메뉴 건너뛰기




Volumn 387, Issue 10018, 2016, Pages 545-557

Nanoliposomal irinotecan with fluorouracil and folinic acid in metastatic pancreatic cancer after previous gemcitabine-based therapy (NAPOLI-1): A global, randomised, open-label, phase 3 trial

(21)  Wang Gillam, Andrea a   Li, Chung Pin b   Bodoky, György c   Dean, Andrew d   Shan, Yan Shen f   Jameson, Gayle g   MacArulla, Teresa h   Lee, Kyung Hun i   Cunningham, David j   Blanc, Jean F k   Hubner, Richard A l   Chiu, Chang Fang m   Schwartsmann, Gilberto n   Siveke, Jens T o   Braiteh, Fadi p   Moyo, Victor q   Belanger, Bruce q   Dhindsa, Navreet q   Bayever, Eliel q   Von Hoff, Daniel D g   more..


Author keywords

[No Author keywords available]

Indexed keywords

ALBUMIN; FLUOROURACIL; FOLINIC ACID; GEMCITABINE; GRANULOCYTE COLONY STIMULATING FACTOR; IRINOTECAN; LIPOSOME; ANTINEOPLASTIC AGENT; CAMPTOTHECIN; DEOXYCYTIDINE;

EID: 84959459386     PISSN: 01406736     EISSN: 1474547X     Source Type: Journal    
DOI: 10.1016/S0140-6736(15)00986-1     Document Type: Article
Times cited : (934)

References (29)
  • 1
    • 0003964361 scopus 로고    scopus 로고
    • American Cancer Society Atlanta
    • American Cancer Society Cancer facts and figures, 2015 2015 American Cancer Society Atlanta
    • (2015) Cancer Facts and Figures, 2015
  • 3
    • 8244254377 scopus 로고    scopus 로고
    • Improvements in survival and clinical benefit with gemcitabine as first-line therapy for patients with advanced pancreas cancer: A randomized trial
    • HA Burris 3rd, MJ Moore, J Andersen et al. Improvements in survival and clinical benefit with gemcitabine as first-line therapy for patients with advanced pancreas cancer: a randomized trial J Clin Oncol 15 1997 2403 2413
    • (1997) J Clin Oncol , vol.15 , pp. 2403-2413
    • Burris, H.A.1    Moore, M.J.2    Andersen, J.3
  • 4
    • 0033559213 scopus 로고    scopus 로고
    • An investigational new drug treatment program for patients with gemcitabine: Results for over 3000 patients with pancreatic carcinoma
    • AM Storniolo, NH Enas, CA Brown, M Voi, ML Rothenberg, R Schilsky An investigational new drug treatment program for patients with gemcitabine: results for over 3000 patients with pancreatic carcinoma Cancer 85 1999 1261 1268
    • (1999) Cancer , vol.85 , pp. 1261-1268
    • Storniolo, A.M.1    Enas, N.H.2    Brown, C.A.3    Voi, M.4    Rothenberg, M.L.5    Schilsky, R.6
  • 5
    • 34249933404 scopus 로고    scopus 로고
    • Erlotinib plus gemcitabine compared with gemcitabine alone in patients with advanced pancreatic cancer: A phase III trial of the National Cancer Institute of Canada Clinical Trials Group
    • MJ Moore, D Goldstein, J Hamm et al. Erlotinib plus gemcitabine compared with gemcitabine alone in patients with advanced pancreatic cancer: a phase III trial of the National Cancer Institute of Canada Clinical Trials Group J Clin Oncol 25 2007 1960 1966
    • (2007) J Clin Oncol , vol.25 , pp. 1960-1966
    • Moore, M.J.1    Goldstein, D.2    Hamm, J.3
  • 6
    • 79955921754 scopus 로고    scopus 로고
    • FOLFIRINOX versus gemcitabine for metastatic pancreatic cancer
    • T Conroy, F Desseigne, M Ychou for the Groupe Tumeurs Digestives of Unicancer and the PRODIGE Intergroup FOLFIRINOX versus gemcitabine for metastatic pancreatic cancer N Engl J Med 364 2011 1817 1825
    • (2011) N Engl J Med , vol.364 , pp. 1817-1825
    • Conroy, T.1    Desseigne, F.2    Ychou, M.3
  • 7
    • 84886741654 scopus 로고    scopus 로고
    • Increased survival in pancreatic cancer with nab-paclitaxel plus gemcitabine
    • DD Von Hoff, T Ervin, FP Arena et al. Increased survival in pancreatic cancer with nab-paclitaxel plus gemcitabine N Engl J Med 369 2013 1691 1703
    • (2013) N Engl J Med , vol.369 , pp. 1691-1703
    • Von Hoff, D.D.1    Ervin, T.2    Arena, F.P.3
  • 8
    • 84895882631 scopus 로고    scopus 로고
    • Beyond first-line chemotherapy for advanced pancreatic cancer: An expanding array of therapeutic options?
    • EJ Walker, AH Ko Beyond first-line chemotherapy for advanced pancreatic cancer: an expanding array of therapeutic options? World J Gastroenterol 20 2014 2224 2236
    • (2014) World J Gastroenterol , vol.20 , pp. 2224-2236
    • Walker, E.J.1    Ko, A.H.2
  • 9
    • 63949084513 scopus 로고    scopus 로고
    • Irinotecan monotherapy as second-line treatment in advanced pancreatic cancer
    • SY Yi, YS Park, HS Kim et al. Irinotecan monotherapy as second-line treatment in advanced pancreatic cancer Cancer Chemother Pharmacol 63 2009 1141 1145
    • (2009) Cancer Chemother Pharmacol , vol.63 , pp. 1141-1145
    • Yi, S.Y.1    Park, Y.S.2    Kim, H.S.3
  • 10
    • 70449525483 scopus 로고    scopus 로고
    • A randomised phase II study of modified FOLFIRI.3 vs modified FOLFOX as second-line therapy in patients with gemcitabine-refractory advanced pancreatic cancer
    • C Yoo, JY Hwang, JE Kim et al. A randomised phase II study of modified FOLFIRI.3 vs modified FOLFOX as second-line therapy in patients with gemcitabine-refractory advanced pancreatic cancer Br J Cancer 101 2009 1658 1663
    • (2009) Br J Cancer , vol.101 , pp. 1658-1663
    • Yoo, C.1    Hwang, J.Y.2    Kim, J.E.3
  • 11
    • 78049421075 scopus 로고    scopus 로고
    • Irinotecan plus bolus/infusional 5-fluorouracil and leucovorin in patients with pretreated advanced pancreatic carcinoma: A multicenter experience of the Gruppo Oncologico Italia Meridionale
    • V Gebbia, E Maiello, F Giuliani, N Borsellino, C Arcara, G Colucci Irinotecan plus bolus/infusional 5-fluorouracil and leucovorin in patients with pretreated advanced pancreatic carcinoma: a multicenter experience of the Gruppo Oncologico Italia Meridionale Am J Clin Oncol 33 2010 461 464
    • (2010) Am J Clin Oncol , vol.33 , pp. 461-464
    • Gebbia, V.1    Maiello, E.2    Giuliani, F.3    Borsellino, N.4    Arcara, C.5    Colucci, G.6
  • 12
    • 78650253617 scopus 로고    scopus 로고
    • XELIRI or FOLFIRI as salvage therapy in advanced pancreatic cancer
    • S Cereda, M Reni, A Rognone et al. XELIRI or FOLFIRI as salvage therapy in advanced pancreatic cancer Anticancer Res 30 2010 4785 4790
    • (2010) Anticancer Res , vol.30 , pp. 4785-4790
    • Cereda, S.1    Reni, M.2    Rognone, A.3
  • 13
    • 84863809711 scopus 로고    scopus 로고
    • FOLFIRI as second-line chemotherapy for advanced pancreatic cancer: A GISCAD multicenter phase II study
    • A Zaniboni, E Aitini, S Barni et al. FOLFIRI as second-line chemotherapy for advanced pancreatic cancer: a GISCAD multicenter phase II study Cancer Chemother Pharmacol 69 2012 1641 1645
    • (2012) Cancer Chemother Pharmacol , vol.69 , pp. 1641-1645
    • Zaniboni, A.1    Aitini, E.2    Barni, S.3
  • 14
    • 84867717109 scopus 로고    scopus 로고
    • FOLFIRI regimen in metastatic pancreatic adenocarcinoma resistant to gemcitabine and platinum-salts
    • C Neuzillet, O Hentic, B Rousseau et al. FOLFIRI regimen in metastatic pancreatic adenocarcinoma resistant to gemcitabine and platinum-salts World J Gastroenterol 18 2012 4533 4541
    • (2012) World J Gastroenterol , vol.18 , pp. 4533-4541
    • Neuzillet, C.1    Hentic, O.2    Rousseau, B.3
  • 15
    • 79960517714 scopus 로고    scopus 로고
    • 5-fluorouracil/leucovorin combined with irinotecan and oxaliplatin (FOLFIRINOX) as second-line chemotherapy in patients with metastatic pancreatic adenocarcinoma
    • E Assaf, M Verlinde-Carvalho, C Delbaldo et al. 5-fluorouracil/leucovorin combined with irinotecan and oxaliplatin (FOLFIRINOX) as second-line chemotherapy in patients with metastatic pancreatic adenocarcinoma Oncology 80 2011 301 306
    • (2011) Oncology , vol.80 , pp. 301-306
    • Assaf, E.1    Verlinde-Carvalho, M.2    Delbaldo, C.3
  • 16
    • 8344288331 scopus 로고    scopus 로고
    • Combined irinotecan and oxaliplatin in patients with advanced pre-treated pancreatic cancer
    • M Cantore, C Rabbi, G Fiorentini et al. Combined irinotecan and oxaliplatin in patients with advanced pre-treated pancreatic cancer Oncology 67 2004 93 97
    • (2004) Oncology , vol.67 , pp. 93-97
    • Cantore, M.1    Rabbi, C.2    Fiorentini, G.3
  • 17
    • 77952240452 scopus 로고    scopus 로고
    • Pilot study of irinotecan/oxalipltin (IROX) combination chemotherapy for patients with gemcitabine- and 5-fluorouracil- refractory pancreatic cancer
    • SY Oh, HJ Kim, TH Kim et al. Pilot study of irinotecan/oxalipltin (IROX) combination chemotherapy for patients with gemcitabine- and 5-fluorouracil- refractory pancreatic cancer Invest New Drugs 28 2010 343 349
    • (2010) Invest New Drugs , vol.28 , pp. 343-349
    • Oh, S.Y.1    Kim, H.J.2    Kim, T.H.3
  • 18
    • 0038823799 scopus 로고    scopus 로고
    • Irinotecan plus raltitrexed vs raltitrexed alone in patients with gemcitabine-pretreated advanced pancreatic adenocarcinoma
    • H Ulrich-Pur, M Raderer, G Verena Kornek et al. Irinotecan plus raltitrexed vs raltitrexed alone in patients with gemcitabine-pretreated advanced pancreatic adenocarcinoma Br J Cancer 88 2003 1180 1184
    • (2003) Br J Cancer , vol.88 , pp. 1180-1184
    • Ulrich-Pur, H.1    Raderer, M.2    Verena Kornek, G.3
  • 19
    • 19944427916 scopus 로고    scopus 로고
    • Salvage chemotherapy with mitomycin, docetaxel, and irinotecan (MDI regimen) in metastatic pancreatic adenocarcinoma: A phase i and II trial
    • M Reni, MG Panucci, P Passoni et al. Salvage chemotherapy with mitomycin, docetaxel, and irinotecan (MDI regimen) in metastatic pancreatic adenocarcinoma: a phase I and II trial Cancer Invest 22 2004 688 696
    • (2004) Cancer Invest , vol.22 , pp. 688-696
    • Reni, M.1    Panucci, M.G.2    Passoni, P.3
  • 20
    • 37849031303 scopus 로고    scopus 로고
    • Excess toxicity associated with docetaxel and irinotecan in patients with metastatic, gemcitabine-refractory pancreatic cancer: Results of a phase II study
    • AH Ko, E Dito, B Schillinger, AP Venook, EK Bergsland, MA Tempero Excess toxicity associated with docetaxel and irinotecan in patients with metastatic, gemcitabine-refractory pancreatic cancer: results of a phase II study Cancer Invest 26 2008 47 52
    • (2008) Cancer Invest , vol.26 , pp. 47-52
    • Ko, A.H.1    Dito, E.2    Schillinger, B.3    Venook, A.P.4    Bergsland, E.K.5    Tempero, M.A.6
  • 21
    • 84918536630 scopus 로고    scopus 로고
    • Preclinical activity of nanoliposomal irinotecan is governed by tumor deposition and intratumor prodrug conversion
    • AV Kalra, J Kim, SG Klinz et al. Preclinical activity of nanoliposomal irinotecan is governed by tumor deposition and intratumor prodrug conversion Cancer Res 74 2014 7003 7013
    • (2014) Cancer Res , vol.74 , pp. 7003-7013
    • Kalra, A.V.1    Kim, J.2    Klinz, S.G.3
  • 22
    • 84878447869 scopus 로고    scopus 로고
    • A randomized phase II study of PEP02 (MM-398), irinotecan or docetaxel as a second-line therapy in patients with locally advanced or metastatic gastric or gastro-oesophageal junction adenocarcinoma
    • AC Roy, SR Park, D Cunningham et al. A randomized phase II study of PEP02 (MM-398), irinotecan or docetaxel as a second-line therapy in patients with locally advanced or metastatic gastric or gastro-oesophageal junction adenocarcinoma Ann Oncol 24 2013 1567 1573
    • (2013) Ann Oncol , vol.24 , pp. 1567-1573
    • Roy, A.C.1    Park, S.R.2    Cunningham, D.3
  • 23
    • 85033400477 scopus 로고    scopus 로고
    • Lesion characterization with ferumoxytol MRI in patients with advanced solid tumors and correlation with treatment response to MM-398, nanoliposomal irinotecan (nal-IRI)
    • Barcelona, Spain; Nov 18-21 Abstract 261
    • Ramanathan RK, Korn RL, Sachdev JC, et al. Lesion characterization with ferumoxytol MRI in patients with advanced solid tumors and correlation with treatment response to MM-398, nanoliposomal irinotecan (nal-IRI). 26th EORTC-NCI-AACR Symposium; Barcelona, Spain; Nov 18-21, 2014. Abstract 261.
    • (2014) 26th EORTC-NCI-AACR Symposium
    • Ramanathan, R.K.1    Korn, R.L.2    Sachdev, J.C.3
  • 24
    • 84883169930 scopus 로고    scopus 로고
    • A multinational phase 2 study of nanoliposomal irinotecan sucrosofate (PEP02, nal-IRI) for patients with gemcitabine-refractory metastatic pancreatic cancer
    • AH Ko, MA Tempero, YS Shan et al. A multinational phase 2 study of nanoliposomal irinotecan sucrosofate (PEP02, nal-IRI) for patients with gemcitabine-refractory metastatic pancreatic cancer Br J Cancer 109 2013 920 925
    • (2013) Br J Cancer , vol.109 , pp. 920-925
    • Ko, A.H.1    Tempero, M.A.2    Shan, Y.S.3
  • 25
    • 84957662323 scopus 로고    scopus 로고
    • PEPCOL: A randomized noncomparative phase II study of PEP02 (MM-398) or irinotecan in combination with leucovorin and 5-fluorouracil as second-line therapy in patients with unresectable metastatic colorectal cancer - A GERCOR study
    • abstr 751.
    • B Chibaudel, F Maindrault-Goebel, T Andre et al. PEPCOL: a randomized noncomparative phase II study of PEP02 (MM-398) or irinotecan in combination with leucovorin and 5-fluorouracil as second-line therapy in patients with unresectable metastatic colorectal cancer - a GERCOR study Proc Am Soc Clin Oncol 33 suppl 3 2015 abstr 751.
    • (2015) Proc Am Soc Clin Oncol , vol.33
    • Chibaudel, B.1    Maindrault-Goebel, F.2    Andre, T.3
  • 26
    • 84923651982 scopus 로고    scopus 로고
    • Phase i study of nanoliposomal irinotecan (PEP02) in advanced solid tumor patients
    • TC Chang, HS Shiah, CH Yang et al. Phase I study of nanoliposomal irinotecan (PEP02) in advanced solid tumor patients Cancer Chemother Pharmacol 75 2015 579 586
    • (2015) Cancer Chemother Pharmacol , vol.75 , pp. 579-586
    • Chang, T.C.1    Shiah, H.S.2    Yang, C.H.3
  • 27
    • 30644464675 scopus 로고    scopus 로고
    • Pharmacogenetics of irinotecan metabolism and transport: An update
    • NF Smith, WD Figg, A Sparreboom Pharmacogenetics of irinotecan metabolism and transport: an update Toxicol In Vitro 20 2006 163 175
    • (2006) Toxicol in Vitro , vol.20 , pp. 163-175
    • Smith, N.F.1    Figg, W.D.2    Sparreboom, A.3
  • 28
    • 84905817411 scopus 로고    scopus 로고
    • Second-line oxaliplatin, folinic acid, and fluorouracil versus folinic acid and fluorouracil alone for gemcitabine-refractory pancreatic cancer: Outcomes from the CONKO-003 trial
    • H Oettle, H Riess, JM Stieler et al. Second-line oxaliplatin, folinic acid, and fluorouracil versus folinic acid and fluorouracil alone for gemcitabine-refractory pancreatic cancer: outcomes from the CONKO-003 trial J Clin Oncol 32 2014 2423 2429
    • (2014) J Clin Oncol , vol.32 , pp. 2423-2429
    • Oettle, H.1    Riess, H.2    Stieler, J.M.3
  • 29
    • 84922004816 scopus 로고    scopus 로고
    • PANCREOX: A randomized phase 3 study of 5FU/LV with or without oxaliplatin for second-line advanced pancreatic cancer (APC) in patients (pts) who have received gemcitabine (GEM)-based chemotherapy (CT)
    • abstr 4022.
    • S Gill, Y-J Ko, MC Cripps et al. PANCREOX: a randomized phase 3 study of 5FU/LV with or without oxaliplatin for second-line advanced pancreatic cancer (APC) in patients (pts) who have received gemcitabine (GEM)-based chemotherapy (CT) Proc Am Soc Clin Oncol 32 suppl 5 2014 abstr 4022.
    • (2014) Proc Am Soc Clin Oncol , vol.32
    • Gill, S.1    Ko, Y.-J.2    Cripps, M.C.3


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.