Evidence map›Paper›PMID 32142532›Full record

Trial reportPloS one2020

The prognostic role of inflammatory markers in patients with metastatic colorectal cancer treated with bevacizumab: A translational study [ASCENT].

Stephen John Clarke, Matthew Burge, Kynan Feeney, Peter Gibbs, Kristian Jones, Gavin Marx, Mark P Molloy, Timothy Price, William H H Reece, Eva Segelov and 1 more

Registry-linked trialOpen access · goldAbstract readClinical Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in PloS one, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01588990 (An Australian Translational Study to Evaluate the Prognostic Role of Inflammatory Markers in Patients With Metastatic Colorectal Cancer Treated With Bevacizumab), which is not on this map. Cited by 12 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed, 3 pooled it
1.1field-weighted citation impact, top 21% 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.

NCT01588990 phase4completednot on this map

An Australian Translational Study to Evaluate the Prognostic Role of Inflammatory Markers in Patients With Metastatic Colorectal Cancer Treated With Bevacizumab (Avastin™)

TypeinterventionalSponsorHoffmann-La RocheRan2012 to 2016Enrolled128ConditionsColorectal NeoplasmsArmsOxaliplatin, Capecitabine, Bevacizumab, Leucovorin, 5-Fluouracil
3 · Its place in the literature

Who cites it

12 citing papers in PubMed, 3 syntheses or guidelines pooled it, 16 citations in OpenAlex.

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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 1 country.

Stephen John ClarkeCancer Services, Royal North Shore Hospital, St Leonards, Australia.ORCID 0000-0001-5817-1222
Matthew BurgeCancer Care Services, Royal Brisbane and Women Hospital, and University of Queensland, Herston, Australia.
Kynan FeeneyDepartment of Oncology, Haematology and Palliative Care, St John of God Murdoch Hospital, Murdoch, Australia.
Peter GibbsMedical Oncology, Western Hospital, Footscray, Australia.
Kristian JonesMedical Affairs, Roche Products, Pty, Limited, Sydney, Australia.
Gavin MarxIntegrated Cancer Centre, Sydney Adventist Hospital, and University of Sydney, Wahroonga, Australia.
Mark P MolloyAustralian Proteome Analysis Facility, Macquarie University, Sydney, Australia.
Timothy PriceHaematology and Medical Oncology, The Queen Elizabeth Hospital and University of Adelaide, Adelaide, Australia.
William H H ReeceBiostatistics, Covance Pty Ltd, Sydney, Australia.
Eva SegelovMedical Oncology, St Vincent's Hospital, Darlinghurst, Australia.
Niall C TebbuttMedical Oncology, Austin Health, Heidelberg, Australia.
AGRF Ltd · AUAustin Health · AUCovance (Australia) · AUFootscray Hospital · AUQueen Elizabeth Hospital · AURoyal North Shore Hospital · AUSt John of God Murdoch Hospital · AUSt Vincent's Hospital Sydney · AUThe University of Queensland · AUThe University of Sydney · AU

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIn spite of demonstrating prognostic and possibly predictive benefit in retrospective cohorts and meta-analyses of cancer populations, including colorectal cancer (CRC), prospective evaluation of the relationship between neutrophil to lymphocyte ratio (NLR) and treatment outcomes in previously untreated mCRC patients receiving bevacizumab-based therapy has not yet been performed.

methodsAn open-label, single arm, multi-centre study. Patients received first-line bevacizumab plus XELOX or mFOLFOX6 (Phase-A) and continued bevacizumab plus FOLFIRI beyond first progression (Phase-B). Analyses included the association of NLR with phase A progression free survival (PFS) and overall survival (OS). A sub-study investigated the safety in patients with the primary in situ tumor. An exploratory sub-study examined relationships of circulating proteomic markers with PFS.

resultsPhase-A enrolled 128 patients; median age was 64 years (range: 26-84), 70 (55%) were female, 71 (56%) were PS-0 and 51 (40%) had primary in situ tumor. Fifty-three (41%) patients entered Phase-B. The median baseline (b) NLR was 3.2 (range: 1.5-20.4) with 32 (25%) patients having bNLR > 5. The PFS hazard ratio (HR) by bNLR > 5 versus ≤ 5 was 1.4 (95% CI: 0.9-2.2; p = 0.101). The median PFS was 9.2 months (95% CI: 7.9-10.8) for Phase-A and 6.7 months (95% CI: 3.0-8.2) for Phase-B. The HR for OS based on bNLR > 5 versus ≤ 5 was 1.6 (95% CI: 1.0-2.7; p = 0.052). The median OS was 25 months (95% CI: 19.2-29.7) for the full analysis set and 14.9 months for Phase-B. Baseline levels of nine proteomic markers showed a relationship with PFS. Treatment related toxicities were consistent with what has previously been published. There were 4 (3%) instances of GI perforation, of which, 3 (6%) occurred in the primary in situ tumor group.

conclusionsResults from this study are aligned with the previously reported trend towards worse PFS and OS in patients with higher bNLR.

trial registrationClinicalTrials.gov: NCT01588990; posted May 1, 2012.

Indexed as

PrognosisAdultAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsBevacizumabBiomarkers, TumorCamptothecinCapecitabineColorectal NeoplasmsDisease-Free SurvivalFemaleFluorouracilHumansInflammationLeucovorinBevacizumabBiomarkers, TumorCamptothecinCapecitabineFluorouracilLeucovorinOrganoplatinum CompoundsOxaloacetates

Identifiers

PMID32142532
PMCPMC7059922
OpenAlexW3009049239

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.