Evidence map›Paper›PMID 31203498›Full record

Trial reportTargeted oncology2019

MINOAS: A Single-arm Translational Phase II Trial of FOLFIRI Plus Aflibercept as First-line Therapy in Unresectable, Metastatic Colorectal Cancer.

Alexios Matikas, John Souglakos, Panagiotis Katsaounis, Athanasios Kotsakis, Panagiotis Kouroupakis, Nikolaos Pantazopoulos, Nikolaos Kentepozidis, Adamantia Nikolaidi, Ippokratis Messaritakis, Ioanna Tzovara and 3 more

Registry-linked trialAbstract readClinical Trial, Phase IIMulticenter Study
PubMed Publisher
In one paragraph

Trial report in Targeted oncology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02624726 (A Open Label, Non Randomized, Phase Two Trial in Metastatic Colorectal Cancer), which is not on this map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
0.7field-weighted citation impact, top 27% 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.

NCT02624726 phase2unknown statusnot on this map

A Open Label, Non Randomized, Phase Two Trial in Metastatic Colorectal Cancer (mCRC) With the Combination of m FOLFIRI Plus Aflibercept as First Line Treatment: MINOAS Trial

TypeinterventionalSponsorHellenic Oncology Research GroupRan2016 to 2019Enrolled31ConditionsMetastatic Colorectal CancerArms5 Fluorouracil, Leucovorin, Irinotecan, Aflibercept
3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 14 citations in OpenAlex.

  1. Article
  2. Article
  3. Review
  4. Review
  5. Review
  6. 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

13 authors at 1 institution in 1 country.

Alexios MatikasHellenic Oncology Research Group (HORG), 55 Lombardou St, 11474, Athens, Greece.
John SouglakosHellenic Oncology Research Group (HORG), 55 Lombardou St, 11474, Athens, Greece.
Panagiotis KatsaounisHellenic Oncology Research Group (HORG), 55 Lombardou St, 11474, Athens, Greece.
Athanasios KotsakisHellenic Oncology Research Group (HORG), 55 Lombardou St, 11474, Athens, Greece.
Panagiotis KouroupakisHellenic Oncology Research Group (HORG), 55 Lombardou St, 11474, Athens, Greece.
Nikolaos PantazopoulosHellenic Oncology Research Group (HORG), 55 Lombardou St, 11474, Athens, Greece.
Nikolaos KentepozidisHellenic Oncology Research Group (HORG), 55 Lombardou St, 11474, Athens, Greece.
Adamantia NikolaidiHellenic Oncology Research Group (HORG), 55 Lombardou St, 11474, Athens, Greece.
Ippokratis MessaritakisHellenic Oncology Research Group (HORG), 55 Lombardou St, 11474, Athens, Greece.
Ioanna TzovaraHellenic Oncology Research Group (HORG), 55 Lombardou St, 11474, Athens, Greece.
Dora HatzidakiHellenic Oncology Research Group (HORG), 55 Lombardou St, 11474, Athens, Greece.
Efthymis PrinarakisHellenic Oncology Research Group (HORG), 55 Lombardou St, 11474, Athens, Greece.
Vassilis GeorgouliasHellenic Oncology Research Group (HORG), 55 Lombardou St, 11474, Athens, Greece. georgoul@uoc.gr.
Hellenic Oncology Research Group · GR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundFOLFIRI/aflibercept is approved as a second-line treatment in metastatic colorectal cancer (mCRC) but there are limited data for its use as a first-line treatment.

objectiveTo investigate the activity and safety of first-line FOLFIRI/aflibercept in mCRC, as well as to prospectively evaluate biomarkers of early response to treatment. PATIENTS AND

methodsMINOAS was a phase II trial that aimed to evaluate the activity and toxicity of first-line FOLFIRI/aflibercept in mCRC. The primary endpoint was objective response rate (ORR). The secondary endpoints were toxicity, progression-free survival (PFS), overall survival (OS), and the evaluation of CEACAM-positive circulating tumor cells (CTC) and diffusion-weighted (DW)-MRI as biomarkers.

resultsThirty-one patients were enrolled and 259 chemotherapy cycles were administered. At the time of the preplanned interim analysis, all patients had discontinued treatment and the ORR was 61.3%, crossing the activity threshold for trial discontinuation. Median PFS was 8.4 months (95% CI 7.8-9.0). Median OS had not been reached. There was one toxic death due to sepsis; grade 3/4 adverse events included neutropenia (n = 5), diarrhea (n = 6), hypertension (n = 4), asthenia (n = 3), proteinuria (n = 1), and bowel perforation (n = 1). Retaining CTC-negative status predicted better OS compared to continuous detection of CTCs (p = 0.015). Early decrease of the apparent diffusion coefficient (ADC) in DW-MRI was associated with an objective response.

conclusionThe activity and safety of first-line FOLFIRI/aflibercept merit further evaluation in randomized studies. CLINICALTRIALS. GOV REGISTRATION NUMBER: NCT02624726.

Indexed as

AdultAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsColorectal NeoplasmsFemaleFluorouracilFollow-Up StudiesHumansIrinotecanLeucovorinLiver NeoplasmsMaleMiddle AgedPrognosisReceptors, Vascular Endothelial Growth FactorafliberceptFluorouracilIrinotecanLeucovorinReceptors, Vascular Endothelial Growth FactorRecombinant Fusion Proteins

Identifiers

PMID31203498
OpenAlexW2950260434

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.