Evidence map›Paper›PMID 24758527›Full record

Trial reportBMC research notes2014

FOLFIRI® and bevacizumab in first-line treatment for colorectal cancer patients: safety, efficacy and genetic polymorphisms.

Yves Bécouarn, Laurent Cany, Marina Pulido, Richard Beyssac, Patrick Texereau, Valérie Le Morvan, Dominique Béchade, René Brunet, Sofiane Aitouferoukh, Caroline Lalet and 3 more

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase II
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMC research notes, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00467142 (Phase II Study Evaluating the Efficacy and Tolerance to Chemotherapy With 5-fluorouracil, Folinic Acid, Irinotecan and Bevacizumab as First-line Treatment in Patients With Metastatic Colorectal Cancer), which is not on this map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
1.8field-weighted citation impact, top 14% 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.

NCT00467142 phase2completednot on this map

Phase II Study Evaluating the Efficacy and Tolerance to Chemotherapy With 5-fluorouracil, Folinic Acid, Irinotecan and Bevacizumab as First-line Treatment in Patients With Metastatic Colorectal Cancer

TypeinterventionalSponsorInstitut BergoniéRan2007 to 2011Enrolled62ConditionsColorectal CancerArmsbevacizumab, fluorouracil, irinotecan hydrochloride, leucovorin calcium, polymorphism analysis
3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 17 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Review
  4. Article
  5. Observational
  6. Targeting angiogenesis in gastrointestinal tumors: current challenges.Translational gastroenterology and hepatology · 2016
    Review
  7. Review
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 5 institutions in 1 country.

Yves BécouarnDepartment of Digestive Oncology, Institut Bergonié, Comprehensive Cancer Centre, 229 cours de l'Argonne, F-33000 Bordeaux, France. y.becouarn@bordeaux.unicancer.fr.
Laurent Cany
Marina Pulido
Richard Beyssac
Patrick Texereau
Valérie Le Morvan
Dominique Béchade
René Brunet
Sofiane Aitouferoukh
Caroline Lalet
Simone Mathoulin-Pélissier
Marianne Fonck
Jacques Robert
Institut Bergonié · FRInfirmerie Protestante · FRInserm · FRPolyclinique de Franche Comté · FRUniversité de Bordeaux · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundOver 50% of colorectal cancer (CRC) patients develop metastases. The aim of this study was to evaluate efficacy and tolerance of first-line FOLFIRI® + bevacizumab (B) treatment for metastatic CRC, and to assess genetic polymorphisms as potential markers.

methodsAdult patients with histologically-proven, non-resectable metastatic CRC and ECOG ≤ 2 were included. 14-day cycles consisted of bevacizumab (5 mg/kg), irinotecan (180 mg/m2), bolus FU (400 mg/m2) and leucovorin (400 mg/m2), followed by 46-hour FU infusions (2400 mg/m2). Primary endpoint was response rate according to RECIST criteria. Secondary endpoints were overall (OS) and progression-free (PFS) survivals, response duration, and toxicity. Associations between clinical data, UGT1A1, thymidylate synthase, VEGFA polymorphisms and PFS, OS and toxicity were analyzed.

resultsSixty-two patients were enrolled (median age 68y). 59/62 patients were eligible and evaluable for response at 6 months: 28 showed partial response (47.5%; 95% CI; 34.3-60.9), 20 stable disease (33.9%) and 11 progression (18.6%). Grade 3/4 toxicities were as follows: neutropenia 16.1%; diarrhea 11.3%; nausea-vomiting 1.6%. Median response duration was 9.5 months (range 2.7-20); median PFS 10.3 months (range 8.8-11.7); and median OS 25.7 months (range 20.2-29.7). 11/59 initially unresectable patients were resectable after treatment. VEGFA polymorphism (rs25648) was associated with better OS (HR: 3.61; 95% CI: 1.57-8.30).

conclusionsFOLFIRI® + bevacizumab is active with good response rate, long median OS, and a good safety profile. A VEGFA polymorphism might have a prognostic value in this malignancy.

trial registrationClinicaltrials.gov: NCT00467142 (registration date: April 25, 2007).

Indexed as

Polymorphism, GeneticAdultAgedAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsBevacizumabCamptothecinColorectal NeoplasmsDemographyDisease-Free SurvivalFemaleFluorouracilGenotyping TechniquesHumansLeucovorinMaleAntibodies, Monoclonal, HumanizedBevacizumabCamptothecinFluorouracilLeucovorin

Identifiers

PMID24758527
PMCPMC4022139
OpenAlexW2060716477

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.