Phase II study of S-1, a novel oral fluoropyrimidine derivative, in patients with metastatic colorectal carcinoma

British Journal of Cancer

Volumn 83, Issue 2, 2000, Pages 141-145

  Ohtsu, A ^a   Baba, H ^b   Sakata, Y ^c   Mitachi, Y ^d   Horikoshi, N ^e   Sugimachi, K ^f   Taguchi, T ^g  

^a NATIONAL CANCER CENTER HOSPITAL EAST   (Japan)

^b NATIONAL KYUSHU CANCER CENTER   (Japan)

^c AOMORI PREFECTURAL CENTRAL HOSPITAL   (Japan)

^d Sendai Kosei Hospital   (Japan)

^e CANCER INSTITUTE HOSPITAL   (Japan)

^f KYUSHU UNIVERSITY   (Japan)

^g Japan Soc for Cancer Chemotherapy   (Japan)

Author keywords

CDHP; Metastatic colorectal carcinoma; S 1; Tegafur

Indexed keywords

5 CHLORO 2,4 DIHYDROXYPYRIDINE PLUS OXONATE POTASSIUM PLUS TEGAFUR; FLUOROURACIL; FOLINIC ACID;

ADJUVANT CHEMOTHERAPY; ADULT; AGED; ANAMNESIS; ARTICLE; BONE MARROW SUPPRESSION; CANCER SURVIVAL; CLINICAL TRIAL; COLORECTAL CANCER; DRUG EFFICACY; FEMALE; GASTROINTESTINAL TOXICITY; HUMAN; MAJOR CLINICAL STUDY; MALE; METASTASIS; NEUTROPENIA; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; TREATMENT OUTCOME;

EID: 0034089123     PISSN: 00070920     EISSN: None     Source Type: Journal    
DOI: 10.1054/bjoc.2000.1236     Document Type: Article

References (28)

1. Advanced Colorectal Cancer Meta-Analysis Project (1992) Modulation of fluorouracil by leucovorin in patients with advanced colorectal cancer. J Clin Oncol 10: 896-903
2. Baccanari DP, Davis ST, Knick VC and Spector T (1993) 776C85: Effects on the pharmacokinetics and antitumor activity of 5-fluorouracil. Proc Natl Acad Sci USA 90: 11064-11068
3. DeMario MD and Ratain MJ (1998) Oral chemotherapy: rationale and future directions. J Clin Oncol 16: 2557-2567
4. Diasio RB, Beavers TL and Carpenter JT (1988) Familial deficiency of dihydropyrimidine dehydrogenase. J Clin Invest 81: 47-51
5. Etienne MC, Cheradame S, Fischel JL, Formento P, Dassonville O, Rence N, Schneider M, Thyss A, Demard F and Milano G (1995) Response to fluorouracil therapy in cancer patients: The role of tumoral dihydropyrimidine dehydrogenase activity. J Clin Oncol 13: 1663-1670
6. Harris BE, Song R, Soong SJ and Diasio RB (1990) Relationship between dihydropyrimidine dehydrogenase activity and plasma 5-fluorouracil levels with evidence for circadian variation of enzyme activity and plasma drug levels in cancer patients receiving 5-fluorouracil by protracted continuous infusion. Cancer Res 50: 197-201
7. Heggie GD, Sommadossi JP, Cross DS, Huster WJ and Diasio RB (1987) Clinical pharmacokinetics of 5-fluorouracil and its metabolites in plasma, urine, and bile. Cancer Res 47: 2203-2206
8. Houghton JA, Houghton PJ and Wooten RS (1979) Mechanism of induction of gastrointestinal toxicity in the mouse by 5-fluorouracil, 5-fluorouridine, and 5-fluoro-2′-deoxyuridine. Cancer Res 39: 2406-2413
9. Ikenaka K, Shirasaka T and Kitano S (1979) Effect of uracil on metabolism o 5-fluorouracil in vitro. Jpn J Cancer Res 70: 353-359
10. Japanese Research Society for Cancer of Colon and Rectum (1994) General rules for clinical and pathological studies on cancer of the colon, rectum und anus. 5th edn. Kanehara Syuppan: Tokyo
11. Japan Society for Cancer Therapy (1993) Criteria for the evaluation of the clinical effects of solid cancer chemotherapy. J Jpn Soc Cancer Ther 28: 101-130
12. Levi F, Misset JL, Brienza S, Adam R, Metzger G, Itzakhi M, Caussanel JP, Kunstlinger F, Lecouturier S, Descorps-Declere A, Jasmin C, Bismuth H and Reinberg A (1992) A chronopharmacologic phase II clinical trial with 5-fluorouracil, folinic acid, and oxaliplatin using an ambulatory multichannel programmable pump. Cancer 69: 893-900
13. Leichman CG, Fleming TR, Muggia FM, Tangen CM, Ardalan B, Doroshow JH, Meyers FJ, Holcombe RF, Weiss GR, Mangalik A and Macdonald JS (1995) Phase II study of fluorouracil and its modulation in advanced colorectal cancer: A Southwest Oncology Group Study. J Clin Oncol 13: 1303-1311
14. Liu G, Franssen E, Fitch MI and Warner E (1997) Patient preference for oral versus intravenous palliative chemotherapy. J Clin Oncol 15: 110-115
15. Malik ST, Talbot D, Clarke PI, Osborne R, Reznek R, Wrigley PF and Slevin ML (1990) Phase II trial of UFT in advanced colorectal and gastric cancer. Br J Cancer 62: 1023-1025
16. Pazdur R, Lassere Y, Rhodes V, Ajani JA, Sugarman SM, Patt YZ, Jones DV Jr, Markowitz AB, Abbruzzese JL, Bready B and Levin B (1994) Phase II trial of uracil and tegafur plus oral leucovorin: An effective oral regimen in the treatment of metastatic colorectal carcinoma. J Clin Oncol 12: 2296-2300
17. Petrelli N, Douglass HO Jr, Herrera L, Russell D, Stablein DM, Bruckner HW, Mayer RJ, Schinella R, Green MD, Muggia FM, Megibow A, Greenwald ES, Bukowski RM, Harris J, Levin B, Gaynor E, Loutfi A, Kalser MH, Barkin JS, Benedetto P, Woolley PV, Nauta R, Weaver DW and Leichman LP for the gastrointestinal tumor study group (1989) The modulation of fuorouracil with leucovorin in metastatic colorectal carcinoma: A prospective randomized phase III trial. J Clin Oncol 7: 1419-1426
18. Poon MA, O'Connel MJ, Moertel CG, Wieand HS, Cullina SA, Everson LK, Krook JE, Mailliard JA, Laurie JA, Tschetter LK and Wiesenfeld M (1989) Biochemical modulation of fluorouracil: Evidence of significant improvement of survival and quality of life in patients with advanced colorectal carcinoma. J Clin Oncol 7: 1407-1418
19. Sakata Y, Ohtsu A, Horikoshi N, Sugimachi K, Mitachi Y and Taguchi T (1998) Late phase II study of novel oral fluoropyrimidine anticancer drugs S-1 (1M tegafur-0.4M gimestat-1M otastat potassium) in advanced gastric cancer patients. Eur J Cancer 34: 1715-1720
20. Schilsky R, Bukowski R, Burris H, Crawford J, Hochster H, O'Rourke M, Steinfeldt H, Doucette M, Levin J and Hohneker J (1997) A phase II study of a five day regimen of 5-fluorouracil (5-FU) plus GW776 (776C85) with or without leucovorin in patients with metastatic colorectal cancer. Proc Am Soc Clin Oncl 16: 271a (abst 961)
21. Shirasaka T, Nakano K, Takechi T, Satake H, Uchida J, Fujioka A, Saito H, Okabe, H Oyama K, Takeda S, Unemi N and Fukushima M (1996) Antitumor activity of 1M tegafur-0.4M 5-chloro-2,4-dihydroxypyridine-1M potassium oxonate (S-1) against human colon carcinoma orthotopically implanted into nude rats. Cancer Res 56: 2602-2606
22. Shirasaka T, Shimamoto Y and Fukushima M (1993) Inhibition by oxonic acid of gastrointestinal toxicity of 5-fluorouracil without loss of its antitumor activity in rats. Cancer Res 53: 4004-4009
23. Sugimachi K, Maehara Y, Horikoshi N, Shimada Y, Sakata Y, Mitachi Y, Taguchi T and The S-1 Gastrointestinal Cancer Study Group (1999) An early phase II study of oral S-1, a newly developed 5-fluorouracil derivative for advanced and recurrent gastrointestinal cancers. Oncology 57: 202-210
24. Takiuchi H and Ajani JA (1998) Uracil-tegafur in gastric carcinoma: a comprehensive review. J Clin Oncol 16: 2877-2885
25. Tatsumi K, Fukushima M, Shirasaka T and Fujii S (1987) Inhibitory effects of pyrimidine, barbituric acid and pyridine derivatives on 5-fluorouracil degradation in rat liver extracts. Jpn J Cancer Res 78: 748-755
26. Takechi T, Nakano K, Uchida J, Mita A, Toko K, Takeda S, Unemi N and Shirasaka T (1997) Antitumor activity and low intestinal toxicity of S-1, a new formulation of oral tegafur, in experimental tumor models in rats. Cancer Chemother Pharmacol 39: 205-211
27. Taguchi T, Inuyama Y, Kanamaru R, Hasegawa K, Akazawa S, Niitani H, Furue H, Kurihara M, Ota K, Suga S, Ariyoshi Y, Takai S, Shimoyama T, Toge T, Takashima S, Sugimachi K, Hara Y, Fujita H, Kimura K, Saito T, Tsukagoshi S and Nakao I (1997) Phase T study of S-1. Jpn J Cancer Chemother 24(15): 2253-2264
28. Tuchman M, Stoeckeler JS, Kiang DT, O'Dea RF, Ramnaraine ML and Mirkin BL (1985) Familial pyrimidinemia and pyrimidinuria associated with severe fluorouracil toxicity. N Engl J Med 313: 245-249