Phase III randomized adjuvant study of tamoxifen alone versus sequential tamoxifen and anastrozole in Japanese postmenopausal women with hormone-responsive breast cancer: N-SAS BC03 study

Breast Cancer Research and Treatment

Volumn 121, Issue 2, 2010, Pages 379-387

  Aihara, Tomohiko ^a   Takatsuka, Yuichi ^b   Ohsumi, Shozo ^c   Aogi, Kenjiro ^c   Hozumi, Yasuo ^d   Imoto, Shigeru ^e   Mukai, Hirofumi ^f   Iwata, Hiroji ^g   Watanabe, Toru ^h   Shimizu, Chikako ⁱ   Nakagami, Kazuhiko ^j   Tamura, Motoshi ^k   Ito, Toshikazu ^l   Masuda, Norikazu ^m   Ogino, Nobuo ⁿ   Hisamatsu, Kazufumi ^o   Mitsuyama, Shoshu ^p   Abe, Hajime ^q   Tanaka, Shiro ^r   Yamaguchi, Takuhiro ^s   Ohashi, Yasuo ^t   more..

^a Aihara Hospital   (Japan)

^b KANSAI ROSAI HOSPITAL   (Japan)

^c NATIONAL HOSPITAL ORGANIZATION SHIKOKU CANCER CENTER   (Japan)

^d JICHI MEDICAL UNIVERSITY   (Japan)

^e KYORIN UNIVERSITY   (Japan)

^f NATIONAL CANCER CENTER HOSPITAL EAST   (Japan)

^g AICHI CANCER CENTER HOSPITAL   (Japan)

^h Hamamatsu Oncology Center   (Japan)

ⁱ NATIONAL CANCER CENTER HOSPITAL   (Japan)

^j SHIZUOKA GENERAL HOSPITAL   (Japan)

^k KKR Sapporo Medical Center   (Japan)

^l Department of Cardiology   (Japan)

^m OSAKA NATIONAL HOSPITAL   (Japan)

ⁿ Tondabayashi Hospital   (Japan)

^o HIROSHIMA CITY ASA HOSPITAL   (Japan)

^p KITAKYUSHU MUNICIPAL MEDICAL CENTER   (Japan)

^q SHIGA UNIVERSITY OF MEDICAL SCIENCE   (Japan)

^r KYOTO UNIVERSITY   (Japan)

^s UNIVERSITY OF TOKYO   (Japan)

^t UNIVERSITY OF TOKYO   (Japan)

more..

Author keywords

Adjuvant therapy; Anastrozole; Breast cancer; Ethnic difference; Hormonal therapy; Tamoxifen

Indexed keywords

ANASTROZOLE; ANTINEOPLASTIC AGENT; TAMOXIFEN;

ADULT; ALANINE AMINOTRANSFERASE BLOOD LEVEL; ANOREXIA; ARTHRALGIA; ARTICLE; ASPARTATE AMINOTRANSFERASE BLOOD LEVEL; BREAST CANCER; CANCER ADJUVANT THERAPY; CANCER RECURRENCE; CANCER SURVIVAL; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DISEASE FREE SURVIVAL; DRUG EFFICACY; DRUG INDUCED HEADACHE; DRUG SAFETY; ENDOMETRIUM CANCER; FATIGUE; FEMALE; FRACTURE; GENITAL BLEEDING; HEART DISEASE; HOT FLUSH; HUMAN; JAPANESE; LEUKOPENIA; MAJOR CLINICAL STUDY; MASTECTOMY; MOOD CHANGE; MULTICENTER STUDY; NAUSEA AND VOMITING; OPEN STUDY; PARTIAL MASTECTOMY; PHASE 3 CLINICAL TRIAL; POSTMENOPAUSE; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SIDE EFFECT; THROMBOEMBOLISM; VAGINA DISCHARGE;

ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; BREAST NEOPLASMS; CHEMOTHERAPY, ADJUVANT; DISEASE-FREE SURVIVAL; FEMALE; HUMANS; JAPAN; KAPLAN-MEIERS ESTIMATE; NEOPLASM STAGING; NITRILES; POSTMENOPAUSE; TAMOXIFEN; TRIAZOLES;

EID: 77953023911     PISSN: 01676806     EISSN: 15737217     Source Type: Journal    
DOI: 10.1007/s10549-010-0888-x     Document Type: Article

References (20)

1. The editorial board of the cancer statistics in Japan (2008) Cancer statistics in Japan, 2008. Foundation for promotion of cancer research, Tokyo, p 35
2. Berry DA, Cronin KA, Plevritis SK et al (2005) Effect of screening and adjuvant therapy on mortality from breast cancer. N Engl J Med 353:1784-1792
3. Fisher B, Costantino JP, Wickerham DL et al (1998) Tamoxifen for prevention of breast cancer: report of the National Surgical Adjuvant Breast and Bowel Project P-1 Study. J Natl Cancer Inst 90:1371-1388
4. Early Breast Cancer Trialists' Collaborative Group (2005) Effects of chemotherapy and hormonal therapy for early breast cancer on recurrence and 15-year survival: an overview of the randomised trials. Lancet 365:1687-1717
5. The Arimidex, Tamoxifen, Alone or in Combination (ATAC) Trialists' Group (2008) Effect of anastrozole and tamoxifen as adjuvant treatment for early-stage breast cancer: 100-month analysis of the ATAC trial. Lancet Oncol 9:45-53
6. Coates AS, Keshaviah A, Thürlimann B et al (2007) Five years of letrozole compared with tamoxifen as initial adjuvant therapy for postmenopausal women with endocrine-responsive early breast cancer: update of study BIG 1-98. J Clin Oncol 25:486-492
7. Boccardo F, Rubagotti A, Puntoni M et al (2005) Switching to anastrozole versus continued tamoxifen treatment of early breast cancer: preliminary results of the Italian Tamoxifen Anastrozole Trial. J Clin Oncol 23:5138-5147
8. Jakesz R, Jonat W, Gnant M et al (2005) Switching of postmenopausal women with endocrine-responsive early breast cancer to anastrozole after 2 years' adjuvant tamoxifen: combined results of ABCSG trial 8 and ARNO 95 trial. Lancet 366:455-462
9. Coombes RC, Hall E, Gibson LJ et al (2004) A randomized trial of exemestane after two to three years of tamoxifen therapy in postmenopausal women with primary breast cancer. N Engl J Med 350:1081-1092 (Pubitemid 38298988)
10. Goetz MP, Rae JM, Suman VJ et al (2005) Pharmacogenetics of tamoxifen biotransformation is associated with clinical outcomes of efficacy and hot flashes. J Clin Oncol 23:9312-9318
11. Broly F, Gaedigk A, Heim M et al (1991) Debrisoquine/sparteine hydroxylation genotype and phenotype: analysis of common mutations and alleles of CYP2D6 in a European population. DNA Cell Biol 10:545-558
12. Yokota H, Tamura S, Furuya H et al (1993) Evidence for a new variant CYP2D6 allele CYP2D6 J in a Japanese population associated with lower in vivo rates of sparteine metabolism. Pharmacogenetics 3:256-263
13. Ma CX, Adjei AA, Salavaggione OE et al (2005) Human aromatase: gene resequencing and functional, genomics. Cancer Res 65:11071-11082
14. Moy B, Tu D, Pater JL et al (2006) Clinical outcomes of ethnic minority women in MA. 17: a trial of letrozole after 5 years of tamoxifen in postmenopausal women with early stage breast cancer. Ann Oncol 17:1637-1643
15. Sobin LH, Fleming ID (1997) TNM classification of malignant tumors, 5th edn. Wiley, New York
16. Lakatos E, Lan KK (1992) A comparison of sample size methods for the logrank statistic. Stat Med 11:179-191
17. Boccardo F, Rubagotti A, Guglielmini P et al (2006) Switching to anastrozole versus continued tamoxifen treatment of early breast cancer. Updated results of the Italian tamoxifen anastrozole (ITA) trial. Ann Oncol 17(Suppl 7):vii 10-vii 14
18. Coombes RC, Kilburn LS, Snowdon CF et al (2007) Survival and safety of exemestane versus tamoxifen after 2-3 years' tamoxifen treatment (Intergroup Exemestane Study). Lancet 369:559-570
19. Barrett-Connor E, Siris ES, Wehren LE et al (2005) Osteoporosis and fracture risk in women of different ethnic groups. J Bone Miner Res 20:185-194
20. White RH, Zhou H, Romano PS (1998) Incidence of idiopathic deep venous thrombosis and secondary thromboembolism among ethnic groups in California. Ann. Intern. Med 128:737-740