Evidence map›Paper›PMID 24608198›Full record

Trial reportAnnals of oncology : official journal of the European Society for Medical Oncology2014

Improved time to treatment failure with an intermittent oxaliplatin strategy: results of CONcePT.

H S Hochster, A Grothey, L Hart, K Rowland, R Ansari, S Alberts, N Chowhan, R K Ramanathan, M Keaton, J D Hainsworth and 1 more

Registry-linked trialOpen access · bronzeAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
In one paragraph

Trial report in Annals of oncology : official journal of the European Society for Medical Oncology, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04543019 (Age, Body Mass Index and Tumor Sidedness in Metastatic Colorectal Cancer Patients as Predictive Factors for Systemic Therapy Outcome), which is not on this map. Cited by 19 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed, 3 pooled it
3.7field-weighted citation impact, top 5% 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.

NCT04543019 unknown statusnot on this mapstarted 2020, after this paper: background citation

Age, Body Mass Index and Tumor Sidedness in Metastatic Colorectal Cancer Patients as Predictive Factors for Systemic Therapy Outcome

TypeobservationalSponsorAssiut UniversityRan2020 to 2022Enrolled50ConditionsColorectal Cancer Metastatic
3 · Its place in the literature

Who cites it

19 citing papers in PubMed, 3 syntheses or guidelines pooled it, 65 citations in OpenAlex.

  1. Pooled it
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  13. Maintenance treatment in metastatic colorectal cancer: in search of the best strategy.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2020
    Review
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  15. 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

11 authors at 8 institutions in 2 countries.

H S HochsterYale Cancer Center, Yale School of Medicine, New Haven.
A GrotheyDepartment of Medical Oncology, Mayo Clinic Rochester, Rochester.
L HartDrug Development Program, Florida Cancer Specialists, Ft. Myers.
K RowlandCancer center, Carle Cancer Center, Urbana.
R AnsariDepartment of Medical Oncology, Michiana Hematology Oncology, South Bend.
S AlbertsDivision of Medical Oncology, Mayo Clinic, Rochester.
N ChowhanDepartment of Medical Oncology, Floyd Memorial Cancer Center of Indiana, New Albany.
R K RamanathanClinical Trials Program, Scottsdale Healthcare Research Institute at The Virginia B. Piper Cancer Center, Scottsdale.
M KeatonDepartment of Hematology and Oncology, Augusta Oncology Associates, Augusta.
J D HainsworthDepartment of Oncology, Sarah Cannon Research Institute, Nashville.
B H ChildsDepartment of Oncology, Sanofi US, Bridgewater, USA howard.hochster@yale.edu.
Mayo Clinic · USBaptist Health Floyd · USCarle Foundation Hospital · USFlorida Cancer Specialists & Research Institute · USSanofi (United States) · USSarah Cannon Research Institute · GBScottsdale Research Institute (United States) · USYale Cancer Center · US

Funding

Women's Cancer ProgramP30CA015083 · NCI · MAYO CLINIC ROCHESTER · PI Keith L. Knutson · 1985 to 2026
$151.3M
Medical Research CouncilNCI NIH HHS P30 CA015083
6 · The paper itself

Abstract

backgroundOxaliplatin is an integral component of colorectal cancer treatment, but its use is limited by neurotoxicity. The Combined Oxaliplatin Neurotoxicity Prevention Trial (CONcePT) tested intermittent oxaliplatin (IO) administration and the use of concurrent calcium and magnesium salts (Ca/Mg), two modifications intended to reduce neurotoxicity and extend the duration of treatment. PATIENTS AND

methodsIn this trial involving double randomization, 140 patients were randomized to receive modified FOLFOX7 plus bevacizumab with IO (eight-cycle blocks of oxaliplatin treatment) versus continuous oxaliplatin (CO); and Ca/Mg versus placebo (pre- and postoxaliplatin infusion). The primary end point was time-to-treatment failure (TTF).

resultsOne hundred thirty-nine patients were entered and treated up to the point of early study termination due to concerns by the data-monitoring committee (DMC) that Ca/Mg adversely affected tumor response. Tumor response was not a study end point. Given DMC concerns, an additional independent, blinded radiology review of all images showed no adverse effect of treatment schedule or Ca/Mg on response by Response Evaluation Criteria In Solid Tumors. The IO schedule was superior to CO [hazard ratio (HR) = 0.581, P = 0.0026] for both TTF and time-to-tumor progression (TTP) (HR = 0.533, P = 0.047).

conclusionsAn IO dosing schedule had a significant benefit on both TTF and TTP versus CO dosing in this trial despite the very attenuated sample. There was no effect of Ca/Mg on response.

Indexed as

AdultAgedAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsBevacizumabCalcium GluconateColorectal NeoplasmsDouble-Blind MethodFemaleFluorouracilHumansKaplan-Meier EstimateLeucovorinMagnesium SulfateMaleMiddle AgedAntibodies, Monoclonal, HumanizedBevacizumabCalcium GluconateFluorouracilLeucovorinMagnesium SulfateOrganoplatinum CompoundsOxaliplatinbevacizumabcalcium and magnesium saltscolorectal cancerdrug-induced neurotoxicityFOLFOXintermittent

Identifiers

PMID24608198
PMCPMC4207881
OpenAlexW2124952847

What OpenQuestion holds

Textmetadata
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.