Evidence map›Paper›PMID 22016477›Full record

Trial reportThe oncologist2011

Cetuximab plus FOLFIRINOX (ERBIRINOX) as first-line treatment for unresectable metastatic colorectal cancer: a phase II trial.

Eric Assenat, Francoise Desseigne, Simon Thezenas, Frédéric Viret, Laurent Mineur, Andrew Kramar, Emmanuelle Samalin, Fabienne Portales, Frédéric Bibeau, Evelyne Crapez-Lopez and 2 more

2 registry-linked trialsAbstract readClinical Trial, Phase IIMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The oncologist, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 48 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
48citing papers in PubMed, 4 pooled it
–field-weighted citation impact
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.

NCT00556413 phase2completednot on this map

Phase II Study Evaluating the Efficacy and Safety of cétuximab Associated With the Protocol FOLFIRINOX (LV5FU Simplified Combined With Irinotecan and Oxaliplatin) in the First Line Treatment in Patients With Metastatic Colorectal Cancer Expressing EGFR or Not

TypeinterventionalSponsorInstitut du Cancer de Montpellier - Val d'AurelleRan2005 to 2011Enrolled42ConditionsColorectal CancerArmscetuximab, fluorouracil, irinotecan hydrochloride, leucovorin calcium, oxaliplatin
NCT02648711 phase1terminatednot on this mapstarted 2015, after this paper: background citation

Evaluation of an Alternative Schedule for CRLX101 Alone in Combination With Bevacizumab and in Combination With mFOLFOX6 in Subjects With Advanced Solid Tumor Malignancies

TypeinterventionalSponsorNewLink Genetics CorporationRan2015 to 2018Enrolled41ConditionsSolid TumorsArmsCRLX101, Bevacizumab, mFOLFOX6
3 · Its place in the literature

Who cites it

48 citing papers in PubMed, 4 syntheses or guidelines pooled it.

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  20. All You Need to Know AboutJCO oncology practice · 2022
    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

12 authors.

Eric AssenatCAC Val d'Aurelle, Montpellier, France. E.assenat@gmail.com
Francoise Desseigne
Simon Thezenas
Frédéric Viret
Laurent Mineur
Andrew Kramar
Emmanuelle Samalin
Fabienne Portales
Frédéric Bibeau
Evelyne Crapez-Lopez
Jean Pierre Bleuse
Marc Ychou

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundTriplet chemotherapy has demonstrated manageable toxicities and a favorable response rate. The addition of cetuximab to chemotherapy can increase treatment efficacy. We evaluated the efficacy and safety of cetuximab plus 5-fluorouracil, leucovorin, irinotecan, and oxaliplatin (FOLFIRINOX), the ERBIRINOX regimen, as first-line treatment in patients with unresectable metastatic colorectal cancer (mCRC). PATIENTS AND

methodsIn a phase II study, treatment consisted of weekly cetuximab plus biweekly. Treatment was continued for a maximum of 12 cycles and tumor response was evaluated every four cycles. The primary efficacy criterion was the complete response (CR) rate.

resultsFrom April 2006 to April 2008, 42 patients were enrolled. The median age was 60 years (range, 32-76 years). The median duration of treatment was 5.2 months (range, 0.7-8.5 months), and a median of nine cycles was given per patient (range, 1-12 cycles). Five patients (11.9%) showed a CR, with a median duration of 23.1 months (95% confidence interval [CI], 10.8-39.7 months). The objective response rate was 80.9% (95% CI, 65.9%-91.4%). The median overall and progression-free survival times were 24.7 months (95% CI, 22.6 months to not reached) and 9.5 months (95% CI, 7.6-10.4 months), respectively. The most frequent grade 3-4 adverse events were diarrhea (52%), neutropenia (38%), and asthenia (32%).

conclusionThe ERBIRINOX regimen appears to be effective and feasible in first-line treatment of mCRC patients. These promising results led us to initiate a multicenter, randomized, phase II trial ([Research Partnership for Digestive Oncology] PRODIGE 14) in patients with potentially resectable mCRC.

Indexed as

AdultAgedAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsCamptothecinCetuximabColorectal NeoplasmsDisease-Free SurvivalDisease ProgressionDrug Administration ScheduleFemaleFluorouracilHumansIrinotecanLeucovorinAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedCamptothecinCetuximabFluorouracilIrinotecanLeucovorinOrganoplatinum CompoundsOxaliplatin

Identifiers

PMID22016477
PMCPMC3233290

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.