Evidence map›Paper›PMID 29080924›Full record

Trial reportJournal of cancer research and clinical oncology2018

Exploratory analyses assessing the impact of early tumour shrinkage and depth of response on survival outcomes in patients with RAS wild-type metastatic colorectal cancer receiving treatment in three randomised panitumumab trials.

Julien Taieb, Fernando Rivera, Salvatore Siena, Meinolf Karthaus, Manuel Valladares-Ayerbes, Javier Gallego, Michael Geissler, Reija Koukakis, Gaston Demonty, Marc Peeters

Erratum issued 3 registry-linked trialsOpen access · hybridAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
In one paragraph

Trial report in Journal of cancer research and clinical oncology, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to 3 registered trials, which are not on this map. Cited by 21 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
21citing papers in PubMed, 3 pooled it
1.8field-weighted citation impact, top 13% 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
NCT00819780 phase2completednot on this map

A Randomized, Multicenter, Phase 2 Study to Compare the Efficacy of Panitumumab in Combination With mFOLFOX6 to the Efficacy of Bevacizumab in Combination With mFOLFOX6 in Patients With Previously Untreated, KRAS Wild-Type, Unresectable, Metastatic Colorectal Cancer

TypeinterventionalSponsorAmgenRan2009 to 2016Enrolled285ConditionsColon Cancer, Colorectal Cancer, Rectal Cancer, Metastatic Colorectal CancerArmsPanitumumab, Bevacizumab, mFOLFOX6
NCT00885885 phase2completednot on this map

An Open Label Randomized, Multi-Centre Exploratory Phase II Study to Evaluate the Efficacy and Safety of the Combination of Panitumumab With FOLFOX 4 Chemotherapy or Panitumumab With FOLFIRI Chemotherapy in Subjects With Wild- Type KRAS Colorectal Cancer and Liver-only Metastases.

TypeinterventionalSponsorSpanish Cooperative Group for the Treatment of Digestive Tumours (TTD)Ran2009 to 2015Enrolled80ConditionsColorectal CancerArmsPanitumumab+FOLFOX-4, Panitumumab+FOLFIRI
3 · Its place in the literature

Who cites it

21 citing papers in PubMed, 3 syntheses or guidelines pooled it, 31 citations in OpenAlex.

  1. Controversies in the treatment of RAS wild-type metastatic colorectal cancer.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2021
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

10 authors at 10 institutions in 7 countries.

Julien TaiebDepartment of Hepatogastroenterology and GI Oncology, Georges Pompidou European Hospital and Sorbonne Paris Cité / Université Paris Descartes, 20 rue Leblanc, 75015, Paris, France. julien.taieb@egp.aphp.fr.ORCID http://orcid.org/0000-0002-9955-4753
Fernando RiveraHospital Universitario Marqués de Valdecilla, Santander, Spain.
Salvatore SienaGrande Ospedale Metropolitano Niguarda and Dipartimento di Oncologia e Emato-Oncologia, Niguarda Cancer Center, Università degli Studi di Milano, Milan, Italy.
Meinolf KarthausStädtisches Klinikum München, Klinikum Neuperlach, Munich, Germany.
Manuel Valladares-AyerbesVirgen del Rocio Hospital, Seville, Spain.
Javier GallegoHospital General Universitario de Elche, Elche, Spain.
Michael GeisslerKlinikum Esslingen, Esslingen, Germany.
Reija KoukakisBiostatistics, Amgen Ltd, Uxbridge, UK.
Gaston DemontyAmgen (Europe) GmbH, Medical Development, Zug, Switzerland.
Marc PeetersAntwerp University Hospital, Antwerp, Belgium.
Amgen (Switzerland) · CHAmgen (United Kingdom) · GBAntwerp University Hospital · BEHospital General Universitario de Elche · ESHospital Universitario Virgen del Rocío · ESKlinikum Esslingen · DEMarqués de Valdecilla University Hospital · ESMünchen Klinik Neuperlach · DEUniversité Paris Cité · FRUniversity of Milan · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeTo report exploratory analyses of early tumour shrinkage (ETS) and depth of response (DpR) in patients with RAS wild-type (WT) metastatic colorectal cancer (mCRC), receiving the first-line treatment in three randomised panitumumab trials.

methodsData from the PRIME (NCT00364013), PEAK (NCT00819780) and PLANET (NCT00885885) studies were included. Median DpR, the proportion of patients achieving ETS ≥ 20% or ≥ 30% at week 8, and the impact of ETS and DpR (including by category) on outcome were analysed. Factors associated with ETS and DpR and the optimal ETS/DpR cut-off values for predicting improved overall survival (OS) were assessed.

resultsOverall, 505, 170 and 53 patients had RAS WT mCRC in PRIME, PEAK and PLANET, respectively. Patients receiving panitumumab had higher ETS rates (≥ 30%: PRIME 59% vs. 38%; PEAK 64% vs. 45%) and greater DpR (PRIME: 54% vs. 46%; PEAK: 65% vs. 46%) than those receiving treatment without panitumumab. In multiple regression analyses, panitumumab treatment, liver-only metastases and WT BRAF status were consistently associated with improved ETS and DpR outcomes. Irrespective of treatment, ETS and DpR were associated with improved progression-free survival, overall survival and resection rates; most resections occurred in patients in the two highest DpR categories. In PRIME and PEAK, respectively, the optimal cut-offs for predicting improved OS were 32 and 34% for ETS, and 59 and 70% for DpR.

conclusionsThese exploratory analyses suggest that panitumumab is associated ETS and DpR benefits in patients with RAS WT mCRC and that achieving these endpoints during first-line treatment is linked with favourable outcomes.

Indexed as

AdultAgedAged, 80 and overAntibodies, MonoclonalAntineoplastic Combined Chemotherapy ProtocolsColorectal NeoplasmsFemaleFluorouracilGTP PhosphohydrolasesHumansLeucovorinMaleMembrane ProteinsMiddle AgedOrganoplatinum CompoundsPanitumumabAntibodies, MonoclonalBRAF protein, humanFluorouracilGTP PhosphohydrolasesKRAS protein, humanLeucovorinMembrane ProteinsNRAS protein, humanOrganoplatinum CompoundsPanitumumabProto-Oncogene Proteins B-rafProto-Oncogene Proteins p21(ras)Depth of responseEarly tumour shrinkageMetastatic colorectal cancerPanitumumabSurvival

Identifiers

PMID29080924
PMCPMC5794806
OpenAlexW2765766854

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.