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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.contributor.author | Chen, Litzong | pt_BR |
dc.contributor.author | Schwartsmann, Gilberto | pt_BR |
dc.contributor.author | Hubner, Richard A. | pt_BR |
dc.date.accessioned | 2019-10-10T03:49:00Z | pt_BR |
dc.date.issued | 2018 | pt_BR |
dc.identifier.issn | 0959-8049 | pt_BR |
dc.identifier.uri | http://hdl.handle.net/10183/200300 | pt_BR |
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. | en |
dc.format.mimetype | application/pdf | pt_BR |
dc.language.iso | eng | pt_BR |
dc.relation.ispartof | European journal of cancer (1990). Oxford. Vol. 105 (Dec. 2018), p. 71-78 | pt_BR |
dc.rights | Open Access | en |
dc.subject | Clinical trial, phase III | en |
dc.subject | Ensaio clínico | pt_BR |
dc.subject | Durg combinations, antineoplastic | en |
dc.subject | Protocolos de quimioterapia combinada antineoplásica | pt_BR |
dc.subject | Gemcitabine | en |
dc.subject | Análise de sobrevida | pt_BR |
dc.subject | Neoplasias pancreáticas | pt_BR |
dc.subject | Neoplasm metastasis | en |
dc.subject | Pancreatic neoplasms | en |
dc.subject | Sensitivity and specificity | en |
dc.subject | Survival analysis | en |
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 | pt_BR |
dc.type | Artigo de periódico | pt_BR |
dc.identifier.nrb | 001102654 | pt_BR |
dc.type.origin | Estrangeiro | pt_BR |
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