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http://ir.nhri.org.tw/handle/3990099045/11365
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| Title: | Prognostic value of baseline biliary stents on outcomes in patients with metastatic pancreatic ductal adenocarcinoma (mPDAC) in the NAPOLI-1 trial |
| Authors: | Lakatos, G;Lee, K;Siveke, J;Blanc, J;Mercade, TM;Dean, A;Bodoky, G;Mirakhur, B;Chen, J;Wang-Gillam, A;Chen, L;de Jong, F |
| Contributors: | National Institute of Cancer Research |
| Abstract: | Introduction: In the NAPOLI-1 phase 3 study ofpatients with mPDAC who progressed following gemcitabine-based therapy (NCT01494506), nal-IRIþ5-FU/LV significantly increased median overall survival (mOS) vs 5-FU/LV control (6.1 vs 4.2 months; unstratified hazard ratio [HR]¼0.67 [0.49–0.92]; P¼0.012). Biliary stenting is used to treat malignant obstructive jaundice and associated complications, allowing bile efflux resulting in normalised bilirubin levels. Patients with a biliary stent were allowed to enter the NAPOLI-1 study ifplasma bilirubin was normal. Methods: This post-hoc analysis explored outcomes in patients in the NAPOLI-1 study population with or without biliary stent at baseline (BL). Results: Prior to study entry, 37/417 (9%) patients had a biliary stent. A higher proportion ofpatients with a BL stent had a primary tumour located in the head ofthe pancreas at diagnosis vs patients without a BL stent (89% vs 58%). In the overall intent-totreat (ITT) population, mOS and median progression-free survival (mPFS) were similar for patients with or without a BL stent (mOS: 5.3 vs 4.8 months, HR¼0.97, P¼0.90; mPFS: 3.5 vs 2.4 months, HR¼0.82, P¼0.32). Patients with a BL stent demonstrated a higher objective response rate (ORR) (16% vs 6%; P¼0.03) and a greater proportion ofcancer antigen 19-9 (CA19-9) responses (37% vs 20%; P<0.05) than those without. mOS was similar among patients in the nal IRIþ5 FU/LV arm with (n¼15) vs without (n¼102) a BL stent (6.2 vs 6.1 months, HR¼0.91, P¼0.78); mPFS (4.5 vs 3.0 months, HR¼0.79, P¼0.47), ORR (27% vs 15%, P¼0.26) and CA19 9 responses (42% vs 27%, P¼0.31) were numerically lower. Patients with a BL stent receiving nal-IRIþ5-FU/LV (n¼15) exhibited trends towards increased mOS (6.2 vs 5.2 months, HR¼0.44, P¼0.16) and ORR (27% vs 0, P¼0.26), improved mPFS (4.5 vs 1.5 months, HR¼0.21, P<0.01), and similar CA19-9 responses (42% vs 40%, P¼1.00) vs patients receiving 5-FU/LV (n¼8). Patients without a BL stent receiving nal IRIþ5 FU/LV (n¼102) had improved mOS (6.1 vs 4.2 months, HR¼0.68, P¼0.02), mPFS (3.0 vs 1.5 months, HR¼0.59, P<0.01), ORR (15% vs 1%, P<0.01) and CA19 9 responses (27% vs 8%, P<0.01) vs patients receiving 5 FU/ LV (n¼111). Treatment-related grade 3–4 adverse events were similar for patients with or without a BL stent, including infectious complications such as febrile neutropenia (overall safety population n¼1/34 vs n¼7/364; nal IRIþ5 FU/LV arm n¼1/14 vs n¼1/103), diarrhoea (overall safety population n¼4/34 vs n¼48/364; nal-IRIþ5FU/LV arm n¼2/14 vs n¼13/103) and decreased neutrophil count (overall safety population n¼7/34 vs n¼43/364; nal IRIþ5 FU/LV n¼2/14 vs n¼21/103). Incidence ofdose modifications with nal IRIþ5 FU/LV was broadly similar to the overall NAPOLI 1 population for patients with or without a BL stent. Conclusion: No clear prognostic effect ofbiliary stent at BL on efficacy outcomes was observed in patients with mPDAC who progressed on gemcitabine-based therapy, both in the NAPOLI-1 ITT population and the nal-IRIþ5-FU/LV treatment arm. Both patients with and without a BL stent benefitted from treatment with nal-IRIþ5-FU/LV compared with 5-FU/LV alone. These findings indicate that irrespective ofthe presence ofa biliary stent before treatment initiation, nal-IRIþ5-FU/LV is well-tolerated and can benefit patients with mPDAC who progressed on gemcitabine-based treatment. |
| Date: | 2018-06 |
| Relation: | Annals of Oncology. 2018 Jun;29(Suppl. 5):Meeting Abstract P-151. |
| Link to: | https://doi.org/10.1093/annonc/mdy151.150 |
| 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:000439970900191 |
| Cited Times(Scopus): | https://www.scopus.com/inward/record.url?partnerID=HzOxMe3b&scp=85081590966 |
| Appears in Collections: | [陳立宗] 會議論文/會議摘要
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| ISI000439970900191.pdf | | 72Kb | Adobe PDF | 245 | View/Open |
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