Evidence map›Paper›PMID 22910320›Full record

ArticleBritish journal of cancer2012

Prediction of early death among patients enrolled in phase I trials: development and validation of a new model based on platelet count and albumin.

A Ploquin, D Olmos, D Lacombe, R A'Hern, A Duhamel, C Twelves, S Marsoni, R Morales-Barrera, J-C Soria, J Verweij and 8 more

Abstract read
In one paragraph

Article in British journal of cancer, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 1 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.

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

10 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Article
  3. Article
  4. Article
  5. Phase i trials in melanoma: A framework to translate preclinical findings to the clinic.European journal of cancer (Oxford, England : 1990) · 2016
    Article
  6. Article
  7. Article
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  9. Nomogram to predict cycle-one serious drug-related toxicity in phase I oncology trials.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2014
    Article
  10. 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

18 authors.

A PloquinCentre Oscar Lambret, Medical Oncology Department, 3 rue Combemale, Lille 59020, France.
D Olmos
D Lacombe
R A'Hern
A Duhamel
C Twelves
S Marsoni
R Morales-Barrera
J-C Soria
J Verweij
E E Voest
P Schöffski
J H Schellens
A Kramar
R S Kristeleit
H-T Arkenau
S B Kaye
N Penel

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundSelecting patients with 'sufficient life expectancy' for Phase I oncology trials remains challenging. The Royal Marsden Hospital Score (RMS) previously identified high-risk patients as those with ≥ 2 of the following: albumin <35 g l(-1); LDH > upper limit of normal; >2 metastatic sites. This study developed an alternative prognostic model, and compared its performance with that of the RMS.

methodsThe primary end point was the 90-day mortality rate. The new model was developed from the same database as RMS, but it used Chi-squared Automatic Interaction Detection (CHAID). The ROC characteristics of both methods were then validated in an independent database of 324 patients enrolled in European Organization on Research and Treatment of Cancer Phase I trials of cytotoxic agents between 2000 and 2009.

resultsThe CHAID method identified high-risk patients as those with albumin <33 g l(-1) or ≥ 33 g l(-1), but platelet counts ≥ 400.000 mm(-3). In the validation data set, the rates of correctly classified patients were 0.79 vs 0.67 for the CHAID model and RMS, respectively. The negative predictive values (NPV) were similar for the CHAID model and RMS.

conclusionThe CHAID model and RMS provided a similarly high level of NPV, but the CHAID model gave a better accuracy in the validation set. Both CHAID model and RMS may improve the screening process in phase I trials.

Indexed as

Models, StatisticalAlgorithmsClinical Trials, Phase I as TopicDecision TreesEndpoint DeterminationFemaleHumansMaleNeoplasmsPatient SelectionPlatelet CountPredictive Value of TestsPrognosisReproducibility of ResultsSerum AlbuminSurvival RateSerum Albumin

Identifiers

PMID22910320
PMCPMC3461164

What OpenQuestion holds

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LicenceCC BY-NC-SA
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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.