Phase II study of S-1, a novel oral derivative of 5-fluorouracil, in advanced gastric cancer

Oncology

Volumn 58, Issue 3, 2000, Pages 191-197

  Koizumi, Wasaburo ^a,e   Kurihara, Minoru ^b   Nakano, Shuji ^c   Hasegawa, Koichi ^d  

^a KITASATO UNIVERSITY   (Japan)

^b SHOWA UNIVERSITY   (Japan)

^c KYUSHU UNIVERSITY   (Japan)

^d Department of Internal Medicine   (Japan)

^e KITASATO UNIVERSITY SCHOOL OF MEDICINE   (Japan)

Author keywords

Gastric cancer; Late phase II study; Oral 5 fluorouracil derivative; S 1

Indexed keywords

5 CHLORO 2,4 DIHYDROXYPYRIDINE PLUS OXONATE POTASSIUM PLUS TEGAFUR; HEMOGLOBIN;

ADULT; ADVANCED CANCER; AGED; ANEMIA; ANOREXIA; ARTICLE; CANCER SURVIVAL; CLINICAL TRIAL; DIARRHEA; DRUG EFFICACY; DRUG SAFETY; FATIGUE; FEMALE; HUMAN; HYPERBILIRUBINEMIA; LEUKOPENIA; MAJOR CLINICAL STUDY; MALE; NEUTROPENIA; PHASE 2 CLINICAL TRIAL; PIGMENT DISORDER; PRIORITY JOURNAL; STOMACH CANCER; STOMATITIS;

EID: 0034029776     PISSN: 00302414     EISSN: None     Source Type: Journal    
DOI: 10.1159/000012099     Document Type: Article

References (42)

1. Comis RL, Carter SK: A review of chemotherapy in gastric cancer. Cancer 1974;34:1576-1586.
2. Kaufman S: 5-Fluorouracil in the treatment of gastrointestinal neoplasia. N Engl J Med 1973; 288:199-201.
3. Schein PS, Macdonald JS, Hoth D, Wooley PV: Mitomycin-C: Experience in the United States with emphasis on gastric cancer. Cancer Chemother Pharmacol 1978;1:73-75.
4. Moertel CG, Lavin PT; Phase II-III chemotherapy studies in advanced gastric cancer. Cancer Treat Rep 1979;63:1863-1869.
5. Lacave AJ, Wils J, Diaz-Rubio E, Clavel M, Planting A, Bleiberg H, Duez N, Dalesio O: Cis-platinum as second-line chemotherapy in advanced gastric adenocarcinoma. A phase II study of the EORTC Gastrointestinal Tract Cancer Cooperative Group. Eur J Cancer Clin Oncol 1985;11:1321-1324.
6. Kambe M, Wakui A, Nakao I, Futatsuki K, Sakata Y, Yoshino M, Shimada Y, Taguchi T: A late phase II study of irinotecan (CPT-11) in patients with advanced gastric cancers (abstract 584). Proc Am Soc Clin Oncol 1993;12: 198.
7. Sulkes A, Smyth J, Sessa C, Dirix LY, Vermorken JB, Kaye S, Wanders J, Franklin H, LeBail N, Verweij J: Docetaxel (Taxotere™) in advanced gastric cancer: Results of a phase II clinical trial. Br J Cancer 1994;70:380-383.
8. Macdonald JS, Schein PS, Woolley PV, Smythe T, Ueno W, Hoth D, Smith F, Boiron M, Glsselbrecht C, Brunet R, Lagarde C: 5-Fluorouracil, doxorubicin, and mitomycin (FAM) combination chemotherapy for advanced gastric cancer. Ann Intern Med 1980; 93:533-536.
9. Moertel CG, Rubin J, O'Connell MJ, Schutt AJ, Wicand HS: A phase II study of combined 5-fluorouracil, doxorubicin, and cisplatin in the treatment of advanced upper gastrointestinal adenocarcinomas. J Clin Oncol 1986;4: 1053-1057.
10. Wils J, Bleiberg H, Dalesio O, Blijham G, Mulder N, Planting A, Splinter T, Duez N: An EORTC gastrointestinal group evaluation of the combination of sequential methotrexate and 5-fluorouracil, combined with Adriamycin in advanced measurable gastric cancer. J Clin Oncol 1986;4:1799-1803.
11. Preusser P, Wilke H, Achterrath W, Fink L, Heinicke A, Meyer J, Meyer H-J, Buente H: Phase II study with the combination of etoposide, doxorubicin and cisplatin in advanced gastric cancer. J Clin Oncol 1989;7:1310-1317.
12. Lacave AJ, Baron FJ, Anton LM, Estrada E, De Sande LMG, Palacio I, Esteban E, Gracia JM, Buesa JM, Fernandez OA, Gonzalez Baron M: Combination chemotherapy with cisplatin and 5-fluorouracil 5 day infusion in the therapy of advanced gastric cancer: A phase II trial. Ann Oncol 1991;2:751-754.
13. Rougier Ph, Ducreux M, Mahjoubi M, Pignon JP, Bellefqih S, Oliveira J, Bognel C, Lasser Ph, Ychou M, Elias D, Cvitkovic E, Armand JP, Droz J-P: Efficacy of combined 5-fluorouracil and cisplatinum in advanced gastric carcinomas. A phase II trial prognostic factor analysis. Eur J Cancer 1994;30A.9:1263-1269.
14. Shirasaka T, Shimamoto Y, Ohshimo H, Yamaguchi M, Kato T, Yonekura K, Fukushima M: Development of a novel form of an oral 5-fluorouracil derivative (S-1) directed to the potentiation of the tumor selective cytotoxicity of 5-fluorouracil by two biochemical modulators. Anticancer Drugs 1996;7:548-557.
15. 1-(α-tetrahydrofuryl) derivatives of natural pyrimidine bases and their antimetabolites (in Russian). Dokl Akad Nauk SSSR 1967;176:332-335.
16. Tatsumi K, Fukushima M, Shirasaka T, Fujii S: Inhibitory effects of pyrimidine, barbituric acid and pyridine derivatives on 5-fluorouracil degradation in rat liver extracts. Jpn J Cancer Res (Gann) 1987;78:748-755.
17. Shirasaka T, Shimamoto Y, Fukushima M: Inhibition by oxionic acid of gastrointestinal toxicity of 5-fluorouracil without loss of its antitumor activity in rats. Cancer Res 1993;53:4004-4009.
18. 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, Nakao I: Phase I study of S-1. Jpn J Cancer Chemother 1997;24:2253-2264.
19. Sugimachi K, Maehara Y, Horikoshi N, Shimada Y, Sakata Y, Mitachi Y, Taguchi T: An early phase II study of oral S-1, a newly developed 5-fluorouracil derivative for advanced and recurrent gastrointestinal cancers. Oncology 1999;57:202-210.
20. Taguchi T, Horikoshi N, Kinoshita H, Toge T, Takashima S: Early phase II study of S-1 in patients with advanced breast cancer (abstract). Proc Am Soc Clin Oncol 1996;15:151.
21. Fujii M, Kanzaki J, Satake B, Baba S, Inuyama Y: Early phase II study of S-1 in patients with advanced head and neck cancer (abstract). Proc Am Soc Clin Oncol 1996;15:894.
22. Oken MM, Davis TE, Creech RH, McFadden ET, Tormey DC, Carbone PP, Horton J: Toxicity and response; criteria of the Eastern Cooperative Oncology Group. Am J Clin Oncol 1982; 5:649-655.
23. World Health Organization: WHO Handbook for Reporting Results of Cancer Treatment. WHO Offset Publ No. 48. Geneva, World Health Organization, 1979.
24. Japanese Research Society for Gastric Cancer: Japanese Classification of Gastric Carcinoma, (in English). Tokyo, Kanehara, 1995, pp 89-100.
25. Japan Society for Cancer Therapy: Criteria for the evaluation of the clinical effects of solid cancer chemotherapy. J Jpn Soc Cancer Chemother 1993;28:101-130.
26. Nakajima T, Okabayashi K, Nakazato H, Iwanaga T, Ota K, Kito T, Yamamura Y, Hurukawa H, Hiratuka M: Individual dose intensity and relative performance as indices for assessing the quality of clinical cancer chemotherapy and their effect on therapeutic results. Oncologia 1989;22:100-108.
27. Duschinsky R, Pleven E, Heidelberger C: The synthesis of 5-fluoropyrimidine. J Am Chem Soc 1957;79:4559-4560.
28. Heggie GD, Sommadossi J-P, Cross DS, Huster WJ, Diasio RB: Clinical pharmacokinetics of 5-fluorouracil and its metabolites in plasma urine, and, bile. Cancer Res 1987;47:2203-2206.
29. Ikenaka K, Shirasaka T, Kitano S, Fujii S: Effect of uracil on metabolism of 5-fluorouracil in vitro. Jpn J Cancer Res (Gann) 1979;70: 353-359.
30. Seifert P, Baker LH, Reed ML, Vaitkevicius VK: Comparison of continuously infused 5-fluorouracil with bolus injection in treatment of patients with colorectal adenocarcinoma. Cancer 1975;36:123-128.
31. Moynihan T, Hansen R, Anderson T, Quebbeman E, Beatty P, Ausman R, Ritch P, Chitanibar C, Vukelich M: Continuous 5-fluorouracil infusion in advanced gastric carcinoma. Am J Clin Oncol 1988;11:461-464.
32. Lokich JJ, Ahlgren JD, Gullo JJ, Philips JA, Fryer JG: A prospective randomized comparison of continuous infusion fluorouracil with a conventional bolus schedule in metastatic colorectal carcinoma: A mid-Atlantic oncology program study. J Clin Oncol 1989;7:425-432.
33. Ansfield FJ, Kallas GJ, Singson JP: Phase I-II studies of oral tegafur (Ftorafur). J Clin Oncol 1983;1:107-111.
34. Takiuchi H, Ajani JA: Uracil-tegafur in gastric carcinoma: A comprehensive review. J Clin Oncol 1998;16:2877-2885.
35. Wakui A: Phase II trial of 5′-deoxy-5-fluorouridine in the treatment of gastric cancer: A multicenter cooperative study. J Int Med Res 1988;16(suppl2):8B-17B.
36. Fujii M, Furue H, Wakui A, Majima H, Kurihara M, Ohta K, Sugimachi K: A phase II randomized study of BOF-A2 (emitefur) in gastric cancer (abstract). Proc Int Congr Chemo 1997; 20:3117.
37. Takechi T, Nakano K, Uchida J, Mita A, Toko K, Takeda S, Unemi N, Shirasaka T: Antitumor activity and low intestinal toxicity of S-1, a new formulation of oral tegafur, in experimental tumor models in rats. Cancer Chemother Pharmacol 1987;39:205-211.
38. Mimori K, Mori M, Baba H, Maehara Y, Sugimachi K: Complete response of transverse colon carcinoma to S-1, a new chemotherapy agent: Report of a case. Surg Today 1995;25: 741-744.
39. Sakata Y, Ohtsu A, Horikoshi N, Sugimachi K, Mitachi Y, Taguchi T: Late phase II study of novel oral fluoropyrimidine anticancer drug S-1 (1 M tegafur-0.4 M gimestat-1 M otastat potassium) in advanced gastric cancer patients. Eur J Cancer 1998;34:1715-1720.
40. Ohtsu A, Shimada Y, Yoshida S, Saito H, Seki S, Morise K, Kurihara M: Phase II study of protracted infusional 5-fluorouracil combined with cisplatinum for advanced gastric cancer: Report from the Japan Clinical Oncology Group (JCOG). Eur J Cancer 1994;30A:2091-2093.
41. Shirao K, Shimada Y, Kondo H, Saito D, Yamao T, Ono H, Yokoyama T, Fukuda H, Oka M, Watanabe Y, Ohtsu A, Boku N, Fujii T, Oda Y, Muro K, Yoshida S: Phase I-II study of irinotecan hydrochloride combined with cisplatin in patients with advanced gastric cancer: J Clin Oncol 1997;15:921-927.
42. Koizumi W, Kurihara M, Sasai T, Yoshida S, Morise K, Imamura A, Akazawa S, Betsuyaku T, Ohkubo S, Takahashi H, Akiya T, Hamada T, Kiyohashi A: A phase II study of combination therapy with 5′-deoxy-5-fluorouridine and cisplatin in the treatment of advanced gastric cancer with primary foci. Cancer 1993;72:658-662.