Phase i study of TAS-102 treatment in Japanese patients with advanced solid tumours

British Journal of Cancer

Volumn 107, Issue 3, 2012, Pages 429-434

  Doi, T ^a   Ohtsu, A ^a   Yoshino, T ^a   Boku, N ^b   Onozawa, Y ^b   Fukutomi, A ^b   Hironaka, S ^b   Koizumi, W ^c   Sasaki, T ^c  

^a NATIONAL CANCER CENTER HOSPITAL EAST   (Japan)

^b SHIZUOKA CANCER CENTER   (Japan)

^c KITASATO UNIVERSITY HOSPITAL   (Japan)

Author keywords

pharmacokinetics; phase I study; TAS 102; TFT; TPI

Indexed keywords

ALPHA, ALPHA, ALPHA TRIFLUOROTHYMIDINE; ANTINEOPLASTIC AGENT; FLUOROURACIL; IRINOTECAN; OXALIPLATIN; TAS 102; THYMIDINE PHOSPHORYLASE INHIBITOR; UNCLASSIFIED DRUG;

ADULT; ADVANCED SOLID TUMOR; AGED; ANOREXIA; AREA UNDER THE CURVE; ARTICLE; CLINICAL ARTICLE; COLORECTAL CANCER; CONTROLLED STUDY; DISEASE CONTROL; DOSE LIMITING TOXICITY; DOSE RESPONSE; DRUG BLOOD LEVEL; DRUG CLEARANCE; DRUG ELIMINATION; DRUG HALF LIFE; DRUG SAFETY; DRUG TOLERANCE; DRUG TOXICITY; DRUG URINE LEVEL; ERYTHROCYTE COUNT; FEMALE; HEMATOCRIT; HEMOGLOBIN BLOOD LEVEL; HUMAN; JAPANESE; LEUKOPENIA; LYMPHOCYTOPENIA; MALE; MAXIMUM PLASMA CONCENTRATION; MAXIMUM TOLERATED DOSE; NAUSEA; NEUTROPENIA; NEUTROPHIL COUNT; PHASE 1 CLINICAL TRIAL; PHASE 1 CLINICAL TRIAL (TOPIC); PNEUMONIA; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; SIDE EFFECT; SOLID TUMOR; SURVIVAL TIME; THROMBOCYTOPENIA; TIME TO MAXIMUM PLASMA CONCENTRATION; TREATMENT DURATION;

ADULT; AGED; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; ASIAN CONTINENTAL ANCESTRY GROUP; DISEASE-FREE SURVIVAL; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG ADMINISTRATION SCHEDULE; DRUG COMBINATIONS; FEMALE; HUMANS; MALE; MAXIMUM TOLERATED DOSE; MIDDLE AGED; NEOPLASMS; THYMIDINE PHOSPHORYLASE; TRIFLURIDINE; URACIL;

EID: 84864350983     PISSN: 00070920     EISSN: 15321827     Source Type: Journal    
DOI: 10.1038/bjc.2012.274     Document Type: Article

References (17)

1. Ansfield FJ, Ramirez G (1971) Phase I and II studies of 2'-deoxy-5-(trifluoromethyl)-uridine (NSC-75520). Cancer Chemother Rep 55: 205-208
2. Emura T, Nakagawa F, Fujioka A, Ohshimo H, Yokogawa T, Okabe H, Kitazato K (2004a) An optimal dosing schedule for a novel combination antimetabolite, TAS-102, based on its intracellular metabolism and its incorporation into DNA. Int J Mol Med 13: 249-255
3. Emura T, Suzuki N, Yamaguchi M, Ohshimo H, Fukushima M (2004b) A novel combination antimetabolite, TAS-102, exhibits antitumor activity in FU-resistant human cancer cells through a mechanism involving FTD incorporation in DNA. Int J Oncol 25: 571-578
4. Fujiwara Y, Heidelberger C (1970a) Fluorinated pyrimidines. XXXVII. The incorporation of 5-trifluoromethyl-2'-deoxyuridine into the deoxyribonucleic acid vaccinia virus. Mol Pharmacol 6: 281-291
5. Fujiwara Y, Oki T, Heidelberger C (1970b) Fluorinated pyrimidines. XXXVII. Effect of 5-trifluoromethyl-2'-deoxyuridine on the synthesis of deoxyribonucleic acid of mammalian cells in culture. Mol Pharmacol 6: 273-280
6. Fukushima M, Suzuki N, Emura T, Yano S, Kazuno H, Tada Y, Yamada Y, Asao T (2000) Structure and activity of specific inhibitors of thymidine phosphorylase to potentiate the function of antitumor 2'-deoxyribonucleosides. Biochem Pharmacol 59: 1227-1236
7. Green MC, Pusztai L, Theriault LR, Adinin RB, Hofweber M, Fukushima M, Mita A, Bindra N, Hortobagyi GN (2006) Phase I study to determine the safety of oral administration of TAS-102 on a twice daily (BID) schedule for five days a week (wk) followed by two days rest for two wks, every (Q) four wks in patients (pts) with metastatic breast cancer (MBC). J Clin Oncol. ASCO Annual Meeting Proceedings Part I 24: 10576
8. Hecht JR, Patnai A, Berlin J, Venook A, Malik I, Tchekmedyian S, Navale L, Amado RG, Meropol NJ (2007) Panitumumab monotherapy in patients with previously treated metastatic colorectal cancer. Cancer 110: 980-988
9. Heidelberger C, Dexter DL, Wolberg WH (1970) Clinical pharmacology of 5-trifluoromethyl-2'-deoxyuridine (F3Tdr). Proc Am Assoc Cancer Res 11: 35
10. Hong DS, Abbruzzese JL, Bogaard K, Lassere Y, Fukushima M, Mita A, Kuwata K, Hoff PM (2006) Phase I study to determine the safety and pharmacokinetics of oral administration of TAS-102 in patients with solid tumors. Cancer 107: 1383-1390
11. Kuboki Y, Yoshino T, Yamazaki K, Nishina T, Komatsu Y, Baba H, Tsuji A, Yamaguchi K, Muro K, Ohtsu A (2011) A multicenter, randomized, double-blind, phase II study of TAS-102 plus best supportive care (BSC) versus placebo plus BSC in patients with chemotherapy-refractory metastatic colorectal cancer. EJC 47: 392
12. Markley JC, Chirakul P, Sologub D, Sigurdsson ST (2011) Incorporation of 20-Deoxy-5-(trifluoromethyl)uridine and 5-Cyano-20-deoxyuridine into DNA. Bioorg Med Chem Lett 11: 2453-2455
13. Overman MJ, Kopetz S, Varadhachary G, Fukushima M, Kuwata K, Mita A, Wolff RA, Hoff P, Xiong H, Abbruzzese JL (2008a) Phase I clinical study of three times a day oral administration of TAS-102 in patients with solid tumors. Cancer Invest 26: 794-799
14. Overman MJ, Varadhachary G, Kopetz S, Thomas MB, Fukushima M, Kuwata K, Mita A, Wolff RA, Hoff PM, Xiong H, Abbruzzese JL (2008b) Phase 1 study of TAS-102 administered once daily on a five-day-per-week schedule in patients with solid tumors. Invest New Drugs 26: 445-454
15. Saltz LB, Meropol NJ, Loehrer Sr PJ, Needle MN, Kopit J, Mayer RJ (2004) Phase II trial of cetuximab in patients with refractory colorectal cancer that expresses the epidermal growth factor receptor. J Clin Oncol 22: 1201-1208
16. Suzuki N, Emura T, Fukushima M (2011) Mode of action of trifluorothymidine (TFT) against DNA replication and repair enzymes. Int J Oncol 39: 263-270
17. Temmink OH, Emura T, de Bruin M, Fukushima M, Peters GJ (2007) Therapeutic potential of the dual-targeted TAS-102 formulation in the treatment of gastrointestinal malignancies. Cancer Sci 98: 779-789