An early phase II study of S-1 in patients with metastatic pancreatic cancer

Oncology

Volumn 68, Issue 2-3, 2005, Pages 171-178

  Ueno, Hideki ^a   Okusaka, Takuji ^a   Ikeda, Masafumi ^a   Takezako, Yoriko ^a   Morizane, Chigusa ^a  

^a NATIONAL CANCER CENTER HOSPITAL   (Japan)

Author keywords

Chemotherapy; Pancreatic cancer; Pharmacokinetics; Phase II study; S 1

Indexed keywords

5 CHLORO 2,4 DIHYDROXYPYRIDINE PLUS OXONATE POTASSIUM PLUS TEGAFUR; ALANINE AMINOTRANSFERASE; ASPARTATE AMINOTRANSFERASE; CREATININE; ANTINEOPLASTIC ANTIMETABOLITE; OXONIC ACID; PYRIDINE DERIVATIVE; S 1 (COMBINATION); TEGAFUR;

ABDOMINAL DISTENSION; ABNORMAL SUBSTRATE CONCENTRATION IN BLOOD; ADULT; AGED; ALANINE AMINOTRANSFERASE BLOOD LEVEL; ANOREXIA; ANTINEOPLASTIC ACTIVITY; ARTICLE; ASPARTATE AMINOTRANSFERASE BLOOD LEVEL; BLOOD TOXICITY; CANCER CHEMOTHERAPY; CANCER GROWTH; CANCER SURVIVAL; CLINICAL ARTICLE; CLINICAL TRIAL; COLITIS; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CREATININE BLOOD LEVEL; DIARRHEA; DOSE RESPONSE; DRUG BLOOD LEVEL; DRUG EFFICACY; DRUG ELIMINATION; DRUG HALF LIFE; DRUG RESPONSE; DRUG SAFETY; DRUG TOLERABILITY; FATIGUE; FEMALE; GASTROINTESTINAL TOXICITY; HISTOLOGY; HUMAN; HUMAN TISSUE; ILEUM DISEASE; LEUKOPENIA; MALE; METASTASIS; NAUSEA; NEUTROPENIA; PANCREAS ADENOCARCINOMA; PHASE 2 CLINICAL TRIAL; PIGMENT DISORDER; PRIORITY JOURNAL; RASH; STOMATITIS; SURVIVAL RATE; SURVIVAL TIME; THROMBOCYTOPENIA; VOMITING; BLOOD; DISEASE COURSE; DRUG COMBINATION; MIDDLE AGED; PANCREAS TUMOR; PATHOLOGY; TREATMENT OUTCOME;

AGED; ANTIMETABOLITES, ANTINEOPLASTIC; DISEASE PROGRESSION; DRUG COMBINATIONS; FEMALE; HUMANS; MALE; MIDDLE AGED; OXONIC ACID; PANCREATIC NEOPLASMS; PYRIDINES; TEGAFUR; TREATMENT OUTCOME;

EID: 23844431643     PISSN: 00302414     EISSN: None     Source Type: Journal    
DOI: 10.1159/000086771     Document Type: Article

References (29)

1. Evans DB, Abbruzzese JL, Willett CG: Cancer of the pancreas; in De Vita VT Jr, Hellman S, Rosenberg SA (eds): Principles and Practice of Oncology, ed 6. Philadelphia, Lippincott, 2001, pp 1126-1161.
2. Burris HA 3rd, Moore MJ, Andersen J, Green MR, Rothenberg ML, Modiano MR, Cripps MC, Portenoy RK, Storniolo AM, Tarassoff P, Nelson R, Dorr FA, Stephens CD, Von Hoff DD: Improvements in survival and clinical benefit with gemcitabine as first-line therapy for patients with advanced pancreas cancer: A randomized trial. J Clin Oncol 1997;15:2403-2413.
3. Casper ES, Green MR, Kelsen DP, Heelan RT, Brown TD, Flombaum CD, Trochanowski B, Tarassoff PG: Phase II trial of gemcitabine (2,2′- difluoro-deoxycytidine) in patients with adenocarcinoma of the pancreas. Invest New Drugs 1994;12:29-34.
4. Carmichael J, Fink U, Russell RC, Spittle MF, Harris AL, Spiessi G, Blatter J: Phase II study of gemcitabine in patients with advanced pancreatic cancer. Br J Cancer 1996;73:101-105.
5. Bramhall SR, Rosemurgy A, Brown PD, Bowry C, Buckels JAC: Marimastat as first-line therapy for patients with unresectable pancreatic cancer: A randomized trial. J Clin Oncol 2001;19:3447-3455.
6. Bramhall SR, Schulz J, Nemunaitis J, Brown PD, Baillet M, Buckels JAC: A double-blind placebo-controlled, randomised study comparing gemcitabine and marimastat with gemcitabine and placebo as first line therapy in patients with advanced pancreatic cancer. Br J Cancer 2002;87:161-167.
7. Berlin JD, Catalano P, Thomas JP, Kugler JW, Haller DG, Benson AB III: Phase III study of gemcitabine in combination with fluorouracil versus gemcitabine alone in patients with advanced pancreatic carcinoma: Eastern Cooperative Oncology Group Trial E2297. J Clin Oncol 2002;20:3270-3275.
8. Colucci G, Giuliani F, Gebbia V, Biglietto M, Rabitti P, Uomo G, Cigolari S, Testa A, Maiello E, Lopez M: Gemcitabine alone or with cisplatin for the treatment of patients with locally advanced and/or metastatic pancreatic carcinoma: A prospective, randomized phase III study of the Gruppo Oncologico dell'Italia Meridionale. Cancer 2002;94:902-910.
9. 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.
10. 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 1987;78:748-755.
11. 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.
12. Ohtsu A, Baba H, Sakata Y, Mitachi Y, Horikoshi N, Sugimachi K, Taguchi T: Phase II study of S-1, a novel oral fluoropyrimidine derivative, in patients with metastatic colorectal carcinoma. S-1 Cooperative Colorectal Carcinoma Study Group. Br J Cancer 2000;83:141-145.
13. Kawahara M, Furuse K, Segawa Y, Yoshimori K, Matsui K, Kudoh S, Hasegawa K, Niitani H: Phase II study of S-1, a novel oral fluorouracil in advanced non-small-cell lung cancer. Br J Cancer 2001;85:939-943.
14. Inuyama Y, Kida A, Tsukuda M, Kohno N, Satake B: Late phase II study of S-1 in patients with advanced head and neck cancer. Gan To Kagaku Ryoho 2001;28:1381-1390.
15. 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.
16. Koizumi W, Kurihara M, Nakano S, Hasegawa K: Phase II study of S-1, a novel oral derivative of 5-fluorouracil, in advanced gastric cancer. For the S-1 Cooperative Gastric Cancer Study Group. Oncology 2000;58:191-197.
17. 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. The S-1 Gastrointestinal Cancer Study Group. Oncology 1999;57:202-210.
18. Furuse K, Kawahara M, Hasegawa K, Kudoh S, Takada M, Sugiura T, Ichinose Y, Fukuoka M, Ohashi Y, Niitani H: Early phase II study of S-1, a new oral fluoropyrimidine, for advanced non-small-cell lung cancer. Int J Clin Oncol 2001;6:236-241.
19. Fukushima M, Satake H, Uchida J, Shimamoto Y, Kato T, Takechi T, Okabe H, Fujioka A, Nakano K, Ohshimo H, Takeda S, Shirasaka T: Preclinical antitumor efficacy of S-1: A new oral formulation of 5-fluorouracil on human tumor xenografts. Int J Oncol 1998;13:693-698.
20. Japan Society for Cancer Therapy: Criteria for the evaluation of the clinical effects of solid cancer chemotherapy. J Jpn Soc Cancer Ther 1993;28:101-130.
21. Aoki K, Okada S, Moriyama N, Ishii H, Nose H, Yoshimori M, Kosuge T, Ozaki H, Wakao F, Mukai K: Accuracy of computed tomography in determining pancreatic cancer tumor size. Jpn J Clin Oncol 1994;24:85-87.
22. Matsushima E, Yoshida K, Kitamura R, Yoshida K: Determination of S-1 (combined drug of tegafur, 5-chloro-2,4-dihydroxypyridine and potassium oxonate) and 5-fluorouracil in human plasma and urine using high-performance liquid chromatography and gas chromatography-negative ion chemical ionization mass spectrometry. J Chromatogr B 1997;691:95-104.
23. 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.
24. Meta-analysis Group In Cancer: Efficacy of intravenous continuous infusion of fluorouracil compared with bolus administration in advanced colorectal cancer. J Clin Oncol 1998;16:301-308.
25. Maisey N, Chau I, Cunningham D, Norman A, Seymour M, Hickish T, Iveson T, O'Brien M, Tebbutt N, Harrington A, Hill M: Multicenter randomized phase III trial comparing protracted venous infusion (PVI) fluorouracil (5-FU) with PVI 5-FU plus mitomycin in inoperable pancreatic cancer. J Clin Oncol 2002;20:3130-3136.
26. Hirata K, Horikoshi N, Aiba K, Okazaki M, Denno R, Sasaki K, Nakano Y, Ishizuka H, Yamada Y, Uno S, Taguchi T, Shirasaka T: Pharmacokinetic study of S-1, a novel oral fluorouracil antitumor drug. Clin Cancer Res 1999;5:2000-2005.
27. van Groeningen C.T, Peters GJ, Schornagel JH, Gall H, Noordhuis P, de Vries MJ, Turner SL, Swart MS, Pinedo HM, Hanauske AR, Giaccone G: Phase I clinical and pharmacokinetic study of oral S-1 in patients with advanced solid tumors. J Clin Oncol 2000;18:2772-2779.
28. Cohen SJ, Leichman CG, Yeslow G, Beard M, Proefrock A, Roedig B, Damle B, Letrent SP, DeCillis AP, Meropol NJ: Phase I and pharmacokinetic study of once daily oral administration of S-1 in patients with advanced cancer. Clin Cancer Res 2002;8:2116-2122.
29. Ohtsu A, Boku N, Nagashima F, Koizumi W, Tanabe S, Saigenji K, Muro K, Matsumura K, Shirao K: A phase I/II study of S-1 plus cisplatin (CDDP) in patients (pts) with advanced gastric cancer (AGC). Proc Am Soc Clin Oncol 2001;20:656.