國家衛生研究院 NHRI:Item 3990099045/11364

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Please use this identifier to cite or link to this item: http://ir.nhri.org.tw/handle/3990099045/11364

Title:	Selected subgroup analyses of liposomal irinotecan (nal-IRI) in patients with metastatic pancreatic ductal adenocarcinoma (mPDAC) in the global NAPOLI-1 phase III trial
Authors:	Mercade, TM;Lee, K;Lakatos, G;Wang-Gillam, A;Chen, L;Mirakhur, B;De Jong, F
Contributors:	National Institute of Cancer Research
Abstract:	Introduction: NAPOLI1 (NCT01494506; Wang-Gillam et al., Lancet 2016;387:545-57) was a global phase 3 study of patients with mPDAC who progressed following gemcitabine-based therapy. In patients receiving nalIRIþ5FU/LV, median overall survival (mOS) was significantly higher (6.1 months) compared with 5FU/LV (4.2 months; unstratified HR ¼ 0.67; P ¼ 0.012). Here, we summarise four separate NAPOLI-1 sub-group analyses investigating the effect of selected baseline parameters. Methods: These post-hoc analyses explored outcomes in patients with or without metabolism and nutrition disorders (including hypercholesterolemia and decreased appetite, comprising anorexia, poor appetite, lack of appetite and loss of appetite; abstract_#327), by primary tumour location (pancreatic head only, body only, tail only, and multiple locations including or excluding the head; abstract_#335), with or without a biliary stent (abstract_#338), and by best response to prior therapy (complete response/partial response [CR/PR] vs not-CR/PR, and CR/PR/stable disease [CR/PR/SD] vs not-CR/PR/SD; abstract_#339).Results: For ITT patients in the metabolism and nutrition disorders analysis (abstract_#327), survival was significantly reduced in those patients (n ¼ 77) with baseline decreased appetite compared with patients (n ¼ 340) without decreased appetite (mOS: 3.6 vs 5.3 months; HR ¼ 1.65; P < 0.001). A trend for lower survival was observed in patients with hypercholesterolemia. In the analysis investigating the effect of primary tumour location on outcomes (abstract_#335), survival was comparable across primary tumour location subgroups (HRs¼0.87–1.06). However, patients receiving nal-IRIþ5-FU/LV showed an increased survival across primary tumour location subgroups compared with 5-FU/LV (HRs¼0.39–0.88 for groups n > 10 per arm). In ITT patients with a biliary stent at baseline (n ¼ 37), survival was comparable to those without a stent (mOS: 5.3 vs 4.8 months; HR ¼ 0.97) (abstract_#338). In patients with a stent and receiving nal-IRIþ5-FU/LV (n ¼ 15), we observed a trend for increased survival compared with patients receiving 5-FU/LV (mOS: 6.2 vs 5.2 months; HR ¼ 0.44; n ¼ 8). In patients without a stent, a similar survival benefit was seen for nal-IRIþ5-FU/LV (n ¼ 102) versus 5-FU/LV (n ¼ 111) (mOS: 6.1 vs 4.2 months; HR ¼ 0.68). For subgroups stratified by response to prior therapy (abstract_#339), there was a trend for increased survival in patients with CR/PR compared with not-CR/PR (mOS: 5.6 vs 4.8 months; HR ¼ 0.73). In patients with CR/PR/SD survival was similar compared with notCR/PR/SD (mOS both 4.9 months, HR ¼ 0.95). A trend for increased survival was also shown in patients receiving nal-IRIþ5-FU/LV with CR/PR (n ¼ 11) compared with notCR/PR (n ¼ 106) (mOS: 9.3 vs 6.1 months; HR ¼ 0.64). Survival was comparable in patients with CR/PR/SD (n ¼ 58) vs not-CR/PR/SD (n ¼ 59) (mOS: 6.2 vs 6.1 months; HR ¼ 1.04).Drug related AEs and dose modifications/discontinuations in the different subgroups were generally comparable to the NAPOLI-1 study. Conclusion: In the NAPOLI-1 study, decreased appetite at baseline was shown to be prognostic for survival in patients with mPDAC who progressed after gemcitabinebased therapy. These results indicate that appropriate management is essential in patients with decreased appetite. We did not identify a significant prognostic effect of primary tumour location, biliary stent, or best response to prior therapy in either the NAPOLI-1 ITT population or the nal-IRIþ5-FU/LV treatment arm on survival after trial inclusion. Nonetheless, a consistent treatment benefit was observed in patients treated with nal-IRIþ5-FU/LV vs 5-FU/LV alone across subgroups.
Date:	2018-06
Relation:	Annals of Oncology. 2018 Jun;29(Suppl. 5):Meeting Abstract O-004.
Link to:	https://doi.org/10.1093/annonc/mdy149.003
JIF/Ranking 2023:	http://gateway.webofknowledge.com/gateway/Gateway.cgi?GWVersion=2&SrcAuth=NHRI&SrcApp=NHRI_IR&KeyISSN=0923-7534&DestApp=IC2JCR
Cited Times(WOS):	https://www.webofscience.com/wos/woscc/full-record/WOS:000439970900004
Cited Times(Scopus):	https://www.scopus.com/inward/record.url?partnerID=HzOxMe3b&scp=85081580952
Appears in Collections:	[Li-Tzong Chen] Conference Papers/Meeting Abstract

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