Evidence map›Paper›PMID 27736842›Full record

Trial reportBritish journal of cancer2016

A phase 3 trial evaluating panitumumab plus best supportive care vs best supportive care in chemorefractory wild-type KRAS or RAS metastatic colorectal cancer.

Tae Won Kim, Anneli Elme, Zvonko Kusic, Joon Oh Park, Anghel Adrian Udrea, Sun Young Kim, Joong Bae Ahn, Ricardo Villalobos Valencia, Srinivasan Krishnan, Ante Bilic and 6 more

Registry-linked trialAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in British journal of cancer, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01412957 (A Phase 3, Multicenter, Randomized, Open-label Trial to Evaluate the Survival Benefit of Panitumumab and Best Supportive Care, Compared to Best Supportive Care Alone, in Subjects With Chemorefractory Wild-type KRAS Metastatic Colorectal Cancer), which is not on this map. Cited by 33 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
33citing 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.

NCT01412957 phase3completednot on this map

A Phase 3, Multicenter, Randomized, Open-label Trial to Evaluate the Survival Benefit of Panitumumab and Best Supportive Care, Compared to Best Supportive Care Alone, in Subjects With Chemorefractory Wild-type KRAS Metastatic Colorectal Cancer

TypeinterventionalSponsorAmgenRan2011 to 2016Enrolled377ConditionsMetastatic Colorectal CancerArmsBest Supportive Care (BSC), Panitumumab
3 · Its place in the literature

Who cites it

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

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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

16 authors.

Tae Won KimDepartment of Oncology, Asan Medical Center, University of Ulsan, Seoul 138-736, South Korea.
Anneli ElmeNorth Estonia Medical Centre Foundation, Tallinn 13419, Estonia.
Zvonko KusicUniversity Hospital Center 'Sestre Milosrdnice', Zagreb 10000, Croatia.
Joon Oh ParkSamsung Medical Center, Sungkyunkwan University School of Medicine, Seoul 135-710, South Korea.
Anghel Adrian UdreaMEDISPROF, Cluj-Napoca 400367, Romania.
Sun Young KimNational Cancer Center, Goyang-si, Gyeonggi-do 410-769, South Korea.
Joong Bae AhnYonsei University Health System Severance Hospital, Seoul 120-752, South Korea.
Ricardo Villalobos ValenciaCentro Medico Nacional Siglo XXI, Mexico City 06725, Mexico.
Srinivasan KrishnanDr Rai Memorial Medical Centre, Chennai 600018, India.
Ante BilicKlinicka bolnica Sveti Duh, Zagreb 10000, Croatia.
Nebojsa ManojlovicClinic for Gastroenterology and Hepatology of Military Medical Academy of Serbia, Belgrade 11000, Serbia.
Jun DongAmgen Inc., Thousand Oaks, CA 91320, USA.
Xuesong GuanAmgen Inc., Thousand Oaks, CA 91320, USA.
Catherine Lofton-DayAmgen Inc., Thousand Oaks, CA 91320, USA.
A Scott JungAmgen Inc., Thousand Oaks, CA 91320, USA.
Eduard VrdoljakDepartment of Oncology, Center of Oncology, Clinical Hospital Center Split, Split 21000, Croatia.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundWe assessed the treatment effect of panitumumab plus best supportive care (BSC) vs BSC on overall survival (OS) in patients with chemorefractory wild-type KRAS exon 2 metastatic colorectal cancer (mCRC) and report the first prospective extended RAS analysis in a phase 3 trial.

methodsPatients with wild-type KRAS exon 2 mCRC were randomised 1 : 1 to panitumumab (6 mg kg

resultsThree hundred seventy seven patients with wild-type KRAS exon 2 mCRC were randomised. Median OS was 10.0 months with panitumumab plus BSC vs 7.4 months with BSC (HR=0.73; 95% CI=0.57-0.93; P=0.0096). RAS ascertainment was 86%. In wild-type RAS mCRC, median OS for panitumumab plus BSC was 10.0 vs 6.9 months for BSC (HR=0.70; 95% CI=0.53-0.93; P=0.0135). Patients with RAS mutations did not benefit from panitumumab (OS HR=0.99; 95% CI=0.49-2.00). No new safety signals were observed.

conclusionsPanitumumab significantly improved OS in wild-type KRAS exon 2 mCRC. The effect was more pronounced in wild-type RAS mCRC, validating previous retrospective analyses.

Indexed as

AdultAgedAged, 80 and overAntibodies, MonoclonalAntineoplastic AgentsColorectal NeoplasmsCombined Modality TherapyCross-Over StudiesExonsFemaleHumansMaleMiddle AgedMutationPanitumumabProspective StudiesAntibodies, MonoclonalAntineoplastic AgentsKRAS protein, humanPanitumumabProto-Oncogene Proteins p21(ras)ras Proteins

Identifiers

PMID27736842
PMCPMC5104888

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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.