FOLFIRINOX-a new paradigm in the treatment of pancreatic cancer

Expert Review of Anticancer Therapy

Volumn 14, Issue 10, 2014, Pages 1115-1125

  Papadatos Pastos, Dionysios ^a   Thillai, Kiruthikah ^a   Rabbie, Roy ^a   Ross, Paul ^a   Sarker, Debashis ^a,b  

^a GUY'S AND ST THOMAS' NHS FOUNDATION TRUST   (United Kingdom)

^b GUY S HOSPITAL   (United Kingdom)

Author keywords

chemoradiotherapy; chemotherapy; clinical trials; genomics; pancreas cancer

Indexed keywords

ALGENPANTUCEL L; FLUOROURACIL; FOLINIC ACID; GEMCITABINE; GLUCURONOSYLTRANSFERASE 1A1; IPILIMUMAB; IRINOTECAN; OXALIPLATIN; PATIDEGIB; SMAD4 PROTEIN; ANTINEOPLASTIC AGENT; CAMPTOTHECIN; DEOXYCYTIDINE; PLATINUM COMPLEX; TUMOR MARKER;

ANTINEOPLASTIC ACTIVITY; CANCER COMBINATION CHEMOTHERAPY; CANCER IMMUNOTHERAPY; CHEMORADIOTHERAPY; DIARRHEA; DISEASE COURSE; DISEASE FREE SURVIVAL; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; FEBRILE NEUTROPENIA; HUMAN; METASTATIC MELANOMA; MULTIPLE CYCLE TREATMENT; NEUTROPENIA; OVERALL SURVIVAL; PANCREAS CANCER; PHASE 1 CLINICAL TRIAL (TOPIC); PHASE 2 CLINICAL TRIAL (TOPIC); PHASE 3 CLINICAL TRIAL (TOPIC); PROGRESSION FREE SURVIVAL; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL (TOPIC); RETROSPECTIVE STUDY; REVIEW; SMAD4 GENE; THROMBOCYTOPENIA; UGT1A1 GENE; ANALOGS AND DERIVATIVES; ANIMAL; COMPARATIVE STUDY; METABOLISM; PANCREATIC NEOPLASMS; PATHOLOGY; TREATMENT OUTCOME;

ANIMALS; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; BIOMARKERS, TUMOR; CAMPTOTHECIN; DEOXYCYTIDINE; FLUOROURACIL; HUMANS; LEUCOVORIN; ORGANOPLATINUM COMPOUNDS; PANCREATIC NEOPLASMS; TREATMENT OUTCOME;

EID: 84907532029     PISSN: 14737140     EISSN: 17448328     Source Type: Journal    
DOI: 10.1586/14737140.2014.957188     Document Type: Review

References (69)

1. Jemal A, Siegel R, Xu J, et al. Cancer statistics, 2010. CA Cancer J Clin 2010; 60(5):277-300
2. Cancerresearchuk.org. Available from: Www. cancerreaserchuk.org/statistics
3. Vincent A, Herman J, Schulick R, et al. Pancreatic cancer. Lancet 2011;378(9791): 607-20
4. Burris HA III, Moore MJ, Andersen J, 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; 15(6):2403-13
5. Berlin JD, Catalano P, Thomas JP, et al. Phase III study of gemcitabine in combination with fluorouracil versus gemcitabine alone in patients with advanced pancreatic carcinoma: Eastern Cooperative Oncology Group Trial E2297. J Clin Oncol 2002;20(15):3270-5
6. Cunningham D, Chau I, Stocken DD, et al. Phase III randomized comparison of gemcitabine versus gemcitabine plus capecitabine in patients with advanced pancreatic cancer. J Clin Oncol 2009; 27(33):5513-18
7. Heinemann V, Labianca R, Hinke A, et al. Increased survival using platinum analog combined with gemcitabine as compared to single-Agent gemcitabine in advanced pancreatic cancer: Pooled analysis of two randomized trials, the GERCOR/GISCAD intergroup study and a German multicenter study. Ann Oncol 2007;18(10):1652-9
8. Jones S, Zhang X, Parsons DW, et al. Core signaling pathways in human pancreatic cancers revealed by global genomic analyses. Science 2008;321(5897):1801-6
9. Moore MJ, Goldstein D, Hamm J, 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 2007; 25(15):1960-6
10. Philip PA, Benedetti J, Corless CL, et al. Phase III study comparing gemcitabine plus cetuximab versus gemcitabine in patients with advanced pancreatic adenocarcinoma: Southwest Oncology Group-directed intergroup trial S0205. J Clin Oncol 2010; 28(22):3605-10
11. Kim GP, Foster NR, Salim M, et al. Randomized phase II trial of panitumumab (P), erlotinib (E), and gemcitabine (G) versus erlotinib-gemcitabine in patients with untreated, metastatic pancreatic adenocarcinoma. J Clin Oncol 2011; 29(Suppl 4):abstract 238
12. Van Cutsem E, van De Velde H, Karasek P, et al. Phase III trial of gemcitabine plus tipifarnib compared with gemcitabine plus placebo in advanced pancreatic cancer. J Clin Oncol 2004;22(8):1430-8
13. Seo Y, Baba H, Fukuda T, et al. High expression of vascular endothelial growth factor is associated with liver metastasis and a poor prognosis for patients with ductal pancreatic adenocarcinoma. Cancer 2000; 88(10):2239-45
14. Kindler HL, Niedzwiecki D, Hollis D, et al. Gemcitabine plus bevacizumab compared with gemcitabine plus placebo in patients with advanced pancreatic cancer: Phase III trial of the Cancer and Leukemia Group B (CALGB 80303). J Clin Oncol 2010; 28(22):3617-22
15. Kindler HL, Ioka T, Richel DJ, et al. Axitinib plus gemcitabine versus placebo plus gemcitabine in patients with advanced pancreatic adenocarcinoma: A double-blind randomised phase 3 study. Lancet Oncol 2011;12(3):256-62
16. Gonçalves A, Gilabert M, François E, et al. BAYPAN study: A double-blind phase III randomized trial comparing gemcitabine plus sorafenib and gemcitabine plus placebo in patients with advanced pancreatic cancer. Ann Oncol 2012;23(11):2799-805
17. Von Hoff DD, Ervin T, Arena FP, et al. Increased survival in pancreatic cancer with nab-paclitaxel plus gemcitabine. N Engl J Med 2013;369(18):1691-703
18. Conroy T, Desseigne F, Ychou M, et al. FOLFIRINOX versus gemcitabine for metastatic pancreatic cancer. N Engl J Med 2011;364(19):1817-25
19. Peddi PF, Lubner S, McWilliams R, et al. Multi-institutional experience with FOLFIRINOX in pancreatic adenocarcinoma. JOP 2012;13(5):497-501
20. Faris JE, Blaszkowsky LS, McDermott S, et al. FOLFIRINOX in locally advanced pancreatic cancer: The Massachusetts General Hospital Cancer Center experience. Oncologist 2013;18(5):543-8
21. Goncalves PH, Ruch JM, Byer J, et al. Multi-institutional experience using 5-fluorouracil, leucovorin, irinotecan, and oxaliplatin (FOLFIRINOX) in patients with pancreatic cancer (PCA). J Clin Oncol 2012;30(Suppl):abstract e14519
22. Mahaseth H, Brutcher E, Kauh J, et al. Modified FOLFIRINOX regimen with improved safety and maintained efficacy in pancreatic adenocarcinoma. Pancreas 2013; 42(8):1311-15
23. Gunturu KS, Yao X, Cong X, et al. FOLFIRINOX for locally advanced and metastatic pancreatic cancer: Single institution retrospective review of efficacy and toxicity. Med Oncol 2013;30(1):361
24. Lowery MA, Yu KH, Adel NG, et al. Activity of front-line FOLFIRINOX (FFX) in stage III/IV pancreatic adenocarcinoma (PC) at Memorial Sloan-Kettering Cancer Center (MSKCC). J Clin Oncol 2012; 30(Suppl):abstract 4057
25. Assaf E, Verlinde-Carvalho M, Delbaldo C, et al. 5-fluorouracil/leucovorin combined with irinotecan and oxaliplatin (FOLFIRINOX) as second-line chemotherapy in patients with metastatic pancreatic adenocarcinoma. Oncology 2011; 80(5-6):301-6
26. Breysacher G, Kaatz O, Lemarignier C, et al. Safety and clinical effectiveness of FOLFIRINOX in metastatic pancreas cancer (MPC) after first-line chemotherapy [abstract 269]. Gastrointestinal Cancers Symposium; Orlando, FL, USA; 2010
27. Gill S, Ho MY, Kennecke HF, et al. Defining eligibility of FOLFIRINOX for first-line metastatic pancreatic adenocarcinoma (MPC) in the province of British Columbia: A population-based retrospective study. J Clin Oncol 2012; 30(Suppl):abstract e14588
28. Philip PA. Locally advanced pancreatic cancer: Where should we go from here?. J Clin Oncol 2011;29(31):4066-8
29. Chauffert B, Mornex F, Bonnetain F, et al. Phase III trial comparing intensive induction chemoradiotherapy (60 Gy, infusional 5-FU and intermittent cisplatin) followed by maintenance gemcitabine with gemcitabine alone for locally advanced unresectable pancreatic cancer. Definitive results of the 2000-01 FFCD/SFRO study. Ann Oncol 2008;19(9):1592-9
30. Loehrer PJ Sr, Feng Y, Cardenes H, et al. Gemcitabine alone versus gemcitabine plus radiotherapy in patients with locally advanced pancreatic cancer: An Eastern Cooperative Oncology Group trial. J Clin Oncol 2011;29(31):4105-12
31. Arvold ND, Ryan DP, Niemierko A, et al. Long-Term outcomes of neoadjuvant chemotherapy before chemoradiation for locally advanced pancreatic cancer. Cancer 2012;118(12):3026-35
32. Hammel P, Huguet F, Van Laethem JL, et al. Comparison of chemoradiotherapy (CRT) and chemotherapy (CT) in patients with a locally advanced pancreatic cancer (LAPC) controlled after 4 months of gemcitabine with or without erlotinib: Final results of the international phase III LAP 07 study. J Clin Oncol 2013;31(Suppl): Abstract LBA4003
33. Yachida S, Jones S, Bozic I, et al. Distant metastasis occurs late during the genetic evolution of pancreatic cancer. Nature 2010;467:1114-17
34. Rhim AD, Mirek ET, Aiello NM, et al. EMT and dissemination precede pancreatic tumor formation. Cell 2012;148:349-61
35. Iacobuzio-Donahue CA, Fu B, Yachida S, et al. DPC4 gene status of the primary carcinoma correlates with patterns of failure in patients with pancreatic cancer. J Clin Oncol 2009;27(11):1806-13
36. Crane CH, Varadhachary GR, Yordy JS, et al. Phase II trial of cetuximab, gemcitabine, and oxaliplatin followed by chemoradiation with cetuximab for locally advanced (T4) pancreatic adenocarcinoma: Correlation of Smad4(Dpc4) immunostaining with pattern of disease progression. J Clin Oncol 2011;29(22): 3037-43
37. Hosein PJ, Macintyre J, Kawamura C, et al. A retrospective study of neoadjuvant FOLFIRINOX in unresectable or borderline-resectable locally advanced pancreatic adenocarcinoma. BMC Cancer 2012;12:199
38. Boone BA, Steve J, Krasinskas AM, et al. Outcomes with FOLFIRINOX for borderline resectable and locally unresectable pancreatic cancer. J Surg Oncol 2013; 108(4):236-41
39. Kharofa J, Kelly TR, Ritch PS, et al. FOLFIRINOX induction followed by chemoXRT in borderline resectable pancreatic cancer. J Clin Oncol 2012; 30(Suppl):abstract e14613
40. Tinchon C, Hubmann E, Pichler A, et al. Safety and efficacy of neoadjuvant FOLFIRINOX treatment in a series of patients with borderline resectable pancreatic ductal adenocarcinoma. Acta Oncol 2013; 52(6):1231-3
41. Faris JE, Hong TS, McDermott S, et al. FOLFIRINOX in locally advanced and metastatic pancreatic cancer. J Clin Oncol 2012;30(Suppl 4):abstract 313
42. Marthey L, Sa-Cunha A, Blanc JF, et al. FOLFIRINOX for locally advanced pancreatic adenocarcinoma. results of an AGEO multicentric prospective study [abstract 716P]. Ann Oncol 2012; 23(Suppl 9):ix238
43. Conroy T, Paillot B, François E, et al. Irinotecan plus oxaliplatin and leucovorin-modulated fluorouracil in advanced pancreatic cancer - A Groupe Tumeurs Digestives of the Fédération Nationale des Centres de Lutte Contre le Cancer study. J Clin Oncol 2005;23:1228-36
44. Vasile E, De Lio N, Cappelli C, et al. Neoadjuvant modified FOLFOXIRI in locally advanced pancreatic cancer [abstract 726P]. Ann Oncol 2012;23(Suppl 9):ix241
45. Dangi-Garimella S, Krantz SB, Barron MR, et al. Three-dimensional collagen I promotes gemcitabine resistance in pancreatic cancer through MT1-MMP-mediated expression of HMGA2. Cancer Res 2011;71(3):1019-28
46. Bramhall SR, Rosemurgy A, Brown PD, et al. Marimastat as first-line therapy for patients with unresectable pancreatic cancer: A randomized trial. J Clin Oncol 2001; 19(15):3447-55
47. Bramhall SR, Schulz J, Nemunaitis J, et al. A double-blind placebo-controlled, randomised study comparing gemcitabine and marimastat with gemcitabine and placebo as first line therapy in patients with advanced pancreatic cancer. Br J Cancer 2002;87(2):161-7
48. Ko AH, LoConte NK, Kantoff E, et al. A phase Ib trial of FOLFIRINOX plus saridegib, an oral hedgehog (Hh) inhibitor, in pts with advanced pancreatic cancer (PDAC). J Clin Oncol 2012;30(Suppl): Abstract 3105
49. Robert C, Thomas L, Bondarenko I, et al. Ipilimumab plus dacarbazine for previously untreated metastatic melanoma. N Engl J Med 2011;364(26):2517-26
50. Hardacre JM, Mulcahy M, Small W, et al. Addition of algenpantucel-L immunotherapy to standard adjuvant therapy for pancreatic cancer: A phase 2 study. J Gastrointest Surg 2013;17(1):94-100
51. Lutz E, Yeo CJ, Lillemoe KD, et al. A lethally irradiated allogeneic granulocyte-macrophage colony stimulating factor-secreting tumor vaccine for pancreatic adenocarcinoma. A Phase II trial of safety, efficacy, and immune activation. Ann Surg 2011;253(2):328-35
52. Carbone DP, Ciernik IF, Kelley MJ, et al. Immunization with mutant p53- And K-ras-derived peptides in cancer patients: Immune response and clinical outcome. J Clin Oncol 2005;23(22):5099-107
53. Vasef MA, Ross JS, Cohen MB. Telomerase activity in human solid tumors. Diagnostic utility and clinical applications. Am J Clin Pathol 1999;112(1 Suppl 1):S68-75
54. Marshall JL, Gulley JL, Arlen PM, et al. Phase I study of sequential vaccinations with fowlpox-CEA(6D)-TRICOM alone and sequentially with vaccinia-CEA(6D)-TRICOM, with and without granulocyte-macrophage colony-stimulating factor, in patients with carcinoembryonic antigen-expressing carcinomas. J Clin Oncol 2005;23(4):720-31
55. Gunturu KS, Rossi GR, Saif MW. Immunotherapy updates in pancreatic cancer: Are we there yet?. Ther Adv Med Oncol 2013;5(1):81-9
56. A Phase 2, Multicenter Study of FOLFIRINOX Followed by Ipilimumab With Allogenic GM-CSF Transfected Pancreatic Tumor Vaccine in the Treatment of Metastatic Pancreatic Cancer. Available from: Http://clinicaltrials.gov/show/NCT01896869
57. Marsh S, McLeod HL. Pharmacogenetics of irinotecan toxicity. Pharmacogenomics 2004;5(7):835-43
58. Ando Y, Saka H, Ando M, et al. Polymorphisms of UDP-glucuronosyltransferase gene and irinotecan toxicity: A pharmacogenetic analysis. Cancer Res 2000;60(24):6921-6
59. Genotype-guided Dosing of mFOLFIRINOX Chemotherapy in Patients With Previously Untreated Advanced Gastrointestinal Malignancies. Available from: Http://clinicaltrials.gov/show/NCT01643499
60. Desai N, Trieu V, Damascelli B, et al. SPARC Expression Correlates with Tumor Response to Albumin-Bound Paclitaxel in Head and Neck Cancer Patients. Transl Oncol 2009;2(2):59-64
61. Phase III FOLFIRINOX (mFFX) +/- SBRT in Locally Advanced Pancreatic Cancer. Available from: Http://clinicaltrials.gov/show/NCT01926197
62. FOLFIRINOX + RT for Pancreatic Cancer. Available from: Http://clinicaltrials.gov/show/NCT01591733
63. Preoperative Folfirinox, Radiation Therapy for Resectable Adenocarcinoma of the Pancreas. Available from: Http://clinicaltrials. gov/show/NCT01560949
64. Proton w/FOLFIRINOX-Losartan for Pancreatic Cancer. Available from: Http:// clinicaltrials.gov/show/NCT01821729
65. Borderline Pancreas Study: FOLFIRINOX +SBRT (GCC 1324). Available from: Http://clinicaltrials.gov/show/NCT01992705
66. A Study of Neoadjuvant FOLFIRINOX and FDR-Gemcitabine With Concurrent IMRT in Patients. Available from: Http:// clinicaltrials.gov/show/NCT01661088
67. Phase I Study of Stereotactic Body Radiation Therapy and FOLFIRINOX in the Neoadjuvant Therapy of Pancreatic Cancer. Available from: Http://clinicaltrials.gov/show/NCT01446458
68. Neoadjuvant Folfirinox Followed by Capecitabine and Limited Field Radiation for Localized Pancreatic Head Adenocarcinoma. Available from: Http:// clinicaltrials.gov/show/NCT01677988
69. A Phase II Study of Locally Advanced Pancreatic Cancer. Available from: Http:// clinicaltrials.gov/show/NCT01867892