filip Janku
Rajyalakshmi Luthra
Yang Ye
Sijin Wen
Donald Berry
Razelle Kurzrock
The University of Texas MD Anderson Cancer Center · US

Funding

Tumor Evolution and Metastasis ProgramP30CA016672 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI Scott Kopetz · 1985 to 2026
$290.8M
U OF TEXAS HLTH SCI CTR HOUSTON CENTER FOR CLINICAL AND TRANSLATIONAL SCIENCESUL1RR024148 · NCRR · UNIVERSITY OF TEXAS HLTH SCI CTR HOUSTON · PI MCPHERSON, DAVID D · 2006 to 2010
$27.9M
NCRR NIH HHS 3UL1RR024148-04SINCRR NIH HHS 5UL1RR024148-04NCRR NIH HHS UL1 RR024148
6 · The paper itself

Abstract

purposeWe initiated a personalized medicine program in the context of early clinical trials, using targeted agents matched with tumor molecular aberrations. Herein, we report our observations. PATIENT AND

methodsPatients with advanced cancer were treated in the Clinical Center for Targeted Therapy. Molecular analysis was conducted in the MD Anderson Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory. Patients whose tumors had an aberration were treated with matched targeted therapy, when available. Treatment assignment was not randomized. The clinical outcomes of patients with molecular aberrations treated with matched targeted therapy were compared with those of consecutive patients who were not treated with matched targeted therapy.

resultsOf 1,144 patients analyzed, 460 (40.2%) had 1 or more aberration. In patients with 1 molecular aberration, matched therapy (n = 175) compared with treatment without matching (n = 116) was associated with a higher overall response rate (27% vs. 5%; P < 0.0001), longer time-to-treatment failure (TTF; median, 5.2 vs. 2.2 months; P < 0.0001), and longer survival (median, 13.4 vs. 9.0 months; P = 0.017). Matched targeted therapy was associated with longer TTF compared with their prior systemic therapy in patients with 1 mutation (5.2 vs. 3.1 months, respectively; P < 0.0001). In multivariate analysis in patients with 1 molecular aberration, matched therapy was an independent factor predicting response (P = 0.001) and TTF (P = 0.0001).

conclusionKeeping in mind that the study was not randomized and patients had diverse tumor types and a median of 5 prior therapies, our results suggest that identifying specific molecular abnormalities and choosing therapy based on these abnormalities is relevant in phase I clinical trials.

Indexed as

Precision MedicineAntineoplastic AgentsCancer Care FacilitiesClinical Trials, Phase I as TopicFemaleGenes, NeoplasmHumansKaplan-Meier EstimateLiver NeoplasmsMaleMiddle AgedMolecular Targeted TherapyMultivariate AnalysisMutationNeoplasmsProportional Hazards ModelsAntineoplastic Agents

Identifiers

PMID22966018
PMCPMC4454458
OpenAlexW2161375781

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

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.