dc.contributor | Vall d'Hebron Barcelona Hospital Campus |
dc.contributor.author | Macarulla Mercadé, Teresa |
dc.contributor.author | Blanc, Jean-Frédéric |
dc.contributor.author | Wang-Gillam, Andrea |
dc.contributor.author | Chen, Li-Tzong |
dc.contributor.author | Siveke, Jens T. |
dc.contributor.author | Mirakhur, Beloo |
dc.date.accessioned | 2021-03-19T12:33:13Z |
dc.date.available | 2021-03-19T12:33:13Z |
dc.date.issued | 2019-05-01 |
dc.identifier.citation | Macarulla T, Blanc JF, Wang-Gillam A, Chen LT, Siveke JT, Mirakhur B, et al. Liposomal irinotecan and 5-fluorouracil/leucovorin in older patients with metastatic pancreatic cancer – A subgroup analysis of the pivotal NAPOLI-1 trial. J Geriatr Oncol. 2019 May 1;10(3):427–35. |
dc.identifier.issn | 1879-4068 |
dc.identifier.uri | https://hdl.handle.net/11351/5777 |
dc.description | Liposomal irinotecan; Older patients; Pancreatic cancer |
dc.description.abstract | Objectives
Pancreatic cancer is a highly lethal disease predominantly affecting older patients. Characterization of outcomes in these patients may help optimise treatment decisions. The global, phase 3 NAPOLI-1 trial ( NCT01494506 ) demonstrated an overall survival (OS) benefit with liposomal irinotecan and 5-flurouracil/leucovorin (nal-IRI + 5-FU/LV) versus 5-FU/LV. This subgroup analysis explored impact of age on outcomes in NAPOLI-1 patients, and nal-IRI + 5-FU/LV efficacy and safety in older patients.
Materials and Methods
This exploratory, post-hoc analysis of the NAPOLI-1 trial included patients aged ≥eighteen years (no upper limit) with metastatic pancreatic adenocarcinoma that had progressed on gemcitabine-based therapy. Patients were stratified by age (cut-offs at 65, 70, and 75 years); OS and progression-free survival (PFS) were estimated by Kaplan-Meier analysis.
Results
Of 417 randomized patients, 192 (46%), 110 (26%) and 43 (10%) were aged ≥65, ≥70 and ≥ 75 years, respectively. Mortality risk and risk of disease progression were similar in older and younger patients independent of treatment (HRs for median [m]OS/mPFS comparisons were 0.88/0.95 [<65 versus ≥65 years], 0.89/0.88 [<70 versus ≥70 years] and 1.04/0.98 [<75 versus ≥75 years]; P > .25). Reduced mortality/morbidity risk with nal-IRI + 5-FU/LV in older subgroups was in line with the wider population. No additional toxicities with nal-IRI + 5-FU/LV were observed in older patients: 86% of patients ≥75 years versus 69% <75 years required a dose delay or reduction due to toxicities (43% versus 32% dose reductions).
Discussion
Results suggest that older patients with metastatic pancreatic adenocarcinoma that progressed on prior gemcitabine-based treatment can benefit from second-line therapy, supporting nal-IRI + 5-FU/LV treatment in older patients. |
dc.language.iso | eng |
dc.publisher | Elsevier |
dc.relation.ispartofseries | Journal of Geriatric Oncology;10 |
dc.rights | Attribution-NonCommercial-NoDerivatives 4.0 International |
dc.rights.uri | http://creativecommons.org/licenses/by-nc-nd/4.0/ |
dc.source | Scientia |
dc.subject | Pàncrees - Càncer |
dc.subject | Metàstasi |
dc.subject | Medicaments - Administració |
dc.subject.mesh | Pancreatic Neoplasms |
dc.subject.mesh | Fluorouracil |
dc.subject.mesh | /administration & dosage |
dc.subject.mesh | Neoplasm Metastasis |
dc.title | Liposomal irinotecan and 5-fluorouracil/leucovorin in older patients with metastatic pancreatic cancer - A subgroup analysis of the pivotal NAPOLI-1 trial |
dc.type | info:eu-repo/semantics/article |
dc.identifier.doi | 10.1016/j.jgo.2019.02.011 |
dc.subject.decs | neoplasias pancreáticas |
dc.subject.decs | fluorouracilo |
dc.subject.decs | /administración & dosificación |
dc.subject.decs | metástasis neoplásica |
dc.relation.publishversion | https://linkinghub.elsevier.com/retrieve/pii/S1879-4068(18)30349-7 |
dc.type.version | info:eu-repo/semantics/publishedVersion |
dc.audience | Professionals |
dc.contributor.organismes | Institut Català de la Salut |
dc.contributor.authoraffiliation | [Macarulla T] Vall d'Hebron Hospital Universitari, Barcelona, Spain. Vall d'Hebron Institute of Oncology (VHIO), Barcelona, Spain. [Blanc JF] Pôle ADEN, Hôpital Haut-Lévêque, CHU Bordeaux, Bordeaux, France. [Wang-Gillam A] Division of Oncology, Washington University in St. Louis, MO, USA. [Chen LT] National Institute of Cancer Research, National Health Research Institutes, National Cheng Kung University, Tainan, Taiwan. Department of Internal Medicine, National Cheng Kung University, Tainan, Taiwan. [Siveke JT] Division of Solid Tumor Translational Oncology, West German Cancer Center, University Hospital Essen, Essen, Germany. Cancer Consortium (DKTK, partner site Essen), German Cancer Research Center, DKFZ, Heidelberg, Germany. [Mirakhur B] Ipsen Biopharmaceuticals, Inc., Cambridge, MA, United States |
dc.identifier.pmid | 30842038 |
dc.identifier.wos | 000470049200012 |
dc.rights.accessrights | info:eu-repo/semantics/openAccess |