Phase I/II study of irinotecan, UFT and leucovorin with hepatic arterial infusion using 5-FU in colorectal cancer patients with unresectable liver metastases

Cancer Chemotherapy and Pharmacology

Volumn 67, Issue 3, 2011, Pages 629-635

  Yamaguchi, Tatsuro ^a   Matsumoto, Hiroshi ^a   Yasutome, Michiya ^a   Mori, Takeo ^a   Takahashi, Keiichi ^a  

^a TOKYO METROPOLITAN KOMAGOME HOSPITAL   (Japan)

Author keywords

Colorectal cancer; Hepatic arterial infusion; Irinotecan; Leucovorin; Phase I II study; UFT

Indexed keywords

FLUOROURACIL; FOLINIC ACID; IRINOTECAN; SEROTONIN 3 ANTAGONIST; UFT; ANTINEOPLASTIC AGENT; CAMPTOTHECIN; DRUG DERIVATIVE; TEGAFUR; URACIL;

ADULT; AGED; ANOREXIA; ARTERY CATHETERIZATION; ARTERY THROMBOSIS; ARTICLE; CANCER PATIENT; CANCER SURVIVAL; CLINICAL ARTICLE; COLORECTAL CANCER; CONTROLLED STUDY; DRUG DOSE ESCALATION; DRUG DOSE REDUCTION; DRUG EFFICACY; DRUG TOLERABILITY; DRUG WITHDRAWAL; FEMALE; HEPATIC ARTERY; HUMAN; LIVER METASTASIS; MALE; MAXIMUM TOLERATED DOSE; MULTIPLE CYCLE TREATMENT; NAUSEA; NEUTROPENIA; PHASE 1 CLINICAL TRIAL; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; TREATMENT OUTCOME; VOMITING; CLINICAL TRIAL; COLORECTAL TUMOR; COMPARATIVE STUDY; DISEASE FREE SURVIVAL; DOSE RESPONSE; INTRAARTERIAL DRUG ADMINISTRATION; LIVER TUMOR; METASTASIS; MIDDLE AGED; PATHOLOGY; SURVIVAL RATE;

ADULT; AGED; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; CAMPTOTHECIN; COLORECTAL NEOPLASMS; DISEASE-FREE SURVIVAL; DOSE-RESPONSE RELATIONSHIP, DRUG; FEMALE; FLUOROURACIL; HUMANS; INFUSIONS, INTRA-ARTERIAL; LEUCOVORIN; LIVER NEOPLASMS; MALE; MAXIMUM TOLERATED DOSE; MIDDLE AGED; SURVIVAL RATE; TEGAFUR; TREATMENT OUTCOME; URACIL;

EID: 79953811276     PISSN: 03445704     EISSN: None     Source Type: Journal    
DOI: 10.1007/s00280-010-1368-z     Document Type: Article

References (36)

1. A Jemal R Siegel E Ward Y Hao J Xu T Murray MJ Thun 2008 Cancer statistics, 2008 CA Cancer J Clin 58 71 96 10.3322/CA.2007.0010 18287387 (Pubitemid 351521864)
2. The editorial board of the cancer statistics in Japan (2007) Cancer statistics in Japan 2007. Available at http://ganjoho.ncc.go.jp/public/ statistics/backnumber/2007-en.html. November 2007; Accessed September 22, 2008
3. Y Fong 1999 Surgical therapy of hepatic colorectal metastasis CA Cancer J Clin 49 231 255 1:STN:280:DC%2BD3M7gsl2hsw%3D%3D 10.3322/canjclin.49.4.231 11198884 (Pubitemid 29525144)
4. H Bismuth R Adam F Levi C Farabos F Waechter D Castaing P Majno L Engerran 1996 Resection of nonresectable liver metastases from colorectal cancer after neoadjuvant chemotherapy Ann Surg 224 509 520 1:STN:280: DyaK2s%2FhtVyhsA%3D%3D 10.1097/00000658-199610000-00009 8857855 (Pubitemid 26337559)
5. J Scheele R Stang A Altendorf-Hofmann M Paul 1995 Resection of colorectal liver metastases World J Surg 19 59 71 1:STN:280:DyaK2M3lvFeltw%3D%3D 10.1007/BF00316981 7740812
6. H Kelly RM Goldberg 2005 Systemic therapy for metastatic colorectal cancer: current options, current evidence J Clin Oncol 23 4553 4560 1:CAS:528:DC%2BD2MXnsl2ksLs%3D 10.1200/JCO.2005.17.749 16002847 (Pubitemid 46196586)
7. DJ Kerr CS McArdle J Lendermann I Taylor DJ Sherlock PM Schlag J Buckels 2003 Intrahepatic arterial versus intravenous fluorouracil and folinic acid for colorectal cancer liver metastases: a multicentre randomised trial Lancet 361 368 373 1:CAS:528:DC%2BD3sXptFejtA%3D%3D 10.1016/S0140-6736(03)12388-4 12573372 (Pubitemid 36164968)
8. N Kemeny M Gonen D Sullivan L Schwartz F Benedetti L Saltz J Stockman Y Fong W Jamagin J Bertino W Tong P Paty 2001 Phase I study of hepatic arterial infusion of floxuridine and dexamethasone with systemic irinotecan for unresectable hepatic metastases from colorectal cancer J Clin Oncol 19 2687 2695 1:CAS:528:DC%2BD3MXkt1Omu7o%3D 11352961 (Pubitemid 32441374)
9. MS Copur M Capadano J Lynch T Goertzen T McCowan R Brand M Tempero 2001 Alternating hepatic arterial infusion and systemic chemotherapy for liver metastases from colorectal cancer: a phase II trial using intermittent percutaneous hepatic arterial access J Clin Oncol 19 2404 2412 1:CAS:528:DC%2BD3MXjvVeltbc%3D 11331319 (Pubitemid 32391211)
10. S Fujii K Ikenaka M Fukushima T Shirasaka 1978 Effect of uracil and its derivatives on antitumor activity of 5-fluorouracil and 1-(2-tetrahydrofuryl)-5- fluorouracil Gann 69 763 772 750271 (Pubitemid 9081584)
11. S Fujii S Kitano K Ikenaka T Shirasaka 1979 Effect of coadministration of uracil or cytosine on the anti-tumor activity of clinical doses of 1-(2-tetrahydrofuryl)-5-fluorouracil and level of 5-fluorouracil in rodents Gann 70 209 214 1:CAS:528:DyaE1MXksV2hsb4%3D 381088 (Pubitemid 9184704)
12. JY Douillard PM Hoff JR Skillings P Eisenberg N Davidson P Harper MD Vincent BC Lembersky S Thompson A Maniero SE Benner 2002 Multicenter phase III study of uracil/tegafur and oral leucovorin versus fluorouracil and leucovorin in patients with previously untreated metastatic colorectal cancer J Clin Oncol 20 3605 3616 1:CAS:528:DC%2BD38XntVynsro%3D 10.1200/JCO.2002.04.123 12202661 (Pubitemid 34983220)
13. J Carmichael T Popiela D Radstone S Falk M Borner A Oza T Skovsgaard S Munier C Martin 2002 Randomized comparative study of tegafur/uracil and oral leucovorin versus parenteral fluorouracil and leucovorin in patients with previously untreated metastatic colorectal cancer J Clin Oncol 20 3617 3627 1:CAS:528:DC%2BD38XntVynsrs%3D 10.1200/JCO.2002.10.129 12202662 (Pubitemid 34983221)
14. E Bajetta M Di Bartolomeo R Buzzoni L Mariani N Zilembo E Ferrario S Lo Vullo E Aitini L Isa C Barone S Jacobelli E Recaldin G Pinotti A Iop 2007 Uracil/ftorafur/leucovorin combined with irinotecan (TEGAFIRI) or oxaliplatin (TEGAFOX) as first-line treatment for metastatic colorectal cancer patients: results of randomised phase II study Br J Cancer 96 439 444 1:CAS:528: DC%2BD2sXhtlKjtrs%3D 10.1038/sj.bjc.6603493 17245343 (Pubitemid 46215214)
15. JP Delord J Bennouna P Artru H Perrier F Husseini F Desseigne E François R Faroux D Smith P Piedbois H Naman JY Douillard R Bugat 2007 Phase II study of UFT with leucovorin and irinotecan (TEGAFIRI): first-line therapy for metastatic colorectal cancer Br J Cancer 97 297 301 1:CAS:528:DC%2BD2sXotlSgt7w%3D 10.1038/sj.bjc.6603889 17637682 (Pubitemid 47196756)
16. TR Fleming 1982 One-sample multiple testing procedure for phase II clinical trials Biometrics 38 143 151 1:STN:280:DyaL383gs12gsA%3D%3D 10.2307/2530297 7082756
17. Meta-Analysis Group in Cancer 1996 Reappraisal of HAI in the treatment of nonresectable liver metastases from colorectal carcinoma J Natl Cancer Inst 88 252 258 10.1093/jnci/88.5.252 (Pubitemid 26073369)
18. LB Saltz JV Cox C Blanke LS Rosen L Fehrenbacher MJ Moore JA Maroun SP Ackland PK Locker N Pirotta L Elfring LL Miller 2000 Irinotecan plus fluorouracil and leucovorin for metastatic colorectal cancer. Irinotecan Study Group N Engl J Med 343 905 914 1:CAS:528:DC%2BD3cXntFOkt7Y%3D 10.1056/NEJM200009283431302 11006366
19. JY Douillard D Cunningham AD Roth M Navarro RD James P Karasek P Jandik T Iveson J Carmichael M Alaki G Gruia L Awad P Rougier 2000 Irinotecan combined with fluorouracil compared with fluorouracil alone as first-line treatment for metastatic colorectal cancer: a multicentre randomised trial Lancet 355 1041 1047 1:CAS:528:DC%2BD3cXisFOnsb4%3D 10.1016/S0140-6736(00)02034-1 10744089 (Pubitemid 30162806)
20. RM Goldberg DJ Sargent RF Morton CS Fuchs RK Ramanathan SK Williamson BP Findlay HC Pitot SR Alberts 2004 A randomized controlled trial of fluorouracil plus leucovorin, irinotecan, and oxaliplatin combinations in patients with previously untreated metastatic colorectal cancer J Clin Oncol 22 23 30 1:CAS:528:DC%2BD2cXpsVKitbY%3D 10.1200/JCO.2004.09.046 14665611 (Pubitemid 41095110)
21. C Tournigand T André E Achille G Lledo M Flesh D Mery-Mignard E Quinaux C Couteau M Buyse G Ganem B Landi P Colin C Louvet A de Gramont 2004 FOLFIRI followed by FOLFOX6 or the reverse sequence in advanced colorectal cancer: a randomized GERCOR study J Clin Oncol 22 229 237 1:CAS:528: DC%2BD2cXpsVKit7w%3D 10.1200/JCO.2004.05.113 14657227 (Pubitemid 41095086)
22. T Delaunoit SR Alberts DJ Sargent E Green RM Goldberg J Krook C Fuchs RK Ramanathan SK Williamson RF Morton BP Findlay 2005 Chemotherapy permits resection of metastatic colorectal cancer: experience from Intergroup N9741 Ann Oncol 16 425 429 1:STN:280:DC%2BD2M%2FptVGkug%3D%3D 10.1093/annonc/mdi092 15677624 (Pubitemid 40458319)
23. R Adam E Avisar A Ariche S Giachetti D Azoulay D Castaing F Kunstlinger F Levi F Bismuth 2001 Five-year survival following hepatic resection after neoadjuvant therapy for nonresectable colorectal [liver] metastases Ann Surg Oncol 8 347 353 1:STN:280:DC%2BD3M3lsVWntg%3D%3D 10.1007/s10434-001-0347-3 11352309 (Pubitemid 32422861)
24. WD Ensminger A Rosowsky V Raso DC Levin M Glode S Come G Steele F Frei III 1978 A clinical-pharmacological evaluation of hepatic arterial infusions of 5-fluoro-2′-deoxyuridine and 5-fluorouracil Cancer Res 38 3784 3792 1:STN:280:DyaE1M%2Fit1yntw%3D%3D 151583 (Pubitemid 9045207)
25. N Kemeny K Seiter D Niedzwiecki D Chapman E Sigurdson A Cohen J Botet P Oderman P Murray 1992 A randomized trial of intrahepatic infusion of fluorodeoxyuridine with dexamethasone versus fluorodeoxyuridine alone in the treatment of metastatic colorectal cancer Cancer 69 327 334 1:STN:280: DyaK38%2Fps12lsA%3D%3D 10.1002/1097-0142(19920115)69:2<327::AID- CNCR2820690209>3.0.CO;2-U 1303612
26. S Mocellin P Pilati M Lise D Nitti 2007 Meta-analysis of hepatic arterial infusion for unresectable liver metastases from colorectal cancer: the end of an era? J Clin Oncol 25 5649 5654 10.1200/JCO.2007.12.1764 18065736
27. GD Leonard B Brenner NE Kemeny 2005 Neoadjuvant chemotherapy before liver resection for patients with unresectable liver metastases from colorectal carcinoma J Clin Oncol 23 2038 2048 1:CAS:528:DC%2BD2MXjt1Cku7Y%3D 10.1200/JCO.2005.00.349 15774795 (Pubitemid 46211384)
28. N Kemeny W Jarnagin P Paty M Gönen L Schwartz M Morse G Leonard M D'Angelica R DeMatteo L Blumgart Y Fong 2005 Phase I trial of systemic oxaliplatin combination chemotherapy with hepatic arterial infusion in patients with unresectable liver metastases from colorectal cancer J Clin Oncol 23 4888 4896 1:CAS:528:DC%2BD2MXpsFWmt7Y%3D 10.1200/JCO.2005.07.100 16009951 (Pubitemid 46223994)
29. C Pozzo M Basso A Cassano M Quirino G Schinzari N Trigila M Vellone F Giuliante G Nuzzo C Barone 2004 Neoadjuvant treatment of unresectable liver disease with irinotecan and 5-fluorouracil plus folinic acid in colorectal cancer patients Ann Oncol 15 933 939 1:STN:280:DC%2BD2c3lt12jsQ%3D%3D 10.1093/annonc/mdh217 15151951 (Pubitemid 39004350)
30. C Barone G Nuzzo A Cassano M Basso G Schinzari F Giuliante E D'Argento N Trigila A Astone C Pozzo 2007 Final analysis of colorectal cancer patients treated with irinotecan and 5-fluorouracil plus folinic acid neoadjuvant chemotherapy for unresectable liver metastases Br J Cancer 97 1035 1039 1:CAS:528:DC%2BD2sXhtFKktb%2FL 10.1038/sj.bjc.6603988 17895897 (Pubitemid 47587006)
31. SR Alberts WL Horvath WC Sternfeld RM Goldberg MR Mahoney SR Dakhil R Levitt K Rowland S Nair DJ Sargent JH Donohue 2005 Oxaliplatin, fluorouracil, and leucovorin for patients with unresectable liver-only metastases from colorectal cancer: a North Central Cancer Treatment Group phase II study J Clin Oncol 23 9243 9249 1:CAS:528:DC%2BD28Xnt1yntw%3D%3D 10.1200/JCO.2005.07.740 16230673
32. JN Vauthey TM Pawlik D Ribero TT Wu D Zorzi PM Hoff HQ Xiong C Eng GY Lauwers M Mino-Kenudson M Risio A Muratore L Capussotti SA Curley EK Abdalla 2006 Chemotherapy regimen predicts steatohepatitis and an increase in 90-day mortality after surgery for hepatic colorectal metastases J Clin Oncol 24 2065 2072 1:CAS:528:DC%2BD28Xlt1amurY%3D 10.1200/JCO.2005.05.3074 16648507 (Pubitemid 46622116)
33. H Hurwitz L Fehrenbacher W Novotny T Cartwright J Hainsworth W Heim J Berlin A Baron S Griffing E Holmgren N Ferrara G Fyfe B Rogers R Ross F Kabbinavar 2004 Bevacizumab plus irinotecan, fluorouracil, and leucovorin for metastatic colorectal cancer N Engl J Med 350 2335 2342 1:CAS:528: DC%2BD2cXks1Gjt74%3D 10.1056/NEJMoa032691 15175435 (Pubitemid 38702844)
34. BJ Giantonio PJ Catalano NJ Meropol PJ O'Dwyer EP Mitchell SR Alberts MA Schwartz AB Benson III 2007 Bevacizumab in combination with oxaliplatin, fluorouracil, and leucovorin (FOLFOX4) for previously treated metastatic colorectal cancer: results from the Eastern Cooperative Oncology Group Study E3200 J Clin Oncol 25 1539 1544 1:CAS:528:DC%2BD2sXlsVyntbc%3D 10.1200/JCO.2006.09.6305 17442997 (Pubitemid 46733080)
35. J Tabernero E Van Cutsem E Díaz-Rubio A Cervantes Y Humblet T André JL Van Laethem P Soulié E Casado C Verslype JS Valera G Tortora F Giardiello O Kisker A de Gramont 2007 Phase II trial of cetuximab in combination with fluorouracil, leucovorin, and oxaliplatin in the first-line treatment of metastatic colorectal cancer J Clin Oncol 25 5225 5232 1:CAS:528:DC%2BD2sXhsVKnsbzI 10.1200/JCO.2007.13.2183 18024868 (Pubitemid 350232254)
36. AF Sobrero J Maurel L Fehrenbacher W Scheithauer YA Abubakr MP Lutz MF Vega-Villegas C Eng EU Steinhauer J Prausova HJ Lenz C Berg G Middleton H Kröning G Luppi O Kisker A Zubel C Langer J Kopit HA Burris III 2008 EPIC: phase III trial of cetuximab plus irinotecan after fluoropyrimidine and oxaliplatin failure in patients with metastatic colorectal cancer J Clin Oncol 26 2311 2319 1:CAS:528:DC%2BD1cXntVOltrk%3D 10.1200/JCO.2007.13.1193 18390971