Evidence map›Paper›PMID 31395900›Full record

Trial reportScientific reports2019

Sex-Related Differences in Impact on Safety of Pharmacogenetic Profile for Colon Cancer Patients Treated with FOLFOX-4 or XELOX Adjuvant Chemotherapy.

Annamaria Ruzzo, Francesco Graziano, Francesca Galli, Fabio Galli, Eliana Rulli, Sara Lonardi, Monica Ronzoni, Bruno Massidda, Vittorina Zagonel, Nicoletta Pella and 19 more

Erratum issuedOpen access · goldAbstract readClinical Trial, Phase IIIRandomized Controlled TrialEquivalence Trial
In one paragraph

Trial report in Scientific reports, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 9 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 1 pooled it
1.1field-weighted citation impact, top 20% 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

9 citing papers in PubMed, 1 synthesis or guideline pooled it, 20 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Article
  4. Review
  5. Review
  6. Impact of Dose, Sex, and Strain on Oxaliplatin-Induced Peripheral Neuropathy in Mice.Frontiers in pain research (Lausanne, Switzerland) · 2021
    Article
  7. Article
  8. Article
  9. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

29 authors at 20 institutions in 1 country.

Annamaria RuzzoDepartment of Biomolecular Sciences, Università degli Studi di Urbino "Carlo Bo", Urbino, Italy. annamaria.ruzzo@uniurb.it.ORCID http://orcid.org/0000-0003-2815-1890
Francesco GrazianoAzienda Ospedaliera "Ospedali Riuniti Marche Nord", Pesaro, Italy. graziano.fda@yahoo.com.
Francesca GalliLaboratory of Methodology for Clinical research, Department of Oncology, Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Milano, Italy.
Fabio GalliLaboratory of Methodology for Clinical research, Department of Oncology, Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Milano, Italy.
Eliana RulliLaboratory of Methodology for Clinical research, Department of Oncology, Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Milano, Italy.ORCID http://orcid.org/0000-0003-1058-4137
Sara LonardiIstituto Oncologico Veneto IOV - IRCCS, Padova, Italy.
Monica RonzoniOspedale San Raffaele, Milano, Italy.
Bruno MassiddaAzienda Ospedaliera Universitaria di Cagliari, P.O. Monserrato, Monserrato, Italy.
Vittorina ZagonelIstituto Oncologico Veneto IOV - IRCCS, Padova, Italy.
Nicoletta PellaAzienda Ospedaliera S. Maria della Misericordia, Udine, Italy.
Claudia MucciariniOspedale "B. Ramazzini", Carpi, Italy.
Roberto LabiancaOspedale Papa Giovanni XXIII, Bergamo, Italy.
Maria Teresa IontaAzienda Ospedaliera Universitaria di Cagliari, P.O. Monserrato, Monserrato, Italy.
Irene BagaloniDepartment of Biomolecular Sciences, Università degli Studi di Urbino "Carlo Bo", Urbino, Italy.
Enzo VeltriOspedale di Gaeta ASL Latina, Gaeta, Italy.
Pietro SozziOspedale degli Infermi di Biella, Biella, Italy.
Sandro BarniOspedale "Treviglio-Caravaggio", Treviglio, Italy.
Vincenzo RicciOspedale San Raffaele, Milano, Italy.
Luisa FoltranAzienda Ospedaliera Santa Maria degli Angeli, Pordenone, Italy.
Mario NicoliniAzienda Ospedaliera Ospedale "Cervesi", Cattolica, Italy.
Edoardo BiondiOspedale "F. Renzetti", Lanciano, Italy.
Annalisa BramatiAzienda Ospedaliera Fatebenefratelli, Milano, Italy.
Daniele TurciAUSL Ospedale di Ravenna, Ravenna, Italy.
Silvia LazzarelliAzienda Ospedaliera di Cremona, Cremona, Italy.
Claudio VerusioOspedale di Saronno, Saronno, Italy.
Francesca BergamoIstituto Oncologico Veneto IOV - IRCCS, Padova, Italy.
Alberto SobreroAzienda Ospedaliera "Ospedale San Martino", Genova, Italy.
Luciano FrontiniFondazione GISCAD, Vanzago, Italy.
Mauro MagnaniDepartment of Biomolecular Sciences, Università degli Studi di Urbino "Carlo Bo", Urbino, Italy.
Istituto Oncologico Veneto · ITMario Negri Institute for Pharmacological Research · ITUniversity of Urbino · ITAzienda Ospedaliero-Universitaria Cagliari · ITIRCCS Ospedale San Raffaele · ITAccademia Italiana Medicina Osteopatica · ITASL Roma · ITAzienda Ospedaliera Fatebenefratelli e Oftalmico · ITAzienda Ospedaliera Santa Maria Degli Angeli · ITAzienda Ospedaliera S.Maria · ITAzienda Ospedaliera Treviglio · ITGruppo Italiano per lo Studio dei Carcinomi dell’Apparato Digerente · ITIstituti Ospitalieri di Cremona · ITIstituto Ramazzini · ITOspedale Cervesi di Cattolica · ITOspedale degli Infermi · ITOspedale "Floraspe Renzetti" · ITOspedale Papa Giovanni XXIII · ITOspedale Policlinico San Martino · ITOspedale "Santa Maria delle Croci" di Ravenna · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Polymorphisms contribute to inter-individual differences and show a promising predictive role for chemotherapy-related toxicity in colon cancer (CC). TOSCA is a multicentre, randomized, non-inferiority, phase III study conducted in high-risk stage II/stage III CC patients treated with 6 vs 3 months of FOLFOX-4 or XELOX adjuvant chemotherapy. During this post-hoc analysis, 218 women and 294 men were genotyped for 17 polymorphisms: TYMS (rs34743033, rs2853542, rs11280056), MTHFR (rs1801133, rs1801131), ERCC1 (rs11615), XRCC1 (rs25487), XRCC3 (rs861539), XPD (rs1799793, rs13181), GSTP1 (rs1695), GSTT1/GSTM1 (deletion +/-), ABCC1 (rs2074087), and ABCC2 (rs3740066, rs1885301, rs4148386). The aim was to assess the interaction between these polymorphisms and sex, on safety in terms of time to grade ≥3 haematological (TTH), grade ≥3 gastrointestinal (TTG) and grade ≥2 neurological (TTN) toxicity. Interactions were detected on TTH for rs1801133 and rs1799793, on TTG for rs13181 and on TTN for rs11615. Rs1799793 GA genotype (p = 0.006) and A allele (p = 0.009) shortened TTH in men. In women, the rs11615 CC genotype worsened TTN (co-dominant model p = 0.008, recessive model p = 0.003) and rs13181 G allele improved the TTG (p = 0.039). Differences between the two sexes in genotype distribution of rs1885301 (p = 0.020) and rs4148386 (p = 0.005) were found. We highlight that polymorphisms could be sex-specific biomarkers. These results, however, need to be confirmed in additional series.

Indexed as

AgedAntineoplastic Combined Chemotherapy ProtocolsBiomarkers, PharmacologicalCapecitabineChemotherapy, AdjuvantColonic NeoplasmsFemaleFluorouracilHumansLeucovorinMaleMiddle AgedMultidrug Resistance-Associated Protein 2Neoplasm ProteinsOrganoplatinum CompoundsOxaloacetatesABCC2 protein, humanBiomarkers, PharmacologicalCapecitabineFluorouracilLeucovorinMultidrug Resistance-Associated Protein 2Neoplasm ProteinsOrganoplatinum CompoundsOxaloacetates

Identifiers

PMID31395900
PMCPMC6687727
OpenAlexW2965687300

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.