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dc.contributor.authorJones, RL
dc.contributor.authorHerzog, TJ
dc.contributor.authorPatel, SR
dc.contributor.authorvon Mehren, M
dc.contributor.authorSchuetze, SM
dc.contributor.authorVan Tine, BA
dc.contributor.authorColeman, RL
dc.contributor.authorKnoblauch, R
dc.contributor.authorTriantos, S
dc.contributor.authorHu, P
dc.contributor.authorShalaby, W
dc.contributor.authorMcGowan, T
dc.contributor.authorMonk, BJ
dc.contributor.authorDemetri, GD
dc.date.accessioned2021-08-05T13:23:04Z
dc.date.available2021-08-05T13:23:04Z
dc.date.issued2021-05-07
dc.identifier.citationCancer medicine, 2021
dc.identifier.issn2045-7634
dc.identifier.urihttps://repository.icr.ac.uk/handle/internal/4728
dc.identifier.eissn2045-7634
dc.identifier.eissn2045-7634en_US
dc.identifier.doi10.1002/cam4.3903
dc.identifier.doi10.1002/cam4.3903en_US
dc.description.abstractBackground As with other alkylating agents, cardiac dysfunction can occur with trabectedin therapy for advanced soft tissue sarcomas (STS) or recurrent ovarian cancer (ROC) where treatment options for advanced disease are still limited. Cardiac safety for trabectedin monotherapy (T) for STS or in combination with pegylated liposomal doxorubicin (T+PLD) for ROC was evaluated in this retrospective postmarketing regulatory commitment.Methods Patient data for multiple cardiac-related treatment-emergent adverse events (cTEAEs) were evaluated in pooled analyses of ten phase 2 trials, one phase 3 trial in STS (n = 982), and two phase 3 trials in ROC (n = 1231).Results Multivariate analyses on pooled trabectedin data revealed that cardiovascular medical history (risk ratio [RR (95% CI)]: 1.90 [1.24-2.91]; p = 0.003) and age ≥65 years (RR [95% CI]: 1.78 [1.12-2.83]; p = 0.014) were associated with increased risk for cTEAEs. Multivariate analyses showed increased risk of experiencing cTEAEs with T+PLD compared to PLD monotherapy (RR [95% CI]: 2.70 [1.75-4.17]; p < 0.0001) and with history of prior cardiac medication (RR [95% CI]: 1.88 [1.16-3.05]; p = 0.010).Conclusions For patients with STS or ROC who still have limited treatment options, trabectedin may be initiated after carefully considering benefit versus risk. Trial Registration (ClinicalTrials.gov): NCT01343277; NCT00113607; NCT01846611.
dc.formatPrint-Electronic
dc.languageeng
dc.language.isoeng
dc.rights.urihttp://creativecommons.org/licenses/by/4.0/
dc.titleCardiac safety of trabectedin monotherapy or in combination with pegylated liposomal doxorubicin in patients with sarcomas and ovarian cancer.
dc.typeJournal Article
dcterms.dateAccepted2021-03-03
rioxxterms.versionVoR
rioxxterms.versionofrecord10.1002/cam4.3903
rioxxterms.licenseref.startdate2021-05-07
rioxxterms.licenseref.startdate2021-05-07en_US
dc.relation.isPartOfCancer medicine
pubs.notesNot known
pubs.organisational-group/ICR
pubs.organisational-group/ICR/Primary Group
pubs.organisational-group/ICR/Primary Group/ICR Divisions
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Clinical Studies
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Clinical Studies/Sarcoma Clinical Trials (R Jones)
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Clinical Studies/Sarcoma Clinical Trials (R Jones)/Sarcoma Clinical Trials (R Jones) (hon.)
pubs.organisational-group/ICR/Primary Group/Royal Marsden Clinical Units
pubs.organisational-group/ICR
pubs.organisational-group/ICR/Primary Group
pubs.organisational-group/ICR/Primary Group/ICR Divisions
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Clinical Studies
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Clinical Studies/Sarcoma Clinical Trials (R Jones)
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Clinical Studies/Sarcoma Clinical Trials (R Jones)/Sarcoma Clinical Trials (R Jones) (hon.)
pubs.organisational-group/ICR/Primary Group/Royal Marsden Clinical Units
pubs.publication-statusPublished
pubs.embargo.termsNot known
icr.researchteamSarcoma Clinical Trials (R Jones)
icr.researchteamSarcoma Clinical Trials (R Jones)en_US
dc.contributor.icrauthorJones, Robinen


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