Evidence map›Paper›PMID 27843597›Full record

ArticleESMO open2016

Quality of life during first-line FOLFOX4±panitumumab in

Salvatore Siena, Josep Tabernero, Gyorgy Bodoky, David Cunningham, Fernando Rivera, Paul Ruff, Jean Luc Canon, Reija Koukakis, Gaston Demonty, Guy Hechmati and 1 more

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in ESMO open, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00364013 (A Randomized, Multicenter, Phase 3 Study to Compare the Efficacy of Panitumumab in Combination With Oxaliplatin/ 5-fluorouracil/ Leucovorin to the Efficacy of Oxaliplatin/ 5-fluorouracil/ Leucovorin Alone in Patients With Previously Untreated Metastatic Colorectal Cancer), which is not on this map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed
1.4field-weighted citation impact, top 17% 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.

NCT00364013 phase3completednot on this map

A Randomized, Multicenter, Phase 3 Study to Compare the Efficacy of Panitumumab in Combination With Oxaliplatin/ 5-fluorouracil/ Leucovorin to the Efficacy of Oxaliplatin/ 5-fluorouracil/ Leucovorin Alone in Patients With Previously Untreated Metastatic Colorectal Cancer

TypeinterventionalSponsorAmgenRan2006 to 2013Enrolled1,183ConditionsMetastatic Colorectal CancerArmsPanitumumab, FOLFOX regimen
3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 19 citations in OpenAlex.

  1. Trial
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  4. Skin toxicity and quality of life during treatment with panitumumab for RAS wild-type metastatic colorectal carcinoma: results from three randomised clinical trials.Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation · 2016
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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 10 institutions in 8 countries.

Salvatore SienaNiguarda Cancer Center, Grande Ospedale Metropolitano Niguarda, Milan, Italy; Department of Oncology, Università degli Studi di Milano, Milan, Italy.
Josep TaberneroVall d'Hebron University Hospital and Institute of Oncology (VHIO), Universitat Autònoma de Barcelona , Barcelona , Spain.
Gyorgy BodokyDepartment of Oncology , Szent László Hospital , Budapest , Hungary.
David CunninghamDepartment of Medicine , Royal Marsden National Health Service Foundation Trust , London , UK.
Fernando RiveraDepartment of Medical Oncology , Hospital Universitario Marqués de Valdecilla , Santander , Spain.
Paul RuffFaculty of Health Sciences , University of the Witwatersrand , Johannesburg , South Africa.
Jean Luc CanonService d'Oncologie-Hématologie , Grand Hôpital de Charleroi , Charleroi , Belgium.
Reija KoukakisDepartment of Biostatistics , Amgen Ltd , Uxbridge , UK.
Gaston DemontyMedical Development, Amgen (Europe) GmbH , Zug , Switzerland.
Guy HechmatiGlobal Health Economics, Amgen (Europe) GmbH , Zug , Switzerland.
Jean-Yves DouillardDepartment of Medical Oncology , Institut de Cancérologie de l'Ouest (ICO) René Gauducheau , Nantes , France.
Amgen (Switzerland) · CHAmgen (United Kingdom) · GBGrand Charleroi Hospital · BEInstitut de Cancérologie de l'Ouest · FRMarqués de Valdecilla University Hospital · ESNational Health Service · GBUnified Szent István and Szent László Hospital · HUUniversitat Autònoma de Barcelona · ESUniversity of Milan · ITUniversity of the Witwatersrand · ZA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionMetastatic colorectal cancer is rarely curable. Improving quality of life is therefore a key treatment goal. We report quality of life for patients with

methodsA randomised phase 3 open-label study of first-line panitumumab+FOLFOX4 vs FOLFOX4 enrolled adults with untreated metastatic colorectal cancer and an Eastern Cooperative Oncology Group performance status of 0-2. This analysis includes patients with wild-type

resultsThere were no statistically significant differences between treatment arms from baseline to progression or to discontinuation. Grade 3+ skin toxicity was reported by 38% of patients receiving panitumumab+FOLFOX4 and 2% receiving FOLFOX4 alone. There were no significant differences in quality of life between patients with grade 0-2 skin toxicity and those with grade 3+ skin toxicity. More patients receiving panitumumab+FOLFOX4 vs FOLFOX4 had early tumour shrinkage (p<.001). In patients with tumour symptoms at baseline, there were statistically significant improvements in quality of life in those with early tumour shrinkage versus those without early tumour shrinkage.

conclusionsAddition of panitumumab to FOLFOX4 in first-line therapy for metastatic colorectal cancer prolongs survival and has no negative effect on overall quality of life compared with FOLFOX4 alone. Specific quality of life assessments for skin toxicity should be included in study designs to better define the direct effect of these adverse events. TRIAL REGISTRATION NUMBER: NCT00364013.

Indexed as

chemotherapyEGFR inhibitorsmetastatic colorectal cancerquality of lifetumour shrinkage

Identifiers

PMID27843597
PMCPMC5070244
OpenAlexW2337497883

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.