Evidence map›Paper›PMID 32893188›Full record

SynthesisESMO open2020

Lessons learnt from scoring adjuvant colon cancer trials and meta-analyses using the ESMO-Magnitude of Clinical Benefit Scale V.1.1.

Daan Geert Knapen, Nathan I Cherny, Panagiota Zygoura, Nicola Jane Latino, Jean-Yves Douillard, Urania Dafni, Elisabeth G E de Vries, Derk Jan de Groot

Open access · goldAbstract readMeta-Analysis
In one paragraph

Synthesis in ESMO open, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
0.5field-weighted citation impact, top 33% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 11 citations in OpenAlex.

  1. Article
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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

8 authors at 5 institutions in 4 countries.

Daan Geert KnapenMedical Oncology, University Medical Centre Groningen, Groningen, Groningen, Netherlands.
Nathan I ChernyMedical Oncology, Shaare Zedek Medical Center, Jerusalem, Jerusalem, Israel.
Panagiota ZygouraStatistics, Frontier Science Foundation-Hellas, Statistics, Athens, Zografou, Greece.
Nicola Jane LatinoESMO-MCBS Working Group, European Society for Medical Oncology, Viganello, Switzerland.
Jean-Yves DouillardESMO-MCBS Working Group, European Society for Medical Oncology, Viganello, Switzerland.
Urania DafniNursing, National and Kapodistrian University of Athens, Goudi-Athens, Greece; University of Athens, Athens, Greece.
Elisabeth G E de VriesMedical Oncology, University Medical Centre Groningen, Groningen, Groningen, Netherlands.
Derk Jan de GrootMedical Oncology, University Medical Centre Groningen, Groningen, Groningen, Netherlands. Electronic address: d.j.a.de.groot@umcg.nl.
University Medical Center Groningen · NLEuropean Society for Medical Oncology · CHFrontier Science Foundation-Hellas · GRNational and Kapodistrian University of Athens · GRShaare Zedek Medical Center · IL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Click here to listen to the Podcast

backgroundForm 1 of the European Society for Medical Oncology-Magnitude of Clinical Benefit Scale (ESMO-MCBS) serves to grade therapies with curative intent. Hitherto only few trials with curative intent have been field tested using form 1. We aimed to evaluate the applicability of the scale and to assess the reasonableness of the generated scores in early colon cancer, in order to identify shortcomings that may be rectified in future amendments.

methodsAdjuvant studies were identified in PubMed, Food and Drug Administration and European Medicines Agency registration sites, as well as ESMO and National Comprehensive Cancer Network guidelines. Studies meeting inclusion criteria were graded using form 1 of the ESMO-MCBS V.1.1 and field tested by ESMO Colorectal Cancer Faculty. Shortcomings of the scale were identified and evaluated.

resultsEighteen of 57 trials and 7 out of 14 meta-analyses identified met criteria for ESMO-MCBS V.1.1 grading. In stage III colon cancer, randomised clinical trials and meta-analyses of modulated 5-fluorouracil (5-FU) based chemotherapy versus surgery scored ESMO-MCBS grade A and randomised controlled trials (RCTs) and meta-analyses comprising oxaliplatin added to this 5-FU backbone showed a more modest additional overall survival benefit (grade A and B). For stage II colon cancer, the findings are less consistent. The fluoropyrimidine trials in stage II were graded 'no evaluable benefit' but the most recent meta-analysis demonstrated a 5.4% survival advantage after 8 years follow-up (grade A). RCTs and a meta-analysis adding oxaliplatin demonstrated no added benefit. Exploratory toxicity evaluation and annotation was problematic given inconsistent toxicity reporting and limited results of late toxicity. Field testers (n=37) reviewed the scores, 25 confirmed their reasonableness, 12 found them mostly reasonable. Moreover, they identified the inability of crediting improved convenience in non-inferiority trials as a shortcoming.

conclusionForm 1 of the ESMO-MCBS V.1.1 provided very reasonable grading for adjuvant colon cancer studies.

Indexed as

Colonic NeoplasmsMedical OncologyFluorouracilHumansOxaliplatinUnited StatesUnited States Food and Drug AdministrationFluorouracilOxaliplatinadjuvant chemotherapyearly colon cancerESMO-MCBSquality of lifetoxicity

Identifiers

PMID32893188
PMCPMC7476457
OpenAlexW3083522136

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

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.