A phase i study of infusional 5-fluorouracil, leucovorin, oxaliplatin and irinotecan in Japanese patients with advanced colorectal cancer who harbor UGT1A1 * 1/ * 1 , * 1/ * 6 or * 1/ * 28

Oncology

Volumn 82, Issue 4, 2012, Pages 242-248

  Sunakawa, Yu ^a   Fujita, Ken Ichi ^a   Ichikawa, Wataru ^a,b   Ishida, Hiroo ^a   Yamashita, Keishi ^a   Araki, Kazuhiro ^a   Miwa, Keisuke ^a   Kawara, Kaori ^a   Akiyama, Yuko ^a   Yamamoto, Wataru ^a   Nagashima, Fumio ^a   Saji, Shigehira ^a   Sasaki, Yasutsuna ^a  

^a SAITAMA MEDICAL UNIVERSITY   (Japan)

^b NATIONAL DEFENSE MEDICAL COLLEGE   (Japan)

Author keywords

Colorectal cancer; Combination chemotherapy; FOLFOXIRI; Irinotecan; Oxaliplatin; Phase 1 study; UDP glucuronosyltransferase 1A1

Indexed keywords

FLUOROURACIL; FOLINIC ACID; GLUCURONOSYLTRANSFERASE 1A1; IRINOTECAN; OXALIPLATIN;

ADULT; ADVANCED CANCER; AGED; ALANINE AMINOTRANSFERASE BLOOD LEVEL; ALOPECIA; ANEMIA; ANOREXIA; ARTICLE; ASPARTATE AMINOTRANSFERASE BLOOD LEVEL; CLINICAL ARTICLE; COLORECTAL CANCER; CONSTIPATION; DIARRHEA; DRUG EFFICACY; DRUG FEVER; DRUG SAFETY; FATIGUE; FEBRILE NEUTROPENIA; FEMALE; GENOTYPE; HUMAN; INFECTION; JAPANESE; LIVER METASTASIS; LYMPH NODE METASTASIS; MALE; MAXIMUM TOLERATED DOSE; MUCOSA INFLAMMATION; MULTIPLE CYCLE TREATMENT; NAUSEA; NEUTROPENIA; PHASE 1 CLINICAL TRIAL; PRIORITY JOURNAL; SENSORY NEUROPATHY; SIDE EFFECT; THROMBOCYTOPENIA; TREATMENT RESPONSE; VOMITING;

ADULT; AGED; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; CAMPTOTHECIN; COLORECTAL NEOPLASMS; FEMALE; FLUOROURACIL; GLUCURONOSYLTRANSFERASE; HUMANS; INFUSIONS, INTRAVENOUS; LEUCOVORIN; MALE; MAXIMUM TOLERATED DOSE; MIDDLE AGED; ORGANOPLATINUM COMPOUNDS; TREATMENT OUTCOME;

EID: 84859700837     PISSN: 00302414     EISSN: 14230232     Source Type: Journal    
DOI: 10.1159/000337225     Document Type: Article

References (27)

1. Grothey A, Sargent D, Goldberg RM, Schmoll HJ: Survival of patients with advanced colorectal cancer improves with the availability of fluorouracil-leucovorin, irinotecan, and oxaliplatin in the course of treatment. J Clin Oncol 2004; 22: 1209-1214. (Pubitemid 41079833)
2. Grothey A, Sargent D: Overall survival of patients with advanced colorectal cancer correlates with availability of fluorouracil, irinotecan, and oxaliplatin regardless of whether doublet or single-agent therapy is used first line. J Clin Oncol 2005; 23: 9441-9442.
3. Falcone A, Ricci S, Brunetti I, Pfanner E, Allegrini G, Barbara C, Crino L, Benedetti G, Evangelista W, Fanchini L, Cortesi E, Picone V, Vitello S, Chiara S, Granetto C, Porcile G, Fioretto L, Orlandini C, Andreuccetti M, Masi G: Phase III trial of infusional fluorouracil, leucovorin, oxaliplatin, and irinotecan (FOLFOXIRI) compared with infusional fluorouracil, leucovorin, and irinotecan (FOLFIRI) as first-line treatment for metastatic colorectal cancer: the Gruppo Oncologico Nord Ovest. J Clin Oncol 2007; 25: 1670-1676. (Pubitemid 46797946)
4. Souglakos J, Androulakis N, Syrigos K, Polyzos A, Ziras N, Athanasiadis A, Kakolyris S, Tsousis S, Kouroussis C, Vamvakas L, Kalykaki A, Samonis G, Mavroudis D, Georgoulias V: FOLFOXIRI (folinic acid, 5-fluorouracil, oxaliplatin and irinotecan) vs FOLFIRI (folinic acid, 5-fluorouracil and irinotecan) as first-line treatment in metastatic colorectal cancer (MCC): a multicentre randomised phase III trial from the Hellenic Oncology Research Group (HORG). Br J Cancer 2006; 94: 798-805.
5. Tournigand C, Andre T, Achille E, Lledo G, Flesh M, Mery-Mignard D, Quinaux E, Couteau C, Buyse M, Ganem G, Landi B, Colin P, Louvet C, de Gramont A: FOLFIRI followed by FOLFOX6 or the reverse sequence in advanced colorectal cancer: a randomized GERCOR study. J Clin Oncol 2004; 22: 229-237. (Pubitemid 41095086)
6. Seymour MT, Maughan TS, Ledermann JA, Topham C, James R, Gwyther SJ, Smith DB, Shepherd S, Maraveyas A, Ferry DR, Meade AM, Thompson L, Griffiths GO, Parmar MK, Stephens RJ: Different strategies of sequential and combination chemotherapy for patients with poor prognosis advanced colorectal cancer (MRC FOCUS): a randomised controlled trial. Lancet 2007; 370: 143-152. (Pubitemid 47042894)
7. Cassidy J, Clarke S, Diaz-Rubio E, Scheithauer W, Figer A, Wong R, Koski S, Lichinitser M, Yang TS, Rivera F, Couture F, Sirzen F, Saltz L: Randomized phase III study of capecitabine plus oxaliplatin compared with fluorouracil/folinic acid plus oxaliplatin as first-line therapy for metastatic colorectal cancer. J Clin Oncol 2008; 26: 2006-2012.
8. Saltz LB, Clarke S, Diaz-Rubio E, Scheithauer W, Figer A, Wong R, Koski S, Lichinitser M, Yang TS, Rivera F, Couture F, Sirzen F, Cassidy J: Bevacizumab in combination with oxaliplatin-based chemotherapy as first-line therapy in metastatic colorectal cancer: a randomized phase III study. J Clin Oncol 2008; 26: 2013-2019.
9. Van Cutsem E, Kohne CH, Hitre E, Zaluski J, Chang Chien CR, Makhson A, D'Haens G, Pinter T, Lim R, Bodoky G, Roh JK, Folprecht G, Ruff P, Stroh C, Tejpar S, Schlichting M, Nippgen J, Rougier P: Cetuximab and chemotherapy as initial treatment for metastatic colorectal cancer. N Engl J Med 2009; 360: 1408-1417.
10. Douillard JY, Siena S, Cassidy J, Tabernero J, Burkes R, Barugel M, Humblet Y, Bodoky G, Cunningham D, Jassem J, Rivera F, Kocakova I, Ruff P, Blasinska-Morawiec M, Smakal M, Canon JL, Rother M, Oliner KS, Wolf M, Gansert J: Randomized, phase III trial of panitumumab with infusional fluorouracil, leucovorin, and oxaliplatin (FOLFOX4) versus FOLFOX4 alone as first-line treatment in patients with previously untreated metastatic colorectal cancer: the PRIME study. J Clin Oncol 2010; 28: 4697-4705.
11. Masi G, Cupini S, Marcucci L, Cerri E, Loupakis F, Allegrini G, Brunetti IM, Pfanner E, Viti M, Goletti O, Filipponi F, Falcone A: Treatment with 5-fluorouracil/folinic acid, oxaliplatin, and irinotecan enables surgical resection of metastases in patients with initially unresectable metastatic colorectal cancer. Ann Surg Oncol 2006; 13: 58-65. (Pubitemid 43117646)
12. Masi G, Loupakis F, Pollina L, Vasile E, Cupini S, Ricci S, Brunetti IM, Ferraldeschi R, Naso G, Filipponi F, Pietrabissa A, Goletti O, Baldi G, Fornaro L, Andreuccetti M, Falcone A: Long-term outcome of initially unresectable metastatic colorectal cancer patients treated with 5-fluorouracil/leucovorin, oxaliplatin, and irinotecan (FOLFOXIRI) followed by radical surgery of metastases. Ann Surg 2009; 249: 420-425.
13. Innocenti F, Undevia SD, Iyer L, Chen PX, Das S, Kocherginsky M, Karrison T, Janisch L, Ramirez J, Rudin CM, Vokes EE, Ratain MJ: Genetic variants in the UCP-glucuronosyltransferase 1A1 gene predict the risk of severe neutropenia of irinotecan. J Clin Oncol 2004; 22: 1382-1388. (Pubitemid 41103619)
14. Ando Y, Saka H, Ando M, Sawa T, Muro K, Ueoka H, Yokoyama A, Saitoh S, Shimokata K, Hasegawa Y: Polymorphisms of UCPglucuronosyltransferase gene and irinotecan toxicity: a pharmacogenetic analysis. Cancer Res 2000; 60: 6921-6926. (Pubitemid 32059164)
15. Beutler E, Gelbart T, Demina A: Racial variability in the UDP-glucuronosyltransferase 1 (UGT1A1) promoter: a balanced polymorphism for regulation of bilirubin metabolism? Proc Natl Acad Sci USA 1998; 95: 8170-8174. (Pubitemid 28326085)
16. Gagne JF, Montminy V, Belanger P, Journault K, Gaucher G, Guillemette C: Common human UGT1A polymorphisms and the altered metabolism of irinotecan active metabolite 7-ethyl-10-hydroxycamptothecin (SN-38). Mol Pharmacol 2002; 62: 608-617. (Pubitemid 36329379)
17. Akiyama Y, Fujita K, Nagashima F, Yamamoto W, Endo H, Sunakawa Y, Yamashita K, Ishida H, Mizuno K, Araki K, Ichikawa W, Miya T, Narabayashi M, Kawara K, Sugiyama M, Hirose T, Ando Y, Sasaki Y: Genetic testing for UGT1A1 * 28 and * 6 in Japanese patients who receive irinotecan chemotherapy. Ann Oncol 2008; 19: 2089-2090.
18. Minami H, Sai K, Saeki M, Saito Y, Ozawa S, Suzuki K, Kaniwa N, Sawada J, Hamaguchi T, Yamamoto N, Shirao K, Yamada Y, Ohmatsu H, Kubota K, Yoshida T, Ohtsu A, Saijo N: Irinotecan pharmacokinetics/pharmacodynamics and UGT1A genetic polymorphisms in Japanese: roles of UGT1A1 * 6 and * 28. Pharmacogenet Genomics 2007; 17: 497-504. (Pubitemid 46905216)
19. Han J-Y, Lim H-S, Shin ES, Yoo Y-K, Park YH, Lee J-E, Jang I-J, Ho Lee D, Soo Lee J: Comprehensive analysis of UGT1A polymorphisms predictive for pharmacokinetics and treatment outcome in patients with nonsmall-cell lung cancer treated with irinotecan and cisplatin. J Clin Oncol 2006; 24: 2237-2244. (Pubitemid 46630652)
20. Therasse P, Arbuck SG, Eisenhauer EA, Wanders J, Kaplan RS, Rubinstein L, Verweij J, Van Glabbeke M, van Oosterom AT, Christian MC, Gwyther SG: New guidelines to evaluate the response to treatment in solid tumors. European Organization for Research and Treatment of Cancer, National Cancer Institute of the United States, National Cancer Institute of Canada. J Natl Cancer Inst 2000; 92: 205-216.
21. Fujita K, Ando Y, Nagashima F, Yamamoto W, Eodo H, Araki K, Kodama K, Miya T, Narabayashi M, Sasaki Y: Genetic linkage of UGT1A7 and UGT1A9 polymorphisms to UGT1A1 * 6 is associated with reduced activity for SN-38 in Japanese patients with cancer. Cancer Chemother Pharmacol 2007; 60: 515-522. (Pubitemid 47084262)
22. Sunakawa Y, Ichikawa W, Fujita KI, Nagashima F, Ishida H, Yamashita K, Mizuno K, Miwa K, Kawara K, Akiyama Y, Araki K, Yamamoto W, Miya T, Narabayashi M, Ando Y, Hirose T, Saji S, Sasaki Y: UGT1A1 * 1/ * 28 and * 1/ * 6 genotypes have no effects on the efficacy and toxicity of FOLFIRI in Japanese patients with advanced colorectal cancer. Cancer Chemother Pharmacol 2011; 68: 279-284.
23. Masi G, Vasile E, Loupakis F, Cupini S, Fornaro L, Baldi G, Salvatore L, Cremolini C, Stasi I, Brunetti I, Fabbri MA, Puglisi M, Trenta P, Granetto C, Chiara S, Fioretto L, Allegrini G, Crino L, Andreuccetti M, Falcone A: Randomized trial of two induction chemotherapy regimens in metastatic colorectal cancer: an updated analysis. J Natl Cancer Inst 2011; 103: 21-30.
24. Falcone A, Masi G, Allegrini G, Danesi R, Pfanner E, Brunetti IM, Di Paolo A, Cupini S, Del Tacca M, Conte P: Biweekly chemotherapy with oxaliplatin, irinotecan, infusional fluorouracil, and leucovorin: a pilot study in patients with metastatic colorectal cancer. J Clin Oncol 2002; 20: 4006-4014.
25. Masi G, Allegrini G, Cupini S, Marcucci L, Cerri E, Brunetti I, Fontana E, Ricci S, Andreuccetti M, Falcone A: First-line treatment of metastatic colorectal cancer with irinotecan, oxaliplatin and 5-fluorouracil/leucovorin (FOLFOXIRI): results of a phase II study with a simplified biweekly schedule. Ann Oncol 2004; 15: 1766-1772. (Pubitemid 40012243)
26. Masi G, Marcucci L, Loupakis F, Cerri E, Barbara C, Bursi S, Allegrini G, Brunetti IM, Murr R, Ricci S, Cupini S, Andreuccetti M, Falcone A: First-line 5-fluorouracil/folinic acid, oxaliplatin and irinotecan (FOLFOXIRI) does not impair the feasibility and the activity of second line treatments in metastatic colorectal cancer. Ann Oncol 2006; 17: 1249-1254. (Pubitemid 44307807)
27. Folprecht G, Gruenberger T, Bechstein WO, Raab HR, Lordick F, Hartmann JT, Lang H, Frilling A, Stoehlmacher J, Weitz J, Konopke R, Stroszczynski C, Liersch T, Ockert D, Herr mann T, Goekkurt E, Parisi F, Kohne CH: Tumour response and secondary resectability of colorectal liver metastases following neoadjuvant chemotherapy with cetuximab: the CELIM randomised phase 2 trial. Lancet Oncol 2010; 11: 38-47.