Evidence map›Paper›PMID 34916320›Full record

Trial reportBMJ open2021

Novel longitudinal Multiple Overall Toxicity (MOTox) score to quantify adverse events experienced by patients during chemotherapy treatment: a retrospective analysis of the MRC BO06 trial in osteosarcoma.

Marta Spreafico, Francesca Ieva, Francesca Arlati, Federico Capello, Federico Fatone, Filippo Fedeli, Gianmarco Genalti, Jakob Anninga, Hans Gelderblom, Marta Fiocco

Open access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in BMJ open, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.5field-weighted citation impact, top 30% 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

3 citing papers in PubMed, 4 citations in OpenAlex.

  1. Article
  2. Review
  3. 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

10 authors at 5 institutions in 2 countries.

Marta SpreaficoMOX, Department of Mathematics, Politecnico di Milano, Milan, Italy marta.spreafico@polimi.it.ORCID 0000-0002-7773-9976
Francesca IevaMOX, Department of Mathematics, Politecnico di Milano, Milan, Italy.ORCID 0000-0003-0165-1983
Francesca ArlatiMOX, Department of Mathematics, Politecnico di Milano, Milan, Italy.
Federico CapelloMOX, Department of Mathematics, Politecnico di Milano, Milan, Italy.
Federico FatoneMOX, Department of Mathematics, Politecnico di Milano, Milan, Italy.
Filippo FedeliMOX, Department of Mathematics, Politecnico di Milano, Milan, Italy.ORCID 0000-0001-5991-2029
Gianmarco GenaltiMOX, Department of Mathematics, Politecnico di Milano, Milan, Italy.
Jakob AnningaDepartment of Solid Tumors, Princess Máxima Center for Pediatric Oncology, Utrecht, Netherlands.
Hans GelderblomDepartment of Medical Oncology, Leiden University Medical Center, Leiden, Netherlands.
Marta FioccoMathematical Institute, Leiden University, Leiden, Netherlands.
Politecnico di Milano · ITLeiden University · NLHuman Technopole · ITLeiden University Medical Center · NLPrincess Máxima Center · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesThis study aims at exploring and quantifying multiple types of adverse events (AEs) experienced by patients during cancer treatment. A novel longitudinal score to evaluate the Multiple Overall Toxicity (MOTox) burden is proposed. The MOTox approach investigates the personalised evolution of high overall toxicity (high-MOTox) during the treatment.

designRetrospective analysis of the MRC-BO06/EORTC-80931 randomised controlled trial for osteosarcoma.

settingInternational multicentre population-based study.

participantsA total of 377 patients with resectable high-grade osteosarcoma, who completed treatment within 180 days after randomisation without abnormal dosages (+25% higher than planned).

interventionsPatients were randomised to six cycles of conventional versus dose-intense regimens of doxorubicin and cisplatin. Non-haematological toxicity data were collected prospectively and graded according to the Common Terminology Criteria for Adverse Events (CTCAE).

main outcome measuresThe MOTox score described the overall toxicity burden in terms of multiple toxic AEs, maximum-severity episode and cycle time-dimension. Evolution of high-MOTox was assessed through multivariable models, that investigated the impact of personalised characteristics (eg, achieved chemotherapy dose, previous AEs or biochemical factors) cycle-by-cycle.

resultsA cycle-by-cycle analysis identifies different evolutions of MOTox levels during treatment, detecting differences in patients' health. Mean MOTox values and percentages of patients with high-MOTox decreased cycle-by-cycle from 2.626 to 1.953 and from 57.8% to 36.6%, respectively. High

conclusionsThe novel longitudinal method developed can be applied to any cancer studies with CTCAE-graded toxicity data. After validation in other studies, the MOTox approach may lead to improvements in healthcare assessment and treatment planning. TRIAL REGISTRATION NUMBER: ISRCTN86294690; Post-results.

Indexed as

Bone NeoplasmsOsteosarcomaAntineoplastic Combined Chemotherapy ProtocolsCisplatinHumansRetrospective StudiesCisplatinChemotherapyLongitudinal dataOsteosarcomaPrediction modelsToxicity

Identifiers

PMID34916320
PMCPMC8679129
OpenAlexW4200516006

What OpenQuestion holds

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Registered trials

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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.