Phase I/II study of oxaliplatin with oral S-1 as first-line therapy for patients with metastatic colorectal cancer

British Journal of Cancer

Volumn 98, Issue 6, 2008, Pages 1034-1038

  Yamada, Y ^a   Tahara, M ^b   Miya, T ^c   Satoh, T ^d   Shirao, K ^a   Shimada, Y ^a   Ohtsu, A ^b   Sasaki, Y ^c   Tanigawara, Y ^e  

^a NATIONAL CANCER CENTER HOSPITAL   (Japan)

^b NATIONAL CANCER CENTER HOSPITAL EAST   (Japan)

^c SAITAMA MEDICAL UNIVERSITY INTERNATIONAL MEDICAL CENTER   (Japan)

^d KINKI UNIVERSITY SCHOOL OF MEDICINE   (Japan)

^e KEIO UNIVERSITY   (Japan)

Author keywords

Colorectal cancer; Oxaliplatin; Phase I II; S 1; SOX

Indexed keywords

5 CHLORO 2,4 DIHYDROXYPYRIDINE PLUS OXONATE POTASSIUM PLUS TEGAFUR; DEXAMETHASONE; FLUOROURACIL; FOLINIC ACID; OXALIPLATIN; SEROTONIN 3 ANTAGONIST; TEGAFUR;

ADULT; ANEMIA; ANOREXIA; ANTINEOPLASTIC ACTIVITY; ARTICLE; CLINICAL ARTICLE; CLINICAL TRIAL; COLORECTAL CANCER; COMBINATION CHEMOTHERAPY; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIARRHEA; DRUG DOSE REGIMEN; DRUG HYPERSENSITIVITY; DRUG SAFETY; DRUG WITHDRAWAL; FATIGUE; FEMALE; FEVER; FUNCTIONAL DISEASE; HAND FOOT SYNDROME; HUMAN; HYPERBILIRUBINEMIA; INJECTION SITE REACTION; LEUKOPENIA; MALE; MAXIMUM TOLERATED DOSE; METASTASIS; MONOTHERAPY; MORNING DOSAGE; MULTIPLE CYCLE TREATMENT; NAUSEA; NEUTROPENIA; PERIPHERAL NEUROPATHY; PHASE 1 CLINICAL TRIAL; PHASE 2 CLINICAL TRIAL; PIGMENT DISORDER; PRIORITY JOURNAL; RASH; RECOMMENDED DRUG DOSE; SENSORY NEUROPATHY; THROMBOCYTOPENIA; TREATMENT RESPONSE; VOMITING;

COLORECTAL NEOPLASMS; DISEASE-FREE SURVIVAL; DRUG ADMINISTRATION ROUTES; FEMALE; HUMANS; MALE; MAXIMUM TOLERATED DOSE; MIDDLE AGED; NEOPLASM METASTASIS; ORGANOPLATINUM COMPOUNDS; SURVIVAL RATE; TIME FACTORS;

EID: 40849136304     PISSN: 00070920     EISSN: 15321827     Source Type: Journal    
DOI: 10.1038/sj.bjc.6604271     Document Type: Article

References (21)

1. Boku N, Ohtsu A, Hyodo I, Shirao K, Miyata Y, Nakagawa K, Tamura T, Hatake K, Tanigawara Y (2007) Phase II study of oxaliplatin in Japanese patients with metastatic colorectal cancer refractory to fluoropyrimidines. Jpn J Clin Oncol 37: 440-445
2. Cassidy J, Clarke S, Díaz-Rubio E, Scheithauer W, Figer A, Wong R, Koski S, Lichinitser M, Yang T, Saltz L (2007) XELOX compared to FOLFOX4: survival and response results from XELOX-1/NO16966, a randomized phase III trial of first-line treatment for patients with metastatic colorectal cancer. Proc Am Soc Clin Oncol 25: 4030
3. Cassidy J, Tabernero J, Twelves C, Brunet R, Butts C, Conroy T, Debraud F, Figer A, Grossmann J, Sawada N, Schöffski P, Sobrero A, Van Cutsem E, Díaz-Rubio E. (2004) XELOX (capecitabine plus oxaliplatin): active firstline therapy for patients with metastatic colorectal cancer. J Clin Oncol 22: 2084-2091
4. de Gramont A, Figer A, Seymour M, Homerin M, Hmissi A, Cassidy J, Boni C, Cortes-Funes H, Cervantes A, Freyer G, Papamichael D, Le Bail N, Louvet C, Hendler D, de Braud F, Wilson C, Morvan F, Bonetti A (2000) Leucovorin and fluorouracil with or without oxaliplatin as first-line treatment in advanced colorectal cancer. J Clin Oncol 18: 2938-2947
5. Diasio RB (1998) The role of dihydropyrimidine dehydrogenase (DPD) modulation in 5-FU pharmacology. Oncology 12: 23-27
6. Díaz-Rubio E, Evans TRJ, Tabernero J, Cassidy J, Sastre J, Eatock M, Bisset D, Regueiro P, Baselga J (2002) Capecitabine (Xeloda) in combination with oxaliplatin: a phase I, dose-escalation study in patients with advanced or metastatic solid tumors. Ann Oncol 13: 558-565
7. Díaz-Rubio E, Sastre J, Zaniboni A, Labianca R, Cortés-Funes H, de Braud F, Boni C, Benavides M, Dallavalle G, Homerin M (1998) Oxaliplatin as a single agent in previously untreated colorectal carcinoma: a phase II multicentric study. Ann Oncol 9: 105-108
8. Díaz-Rubio E, Tabernero J, Gómez-Espaòa A, Massutí B, Sastre J, Chaves M, Abad A, Carrato A, Queralt B, Reina JJ, Maurel J, González-Flores E, Aparicio J, Rivera F, Losa F, Aranda E (2007) Phase III study of capecitabine plus oxaliplatin compared with continuous-infusion fluorouracil plus oxaliplatin as first-line therapy in metastatic colorectal cancer: final report of the Spanish Cooperative Group for the Treatment of Digestive Tumors Trial. J Clin Oncol 25: 4224-4230
9. Goldberg RM, Sargent DJ, Morton RF, Fuchs CS, Ramanathan RK, Williamson SK, Findlay BP, Pitot HC, Alberts SR (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
10. Kato T, Shimamoto Y, Uchida J, Ohshimo H, Abe M, Shirasaka T (2001) Possible regulation of 5-fluorouracil-induced neuro- and oral toxicities by two biochemical modulators consisting of S-1, a new oral formulation of 5-fluorouracil. Anticancer Res 21: 1705-1712
11. Maindrault-Goebel F, de Gramont A, Louvet C, André T, Carola E, Mabro M, Artru P, Gilles V, Lotz JP, Izrael V, Krulik M (2001) High-dose intensity oxaliplatin added to the simplified bimonthly leucovorin and 5-fluorouracil regimen as second-line therapy for metastatic colorectal cancer (FOLFOX7). Eur J Cancer 40: 1000-1005
12. Ohtsu A, Baba H, Sakata Y, Mitachi Y, Horikoshi N, Sugimachi K, Taguchi T (2000) Phase II study of S-1, a novel oral fluoropyrimidine derivative, in patients with metastatic colorectal carcinoma. Br J Cancer 83: 141-145
13. Okeda R, Shibutani M, Matsuo T, Kuroiwa T, Shimokawa R, Tajima T (1990) Experimental neurotoxicity of 5-fluorouracil and its derivatives is due to poisoning the monofluorinated organic metabolites, monofluoroacetic acid and α-fluoro-β-alanine. Acta Neuropathol 81: 66-73
14. Porschen R, Arkenau HT, Kubicka S, Greil R, Seufferlein T, Freier W, Kretzschmar A, Graeven U, Grothey A, Hinke A, Schmiegel W, Schmoll H-J (2007) Phase III study of capecitabine plus oxaliplatin compared with fluorouracil and leucovorin plus oxaliplatin in metastatic colorectal cancer: a final report of the AIO Colorectal Study Group. J Clin Oncol 25: 4217-4223
15. Robben NC, Pippas AW, Moore JO (1993) The syndrome of 5-fluorouracil cardiotoxicity. Cancer 71: 493-509
16. Rothenberg ML, Oza AM, Bigelow RH, Berlin JD, Marshall JL, Romanathan RK, Hart LL, Gupta S, Garay CA, Burger BG, Bail NL, Haller DG (2003) Superiority of oxaliplatin and fluorouracil-leucovorin compared with either therapy alone in patients with progressive colorectal cancer after irinotecan and fluorouracil- leucovorin: interim results of a phase III trial. J Clin Oncol 21: 2059-2069
17. Shimoyama M (1999) The Japanese edition of the National Cancer Institute - common toxicity criteria. Jpn J Cancer Chemother 26: 1084-1144, (in Japanese)
18. Shirao K, Ohtsu A, Takada H, Mitachi Y, Hirakawa K, Horikoshi N, Okamura T, Hirata K, Saitoh S, Isomoto H, Satoh A (2004) Phase II study of oral S-1 for treatment of metastatic colorectal carcinoma. Cancer 100: 2355-2361
19. Therasse P, Arbuck SG, Eisenhauer EA, Wanders J, Kaplan RS, Rubinstein L, Verweij J, Glabbeke MV, van Oosterom AT, Christian MC, Gwyther SG (2000) 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 Center Institute of Canada. J Natl Cancer Inst 92: 205-216
20. Tournigand C, Cervantes A, Figer A, Lledo G, Flesch M, Buyse M, Mineur L, Carola E, Etienne PL, Rivera F, Chirivella I, Perez-Staub N, Louvet C, André T, Tabah-Fisch I, de Gramont A (2006) OPTIMOX1: a randomized study of FOLFOX4 or FOLFOX7 with oxaliplatin in a stop-and-go fashion in advanced colorectal cancer - a GERCOR Study. J Clin Oncol 24: 394-400
21. Yamada Y, Hamaguchi T, Goto M, Muro K, Matsumura Y, Shimada Y, Shirao K, Nagayama S (2003) Plasma concentrations of 5-fluorouracil and F-β-alanine following oral administration of S-1, a dihydropyrimidine dehydrogenase inhibitory fluoropyrimidine, as compared with protracted venous infusion of 5-fluorouracil. Br J Cancer 89: 816-820