dc.contributor.author | Chen, L-T | |
dc.contributor.author | Siveke, JT | |
dc.contributor.author | Wang-Gillam, A | |
dc.contributor.author | Li, C-P | |
dc.contributor.author | Bodoky, G | |
dc.contributor.author | Dean, AP | |
dc.contributor.author | Shan, Y-S | |
dc.contributor.author | Jameson, GS | |
dc.contributor.author | Macarulla, T | |
dc.contributor.author | Lee, K-H | |
dc.contributor.author | Cunningham, D | |
dc.contributor.author | Blanc, J-F | |
dc.contributor.author | Chiu, C-F | |
dc.contributor.author | Schwartsmann, G | |
dc.contributor.author | Braiteh, FS | |
dc.contributor.author | Mamlouk, K | |
dc.contributor.author | Belanger, B | |
dc.contributor.author | de Jong, FA | |
dc.contributor.author | Hubner, RA | |
dc.date.accessioned | 2019-02-20T07:52:01Z | |
dc.date.issued | 2018-12 | |
dc.identifier.citation | European journal of cancer (Oxford, England : 1990), 2018, 105 pp. 71 - 78 | |
dc.identifier.issn | 0959-8049 | |
dc.identifier.uri | https://repository.icr.ac.uk/handle/internal/3067 | |
dc.identifier.eissn | 1879-0852 | |
dc.identifier.doi | 10.1016/j.ejca.2018.09.010 | |
dc.description.abstract | Background 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. | |
dc.format | Print-Electronic | |
dc.format.extent | 71 - 78 | |
dc.language | eng | |
dc.language.iso | eng | |
dc.rights.uri | https://creativecommons.org/licenses/by/4.0 | |
dc.subject | Humans | |
dc.subject | Carcinoma, Pancreatic Ductal | |
dc.subject | Pancreatic Neoplasms | |
dc.subject | Gastrointestinal Diseases | |
dc.subject | Hematologic Diseases | |
dc.subject | Polyethylene Glycols | |
dc.subject | Fluorouracil | |
dc.subject | Leucovorin | |
dc.subject | Deoxycytidine | |
dc.subject | Antimetabolites, Antineoplastic | |
dc.subject | Antineoplastic Combined Chemotherapy Protocols | |
dc.subject | Liposomes | |
dc.subject | Proportional Hazards Models | |
dc.subject | Drug Resistance, Neoplasm | |
dc.subject | Aged | |
dc.subject | Middle Aged | |
dc.subject | Kaplan-Meier Estimate | |
dc.subject | Irinotecan | |
dc.subject | Progression-Free Survival | |
dc.title | Survival 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. | |
dc.type | Journal Article | |
dcterms.dateAccepted | 2018-09-14 | |
rioxxterms.versionofrecord | 10.1016/j.ejca.2018.09.010 | |
rioxxterms.licenseref.uri | https://creativecommons.org/licenses/by/4.0 | |
rioxxterms.licenseref.startdate | 2018-12 | |
rioxxterms.type | Journal Article/Review | |
dc.relation.isPartOf | European journal of cancer (Oxford, England : 1990) | |
pubs.notes | Not 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/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.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-status | Published | |
pubs.volume | 105 | en_US |
pubs.embargo.terms | Not known | |
icr.researchteam | Medicine (RMH Smith Cunningham) | en_US |
dc.contributor.icrauthor | Cunningham, David | |