Phase II study of S-1 as first-line treatment for elderly patients over 75 years of age with advanced gastric cancer: The tokyo cooperative oncology group study

Cancer Chemotherapy and Pharmacology

Volumn 65, Issue 6, 2010, Pages 1093-1099

  Koizumi, Wasaburo ^a   Akiya, Toshikazu ^b   Sato, Atsushi ^c   Sakuyama, Toshikazu ^d   Sasaki, Eisaku ^e   Tomidokoro, Takashi ^f   Hamada, Tsutomu ^g   Fujimori, Mototsugu ^h   Kikuchi, Yoshinori ⁱ   Shimada, Ken ^j   Mine, Tetsuya ^k   Yamaguchi, Kensei ^l   Sasaki, Tsuneo ^e   Kurihara, Minoru ^a,m  

^a KITASATO UNIVERSITY   (Japan)

^b GUNMA PREFECTURAL CANCER CENTER   (Japan)

^c SHOWA UNIVERSITY SCHOOL OF MEDICINE   (Japan)

^d JIKEI UNIVERSITY SCHOOL OF MEDICINE   (Japan)

^e TOKYO METROPOLITAN KOMAGOME HOSPITAL   (Japan)

^f Nagaoka Chuo General Hospital   (Japan)

^g Tokyo Metropolitan Health and Medical Treatment Corporation   (Japan)

^h KIMITSU CHUO HOSPITAL   (Japan)

ⁱ TOHO UNIVERSITY   (Japan)

^j SHOWA UNIVERSITY   (Japan)

^k TOKAI UNIVERSITY   (Japan)

^l SAITAMA CANCER CENTER   (Japan)

^m Tokyo Cooperative Oncology Group   (Japan)

more..

Author keywords

Elderly; Gastric cancer; Phase ii study; S 1

Indexed keywords

5 CHLORO 2,4 DIHYDROXYPYRIDINE PLUS OXONATE POTASSIUM PLUS TEGAFUR; IRINOTECAN; PACLITAXEL; UFT; ANTINEOPLASTIC ANTIMETABOLITE; OXONIC ACID; S 1 (COMBINATION); TEGAFUR;

ADVANCED CANCER; AGED; ANEMIA; ANOREXIA; ARTICLE; BODY SURFACE; CANCER SURVIVAL; CLINICAL ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CREATININE CLEARANCE; DIARRHEA; DISEASE SEVERITY; DOSE RESPONSE; DRUG BLOOD LEVEL; DRUG DOSE REDUCTION; DRUG EFFICACY; DRUG SAFETY; DRUG WITHDRAWAL; ELDERLY CARE; FATIGUE; FEMALE; HUMAN; HUMAN TISSUE; HYPERBILIRUBINEMIA; JAPANESE; LEUKOPENIA; MALE; MAXIMUM PLASMA CONCENTRATION; MUCOSA INFLAMMATION; MULTICENTER STUDY; NAUSEA; NEUTROPENIA; OVERALL SURVIVAL; PHASE 2 CLINICAL TRIAL; PIGMENT DISORDER; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; RECURRENT CANCER; SIDE EFFECT; STOMACH CANCER; THROMBOCYTOPENIA; VOMITING; CHEMICALLY INDUCED DISORDER; DRUG COMBINATION; METABOLIC CLEARANCE RATE; PATHOLOGY; PROSPECTIVE STUDY; STOMACH TUMOR; SURVIVAL; TREATMENT OUTCOME;

AGED; AGED, 80 AND OVER; ANOREXIA; ANTIMETABOLITES, ANTINEOPLASTIC; DRUG COMBINATIONS; FATIGUE; FEMALE; HUMANS; LEUKOPENIA; MALE; METABOLIC CLEARANCE RATE; NEUTROPENIA; OXONIC ACID; PROSPECTIVE STUDIES; STOMACH NEOPLASMS; SURVIVAL ANALYSIS; TEGAFUR; TREATMENT OUTCOME;

EID: 77951886449     PISSN: 03445704     EISSN: None     Source Type: Journal    
DOI: 10.1007/s00280-009-1114-6     Document Type: Article

References (25)

1. Inoue M, Tsugane S (2005) Epidemiology of gastric cancer in Japan. Postgrad Med J 81:419-424
2. Parkin DM, Bray F, Ferlay J, Pisani P (2005) Global cancer statistics, 2002. CA Cancer J Clin 55:74-108
3. Ohtsu A, Shimada Y, Shirao K, Boku N, Hyodo I, Saito H, Yamamichi N, Miyata Y, Ikeda N, Yamamoto S, Fukuda H, Yoshida S (2003) Randomized phase III trial of fluorouracil alone versus fluorouracil plus cisplatin versus uracil and tegafur plus mitomycin in patients with unresectable, advanced gastric cancer: The Japan Clinical Oncology Group Study (JCOG9205). J Clin Oncol 21:54-59
4. Boku N, Yamamoto S, Shirao K, Doi T, Sawaki A, Koizumi W, Saito H, Yamaguchi K, Kimura A, Ohtsu A (2007) Randomized phase III study of 5-fluorouracil (5-FU) alone versus combination of irinotecan and cisplatin (CP) versus S-1 alone in advanced gastric cancer (JCOG9912). Proc Am Soc Clin Oncol 25: Abstract LBA4513
5. Shirasaka T, Shimamato Y, Ohshimo H, Yamaguchi M, Kato T, Yonekura K, Fukushima M (1996) 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 7:548-557
6. Tatsumi K, Fukushima M, Shirasaka T, 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
7. Shirasaka T, Shimamoto Y, 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
8. Koizumi W, Narahara H, Hara T, Takagane A, Akiya T, Takagi M, Miyashita K, Nishizaki T, Kobayashi O, Takiyama W, Toh Y, Nagaie T, Takagi S, Yamamura Y, Yanaoka K, Orita H, Takeuchi M (2008) S-1 plus cisplatin versus S-1 alone for first-line treatment of advanced gastric cancer (SPIRITS trial) : a phase III trial. Lancet Oncol 9:215-221
9. Imamura H, Iishi H, Tsuburaya A, Hatake K, Imamoto H, Esaki T, Kato M, Furukawa H, Hamada C, Sakata Y (2008) randomized phase III study of irinotecan plus S-1 (IRIS) versus S-1 alone as first-line treatment for advanced gastric cancer (GC0301/TOP-002). Gastrointestinal Cancers Symposium: abstract 5
10. Sakata Y, Ohtsu A, Horikoshi N, Sugimachi K, Mitachi Y, Taguchi T (1998) 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 34:1715-1720
11. Koizumi W, Kurihara M, Nakano S, Hasegawa K (2000) 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 58:191-197
12. Japanese Gastric Cancer Association (1999) Japanese Classification of Gastric Carcinoma (In Japanese), 13th edn. Kanehara, Tokyo
13. Japanese Gastric Cancer Association (2001) Japanese classification of gastric carcinoma-2nd English edition-response assessment of chemotherapy and radiotherapy for gastric carcinoma: clinical criteria. Gastric Cancer 4:1-8
14. Kurihara M, Aiko T (2001) The new Japanese classification of gastric carcinoma: revised explanation of "response assessment of chemotherapy and radiotherapy for gastric carcinoma". Gastric Cancer 4:9-13
15. Cockcroft D, Gault H (1976) Prediction of clearance from serum creatinine. Nephron 16:31-41
16. Matsushima E, Yoshida K, Kitamura R, Yoshida K (1997) 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 Biomed Sci Appl 691:95-104
17. Ishido K, Koizumi W, Tanabe S, Higuchi K, Sasaki T, Katada C, Azuma M, Saigenji K, Futawatari N, Saegusa M (2008) A patient with stage IV type 4 advanced gastric cancer who had a complete pathological response to short-term treatment with S-1 alone. Anticancer Drugs 19:921-925
18. Ikeda M, Furukawa H, Imamura H, Shimizu J, Ishida H, Masutani S, Tatsuta M, Kawasaki T, Satomi T (2002) Pharmacokinetic study of S-1, a novel oral fluorouracil antitumor agent in animal model and in patients with impaired renal function. Cancer Chemother Pharmacol 50:25-32
19. Hirata K, Horikoshi N, Aiba K, Okazaki M, Denno R, Sasaki K, Nakano Y, Ishizuka H, Yamada Y, Uno S, Taguchi T, Shirasaka T (1999) Pharmacokinetic study of S-1, a novel oral fluorouracil antitumor drug. Clin Cancer Res 5:2000-2005
20. Therasse P, Arbuck S, Eisenhauer E, Wanders J, Kaplan R, Rubinstein L, Verweij J, Van Glabbeke M, Vo AT, Christian M, Gwyther S (2000) New guidelines to evaluate the response to treatment in solid tumors. J Natl Cancer Inst 92:205-216 (Pubitemid 30099779)
21. Ohtsu A, Boku N, Yoshida S, Miyata Y, Shirao K, Shimada Y, Kurihara M (1998) Response of the primary lesion in gastric cancer o chemotherapeutic trials. Int J Clin Oncol 3:3-6
22. Koizumi W, Kurihara M, Tanabe S, Kondo I, Yamazaki I, Nonaka M, Shimamura Y, Saigenji K (1999) Advantages of Japanese response criteria for estimating the survival of patients with primary gastric cancer. Gastric Cancer 2:14-19
23. Lee JL, Kang YK, Kang HJ, Lee KH, Zang DY, Ryoo BY, Kim JG, Park SR, Kang WK, Shin DB, Ryu MH, Chang HM, Kim TW, Baek JH, Min YJ (2008) A randomised multicentre phase II trial of capecitabine vs S-1 as first-line treatment in elderly patients with metastatic or recurrent unresectable gastric cancer. Br J Cancer 99:584-590
24. Graziano F, Santini D, Testa E, Catalano V, Beretta GD, Mosconi S, Tonini G, Lai V, Labianca R, Cascinu S (2003) A phase II study of weekly cisplatin, 6S-stereoisomer leucovorin and fluorouracil as first-line chemotherapy for elderly patients with advanced gastric cancer. Br J Cancer 89:1428-1432
25. Santini D, Graziano F, Catalano V, Di Seri M, Testa E, Baldelli AM, Giordani P, La Cesa A, Spalletta B, Vincenzi B, Russo A, Caraglia M, Virzi V, Cascinu S, Tonini G (2006) Weekly oxaliplatin, 5-fluorouracil and folinic acid (OXALF) as first-line chemotherapy for elderly patients with advanced gastric cancer: results of a phase II trial. BMC Cancer 6:125