Evidence map›Paper›PMID 31300973›Full record

Trial reportDrugs in R&D2019

Impact of Primary Tumour Location and Early Tumour Shrinkage on Outcomes in Patients with RAS Wild-Type Metastatic Colorectal Cancer Following First-Line FOLFIRI Plus Panitumumab.

Claus-Henning Köhne, Meinolf Karthaus, Laurent Mineur, Josef Thaler, Marc Van den Eynde, Javier Gallego, Reija Koukakis, Marloes Berkhout, Ralf-Dieter Hofheinz

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase II
In one paragraph

Trial report in Drugs in R&D, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00508404 (A Single Arm Multicentre Phase II Study of Panitumumab in Combination With Irinotecan/5-fluorouracil/Leucovorin in Patients With Metastatic Colorectal Cancer), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.3field-weighted citation impact, top 37% 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.

NCT00508404 phase2completednot on this map

A Single Arm Multicentre Phase II Study of Panitumumab in Combination With Irinotecan/5-fluorouracil/Leucovorin in Patients With Metastatic Colorectal Cancer

TypeinterventionalSponsorAmgenRan2007 to 2012Enrolled154ConditionsMetastatic Colorectal CancerArmsPanitumumab, FOLFIRI
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 4 citations in OpenAlex.

  1. Trial
  2. The potential of monoclonal antibodies for colorectal cancer therapy.Medical oncology (Northwood, London, England) · 2023
    Review
  3. Journal of gastrointestinal oncology · 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

9 authors at 9 institutions in 7 countries.

Claus-Henning KöhneDepartment of Oncology and Haematology, Klinikum Oldenburg, Oldenburg, Germany. Koehne.Claus-Henning@klinikum-oldenburg.de.
Meinolf KarthausDepartment of Hematology and Oncology, Städtisches Klinikum München, Munich, Germany.
Laurent MineurDépartement de Cancérologie Digestive, Institut Sainte Catherine, Avignon, France.
Josef ThalerInternal Medicine IV (Hematology and Medical Oncology), Klinikum Wels-Grieskirchen, Wels, Austria.
Marc Van den EyndeDepartment of Gastroenterology and Medical Oncology, Institut Roi Albert II, Cliniques Universitaires Saint-Luc UCL, Brussels, Belgium.
Javier GallegoServicio de Oncología Médica, Hospital General Universitario de Elche, Alicante, Spain.ORCID http://orcid.org/0000-0002-0584-1242
Reija KoukakisDepartment of Biostatistics, Amgen Ltd, Uxbridge, Middlesex, UK.
Marloes BerkhoutMedical Development, Amgen B.V., Breda, The Netherlands.
Ralf-Dieter HofheinzTagestherapiezentrum, Interdisziplinäres Tumorzentrum, Universitätsmedizin Mannheim, Mannheim, Germany.
Amgen (Netherlands) · NLAmgen (United Kingdom) · GBCliniques Universitaires Saint-Luc · BEHeidelberg University · DEHospital General Universitario de Elche · ESInstitut Sainte Catherine · FRKlinikum Oldenburg · DEKlinikum Wels-Grieskirchen · ATMünchen Klinik · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveData from a trial of first-line panitumumab plus FOLFIRI (folinic acid, infusional 5-fluorouracil and irinotecan) in metastatic colorectal cancer were retrospectively analysed to investigate the effects of primary tumour location and early tumour shrinkage on outcomes.

methodsPatients with RAS wild-type metastatic colorectal cancer from a single-arm, open-label phase II study (NCT00508404) were included. Tumours located from the splenic flexure to rectum and in the caecum to transverse colon were defined as left- and right-sided, respectively. Baseline characteristics were summarised by primary tumour location and the effects of primary tumour location on outcomes-including objective response rate, resection rate, depth of response, duration of response and progression-free survival-were analysed. Progression-free survival and objective response rate were analysed by early tumour shrinkage status.

resultsPrimary tumour location was determined in 52/69 (75%) patients with RAS wild-type metastatic colorectal cancer; 45 (87%) had left-sided disease. Median progression-free survival was longer in patients with left-sided tumours (11.2 vs. 7.2 months for right-sided disease) and more of these patients experienced early tumour shrinkage ≥ 30% (53% vs. 29%). Early tumour shrinkage ≥ 30% was associated with improved progression-free survival irrespective of tumour location. More patients with early tumour shrinkage ≥ 30% achieved a partial or complete response. Objective response rate, duration of response, depth of response and resection rates were similar in patients with left- and right-sided tumours.

conclusionsThis analysis has confirmed a prognostic effect of primary tumour location in patients with RAS wild-type metastatic colorectal cancer receiving first-line panitumumab plus FOLFIRI. Early tumour shrinkage was associated with improved progression-free survival irrespective of tumour location. In right-sided disease, early tumour shrinkage may identify a subgroup of patients who might respond to panitumumab. CLINICALTRIALS. GOV IDENTIFIER: NCT00508404.

Indexed as

AdultAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsCamptothecinColorectal NeoplasmsDisease-Free SurvivalFemaleFluorouracilHumansLeucovorinMaleMiddle AgedPanitumumabRetrospective StudiesCamptothecinFluorouracilLeucovorinPanitumumab

Identifiers

PMID31300973
PMCPMC6738356
OpenAlexW2956964277

What OpenQuestion holds

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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.