Nanoliposomal irinotecan plus fluorouracil and folinic acid: a new treatment option in metastatic pancreatic cancer

Expert Review of Anticancer Therapy

Volumn 16, Issue 5, 2016, Pages 485-492

  Ur Rehman, Sana Saif ^a   Lim, Kian ^a,b   Wang Gillam, Andrea ^a,b  

^a WASHINGTON UNIVERSITY   (United States)

^b Washington University in St Louis School of Medicine   (United States)

Author keywords

clinical trials; gemcitabine refractory; metastatic pancreatic cancer; Nanoliposomal irinotecan; second line chemotherapy

Indexed keywords

FLUOROURACIL; FOLINIC ACID; GEMCITABINE; IRINOTECAN; IRINOTECAN SUCROSOFATE; LIPOSOME; NANOCARRIER; OXALIPLATIN; PACLITAXEL; ANTINEOPLASTIC AGENT; CAMPTOTHECIN; NANOPARTICLE;

ADVANCED CANCER; ADVERSE OUTCOME; ARTICLE; BLEEDING; CANCER COMBINATION CHEMOTHERAPY; CANCER SURVIVAL; CLINICAL STUDY; DIARRHEA; DRUG EFFICACY; DRUG SAFETY; HUMAN; LIPOSOMAL DELIVERY; METASTASIS; NEUTROPENIA; OVERALL SURVIVAL; PANCREAS ADENOCARCINOMA; PANCREAS CANCER; SURVIVAL RATE; SURVIVAL TIME; THROMBOCYTOPENIA; TREATMENT OUTCOME; ADENOCARCINOMA; ANALOGS AND DERIVATIVES; ANIMAL; CARCINOMA, PANCREATIC DUCTAL; PANCREATIC NEOPLASMS; PATHOLOGY; RANDOMIZED CONTROLLED TRIAL (TOPIC);

ADENOCARCINOMA; ANIMALS; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; CAMPTOTHECIN; CARCINOMA, PANCREATIC DUCTAL; FLUOROURACIL; HUMANS; LEUCOVORIN; LIPOSOMES; NANOPARTICLES; PANCREATIC NEOPLASMS; RANDOMIZED CONTROLLED TRIALS AS TOPIC;

EID: 84964526763     PISSN: 14737140     EISSN: 17448328     Source Type: Journal    
DOI: 10.1080/14737140.2016.1174581     Document Type: Article

References (50)

1. R.L.Siegel, K.D.Miller, A.Jemal Cancer statistics, 2015. CA Cancer J Clin. 2015 Jan-Feb;65(1): 5–29. doi:10.3322/caac.21254. Epub 2015 Jan 5.
2. C.N.Mallinson, M.O.Rake, J.B.Cocking, et al. Chemotherapy in pancreatic cancer: results of a controlled, prospective, randomised, multicentre trial. Br Med J. 1980;281(6255):1589–1591.
3. P.S.Schein, P.T.Lavin, C.G.Moertel, et al. Randomized phase II clinical trial of adriamycin, methotrexate, and actinomycin-D in advanced measurable pancreatic carcinoma: a gastrointestinal tumor study group report. Cancer. 1978 Jul;42(1):19–22.
4. D.Kelsen, C.Hudis, D.Niedzwiecki, et al. A phase III comparison trial of streptozotocin, mitomycin, and 5-fluorouracil with cisplatin, cytosine arabinoside, and caffeine in patients with advanced pancreatic carcinoma. Cancer. 1991;68(5):965–969.
5. S.Cullinan, C.G.Moertel, H.S.Wieand, et al. A phase III trial on the therapy of advanced pancreatic carcinoma. Evaluations of the Mallinson regimen and combined 5-fluorouracil, doxorubicin, and cisplatin. Cancer. 1990;65(10):2207–2212.
6. H.A.Burris3rd, M.J.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. 1997 Jun;15(6):2403–2413.
7. T.Conroy, F.Desseigne, M.Ychou, et al. Groupe tumeurs digestives of unicancer; PRODIGE intergroup. FOLFIRINOX versus gemcitabine for metastatic pancreatic cancer. N Engl J Med. 2011;364(19):1817–1825. doi:10.1056/NEJMoa1011923.
8. D.D.Von Hoff, T.Ervin, F.P.Arena, et al. Increased survival in pancreatic cancer with nab-paclitaxel plus gemcitabine. N Engl J Med. 2013 [Oct31];369(18):1691–1703. doi:10.1056/NEJMoa1304369. Epub 2013 Oct 16.
9. U.Pelzer, I.Schwaner, J.Stieler, et al. Best supportive care (BSC) versus oxaliplatin, folinic acid and 5-fluorouracil (OFF) plus BSC in patients for second-line advanced pancreatic cancer: a phase III-study from the German CONKO-study group. Eur J Cancer. 2011 Jul;47(11):1676–1681. doi:10.1016/j.ejca.2011.04.011. Epub 2011 May 10.
10. H.Oettle, H.Riess, J.M.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. 2014 [Aug10];32(23):2423–2429. doi:10.1200/JCO.2013.53.6995. Epub 2014 Jun 30.
11. S.Gill, Y.-J.Ko, M.C.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. 2014;32(suppl 5):abstr 4022.
12. C.Louvet, R.Labianca, P.Hammel, et al. Gemcitabine in combination with oxaliplatin compared with gemcitabine alone in locally advanced or metastatic pancreatic cancer: results of a GERCOR and GISCAD phase III trial. J Clin Oncol. 2005 [May20];23(15):3509–3516.
13. S.Ohkawa, T.Okusaka, H.Isayama, et al. Randomised phase II trial of S-1 plus oxaliplatin vs S-1 in patients with gemcitabine-refractory pancreatic cancer. Br J Cancer. 2015 [Apr28];112(9):1428–1434. doi:10.1038/bjc.2015.103. Epub 2015 Apr 16.
14. S.Boeck, K.Weigang-Köhler, M.Fuchs, et al. Second-line chemotherapy with pemetrexed after gemcitabine failure in patients with advanced pancreatic cancer: a multicenter phase II trial. Ann Oncol. 2007;18(4):745–751. Epub 2007 Jan 17.
15. H.Oettle, D.Arnold, M.Esser, et al., et al. Paclitaxel as weekly second-line therapy in patients with advanced pancreatic carcinoma. Anticancer Drugs. 2000 Sep;11(8):635–638.
16. N.Androulakis, K.Syrigos, A.Polyzos, et al. Oxaliplatin for pretreated patients with advanced or metastatic pancreatic cancer: a multicenter phase II study. Cancer Invest. 2005;23(1):9–12.
17. S.Boeck, R.Wilkowski, C.J.Bruns, et al. Oral capecitabine in gemcitabine-pretreated patients with advanced pancreatic cancer. Oncology. 2007;73(3–4):221–227. doi:10.1159/000127413. Epub 2008 Apr 17.
18. G.Bodoky, C.Timcheva, D.R.Spigel, et al. A phase II open-label randomized study to assess the efficacy and safety of selumetinib (AZD6244 [ARRY-142886]) versus capecitabine in patients with advanced or metastatic pancreatic cancer who have failed first-line gemcitabine therapy. Invest New Drugs. 2012;30:1216–1223.
19. A.H.Ko, M.A.Tempero, T.B.Bekaii-Saab, et al. Dual MEK/EGFR inhibition for advanced, chemotherapy-refractory pancreatic cancer: a multicenter phase II trial of selumetinib (AZD6244; ARRY-142886) plus erlotinib. J Clin Oncol. 2013;31 Suppl:Abstract4014.
20. V.M.Chung, S.L.McDonough, P.A.Philip, et al. SWOG S1115: randomized phase II trial of selumetinib (AZD6244; ARRY 142886) hydrogen sulfate (NSC-748727) and MK-2206 (NSC-749607) vs. mFOLFOX in pretreated patients (Pts) with metastatic pancreatic cancer. J Clin Oncol. 2015;33(suppl):abstr 4119.
21. H.I.Hurwitz, N.Uppal, S.A.Wagner, et al. Randomized, double-blind, phase II study of ruxolitinib or placebo in combination with capecitabine in patients with metastatic pancreatic cancer for whom therapy with gemcitabine has failed. J Clin Oncol. 2015 [Dec1];33(34):4039–4047. doi:10.1200/JCO.2015.61.4578. Epub 2015 Sep 8.
22. D.C.Drummond, O.M.Meyer, K.Hong, et al. Optimizing liposomes for delivery of chemotherapeutic agents to solid tumors. Pharmacol Rev. 1999;51:691–743.
23. T.M.Allen, P.R.Cullis. Drug delivery systems: entering the mainstream. Science. 2004 [Mar19];303(5665):1818–1822.
24. A.Gabizon, R.Catane, B.Uziely, et al. Prolonged circulation time and enhanced accumulation in malignant exudates of doxorubicin encapsulated in polyethylene-glycol coated liposomes. Cancer Res. 1994 [Feb15];54(4):987–992.
25. R.Krishna, M.S.Webb, G.St Onge, et al. Liposomal and nonliposomal drug pharmacokinetics after administration of liposome-encapsulated vincristine and their contribution to drug tissue distribution properties. J Pharmacol Exp Ther. 2001 Sep;298(3):1206–1212.
26. T.M.Allen, M.S.Newman, M.C.Woodle, et al. Pharmacokinetics and anti-tumor activity of vincristine encapsulated in sterically stabilized liposomes. Int J Cancer. 1995;62:199–204.
27. M.S.Webb, T.O.Harasym, D.Masin, et al. Sphingomyelin-cholesterol liposomes significantly enhance the pharmacokinetic and therapeutic properties of vincristine in murine and human tumour models. Br J Cancer. 1995;72:896–904.
28. Y.Kawato, M.Aonuma, Y.Hirota, et al. Intracellular roles of SN-38, a metabolite of the camptothecin derivative CPT-11, in the antitumor effect of CPT-11. Cancer Res. 1991 [Aug15];51(16):4187–4191.
29. W.Lee, A.C.Lockhart, R.B.Kim, et al. Cancer pharmacogenomics: powerful tools in cancer chemotherapy and drug development. Oncologist. 2005 Feb;10(2):104–111.
30. K.Akimoto, A.Kawai, K.Ohya. Kinetic studies of the hydrolysis and lactonization of camptothecin and its derivatives, CPT-11 and SN-38, in aqueous solution. Chem Pharm Bull. 1994;42:2135–2138.
31. D.C.Drummond, C.O.Noble, Z.Guo, et al. Development of a highly active nanoliposomal irinotecan using a novel intra liposomal stabilization strategy. Cancer Res. 2006 [Mar15];66(6):3271–3277.
32. M.H.Kang, J.Wang, M.R.Makena, et al. Activity of MM-398, nanoliposomal irinotecan (nal-IRI), in Ewing’s family tumor xenografts is associated with high exposure of tumor to drug and high SLFN11 expression. Clin Cancer Res. 2015;21(5):1139–1150. doi:10.1158/1078-0432.CCR-14-1882.
33. T.C.Chang, H.S.Shiah, C.H.Yang, et al. Phase I study of nanoliposomal irinotecan (PEP02) in advanced solid tumor patients. Cancer Chemother Pharmacol. 2015 Mar;75(3):579–586. doi:10.1007/s00280-014-2671-x. Epub 2015 Jan 11.
34. M.L.Rothenberg, J.G.Kuhn, H.A.Burris3rd, et al. Phase I and pharmacokinetic trial of weekly CPT-11. J Clin Oncol. 1993 Nov;11(11):2194–2204.
35. L.P.Rivory, M.C.Haaz, P.Canal, et al. Pharmacokinetic interrelationships of irinotecan (CPT-11) and its three major plasma metabolites in patients enrolled in phase I/II trials. Clin Cancer Res. 1997 Aug;3(8):1261–1266.
36. K.Araki, K.Fujita, Y.Ando, et al. Pharmacogenetic impact of polymorphisms in the coding region of the UGT1A1 gene on SN-38 glucuronidation in Japanese patients with cancer. Cancer Sci. 2006;97:1255–1259. doi:10.1111/j.1349-7006.2006.00321.x.
37. H.Minami, K.Sai, M.Saeki, et al. Irinotecan pharmacokinetics/pharmacodynamics and UGT1A genetic polymorphisms in Japanese: roles of UGT1A1*6 and *28. Pharmacogenet Genomics. 2007;17:497–504. doi:10.1097/FPC.0b013e328014341f.
38. L.T.Chen, H.S.Shiah, P.C.Lin, et al. Phase I study of biweekly liposome irinotecan (PEP02, MM-398) in metastatic colorectal cancer after first-line oxaliplatin-based chemotherapy. J Clin Oncol. 2012;30(4):abstr 613.
39. A.C.Roy, S.R.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. 2013 Jun;24(6):1567–1573. doi:10.1093/annonc/mdt002. Epub 2013 Feb 13.
40. G.G.Chabot, D.Abigerges, G.Catimel, et al. Population pharmacokinetics and pharmacodynamics of irinotecan (CPT-11) and active metabolite SN-38 during phase I trials. Ann Oncol. 1995;6:141–151.
41. G.G.Chabot. Clinical pharmacokinetics of irinotecan. Clin Pharmacokinet. 1997 Oct;33(4):245–259.
42. A.H.Ko, M.A.Tempero, Y.-S.Shan, et al. A multinational phase 2 study of nanoliposomal irinotecan sucrosofate (PEP02, MM-398) for patients with gemcitabine-refractory metastatic pancreatic cancer. Br J Cancer. 2013 [Aug20];109(4):920–925. doi:10.1038/bjc.2013.408. Epub 2013 Jul 23.
43. A.Wang-Gillam, C.P.Li, G.Bodoky, et al. NAPOLI-1 study group. 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. Lancet. 2015 [Nov20]:pii: S0140-6736(15)00986-1. doi:10.1016/S0140-6736(15)00986-1. [Epub ahead of print].
44. R.K.Ramanathan, R.L.Korn, J.C.Sachdev, et al. Pilot study in patients with advanced solid tumors to evaluate feasibility of ferumoxytol (FMX) as tumor imaging agent prior to MM-398, a nanoliposomal irinotecan (nal-IRI). [Abstract]. In: Proceedings of the 105th Annual Meeting of the American Association for Cancer Research; 2014 Apr5–9; San Diego, CA. Philadelphia (PA): AACR; Cancer Res 2014; 74(19Suppl):Abstract nr CT224. doi:10.1158/1538-7445.AM2014-CT224
45. J.Mollenhauer, I.Roether, H.F.Kern. Distribution of extracellular matrix proteins in pancreatic ductal adenocarcinoma and its influence on tumor cell proliferation in vitro. Pancreas. 1987;2:14–24.
46. I.Watanabe, T.Hasebe, S.Sasaki, et al. Advanced pancreatic ductal cancer: fibrotic focus and beta-catenin expression correlate with outcome. Pancreas. 2003 May;26(4):326–333.
47. R.Neijzen, M.Q.Wong, N.Gill, et al. Irinophore C™, a lipid nanoparticulate formulation of irinotecan, improves vascular function, increases the delivery of sequentially administered 5-FU in HT-29 tumors, and controls tumor growth in patient derived xenografts of colon cancer. J Control Release. 2015 [Feb10];199:72–83. doi:10.1016/j.jconrel.2014.11.031. Epub 2014 Dec 8.
48. M.Verreault, M.Wehbe, D.Strutt, et al. Determination of an optimal dosing schedule for combining Irinophore C™ and temozolomide in an orthotopic model of glioblastoma. J Control Release. 2015 [Dec28];220(Pt A):348–357. doi:10.1016/j.jconrel.2015.10.053. Epub 2015 Nov 1.
49. L.Zhang, D.-Y.Cao, J.Wang, et al. PEG-coated irinotecan cationic liposomes improve the therapeutic efficacy of breast cancer in animals. Eur Rev Med Pharmacol Sci. 2013 Dec;17(24):3347–3361.
50. C.Yang, Z.X.Fu. PEG-liposomal oxaliplatin combined with nuclear factor-κB inhibitor (PDTC) induces apoptosis in human colorectal cancer cells. Oncol Rep. 2014 Oct;32(4): 1617–1621. doi:10.3892/or.2014.3336. Epub 2014 Jul 17.