European Journal of Cancer
Volume 39, Issue 9 , Pages 1264-1270 , June 2003

Phase II trial with S-1 in chemotherapy-naı̈ve patients with gastric cancer. A trial performed by the EORTC Early Clinical Studies Group (ECSG)

  • P Chollet

      Affiliations

    • Department of Medical Oncology, Centre Jean-Perrin, 58 Rue Montalembert, F-63011 Clermont-Ferrand, Cedex 1, France
    • Corresponding Author InformationCorresponding author. Tel.: +33-4-7327-8005; fax: +33-4-7327-8029
    • ,
  • P Schöffski

      Affiliations

    • Abteilung Hämatologie und Onkologie, Medizinische Hochschule Hannover, Carl-Neuberg Str. 1, Hannover D-30625, Germany
    • ,
  • K Weigang-Köhler

      Affiliations

    • Klinikum Nürnberg, Prof.-Ernst-Nathan-Str. 1, 90419 Nürnberg, Germany
    • ,
  • J.H.M Schellens

      Affiliations

    • Antoni van Leeuwenhoek Ziekenhuis/The Netherlands Cancer Institute, Plesmanlaan 121, Amsterdam 1066 CX, The Netherlands
    • ,
  • H Cure

      Affiliations

    • Department of Medical Oncology, Centre Jean-Perrin, 58 Rue Montalembert, F-63011 Clermont-Ferrand, Cedex 1, France
    • ,
  • N Pavlidis

      Affiliations

    • Department Medical Oncology, University of Ioannina, Panepistimiou 1, 45500 Ioannina, Greece
    • ,
  • V Grünwald

      Affiliations

    • Abteilung Hämatologie und Onkologie, Medizinische Hochschule Hannover, Carl-Neuberg Str. 1, Hannover D-30625, Germany
    • ,
  • R De Boer

      Affiliations

    • NDDO Oncology, Noordhollandstraat 71, Amsterdam 1081 AS, The Netherlands
    • ,
  • J Wanders

      Affiliations

    • NDDO Oncology, Noordhollandstraat 71, Amsterdam 1081 AS, The Netherlands
    • ,
  • P Fumoleau

      Affiliations

    • Department of Medical Oncology, Centre René Gauducheau, Site Hospitalier Nord, Bd Jacques Monod, Saint-Herblain F-44805, France

Received 3 February 2003 ,Accepted 14 February 2003.

References 

  1. Karpeh MS, Kelsen DP, Tepper JE. Cancer of the stomach. Section 3 p 1092. In:  De Vita VT,  Hellman S,  Rosenberg SA editor. Cancer Principles and Practice of Oncology. 6th edn.. Lippincott Williams Wilkins; 2001;
  2. The Gastro-intestinal Tumor Study group . Controlled trial of adjuvant chemotherapy following curative resection for gastric cancer. Cancer. 1982;49:1116–1122
  3. Serlin O, Keehn RJ, Higgins GA, et al.  Factors related to survival following resection for gastric carcinoma; analysis of 903 cases. Cancer. 1977;40:1318–1329
  4. Douglass HO, Nava HR. Gastric adenocarcinoma (management of the primary disease). Semin. Oncol. 1985;12:32–45
  5. Kelsen D. Chemotherapy of gastric cancer (a review). Israel J. Med. Sci. 1988;24:557–561
  6. Shirasaka T, Shimamato Y, Oshimo H, et al.  Development of a novel form of oral 5-fluorouracil derivative directed to the potentiation of the tumor selective cytotoxicity of 5-fluorouracil by two biochemical modulators. Anticancer Drugs. 1996;7:548–557
  7. Kimura K, Suga S, Shimaji T, et al.  Clinical basis of chemotherapy for gastric cancer with uracil and 1-(2′-tetrahydrofuryl)-5-fluorouracil. Gastroenterol Jpn. 1980;15:324–329
  8. Shirasaka T, Shimamoto Y, Fukushima M. Inhibition by oxonic acid of gastrointestinal toxicity of 5-fluorouracil without loss of its antitumor activity in rats. Cancer Res. 1993;53:4004–4009
  9. Takechi T, Nakano K, Uchida J, et al.  Antitumor activity and low intestinal toxicity of S-1, a new oral fluoropyrimidine, in experimental tumor models in rats. Cancer Chemother. Pharmacol. 1997;93:205–211
  10. Taguchi T, Inuyama Y, Kanamaru R, et al.  Phase I study of S1. Gan To Kagaku Ryoho. 1997;24:2253–2264
  11. Sugimachi K, Maehara Y, Horikoshi N, et al.  An early phase II study of oral S1, a newly developed 5-fluorouracil derivative for advanced and recurrent gastrointestinal cancers. Oncology. 1999;57:202–210
  12. Koizumi W, Kurihara M, Nakano S, et al.  Phase II study of S1, a novel oral derivative of 5-fluorouracil, in advanced gastric cancer. Oncology. 2000;58:191–197
  13. Sakata Y, Ohtsu A, Horikoshi N, et al.  Late phase II study of novel oral fluoropyrimidine anticancer drug S1 (1M tegafur-0.4M gimestat-1M otastat potassium) in advanced cancer patients. Eur. J. Cancer. 1998;34:1715–1720
  14. Ohtsu A, Baba H, Sakata Y, et al.  Phase II study of SI, a novel oral fluoropyrimidine derivative, in patients with metastatic colorectal carcinoma. B. J. Cancer. 2000;83:141–145
  15. Taguchi T, Morimoto K, Horikoshi N, et al.  An early phase II study of S1 in patients with breast cancer. Gan To Kagaku Ryoho. 1998;25:1035–1043
  16. Inuyama Y, Kida A, Tsukuda M, et al.  Early phase II study of S1 in patients with advanced head and neck cancer. Japan. Gan To Kagaku Ryoho. 1998;25:1151–1158
  17. Van Groeningen CJ, Peters GJ, Schornagel JH, et al.  Phase I clinical and pharmacokinetic study of oral S1 in patients with advanced solid tumors. J. Clin. Oncol. 2000;18:2772–2779
  18. Gehan EA. The determination of the number of patients required in a preliminary and a follow-up trial of a new chemotherapeutic agent. J. Chronic Diseases. 1961;13:346–353
  19. Schöffski P, Chollet P, Ganser A, et al.  Complete response of a gastric primary after a short but toxic course of S1. Ann. Oncol. 1999;10:1117–1120
  20. Vermorken JB, Schöffski P, Schellens J, et al.  for the EORTC Early Clinical Studies Group (ECSG)/NDDO Oncology (supported by Taiho Pharmaceuticals)   S-1 in metastatic colorectal cancer (CRC) (interim analysis of an early phase II study). Ann. Oncol. 2000;11(Suppl. 4):60
  21. Van Groeningen CJ, Peters GJ, Schornagel JH, et al.  Phase I clinical and pharmacokinetic study of oral S-1 in patients with advanced solid tumors. J. Clin. Oncol. 2000;18:2772–2779
  22. Christophidis N, Vajda FJ, Lucas I, et al.  Ocular side effects with 5-fluorouracil. Aust. N.Z. Med. 1979;9:143–144

PII: S0959-8049(03)00237-5

doi: 10.1016/S0959-8049(03)00237-5

European Journal of Cancer
Volume 39, Issue 9 , Pages 1264-1270 , June 2003

Article Tools