Evidence map›Paper›PMID 37143108›Full record

Trial reportJournal of experimental & clinical cancer research : CR2023

Precision medicine applied to metastatic colorectal cancer using tumor-derived organoids and in-vitro sensitivity testing: a phase 2, single-center, open-label, and non-comparative study.

Lars Henrik Jensen, Silvia Regina Rogatto, Jan Lindebjerg, Birgitte Havelund, Cecilie Abildgaard, Luisa Matos do Canto, Chris Vagn-Hansen, Claus Dam, Søren Rafaelsen, Torben Frøstrup Hansen

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase II
In one paragraph

Trial report in Journal of experimental & clinical cancer research : CR, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03251612 (Predictive Value of In-vitro Testing Anti-cancer Therapy Sensitivity on Tumorspheres From Patients With Metastatic Colorectal Cancer), which is not on this map. Cited by 43 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
43citing papers in PubMed, 1 pooled it
14.0field-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.

NCT03251612 phase2completednot on this map

Predictive Value of In-vitro Testing Anti-cancer Therapy Sensitivity on Tumorspheres From Patients With Metastatic Colorectal Cancer

TypeinterventionalSponsorVejle HospitalRan2017 to 2022Enrolled90ConditionsColorectal Cancer MetastaticArmsBased on sensitivity analysis
3 · Its place in the literature

Who cites it

43 citing papers in PubMed, 1 synthesis or guideline pooled it, 59 citations in OpenAlex.

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  16. Patient-Derived Organoids Predict Treatment Response in Metastatic Colorectal Cancer.Clinical cancer research : an official journal of the American Association for Cancer Research · 2025
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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

10 authors at 3 institutions in 1 country.

Lars Henrik JensenDepartment of Oncology, University Hospital of Southern Denmark, Lillebaelt Hospital, Beriderbakken 4, Vejle, 7100, Denmark. lars.henrik.jensen@rsyd.dk.ORCID http://orcid.org/0000-0002-0020-1537
Silvia Regina RogattoDanish Colorectal Cancer Center South, University Hospital of Southern Denmark, Vejle, Denmark.
Jan LindebjergDanish Colorectal Cancer Center South, University Hospital of Southern Denmark, Vejle, Denmark.
Birgitte HavelundDepartment of Oncology, University Hospital of Southern Denmark, Lillebaelt Hospital, Beriderbakken 4, Vejle, 7100, Denmark.
Cecilie AbildgaardClinical Genetics Department, University Hospital of Southern Denmark, Lillebaelt Hospital, Vejle, Denmark.
Luisa Matos do CantoClinical Genetics Department, University Hospital of Southern Denmark, Lillebaelt Hospital, Vejle, Denmark.
Chris Vagn-HansenDepartment of Pathology, University Hospital of Southern Denmark, Lillebalt Hospital, Vejle, Denmark.
Claus DamDepartment of Pathology, University Hospital of Southern Denmark, Lillebalt Hospital, Vejle, Denmark.
Søren RafaelsenDanish Colorectal Cancer Center South, University Hospital of Southern Denmark, Vejle, Denmark.
Torben Frøstrup HansenDepartment of Oncology, University Hospital of Southern Denmark, Lillebaelt Hospital, Beriderbakken 4, Vejle, 7100, Denmark.
Lillebaelt Hospital · DKUniversity of Southern Denmark · DKRegion of Southern Denmark · DK

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPatients with colorectal metastatic disease have a poor prognosis, limited therapeutic options, and frequent development of resistance. Strategies based on tumor-derived organoids are a powerful tool to assess drug sensitivity at an individual level and to suggest new treatment options or re-challenge. Here, we evaluated the method's feasibility and clinical outcome as applied to patients with no satisfactory treatment options.

methodsIn this phase 2, single-center, open-label, non-comparative study (ClinicalTrials.gov, register NCT03251612), we enrolled 90 patients with metastatic colorectal cancer following progression on or after standard therapy. Participants were 18 years or older with an Eastern Cooperative Oncology Group performance status of 0-2, adequate organ function, and metastasis available for biopsy. Biopsies from the metastatic site were cultured using organoids model. Sensitivity testing was performed with a panel of drugs with proven activity in phase II or III trials. At the discretion of the investigator considering toxicity, the drug with the highest relative activity was offered. The primary endpoint was the proportion of patients alive without disease progression at two months per local assessment.

resultsBiopsies available from 82 to 90 patients were processed for cell culture, of which 44 successfully generated organoids with at least one treatment suggested. The precision cohort of 34 patients started treatment and the primary endpoint, progression-free survival (PFS) at two months was met in 17 patients (50%, 95% CI 32-68), exceeding the pre-defined level (14 of 45; 31%). The median PFS was 67 days (95% CI 51-108), and the median overall survival was 189 days (95% CI 103-277).

conclusionsPatient-derived organoids and in-vitro sensitivity testing were feasible in a cohort of metastatic colorectal cancer. The primary endpoint was met, as half of the patients were without progression at two months. Cancer patients may benefit from functional testing using tumor-derived organoids.

trial registrationClinicalTrials.gov, register NCT03251612.

Indexed as

Colonic NeoplasmsColorectal NeoplasmsAntineoplastic Combined Chemotherapy ProtocolsHumansPrecision MedicineDrug screeningHistorical controlled phase II trialMetastatic colorectal cancerTumor-derived organoids

Identifiers

PMID37143108
PMCPMC10161587
OpenAlexW4368341023

What OpenQuestion holds

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LicenceCC BY
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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.