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dc.contributor.authorChen, L-Ten_US
dc.contributor.authorSiveke, JTen_US
dc.contributor.authorWang-Gillam, Aen_US
dc.contributor.authorLi, C-Pen_US
dc.contributor.authorBodoky, Gen_US
dc.contributor.authorDean, APen_US
dc.contributor.authorShan, Y-Sen_US
dc.contributor.authorJameson, GSen_US
dc.contributor.authorMacarulla, Ten_US
dc.contributor.authorLee, K-Hen_US
dc.contributor.authorCunningham, Den_US
dc.contributor.authorBlanc, J-Fen_US
dc.contributor.authorChiu, C-Fen_US
dc.contributor.authorSchwartsmann, Gen_US
dc.contributor.authorBraiteh, FSen_US
dc.contributor.authorMamlouk, Ken_US
dc.contributor.authorBelanger, Ben_US
dc.contributor.authorde Jong, FAen_US
dc.contributor.authorHubner, RAen_US
dc.coverage.spatialEnglanden_US
dc.date.accessioned2019-02-20T07:52:01Z
dc.date.issued2018-12en_US
dc.identifierhttps://www.ncbi.nlm.nih.gov/pubmed/30414528en_US
dc.identifierS0959-8049(18)31380-7en_US
dc.identifier.citationEur J Cancer, 2018, 105 pp. 71 - 78en_US
dc.identifier.urihttps://repository.icr.ac.uk/handle/internal/3067
dc.identifier.eissn1879-0852en_US
dc.identifier.doi10.1016/j.ejca.2018.09.010en_US
dc.description.abstractBACKGROUND: In the phase 3 randomised NAPOLI-1 clinical study, a 45% increase in median overall survival (OS) was shown with liposomal irinotecan, 5-fluorouracil and leucovorin (nal-IRI+5-FU/LV) versus 5-FU/LV in patients with metastatic pancreatic cancer progressing after gemcitabine-based therapy. Here, we report data from a pre-specified, expanded analysis of outcomes in the per-protocol (PP) population. MATERIALS AND METHODS: The PP population comprised patients receiving ≥80% of planned treatment during the first 6 weeks, with no major protocol violations. A post-hoc analysis of the non-PP population was also performed. RESULTS: For PP patients, median OS was 8.9 (95% confidence interval: 6.4-10.5) months with nal-IRI+5-FU/LV (n = 66) vs 5.1 (4.0-7.2) months with 5-FU/LV (n = 71; unstratified hazard ratio [HR] 0.57, p = 0.011). For non-PP patients, it was 4.4 (3.3-5.3) months with nal-IRI+5-FU/LV (n = 51) vs 2.8 (1.7-3.2) months with 5-FU/LV (n = 48; unstratified HR 0.64, p = 0.0648). CONCLUSION: A statistically significant survival advantage was observed with nal-IRI+5-FU/LV vs 5-FU/LV in the PP patient population.en_US
dc.format.extent71 - 78en_US
dc.languageengen_US
dc.language.isoengen_US
dc.rights.urihttp://creativecommons.org/licenses/by/4.0/en_US
dc.subjectClinical trial, phase IIIen_US
dc.subjectDrug combinations, Antineoplasticen_US
dc.subjectGemcitabineen_US
dc.subjectNeoplasm metastasisen_US
dc.subjectPancreatic neoplasmsen_US
dc.subjectSensitivity and specificityen_US
dc.subjectSurvival analysisen_US
dc.titleSurvival with nal-IRI (liposomal irinotecan) plus 5-fluorouracil and leucovorin versus 5-fluorouracil and leucovorin in per-protocol and non-per-protocol populations of NAPOLI-1: Expanded analysis of a global phase 3 trial.en_US
dc.typeJournal Article
dcterms.dateAccepted2018-09-14en_US
rioxxterms.versionofrecord10.1016/j.ejca.2018.09.010en_US
rioxxterms.licenseref.startdate2018-12en_US
rioxxterms.typeJournal Article/Reviewen_US
dc.relation.isPartOfEur J Canceren_US
pubs.notesNot knownen_US
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/Medicine (RMH Smith Cunningham)
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Clinical Studies/Medicine (RMH Smith Cunningham)/Medicine (RMH Smith Cunningham) (hon.)
pubs.organisational-group/ICR/Primary Group/Royal Marsden Clinical Units
pubs.publication-statusPublisheden_US
pubs.volume105en_US
pubs.embargo.termsNot knownen_US
icr.researchteamMedicine (RMH Smith Cunningham)en_US
dc.contributor.icrauthorCunningham, Daviden_US


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