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

Chen Li-Tzong; Siveke Jens T.; Wang-Gillam Andrea; Li Chung-Pin; Bodoky Gyorgy; Dean Andrew P.; Shan Yan-Shen; Jameson Gayle S.; Macarulla Teresa; Lee Kyung-Hun; Cunningham David; Blanc Jean-Frederic; Chiu Chang-Fang; Schwartsmann Gilberto; Braiteh Fadi S.; Mamlouk Khalid; Belanger Bruce; de Jong Floris A.; Hubner Richard A.

首页> 外文期刊>European journal of cancer: official journal for European Organization for Research and Treatment of Cancer (EORTC) [and] European Association for Cancer Research (EACR) >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

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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

机译：与NAL-IRI（脂质体IRINOTECAN）加上5-氟尿嘧啶和白瓜和Leucovorin的生存，每方例和NAPOLI-1的非每组议程种群：对全球第3阶段试验的扩展分析

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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.

机译：背景：在第3期随机的Napoli-1临床研究中，中位数总存活（OS）增加了45％的增长，用脂质体Irinotecan，5-氟尿嘧啶和白杨（NAL-IRI + 5-FU / LV）与5-FU / LV在吉西他滨治疗后进展的转移性胰腺癌患者。在这里，我们从每协议（PP）人口中的预先规定的，扩展分析的分析报告数据。

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《European journal of cancer: official journal for European Organization for Research and Treatment of Cancer (EORTC) [and] European Association for Cancer Research (EACR) 》 |2018年第2018期| 共8页
作者
Chen Li-Tzong; Siveke Jens T.; Wang-Gillam Andrea; Li Chung-Pin; Bodoky Gyorgy; Dean Andrew P.; Shan Yan-Shen; Jameson Gayle S.; Macarulla Teresa; Lee Kyung-Hun; Cunningham David; Blanc Jean-Frederic; Chiu Chang-Fang; Schwartsmann Gilberto; Braiteh Fadi S.; Mamlouk Khalid; Belanger Bruce; de Jong Floris A.; Hubner Richard A.;
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作者单位

Natl Hlth Res Inst Natl Inst Canc Res 367 Sheng Li Rd Tainan 704 Taiwan;

Univ Hosp Essen West German Canc Ctr Div Solid Tumor Translat Oncol Hufelandstr 55 D-45147;

Washington Univ Div Oncol 660 South Euclid Ave St Louis MO 63110 USA;

Taipei Vet Gen Hosp Dept Med Div Gastroenterol &

Hepatol 201 Sect 2 Shipai Rd Taipei 112 Taiwan;

Szent Laszlo Hosp Dept Oncol Albert Florian Ut 5 H-1097 Budapest Hungary;

St John God Hosp 12 Salvado Rd Subiaco WA 6008 Australia;

Natl Cheng Kung Univ Hosp Dept Surg 138 Shengli Rd Tainan 704 Taiwan;

HonorHlth TGen Virginia G Piper Canc Ctr 10460N 92nd St 206 Scottsdale AZ 85258 USA;

HUVH Passeig Vall dHebron 119-129 Barcelona 08035 Spain;

Seoul Natl Univ Seoul Natl Univ Hosp Coll Med Dept Internal Med 1 Gwanak Ro Seoul 03080 South;

Royal Marsden Hosp NHS Fdn Trust 203 Fulham Rd London SW3 6JJ England;

CHU Bordeaux Hop Haut Leveque Pole ADEN F-33075 Bordeaux France;

China Med Univ Hosp 2 Yuh Der Rd Taichung 404 Taiwan;

Univ Fed Rio Grande do Sul Ave Paulo Gama 110 BR-90040060 Porto Alegre RS Brazil;

Univ Nevada Sch Med Comprehens Canc Ctr Nevada 3730 S Eastern Ave Las Vegas NV 89169 USA;

Ipsen Biosci Inc 650 East Kendall St Cambridge MA 02142 USA;

Ipsen Biosci Inc 650 East Kendall St Cambridge MA 02142 USA;

Shire Zahlerweg 10 CH-6300 Zug Switzerland;

Christie Hosp NHS Fdn Trust Dept Med Oncol 550 Wilmslow Rd Manchester M20 4BX Lancs England;

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原文格式 PDF
正文语种 eng
中图分类肿瘤学 ;
关键词
Clinical trial; phase III; Drug combinations; Antineoplastic; Gemcitabine; Neoplasm metastasis; Pancreatic neoplasms; Sensitivity and specificity; Survival analysis;

机译：临床试验;III期;药物组合;抗肿瘤;吉西他滨;肿瘤转移;胰腺肿瘤;敏感性和特异性;生存分析;

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专利

1. 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 [J] . Chen Li-Tzong, Siveke Jens T., Wang-Gillam Andrea, European journal of cancer: official journal for European Organization for Research and Treatment of Cancer (EORTC) [and] European Association for Cancer Research (EACR) . 2018 ,第期

机译：与NAL-IRI（脂质体IRINOTECAN）加上5-氟尿嘧啶和白瓜和Leucovorin的生存，每方例和NAPOLI-1的非每组议程种群：对全球第3阶段试验的扩展分析
2. MULTIVARIATE ANALYSIS OF HEALTH-RELATED QUALITY OF LIFE (HR-QOL) IN METASTATIC PANCREATIC CANCER (MPC) TREATED WITH 5-FLUOROURACIL AND LEUCOVORIN, WITH AND WITHOUT LIPOSOMAL IRINOTECAN (NAL-IRI) [J] . Becker C. C., Amzal B., de Jong F. A., Value in health: the journal of the International Society for Pharmacoeconomics and Outcomes Research . 2017 ,第5期

机译：用5氟尿嘧啶和白杨蛋白处理的转移性胰腺癌（MPC）中的健康相关寿命（HR-QOL）的多元分析，有脂质体IRINOTECAN（NAL-IRI）
3. IMPUTING MISSING VALUES TO ESTIMATE HEALTH-RELATED QUALITY OF LIFE (HR-QOL) IN METASTATIC PANCREATIC CANCER (MPC) TREATED WITH 5-FLUOROURACIL AND LEUCOVORIN, WITH AND WITHOUT LIPOSOMAL IRINOTECAN (NAL-IRI) [J] . Amzal B., Senecal M., de Jong F. A., Value in health: the journal of the International Society for Pharmacoeconomics and Outcomes Research . 2017 ,第5期

机译：抵消缺失的值以估计用5-氟尿嘧啶和白杨蛋白处理的转移性胰腺癌（MPC）中的健康相关的寿命质量（HR-QOL），有和没有脂质体IRINOTECAN（NAL-IRI）
4. PD-023Safety across subgroups in NAPOLI-1: a phase 3 study of nal-IRI (MM-398) ± 5-fluorouracil and leucovorin (5-FU/LV) versus 5-FU/LV in metastatic pancreatic cancer (mPAC) previously treated with gemcitabine-based therapy [O] . L.-T. Chen, J. Siveke, A. Wang-Gillam, -1

机译：PD-023 NAPOLI-1中各亚组之间的安全性：先前在转移性胰腺癌（mPAC）中对nal-IRI（MM-398）±5-氟尿嘧啶和亚叶酸钙（5-FU / LV）与5-FU / LV进行的3期研究吉西他滨治疗
5. Expanded analyses of NAPOLI-1: Phase 3 study of nal-IRI (MM-398), with or without 5-fluorouracil (5FU) and leucovorin (LV), versus 5-fluorouracil and leucovorin (5FU/LV), in metastatic pancreatic cancer (mPAC) previously treated with gemcitabine-based therapy [O] . Siveke, JT 2016

机译：扩大NAPOLI-1的分析：在有或没有5-氟尿嘧啶（5FU）和亚叶酸（LV）与5-氟尿嘧啶和亚叶酸（5FU / LV）相对的转移性胰腺中nal-IRI（MM-398）的3期研究先前使用吉西他滨治疗的癌症（mPAC）

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

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