Evaluation of the safety and tolerability of oral TAS-108 in postmenopausal patients with metastatic breast cancer

Annals of Oncology

Volumn 20, Issue 5, 2009, Pages 868-873

  Saeki, T ^a,c   Noguchi, S ^b   Aogi, K ^c   Inaji, H ^d   Tabei, T ^e   Ikeda, T ^f  

^a SAITAMA MEDICAL UNIVERSITY INTERNATIONAL MEDICAL CENTER   (Japan)

^b OSAKA UNIVERSITY GRADUATE SCHOOL OF MEDICINE   (Japan)

^c NATIONAL HOSPITAL ORGANIZATION SHIKOKU CANCER CENTER   (Japan)

^d OSAKA MEDICAL CENTER FOR CANCER AND CARDIOVASCULAR DISEASES   (Japan)

^e SAITAMA CANCER CENTER   (Japan)

^f TEIKYO UNIVERSITY SCHOOL OF MEDICINE   (Japan)

Author keywords

Breast cancer; Pharmacokinetics; Phase I; Postmenopausal; SERM; TAS 108

Indexed keywords

21 (4 DIETHYLAMINOMETHYL 2 METHOXYPHENOXY) 7ALPHA METHYL 19 NORPREGNA 1,3,5(10) TRIEN 3 OL; ANASTROZOLE; DRUG METABOLITE; MEDROXYPROGESTERONE ACETATE; TAMOXIFEN;

ADJUVANT THERAPY; ADULT; AGED; ALANINE AMINOTRANSFERASE BLOOD LEVEL; ARTHRALGIA; ARTICLE; ASPARTATE AMINOTRANSFERASE BLOOD LEVEL; BONE METABOLISM; BREAST CANCER; CANCER HORMONE THERAPY; CHOLESTEROL BLOOD LEVEL; CLINICAL ARTICLE; CLINICAL TRIAL; CONTROLLED STUDY; DRUG BLOOD LEVEL; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; ENDOMETRIUM HYPERPLASIA; FEMALE; HEADACHE; HORMONE DETERMINATION; HOT FLUSH; HUMAN; HYPERHIDROSIS; JAPANESE; LIMB PAIN; METASTASIS; MUSCULOSKELETAL STIFFNESS; NAUSEA; PHASE 1 CLINICAL TRIAL; POSTMENOPAUSE; PRIORITY JOURNAL; SIDE EFFECT; TREATMENT DURATION;

EID: 65549145127     PISSN: 09237534     EISSN: 15698041     Source Type: Journal    
DOI: 10.1093/annonc/mdn714     Document Type: Article

References (20)

1. Osborne CK. Tamoxifen in the treatment of breast cancer. New Engl J Med 1998; 339: 1609-1618.
2. Early Breast Cancer Trialists' Collaborative Group. Tamoxifen for early breast cancer: An overview of the randomised trials. Lancet 1998; 351: 1451-1467.
3. Clemons M, Danson S, Howell A. Tamoxifen ('Nolvadex'): A review. Cancer Treat Rev 2002; 28: 165-180.
4. Jaiyesimi IA, Buzdar AU, Decker DA et al. Use of tamoxifen for breast cancer: Twenty-eight years later. J Clin Oncol 1995; 13: 513-529.
5. Goetz MP, Knox SK, Suman VJ et al. The impact of cytochrome P450 2D6 metabolism in women receiving adjuvant tamoxifen. Breast Cancer Res Treat 2007; 101: 113-121.
6. Lim HS, Lee HJ, Lee KS et al. Clinical Implications of CYP2D6 genotypes predictive of tamoxifen pharmacokinetics in metastatic breast cancer. J Clin Oncol 2007; 25: 3837-3845.
7. Yamamoto Y, Shibata J, Yonekura K et al. TAS-108, a novel oral steroidal antiestrogenic agent, is a pure antagonist on estrogen receptor a and a partial agonist on estrogen receptor b with low uterotrophic effect. Clin Cancer Res 2005; 11: 315-322.
8. Yamamoto Y, Wada O, Takada I et al. Both N- and C-terminal transactivation functions of DNA-bound ERa are blocked by a novel synthetic estrogen ligand. Biochem Biophys Res Commun 2003; 312: 656-662.
9. Toko T, Shibata J, Sato K et al. Antiestrogenic/estrogenic activities of TAS-108 (SR16234), a new steroidal selective estrogen receptor modulator. Breast Cancer Res Treat 1999; 57: 52.
10. Yamaya H, Yoshida K, Kuritani J et al. Safety, tolerability, and pharmacokinetics of TAS-108 in normal healthy post-menopausal female subjects: A phase I study on single oral dose. J Clin Pharm Ther 2005; 30: 459-470.
11. Blakely LJ, Buzdar A, Chang HY et al. A phase I and pharmacokinetic study of TAS-108 in postmenopausal female patients with locally advanced, locally recurrent inoperable, or progressive metastatic breast cancer. Clin Cancer Res 2004; 10: 5425-5431.
12. The Japanese Breast Cancer Society. General Rules for Clinical and Pathological Recording of Breast Cancer, Edition 14. Tokyo: Kanehara Public Co., 2000.
13. Ellmen J, Hakulinen P, Partanen A et al. Estrogenic effects of toremifene and tamoxifen in postmenopausal breast cancer patients. Breast Cancer Res Treat 2003; 82: 103-111.
14. Fisher B, Costantino JP, Wickerham DL et al. Tamoxifen for the prevention of breast cancer: Current status of the National Surgical Adjuvant Breast and Bowel Project P-1 study. J Natl Cancer Inst 2005; 97: 1652-1662.
15. Fisher B, Dignam J, Bryant J et al. Five versus more than five years of tamoxifen therapy for breast cancer patients with negative lymph nodes and estrogen receptor-positive tumors. J Natl Cancer Inst 1996; 88: 1529-1542.
16. Brueggemeier RW, Hackett JC, Diaz-Cruz ES. Aromatase inhibitors in the treatment of breast cancer. Endocr Rev 2005; 26: 331-345.
17. Smith IE, Dowsett M. Aromatase inhibitors in breast cancer. N Engl J Med 2003; 348: 2431-2442.
18. Mouridsen HT, Robert NJ. The role of aromatase inhibitors as adjuvant therapy for early breast cancer in postmenopausal women. Eur J Cancer 2005; 41: 1678-1689.
19. Crew KD, Greenlee H, Capodice J et al. Prevalence of joint symptoms in postmenopausal women taking aromatase inhibitors for early-stage breast cancer. J Clin Oncol 2007; 25: 3877-3883.
20. Burstein HJ. Aromatase inhibitor-associated arthralgia syndrome. Breast 2007; 16: 223-234.